Saturday, 6 October 2012

Timoptol 0.25% and 0.5% w / v Eye Drops Solution





Timoptol 0.25% w/v Eye Drops Solution



Timoptol 0.5% w/v Eye Drops Solution



timolol (as maleate)




Read all of this leaflet carefully before you start using this medicine.



  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:



  • 1. What Timoptol is and what it is used for

  • 2. Before you use Timoptol

  • 3. How to use Timoptol

  • 4. Possible side effects

  • 5. How to store Timoptol

  • 6. Further information





What Timoptol Is And What It Is Used For



Timoptol contains a substance called timolol which belongs to a group of medicines called beta-blockers. Timolol lowers the pressure in your eye(s). It is used to treat glaucoma, when the pressure in the eye is raised.





Before You Use Timoptol




Do not use Timoptol if:



  • you are allergic (hypersensitive) to timolol maleate or any of the other ingredients of Timoptol (see section 6 for Further Information)

  • you have respiratory disease, such as asthma, a history of asthma or chronic obstructive lung disease

  • you have heart problems

    • slow or irregular heart beat

    • heart failure

    • “cardiogenic shock” – a serious heart condition caused by very low blood pressure, which may result in the following symptoms: dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness, loss of consciousness.


If you are not sure whether you should use Timoptol talk to your doctor or pharmacist.





Take special care with Timoptol



Tell your doctor about any medical problems you have now or have had in the past. In particular tell them about any of the following, before you use Timoptol.



  • asthma and other lung problems

  • heart or circulation problems

  • low blood pressure

  • allergies to any medicines

  • you wear soft contact lenses. Your eye drops contain a preservative which can be deposited on soft contact lenses. It is imoprtant that your lenses are removed before using your eye drops and not put back into your eyes for 15 minutes.

If your eye becomes irritated or any new eye problems come on, talk to your doctor straight away. Eye problems could include redness of the eye or swelling of the eyelids (see Section 4: Possible Side Effects).



If you suspect that Timoptol is causing an allergic reaction or hypersensitivity (for example, skin rash, or redness and itching of the eye), stop using Timoptol and contact your doctor immediately.



Tell you doctor if:



  • you get an eye infection

  • you injure your eye or have an operation on it

  • your eye problems get worse or you get any new symptoms.




Use in children



Timoptol is not recommended for use in children and adolescents.





Using other medicines



Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including other eye drops or medicines obtained without a prescription. It is important to tell your doctor before using Timoptol if you are taking one or more of the following medicines:



  • a calcium antagonist, such as nifedipine, verapamil or diltiazem, often used to treat high blood pressure, angina, an abnormal heartbeat or Raynaud’s syndrome

  • digoxin, a medicine used to relieve heart failure or treat abnormal heartbeat

  • medicines known as catecholamine-depleting agents, such as rauwolfia alkaloids or reserpine, used for high blood pressure

  • medicines called pressor amines, such as adrenaline used to treat severe allergic reaction

  • quinidine, a medicine often used to treat abnormal heartbeat

  • clonidine, a medicine used to treat high blood pressure

  • other beta-blockers taken by mouth or used as eye drops, because they belong to the same group of medicines as Timoptol and could have an additive effect.




Pregnancy and breast-feeding



Ask your doctor for advice before taking any medicine.



Use in pregnancy



You should not use Timoptol during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.



Use in breast-feeding



You should not use Timoptol if you are breast-feeding. Tell your doctor if you are breast-feeding or intend to breast-feed.





Driving and using machines



There are possible side effects associated with Timoptol, such as dizziness and changes in your eyesight, which may affect your ability to drive and/or operate machinery. Do not drive and/or operate machinery until you feel well and your vision is clear.






How To Use Timoptol



Always use Timoptol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The doctor will decide how many drops you should take each day and how long you should use them.



The usual dose is one drop in the affected eye(s) twice each day:



  • one in the morning

  • one in the evening.

Do not change your usual dose without talking to your doctor.



Do not allow the tip of the container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infection leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.




Instructions for use.



It is recommended that you wash your hands before putting in your eye drops.



  • 1. Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle

  • 2. Tear off the safety strip to break the seal.

  • 3. To open the bottle, unscrew the cap by turning as indicated by the arrows on top of the cap. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.

  • 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.

  • 5. Invert the bottle, and press lightly with your thumb or first finger over the ‘Finger-Push Area’ as shown until a single drop is dispensed into your eye, as directed by your doctor.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.



Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.



  • 6. If drop dispensing is difficult after opening for the first time, replace the cap on the bottle and tighten (do not overtighten) and then remove by turning the cap in the opposite direction as indicated by the arrows on top of the cap.


  • 7. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.


  • 8. Replace the cap by turning until it is firmly touching the bottle. The arrow on the left side of the cap must be aligned with the arrow on the left side of the bottle label for proper closure. Do not overtighten or you may damage the bottle and cap.


  • 9. The dispenser tip is designed to provide a single drop; therefore do NOT enlarge the hole of the dispenser tip.


  • 10. After you have used all doses there will be some Timoptol left in the bottle. You should not be concerned since an extra amount of Timoptol has been added and you will get the full amount of Timoptol that your doctor has prescribed. Do not attempt to remove the excess medicine from the bottle.




If you use more Timoptol than you should



If you put too many drops in your eye or swallow any of the drops, you may:



  • have a headache

  • feel dizzy or light-headed

  • have difficulty breathing

  • feel that your heart rate has slowed down.

If this happens, contact your doctor immediately.





If you forget to use Timoptol



It is important to take Timoptol as prescribed by your doctor.



  • If you miss a dose, use the drops as soon as possible.

  • If it is almost time for the next dose, skip the missed dose and take the next dose at the usual time.

  • Do not take a double dose to make up for the forgotten dose.




If you stop using Timoptol



If you want to stop using this medicine talk to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.






Possible Side Effects



Like all medicines Timoptol may cause side effects, although not everybody gets them. If they do occur, you may need medical attention. In some patients these may include:




Allergic reactions



  • allergic skin rash and hives

  • severe allergic reaction which causes difficulty in breathing or dizziness.




Eyes an ears



  • burning and stinging

  • dry eyes

  • irritation and redness of the eye or eyelid

  • sensitivity to light

  • discharge from the eye

  • visual changes such as double vision

  • decreased sensation of your eye surface

  • pain in your eye

  • drooping eyelid

  • ringing in your ears.




Heart and circulation



  • chest pain

  • heart attack

  • fainting

  • palpitations

  • an irregular heartbeat

  • a slowing of your heart rate

  • low blood pressure

  • interference with the blood supply to the brain which may lead to a stroke

  • too much fluid, mainly water, accumulating in the body

  • limping because there is a reduced blood supply to your legs

  • swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels.




Chest



  • wheezing

  • shortness of breath

  • difficulty breathing

  • cough.




Stomach and gut



  • nausea

  • diarrhoea

  • indigestion

  • dry mouth.




Sexual



  • decreased sex drive

  • in men a condition which effects your penis called Peyronie’s disease. The signs may be abnormal curve, pain or hardening of the tissue of your penis




Skin and hair



  • hair loss

  • a skin disease called psoriasis, where areas of skin such as knees and elbows are covered in scales

  • worsening of psoriasis.




Nervous system



  • dizziness

  • depression

  • unable to sleep

  • nightmares

  • memory loss

  • increase in signs and symptoms of myasthenia gravis

  • tingling sensation.




General



  • headache

  • tiredness

  • weakness

  • a condition called lupus (systemic lupus erythematosus).



Ask your doctor or pharmacist for more information about the side effects. Both have a more complete list of side effects.



If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





How To Store Timoptol



Keep your eye drops out of the reach and sight of children.



  • Do not store your eye drops above 25°C.

  • Store the bottle in the outer carton.

  • You can use Timoptol for 28 days after first opening the bottle.

Do not use Timoptol after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.



Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.





Further Information




What Timoptol contains



The active substance is timolol maleate.



Timoptol is available in two strengths:



  • 0.25% w/v solution of timolol maleate

  • 0.5% w/v solution of timolol maleate.

The other ingredients are:



  • benzalkonium chloride as preservative

  • disodium phosphate dodecahydrate E339

  • sodium dihydrogen phosphate dihydrate E339

  • sodium hydroxide

  • water for injections.




What Timoptol looks like and contents of the pack



Timoptol is a clear colourless to light yellow sterile eye drops solution and is available in bottles containing 5 ml of sterile eye drops solution.





Marketing Authorisation Holder and Manufacturer



Marketing Authorisation Holder UK and Malta




Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

United Kingdom



Marketing Authorisation Holder Ireland




Merck Sharp & Dohme Ireland (Human Health) Ltd

Pelham House

South County Business Park

Leopardstown

Dublin 18

Ireland



Manufacturer




Laboratories Merck Sharp & Dohme – Chibret (Mirabel)

Route de Marsat

RIOM 63963Clermont –Ferrand

Cedex 9

France




This leaflet was last approved in June 2008.



This leaflet gives the most important patient information about Timoptol. If you have any questions after you have read it, ask your doctor or pharmacist who will give you further information.



Further information about glaucoma is available from:




International Glaucoma Association (IGA)

15A Highpoint Business Village

Henwood

Ashford

Kent

TN24 8DH

Tel:01233 648170

E-mail:info@iga.org.uk



Registered Charity number 274681.



(The IGA is an independent charity organisation which helps glaucoma patients and their relatives, and is not associated with Merck Sharp & Dohme Limited.)



Alternatively, if you or someone you know has problems with their vision, and you require further advice or information, please phone the Royal National Institute for the Blind (RNIB) Helpline on 0845 776 9999, Monday to Friday 9am to 5 pm, calls charged at local rates.



(The RNIB is an independent UK charity and is not associated with Merck Sharp & Dohme Limited).



denotes registered trademark of




Merck & Co., Inc.

Whitehouse Station

NJ

USA



© Merck Sharp & Dohme Limited 2008. All rights reserved.




PIL.TOTOS.07.UK.2766 F.T. 120908






Thursday, 4 October 2012

KOGENATE Bayer 250 IU Powder and solvent for solution for injection (Medimop)





1. Name Of The Medicinal Product



KOGENATE Bayer 250 IU powder and solvent for solution for injection.


2. Qualitative And Quantitative Composition



2.1 General description



Each vial contains nominally 250 IU human coagulation factor VIII (octocog alfa).



Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.



2.2 Qualitative and quantitative composition



One ml of KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 ml) of human coagulation factor VIII (octocog alfa) after reconstitution.



The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).



The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.



Solvent: water for injections.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Powder and solvent for solution for injection.



Powder: dry white to slightly yellow powder or cake.



Solvent: water for injection, a clear, colourless solution.



The reconstituted medicinal product is a clear and colourless solution.



4. Clinical Particulars



4.1 Therapeutic Indications



Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).



This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.



4.2 Posology And Method Of Administration



Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.



Posology



The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma). One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma. The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity. The required dose is determined using the following formulae:








I. Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5


 


II. Expected factor VIII rise (% of normal) =




2 × administered IU



body weight (kg)



On demand treatment



The dose, frequency and duration of the substitution therapy must be individualised according to the patient's needs (weight, severity of disorder of the haemostatic function, the site and extent of the bleeding, the presence of inhibitors, and the factor VIII level desired).



The following table provides a guide for factor VIII minimum blood levels. In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period:






















Degree of haemorrhage/ Type of surgical procedure




Factor VIII level required (%) (IU/dl)




Frequency of doses (hours)/ Duration of therapy (days)




Haemorrhage



Early haemarthrosis, muscle bleed or oral bleed




 



20 - 40




 



Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.




More extensive haemarthrosis, muscle bleed or haematoma




30 - 60




Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.




Life threatening bleeds such as intracranial bleed, throat bleed, severe abdominal bleed




60 - 100




Repeat infusion every 8 to 24 hours until threat is resolved




Surgery



Minor



including tooth extraction




 



30 - 60




 



Every 24 hours, at least 1 day, until healing is achieved.




Major




80 - 100



(pre- and postoperative)




a) By bolus infusions



Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60%



b) By continuous infusion



Raise factor VIII activity pre-surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/Kg/h) adjusting according to patient's daily clearance and desired factor VIII levels for at least 7 days.



The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case. Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.



During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.



Continuous Infusion



It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative). In this study heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions. For the calculation of the initial infusion rate, clearance can be obtained by performing a pre-surgery decay curve, or by starting from an average population value (3.0-3.5 ml/h/kg) and then adjust accordingly.



Infusion rate (in IU/kg/h) = Clearance (in ml/h/kg) × desired factor VIII level (in IU/ml)



For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir. KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials. This should be considered for a continuous infusion administration.



Prophylaxis



For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of KOGENATE Bayer per kg body weight at intervals of 2 to 3 days.



In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.



Paediatric population



Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.



Patients with inhibitors



Patients should be monitored for the development of factor VIII inhibitors. If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present. If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer. However, in the presence of an inhibitor the doses required are variable and must be adjusted according to clinical response and monitoring of plasma factor VIII activity. In patients with inhibitor titres above 10 BU or with high anamnestic response, the use of (activated) prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) preparations has to be considered. These therapies should be directed by physicians with experience in the care of patients with haemophilia.



Method of administration



For intravenous use.



KOGENATE Bayer should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).



Continuous infusion



KOGENATE Bayer can be infused by continuous infusion. The infusion rate should be calculated based on the clearance and the desired FVIII level.



Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%. For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).



Example for calculation of infusion rate for continuous infusion after initial bolus injection







































 


Desired plasma FVIII level




Infusion rate



IU/h/kg




Infusion rate for 75 kg patient



ml/h


  


Clearance: 3 ml/h/kg



 

 


Concentrations of rFVIII solution


  

 

 

 


100 IU/ml




200 IU/ml




400 IU/ml



 


100 % (1 IU/ml)




3.0




2.25




1.125




0.56



 


60 % (0.6 IU/ml)




1.8




1.35




0.68




0.34



 


40 % (0.4 IU/ml)




1.2




0.9




0.45




0.225



Higher infusion rates may be required in conditions with accelerated clearance during major bleedings or extensive tissue damage during surgical interventions.



After the initial 24 hours of continuous infusion, the clearance should be recalculated every day using the steady state equation with the measured FVIII level and the rate of infusion using the following equation:



clearance = infusion rate/actual FVIII level.



During continuous infusion, infusion bags should be changed every 24 hours.



For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.



4.3 Contraindications



- Known hypersensitivity to the active substance or to any of the excipients.



- Known allergic reactions to mouse or hamster protein.



4.4 Special Warnings And Precautions For Use



Hypersensitivity reactions



As with any intravenous protein product, allergic type hypersensitivity reactions are possible.



Patients should be made aware that the potential occurrence of chest tightness, dizziness, mild hypotension and nausea during infusion can constitute an early warning for hypersensitivity and anaphylactic reactions. Symptomatic treatment and therapy for hypersensitivity should be instituted as appropriate. If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately and patient should contact their physician. In case of shock, the current medical standards for shock treatment should be observed.



Antibodies (inhibitors)



The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Modified Bethesda Units (BU) per ml of plasma. The risk of developing inhibitors is correlated to the exposure to anti-haemophilic factor VIII and to genetic factors among others, this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days.



Cases of recurrence of inhibitors (low titre) have been observed after switching from one recombinant factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.



Patients treated with recombinant coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. (See also section 4.8)



Continuous infusion



In a clinical study about the use of continuous infusion in surgeries, heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.



Registration



In the interest of the patients, it is recommended that, whenever possible, every time that KOGENATE Bayer is administered to them, the name and the batch number of the product is registered.



Sodium content



This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No interactions of KOGENATE Bayer with other medicinal products are known.



4.6 Pregnancy And Lactation



Animal reproduction studies have not been conducted with KOGENATE Bayer.



Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer during pregnancy and breast-feeding is not available. Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated.



There are no fertility data available.



4.7 Effects On Ability To Drive And Use Machines



KOGENATE Bayer has no influence on the ability to drive or to use machines.



4.8 Undesirable Effects



The most commonly reported adverse drug reaction occurring is the formation of neutralising antibodies (prevalent in previously untreated or minimally treated patients).



The frequencies of adverse reactions reported with KOGENATE Bayer are summarized in the table below. Within each frequency group, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as common (




















MedDRA Standard



System Organ Class




Common




Uncommon




Rare




Blood and the Lymphatic System Disorders




Inhibitor Formation to FVIII



(Reported in PUP and minimally treated patients in clinical trials)*




Inhibitor Formation to FVIII



(Reported in PTP in clinical trials and Post Marketing Studies)*



 


General Disorders and Administration Site Conditions




Infusion site reaction



 


Infusion related febrile reaction (pyrexia)




Immune System Disorders




Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)



 


Systemic Hypersensitivity reactions (including one anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)



* see section below



Description of selected adverse reactions



The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the management of individuals with haemophilia A. In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs. Patients should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.



In clinical studies, KOGENATE Bayer has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days). Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with KOGENATE Bayer developed inhibitors: Overall, 9 out of 60 (15%) developed inhibitors, 6 out of 60 (10%) with a titre above 10 BU and 3 out of 60 (5%) with a titre below 10 BU. The median number of exposure days at the time of inhibitor detection in these patients was 9 days (range 3 - 18 days).



The median number of exposure days in the clinical studies was 114 (range: 4-478). Four of the five patients, who had not achieved 20 exposure days at the end of the study, ultimately achieved more than 20 exposure days in post-study follow-up and one of them developed a low titre inhibitor. The fifth patient was lost to follow-up.



In clinical studies with 73 previously treated patients (PTP, defined as having more than 100 exposure days), followed over four years, no de-novo inhibitors were observed.



In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors. In a subset defined as having less than 20 exposure days at study entry, less than 11% developed de-novo inhibitors.



During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see sections 4.3 and 4.4).



4.9 Overdose



No case of overdose with recombinant coagulation factor VIII has been reported.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.



The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions. When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.



Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII. The aPTT is prolonged in all haemophiliacs. The degree and duration of aPTT normalisation observed after administration of KOGENATE Bayer is similar to that achieved with plasma-derived factor VIII.



5.2 Pharmacokinetic Properties



The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2 % per IU/kg body weight for KOGENATE Bayer. This result is similar to the reported values for factor VIII derived from human plasma.



After administration of KOGENATE Bayer, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours. This is similar to that of plasma-derived factor VIII which has a mean terminal half-life of approx. 13 hours. Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h. Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).



5.3 Preclinical Safety Data



Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog).



Specific studies with repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with octocog alfa due to the immune response to heterologous proteins in all non-human mammalian species.



No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Powder



Glycine



Sodium chloride



Calcium chloride



Histidine



Polysorbate 80



Sucrose



Solvent



Water for injections



6.2 Incompatibilities



This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6..



Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.



6.3 Shelf Life



30 months.



After reconstitution, the product should be used immediately.



However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion.



Do not refrigerate after reconstitution.



6.4 Special Precautions For Storage



Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.



The product when kept in its outer carton may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months. In this case, the product expires at the end of this 12-month period; the new expiry date must be noted on the outer carton.



For storage conditions of the reconstituted medicinal product, see section 6.3.



6.5 Nature And Contents Of Container



Each package of KOGENATE Bayer contains:



• one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)



• one pre-filled syringe with 2.5 ml solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)



• syringe plunger rod



• vial adapter



• one venipuncture set



• two sterile alcohol swabs for single use



• two dry swabs



• two plasters



6.6 Special Precautions For Disposal And Other Handling



Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.



KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the vial adapter. Reconstitution should be performed in accordance with good practices rules, particularly with attention to asepsis. Gently rotate the vial until all powder is dissolved. After reconstitution the solution is clear. Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity.



After reconstitution, the solution is drawn back into the syringe.



Use the provided venipuncture set for intravenous injection.



For continuous infusion, the product must be prepared under aseptic conditions.



For single use only. Any unused solution must be discarded.



Any unused product or waste material should be disposed of in accordance with local requirements.



7. Marketing Authorisation Holder



Bayer Pharma AG



13342 Berlin



Germany



8. Marketing Authorisation Number(S)



EU/1/00/143/007



9. Date Of First Authorisation/Renewal Of The Authorisation



Date of first authorisation: 04 August 2000



Date of latest renewal: 06 August 2010



10. Date Of Revision Of The Text



1 July 2011



Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.






Saturday, 29 September 2012

Riamet 20 / 120mg tablets






Riamet 20 mg/120 mg tablets


artemether and lumefantrine



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What Riamet is and what it is used for

  • 2. Before you take or give Riamet to your child

  • 3. How to take or give Riamet to your child

  • 4. Possible side effects

  • 5. How to store Riamet

  • 6. Further information




What Riamet Is And What It Is Used For


Riamet contains two substances called artemether and lumefantrine. They belong to a group of medicines called anti-malarials.


Riamet is only used for the treatment of acute uncomplicated malaria infections caused by a parasite called “Plasmodium falciparum”. This parasite is a tiny organism made up of one cell that is found inside red blood cells.


Riamet is used to treat adults, children and infants of 5 kg body weight and above.


Riamet is not used to prevent malaria or to treat severe malaria (where it has affected the brain, lungs or kidneys).




Before You Take Or Give Riamet To Your Child



Do not take Riamet


  • if you are allergic (hypersensitive) to artemether, lumefantrine, or any of the other ingredients of Riamet listed at the end of this leaflet.

  • if you have a severe type of malaria infection where it has affected parts of your body such as the brain, lungs or kidneys.

  • if you have a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease.

  • if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.

  • if your doctor has told you that you have low levels of electrolytes such as potassium or magnesium in your blood.

  • if you are taking the following medicines: flecainide, metoprolol, imipramine, amitriptyline, clomipramine, certain antibiotics (macrolides, fluoroquinolones, imidazole), triazole antifungal agents, terfenadine, astemizole, cisapride (see also “Taking other medicines”).

If any of the above apply to you, tell your doctor without taking Riamet.




Take special care with Riamet


Check with your doctor or pharmacist before taking Riamet:


  • if you have severe liver or kidney problems.

  • if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”.

  • if you are infected with both the “Plasmodium falciparum” and “Plasmodium vivax” parasites.

  • if you are taking or have taken any other medicines for the treatment of malaria. Some of these medicines must not be given together with Riamet.

  • if you are in the first 3 months of pregnancy or intend to become pregnant. Your doctor will try to give you an alternative medicine first.

  • if you feel worse, or if you feel too unwell to eat and drink.

If any of these apply to you, talk to your doctor before you take Riamet.




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


In particular, do not take this medicine and tell your doctor if you are taking any of the following:


  • medicines used to treat heart rhythm problems such as flecainide or metoprolol.

  • medicines used to treat depression such as imipramine, amitriptyline or clomipramine.

  • medicines used to treat infections called:

    • antibiotics, including the following types: macrolides, fluoroquinolones or imidazole,
    • triazole antifungal agents.

  • medicines used to treat allergies or inflammation called “non-sedating antihistamics” such as terfenadine or astemizole.

  • cisapride - a medicine used to treat stomach problems.

If you are taking any of the above medicines, do not take Riamet.


Please tell your doctor if you are taking:


  • any other medicines to treat malaria.

  • medicines to treat HIV infections or AIDS called “anti-retroviral medicines” or “protease inhibitors”.



Taking Riamet with food and drink


Riamet should be taken with food or drinks rich in fat such as milk. Please ask your doctor for advice on the
best food or drinks to take Riamet with.




Pregnancy and breast-feeding


Tell your doctor if you are pregnant, think you may be pregnant or become pregnant while taking Riamet. Riamet must not be used during the first 3 months of pregnancy if it is possible for the doctor to give an alternative medicine first. In the later stages of pregnancy, you should take Riamet only if clearly necessary. Your doctor will discuss with you the potential risk of taking Riamet during pregnancy.


You should not breast-feed while you are taking Riamet. Once you have stopped taking Riamet, you should wait at least 1 week before starting to breast-feed again.


Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while you are breast-feeding.




Driving and using machines


Riamet may make you feel sleepy, dizzy or generally weak. If this happens to you, do not drive or use any tools or machines.





How To Take Or Give Riamet To Your Child


Always take or give Riamet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



Taking or giving Riamet


  • the tablets should be taken with food or drinks rich in fat such as milk. Please ask your doctor for advice on the best food or drinks to take Riamet with.

  • if you feel worse or are too unwell to eat or drink, please talk to your doctor.

  • if you are sick (vomit) within 1 hour of taking the tablets take another dose. If in doubt, talk to your doctor.

  • when given to small children or infants, the tablets may be crushed.

When treating your child, a 24-tablet pack will be provided. Follow your doctor´s instructions carefully and use only the number of tablets needed. Return the remaining tablets to your pharmacist.




How much to take or give


  • six doses are taken over 3 days.

  • the first dose should be taken as soon as possible and should be followed by five further doses at 8, 24, 36, 48 and 60 hours after the first dose, as described in the next section.

  • when you take your first dose, work out the times you will need to take the rest of the doses at and write them down.

  • all doses must be taken and at the right times, to gain the full benefits of this medicine.


Adults and children weighing 35 kg and above


Take four tablets at each time interval.


So you take or give:



  • 4 tablets as soon as possible, then


  • 4 tablets 8 hours later, then


  • 4 tablets 24 hours after the first dose, then


  • 4 tablets 36 hours after the first dose, then


  • 4 tablets 48 hours after the first dose and then

  • the final 4 tablets 60 hours after the first dose.

This will mean you take or give a total of 24 tablets.


No special precautions or dosage adjustments are considered to be necessary in elderly patients.



Infants and children weighing 5 kg to less than 35 kg


The number of tablets you need to give to your child depends on their weight:



  • children 5 kg to less than 15 kg bodyweight: give 1 tablet at each of the time intervals outlined above. This means your child will take a total of 6 tablets.


  • children 15 kg to less than 25 kg bodyweight: give 2 tablets at each of the time intervals outlined above. This means your child will take a total of 12 tablets.


  • children 25 kg to less than 35 kg bodyweight: give 3 tablets at each of the time intervals outlined above. This means your child will take a total of 18 tablets.



If the malaria infection returns


A second course of Riamet may be necessary if the malaria infection returns, or if you are re-infected with
the parasite “Plasmodium falciparum” after having been cured. If this happens to you please talk to your
doctor.




If you take more Riamet than you should


If you have accidentally taken too many tablets, talk to your doctor straight away, or go to your nearest emergency unit. You may require medical attention. Remember to take your medicine with you, and show it to your doctor or the staff of the emergency unit. If you have run out of tablets, take the empty packaging along with you.




If you forget to take Riamet


Try to make sure that you do not miss any doses. However, if you do forget a dose of Riamet, take the missed dose as soon as you remember unless it is almost time for your next dose. Then take your next dose at the usual time. Ask your doctor for advice. Do not take a double dose to make up for a forgotten dose.




If you stop taking Riamet


Do not stop taking your medicine unless your doctor tells you to. Always follow your doctor´s instructions carefully, and complete the course of medication.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Possible Side Effects


Like all medicines, Riamet can cause side effects, although not everybody gets them.


Most of the side effects are mild to moderate and generally disappear after a few days to a few weeks after treatment. Some side effects are more commonly reported in children and others are more commonly reported in adults. In cases where there is a difference, the frequency listed below is the more common one.



Some side effects could be serious and need immediate medical attention.



Rare
(affecting less than 1 in 1,000 patients)


If you get a rash, swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing, tell your doctor straight away. These are signs of an allergic reaction.




Other side effects are:



Very common
(affecting more than 1 in 10 patients)


Fast heart beat, headache, dizziness, cough, being sick (vomiting), stomach pain, feeling sick (nausea), joints or muscles aching, loss of appetite, general weakness, tiredness, trouble with sleeping.



Common
(affecting less than 1 in 10 patients)


Heart rhythm disturbances (called QTc prolongation), Symptoms such as unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (signs of liver problems),diarrhoea, abnormal walking, tingling or numbness of the hands and feet, a rash or itching on the skin, insomnia.





Uncommon
(affecting less than 1 in 100 patients)


inability to coordinate movements, muscle twitching, decreased skin sensitivity, sleepiness.






Of these side effects, the following were reported in adults and adolescents above 12 years of age: abnormal walking, tingling or numbness of the hands and feet, inability to coordinate movements, decreased skin sensitivity.



If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.




How To Store Riamet


Keep out of the reach and sight of children.


Do not use Riamet after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.


Do not store above 30°C.


Do not use Riamet if you notice that the pack is damaged or shows signs of tampering.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What Riamet contains


  • The active substances of Riamet are artemether and lumefantrine.

  • The other ingredients are polysorbate 80, hypromellose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, and magnesium stearate.



What Riamet looks like and contents of the pack


Riamet tablets are light yellow, round with the imprint “NC” on one side and “CG” on the other side.


Riamet tablets are available in blister packs containing 24 tablets.




Marketing Authorisation Holder



Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

England




Manufacturer



Novartis Pharma GmbH

Oeflinger Strasse 44

D-79664 Wehr/Baden

Germany





This leaflet was last approved in September 2008





Tuesday, 25 September 2012

Justin




Justin may be available in the countries listed below.


Ingredient matches for Justin



Lovastatin

Lovastatin is reported as an ingredient of Justin in the following countries:


  • Indonesia

International Drug Name Search

Monday, 24 September 2012

Equaline Hair Regrowth Treatment for Men




Generic Name: minoxidil

Dosage Form: solution
SuperValu Hair Regrowth Treatment for Men Drug Facts

Active ingredient


Minoxidil 5% w/v



Purpose


Hair regrowth treatment for men



Uses


to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)



Warnings


For external use only. For use by men only.


Flammable: Keep away from fire or flame



Do not use if


  • you are a woman

  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.

  • you have no family history of hair loss

  • your hair loss is sudden and/or patchy

  • you do not know the reason for your hair loss

  • you are under 18 years of age. Do not use on babies and children.

  • your scalp is red, inflamed, infected, irritated, or painful

  • you use other medicines on the scalp


Ask a doctor before use if you have


heart disease



When using this product


  • do not apply on other parts of the body

  • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

  • some people have experienced changes in hair color and/or texture

  • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.

  • the amount of hair regrowth is different for each person. This product will not work for all men.


Stop use and ask a doctor if


  • chest pain, rapid heartbeat, faintness, or dizziness occurs

  • sudden, unexplained weight gain occurs

  • your hands or feet swell

  • scalp irritation or redness occurs

  • unwanted facial hair growth occurs

  • you do not see hair regrowth in 4 months


May be harmful if used when pregnant or breast-feeding.



Keep out of reach of children.


If swallowed, get medical help or contact a Poison Control Center right away.



Directions


  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area

  • using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again


Other information


  • see hair loss pictures on side of this carton

  • before use, read all information on carton and enclosed leaflet

  • keep the carton. It contains important information.

  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men

  • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%

  • store at 20° to 25°C (68° to 77°F). Keep tightly closed.


Inactive ingredients


alcohol, propylene glycol, purified water



Questions or comments?


1-877-932-7948



Principal Display Panel


Compare to Men’s Rogaine® Extra Strength active ingredient


Extra Strength


Minoxidil Topical Solution USP, 5%


Hair Regrowth Treatment


For Men


Unscented


Clinically Proven to Help Regrow Hair


Revitalizes Hair Follicles


Topical Solution


# Month Supply


Not for Use by Women


Hair Regrowth Treatment for Men Carton










EQUALINE HAIR REGROWTH TREATMENT  FOR MEN
minoxidil  solution










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)41163-798
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL)MINOXIDIL3 g  in 60 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorYELLOW (Light Amber)Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
141163-798-161 BOTTLE In 1 CARTONcontains a BOTTLE
160 mL In 1 BOTTLEThis package is contained within the CARTON (41163-798-16)
241163-798-303 BOTTLE In 1 CARTONcontains a BOTTLE
260 mL In 1 BOTTLEThis package is contained within the CARTON (41163-798-30)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07559812/04/2009


Labeler - Supervalu Inc (006961411)
Revised: 06/2009Supervalu Inc




More Equaline Hair Regrowth Treatment for Men resources


  • Equaline Hair Regrowth Treatment for Men Use in Pregnancy & Breastfeeding
  • Equaline Hair Regrowth Treatment for Men Drug Interactions
  • Equaline Hair Regrowth Treatment for Men Support Group
  • 7 Reviews for Equaline Hair Regrowth Treatment for Men - Add your own review/rating


Compare Equaline Hair Regrowth Treatment for Men with other medications


  • Alopecia

Sunday, 23 September 2012

Fluoritab


Generic Name: fluoride (FLOR ide)

Brand Names: Altaflor, Ethedent Chewable, Fluor-A-Day, Fluoritab, Flura-Drops, Flura-Loz, Flura-Tab, Karidium, Lozi-Flur, Luride, Nafrinse, Pharmaflur, Pharmaflur 1.1


What is Fluoritab (fluoride)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.


Fluoride is used as a medication to prevent tooth decay in people that have a low level of fluoride in their drinking water. Fluoride is also used to prevent tooth decay in people who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.


Fluoride may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Fluoritab (fluoride)?


You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.


Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.


What should I discuss with my healthcare provider before taking Fluoritab (fluoride)?


You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.


Talk to your doctor and dentist before taking fluoride if you are pregnant or could become pregnant during treatment. Talk to your doctor and dentist before taking fluoride if you are breast-feeding. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age; the American Academy of Pediatrics recommends fluoride supplementation by children until the age of 16 years of age. Do not give a 1-mg tablet to a child younger than 3 years old, or when your drinking water fluoride content is equal to or greater than 0.3 ppm.

How should I take Fluoritab (fluoride)?


Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.


Take this medicine with a full glass of water. Do not take fluoride with milk or other dairy products. Calcium can make it harder for your body to absorb fluoride.

Suck on the fluoride lozenge until it dissolves completely in your mouth. Do not chew the lozenge or swallow it whole.


The chewable forms of fluoride can be chewed, swallowed, dissolved in the mouth, added to drinking water or fruit juice, or added to water for use in infant formula or other food.


The fluoride drops can be taken by mouth undiluted, or mixed with fluid or food.


If you mix fluoride with food or water, drink or eat this mixture right away. Do not save it for later use.


It is important to take fluoride regularly to get the most benefit.


Store fluoride at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).


What should I avoid while taking Fluoritab (fluoride)?


Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.


Fluoritab (fluoride) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of the following side effects:

  • discolored teeth;




  • weakened tooth enamel; or




  • any changes in the appearance of your teeth.



Less serious side effects may include:



  • stomach upset;




  • headache; or




  • weakness.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Fluoritab (fluoride)?


There may be other drugs that can interact with fluoride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Fluoritab resources


  • Fluoritab Side Effects (in more detail)
  • Fluoritab Use in Pregnancy & Breastfeeding
  • Fluoritab Support Group
  • 0 Reviews for Fluoritab - Add your own review/rating


  • Fluoritab Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Epiflur Prescribing Information (FDA)

  • Fluor-A-Day Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluor-A-Day Advanced Consumer (Micromedex) - Includes Dosage Information

  • Fluor-a-Day Prescribing Information (FDA)

  • Fluorides Monograph (AHFS DI)

  • Lozi-Flur Lozenges MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Fluoritab with other medications


  • Prevention of Dental Caries


Where can I get more information?


  • Your pharmacist can provide more information about fluoride.

See also: Fluoritab side effects (in more detail)


Saturday, 22 September 2012

Epinephrine eent


Class: Mydriatics
VA Class: OP900
CAS Number: 51-42-3
Brands: Adrenalin Chloride, Epifrin

Introduction

An endogenous catecholamine that is a mydriatic and vasoconstrictor.a c


Uses for Epinephrine


Open-Angle Glaucoma


Reduction of elevated IOP in patients with open-angle glaucoma.a b c Generally used adjunctively with topical miotics, topical β-adrenergic blocking agents, osmotic agents, and/or systemically administered carbonic anhydrase inhibitors;a b c may have an additive effect on IOP lowering.a b c Epinephrine in conjunction with miotics may reduce miosis and ciliary spasm that often occur when miotics are used alone.a


Dipivefrin, a prodrug of epinephrine, may be preferred in certain patients because of increased intraocular penetration (lower doses are needed) and resultant decreased adverse extraocular effects.c f


Patient response to epinephrine is highly variable; some patients are unresponsive.a Repeated tonometric readings are advisable during the course of treatment, especially in geriatric patients.a


Diagnosis of open-angle glaucoma by careful gonioscopic and slit lamp studies; use in patients with angle-closure glaucoma or those who may be predisposed to angle closure is contraindicated.a b c


Mydriasis for Surgery


Although less effective than other mydriatics in normal eyes, epinephrine produces effective mydriasis when the permeability of the eye is increased by trauma (e.g., during surgery).a c


Induction of rapid mydriasis during surgery (e.g., cataract extraction) via topical application to the conjunctiva or injection into the anterior chamber of the eye.a c


Mydriasis for Synechiae


Prolonged topical contact (e.g., via a saturated cotton wick) with the eye to induce sufficient mydriasis to break posterior synechiae.a c


Administered subconjunctivally concomitantly with atropine and cocaine to produce mydriasis and thereby break posterior synechiae unresponsive to topical therapy.a


Mydriasis for Ophthalmoscopy


Although generally contraindicated in patients with angle-closure glaucoma, epinephrine may be used to produce mydriasis for ophthalmoscopy in patients predisposed to angle closure.a Give a carbonic anhydrase inhibitor and an osmotic agent (e.g., glycerin) orally prior to the examination.a However, even these measures may not prevent attacks of acute angle-closure glaucoma unresponsive to treatment; surgery may be required.a


Superficial Bleeding


Used locally as a hemostatic agent to control superficial bleeding from arterioles and capillaries in the skin and mucous membranes of the eye, nose, mouth, throat or larynx, mainly during surgery.a b c Ineffective for bleeding from larger vessels.a c


Especially useful to prevent oozing from small vessels that obscures surgical details during ophthalmic surgery.c


Especially useful as a hemostatic agent in dental surgery.a


Adjunct to Local Anesthesia


Added to solutions of some local anesthetics to decrease the rate of their vascular absorption (to localize and prolong the duration of anesthesia).a c d Risk of systemic toxicity caused by the local anesthetic also is decreased, and bleeding in the operative field may be reduced.a c


Adjunct to Other Local Drugs


Enhancement of intraocular penetration of subconjunctivally injected drugs.c Local vasoconstriction enhances local effect secondary to decreased drug loss from the subconjunctival depot into systemic circulation, with resultant increased intraocular penetration.c


Vasoconstriction to decrease conjunctival hyperemia and thus enhance location of extraocular muscles prior to botulinum toxin injection into these muscles.c Also reduces the risk of subconjunctival hemorrhage secondary to conjunctival vessel damage.c


Conjunctivitis


Decongestion when applied topically to the conjunctiva for conjunctivitis secondary to nonspecific chronic irritation or allergy.a c d Decongestion usually persists less than 1 hour and may be followed by reactive hyperemia.a c Longer-acting decongestants are preferred.c


Nasal Congestion


Decongestion for allergic or nonallergic rhinitis or acute sinusitis when applied topically to the nasal mucosa.a d h Duration of action is short and rebound congestion frequently occurs.a Longer-acting decongestants are preferred.a


Epinephrine Dosage and Administration


Administration


Apply topically to the skin and mucous membranes of the eye, nose, mouth, throat, or larynx.a b c d h


For ophthalmic use, parenteral preparations may be injected intracamerally or subconjunctivally.a


For local oral use, parenteral preparations may be infiltrated into buccal and mucosal vestibules.a c d


Ophthalmic Administration


Ophthalmic solutions are intended for topical use only and must not be injected.a b For injection, only parenteral preparations should be used.a d


Usually apply topically to the conjunctiva of the affected eye(s).a b c


To avoid visual disturbances resulting from mydriasis, administer at bedtime whenever possible.a


Ophthalmic preparations generally should not be used in conjunction with the wearing of soft contact lenses, since epinephrine may cause adrenochrome staining (black discoloration) of the lenses.a b c


When separate solutions of epinephrine and a topical miotic are used, the miotic should be instilled 2–10 minutes prior to epinephrine because of the limited capacity of the conjunctival sac.a


May be injected intracamerally (into the anterior chamber of the eye) or subconjunctivally (beneath Tenon’s capsule) (e.g., to control hemorrhage or produce mydriasis).a c


To provide rapid mydriasis during surgery (e.g., cataract extraction), apply topically to the conjunctiva or inject into the anterior chamber of the eye.a c


To break posterior synechiae, apply topically via a saturated cotton wick placed in the lower conjunctival cul-de-sac or inject subconjunctivally for synechiae unresponsive to topical therapy.a c


Nasal Administration


Nasal solutions are intended for topical use only and must not be injected.a h


Apply topically to nasal mucosa as drops or spray or with a sterile swab.a h


Dosage


Available as epinephrine hydrochloride; dosage expressed in terms of epinephrine.a b d


When epinephrine is used as a mydriatic, it is less effective in dark than in light colored eyes; higher concentrations and/or dosages may be needed in patients with brown or hazel eyes.a c


Ocular discomfort and conjunctival irritation associated with topical instillation in the eye may be decreased by switching to a lower concentration.a b


Pediatric Patients


Nasal Congestion

Intranasal Local

Children ≥6 years of age: To produce nasal decongestion, apply a 0.1% (1:1000) solution topically as drops or spray to mucosa as required.a Solution concentrations of 1:10,000 to 1:2000 also have been used.h


Adults


Open-Angle Glaucoma

Ophthalmic Topical

Usual dosage is 1 or 2 drops of a 1 or 2% ophthalmic solution once or twice daily instilled in the affected eye(s); however, dosing frequency may vary from once every 2–4 days to 4 times daily.a b


Adjust concentration and dosage to individual requirements and responses as determined by tonometric readings before and during therapy.a b


Mydriasis for Surgery

Ophthalmic Topical

Apply 1 or more drops of a 0.1% (1:1000) solution topically to the conjunctiva 1–3 times or as necessary to control bleeding or to provide a mydriatic effect during surgery.a c d


Ophthalmic Local Injection

Intraocular injections of 1:10,000 (0.01%) to 1:1000 (0.1%) concentrations can be used to provide mydriasis during surgery; this also can control bleeding.a d


In round-pupil cataract extraction, 0.2 mL (0.2 mg) of a 1:1000 injection may be injected intracamerally; in other cases of cataract extraction, 0.1 mL (0.1 mg) of a 1:1000 injection may be injected subconjunctivally.a


Mydriasis for Synechiae

Ophthalmic Topical

To break posterior synechiae, a cotton wick saturated with epinephrine is placed in the lower conjunctival cul-de-sac.a c


Ophthalmic Local Injection

To break posterior synechiae unresponsive to topical therapy, 0.1 mL of a solution containing equal parts of 0.1% (1:1000) epinephrine, 4% cocaine, and 1% atropine may be injected at the limbus.a


Mydriasis for Ophthalmoscopy

Ophthalmic Topical

To provide mydriasis for ophthalmoscopy in patients predisposed to angle closure, a carbonic anhydrase inhibitor (e.g., 250 mg of acetazolamide) and glycerin 1–1.5 g/kg are given orally 2 hours and 1 hour, respectively, prior to epinephrine.a After the eye is anesthetized topically with a drug other than cocaine, the tip of a 1 × 5 mm strip of filter paper moistened with 1 or 2% epinephrine ophthalmic solution is inserted in the inferior cul-de-sac for 1–3 minutes.a


Superficial Bleeding

EENT Topical

As a topical hemostatic agent, solution concentrations of 1:50,000 (0.002%) to 1:1000 (0.1%) may be sprayed or applied with cotton or gauze to the skin or mucous membranes of the eye, nose, mouth, throat, or larynx.a d e


To control mucosal bleeding, a 0.1% (1:1000) solution can be applied topically as drops or spray to mucosa as required.a


To control bleeding during ocular surgery, apply 1 or more drops of a 0.1% (1:1000) solution topically to the conjunctiva 1–3 times or as necessary.a


EENT Local Injection

Injections of 1:10,000 (0.01%) to 1:1000 (0.1%) concentrations can be used to control bleeding (e.g., during surgery).a d To control ocular bleeding, inject these concentrations into the anterior chamber of the eye or subconjunctivally.a


For use as a local hemostatic agent in combination with local anesthetics (e.g., during ocular surgery), epinephrine may be used in concentrations of 1:200,000 to 1:50,000;a c 1:200.000 is used most commonly.c e


To control bleeding during oral surgery, infiltrate the buccal and labial vestibules of the maxilla and mandible in each quadrant with 4 mL of a 0.0005% (1:200,000) solution.a


Adjunct to Local Anesthesia

EENT Local Injection

To localize and prolong the duration of local anesthesia, epinephrine may be used in concentrations of 1:500,000 to 1:50,000;a c e 1:200.000 is used most commonly.c e


Adjunct to Other Local Drugs

Ophthalmic Local Injection

To enhance intraocular penetration and prolong the duration of subconjuntivally injected drugs, epinephrine may be used in concentrations of 1:200,000 to 1:50,000;a c 1:200.000 is used most commonly.c e


Ophthalmic Topical

To aid in botulinum toxin therapy for strabismus, instill 1 drop of an epinephrine ophthalmic solution in the affected eye as a local vasoconstrictor.c


Conjunctivitis

Ophthalmic Local

For conjunctrival decongestion, apply 1 or more drops of a 0.1% (1:1000) solution topically to the conjunctiva 1–3 times or as necessary.a c


Nasal Congestion

Intranasal Local

To produce nasal decongestion, apply a 0.1% (1:1000) solution topically as drops or spray to mucosa as required.a Solution concentrations of 1:10,000 to 1:2000 also have been used.h


Special Populations


Geriatric Patients


No specific dosage recommendations, but repeated tonometric readings during glaucoma therapy are especially advisable in this age group.a


Cautions for Epinephrine


Contraindications



  • Angle-closure glaucoma.a b Dilation of the pupil may trigger an acute attack.b




  • Use cautiously, if at all, if the nature of the glaucoma has not been established.a c




  • Known hypersensitivity to epinephrine or any ingredient in the formulation.a




  • Organic brain syndrome.a




  • Cardiac dilatation and coronary insufficiency.a




  • Contraindicated in conjunction with local anesthetics for use in the ears, nose, fingers, toes, or genitalia.a



Warnings/Precautions


Warnings


Narrow Angle

Caution in patients with a narrow angle since pupil dilation may precipitate an acute attack of angle-closure glaucoma.b


Aphakia

Chronic therapy may produce reversible macular edema in aphakic patients; caution is advised.a b c


Changes in central vision in aphakic patients should prompt evaluation for maculopathy; epinephrine discontinuance usually is followed by improvement in visual acuity and ophthalmoscopic findings within 1 month but may not be maximal for 6 months or longer.a c


Cardiovascular Effects

Consider cardiovascular status before initiating therapy.a b c d


Use with caution in patients with vascular hypertension or cardiac disorders, including arrhythmias and cardiovascular disease (e.g., coronary artery disease).a b h


Use with extreme caution in patients with degenerative heart disease.a (See Asthma and Emphysema under Cautions.)


Use with caution, if at all, prior to or during surgery with cyclopropane or halogenated hydrocarbon anesthetics such as halothane.a c f The danger of ventricular arrhythmias such as VPCs, tachycardia, or fibrillation may be increased.a c f


If epinephrine is used prior to ocular surgery, especially for injection with a local anesthetic, systemic sympathomimetic effects may occur; surgery should not be started until restlessness has subsided.a


Overdosage or inadvertent IV administration may cause cerebrovascular hemorrhage secondary to a marked increase in blood pressure.a


Asthma and Emphysema

Use with extreme caution in patients with long-standing bronchial asthma or emphysema who have developed degenerative heart disease.a


Diabetes, Hyperthyridism, and Cerebral Arteriosclerosis

Use with caution in diabetic and hyperthyroid patients and those with cerebral arteriosclerosis.a c d h


Sensitivity Reactions


Allergic Reactions

Ophthalmic use may cause allergic reactions (sensitization reaction to chronic therapy) characterized by diffuse vascular engorgement, follicular hypertrophy, chemosis, conjunctivitis, and/or iritis.a c Allergic contact dermatitis of the eyelids, producing such symptoms as edema of the lower lids, thick yellow discharge, and crusting and fissuring of the skin of the eyelids, also may occur.a


Allergic reactions occasionally may be caused by the preservatives in the preparations.a


Some ophthalmic formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.a b


General Precautions


Ocular Irritation

Adverse local reactions occur frequently during topical ocular therapy and prolonged use may not be tolerated.a


Topical application to the conjunctiva frequently causes ocular discomfort and conjunctival irritation including transient burning or stinging, lacrimation, pain or ache around or in the eye, and rebound conjunctival hyperemia.a b


Some of these local ocular effects may be reduced if a lower epinephrine concentration is used.a b


Ocular Pigmentary Changes

Prolonged use may result in localized melanin-like pigmentary (e.g., adrenochrome) deposits in the conjunctiva, eyelids, and/or roughened or edematous areas of the cornea.a c Such pigmenation may be increased by use of old or disclored solutions containing oxidixed epinephrine.c


Large brownish-black casts occasionally may form in the lacrimal sac and nasolacrimal duct, resulting in obstruction and epiphora. These casts may be removed by irrigation.


Increased IOP

Rarely, a temporary but clinically important increase in IOP and impairment of outflow facility (even when the angle of the eye remained open) have occurred in glaucoma patients when epinephrine was used initially without a miotic.


Acute Angle Closure

In patients with angle-closure glaucoma, dilation of the pupil may precipitate an acute attack.a


Mydriasis, Blurred Vision, and Light Sensitivity

Mydriasis, blurred vision, and sensitivity to light may occur in glaucoma patients; inconvenience may be minimized if epinephrine is administered at bedtime or following a miotic.a


Corneal Effects

Prolonged ophthalmic use may cause corneal edema; after very prolonged use, superficial blood vessels in the eye may lose the ability to constrict.a


Intracameral injection of epinephrine 1:1000 has been associated with endothelial damage, irreversible edema, and opacification of the cornea.a


Other Local Effects

Headache or browache frequently occurs at the beginning of ocular therapy and may diminish with continued treatment.a


Systemic Effects

Ophthalmic use occasionally causes systemic sympathomimetic effects such as palpitation, tachycardia, extrasystoles, ventricular premature complexes, hypertension, occipital headaches, pallor, trembling, faintness, and increased perspiration.a Such effects are common with local ophthalmic injection.c


Excessively large local dosages may cause cerebral hemorrhage and ventricular fibrillation.c Patients with preexisting hypertension, hyperthyroidism, coronary artery disease, or advancedcerebral arteriosclerosis are particulaly susceptible.c


Systemic sympathomimetic effects occur very rarely after application to the conjunctiva but are more likely to occur if the drug is instilled after the corneal epithelium has been damaged or permeability is increased by tonometry, surgery, inflammation, or topical application of a local anesthetic.a


Systemic sympathomimetic effects also may occur with other mucosal (e.g., intranasal) use.a


Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.


Specific Populations


Pregnancy

Category C.b d


Lactation

Risk unknown.i


Pediatric Use

Safety and efficacy of ophthalmic solutions not established.a


Nasal solutions should be used in children <6 years of age only under the advice af a clinician.h


Geriatric Use

Use with caution.a h Melanin-like pigmentary deposits may occur within translucent conjunctival cysts.a


Common Adverse Effects


Ocular use: irritation and discomfort,a b c ocular pain or ache, browache, headache, conjunctival hyperemia, allergic lid reactions.


Intranasal use: CNS symptoms (e.g., nervousness, restlessness)a rebound nasal congestion.a Slight stinging after intranasal application (because of the presence of sodium bisulfite).a


Interactions for Epinephrine


Specific Drugs

































Drug



Interaction



Comments



Anesthetics, general (cyclopropane, halogenated hydrocarbons)



Increased cardiosensitivity to epinephrinea c f



Use with caution, if at all; increased risk of ventricular arrhythmias such as ventricular premature complexes, tachycardia, or fibrillation; contraindicated with chloroform, trichloroethylene, or cyclopropanea c e f


May not be absorbed rapidly enough with topical hemostatic use to present a problem in short procedurese


Propylactic lidocaine or procainamide may provide some protectiona e


IV propranolol may reverse arrhythmiasa



Antidepressants, tricyclic



Potentiation of epinephrine effects (especially on heart rate and rhythm)a



Antihistamines, first generation (especially diphenhydramine, dexchlorpheniramine, tripelennamine)



Potentiation of epinephrine effects (especially on heart rate and rhythm)a



β-Adrenergic blocking agents



Less than additive IOP reductiona



Therapeutically beneficiala



Carbonic anhydrase inhibitors



Additive IOP reductiona



Therapeutically beneficiala



Digoxin



Increased cardiosensitivity to epinephrinea



Avoid epinephrine with high digoxin dosages



Miotics (topical)



Additive IOP reduction; eipnephrine decreases miosis and ciliary spasm; miotics decrease mydriasis and blurred visiona



Therapeutically beneficiala



Osmotic agents (topical)



Additive IOP reductiona



Therapeutically beneficiala



Thyroid agents



Potentiation of epinephrine effects (especially on heart rate and rhythm)a


Epinephrine Pharmacokinetics


Absorption


Bioavailability


Occasionally, sufficient absorption following topical application to the conjunctiva or nasal mucosa or intraocular injection to cause systemic sympathomimetic effects may occur.a c


Onset


Following topical application to the conjunctiva, IOP reduction may occur within 1 hour and reach a maximum in 4–8 hours.a


Following local ocular administration, mydriasis may occur within a few minutes.a


Vasoconstriction usually occurs within 5 minutes after topical (e.g., ocular, intranasal) administration or intraocular injection.a c


Duration


Following topical application to the conjunctiva, IOP reduction may persist for 12–24 hours or longer.a


Following local ocular administration, mydriasis may persist for several hours.a


Vasoconstriction generally lasts less than 1 hour after topical (e.g., ocular, intranasal) administration or intraocular injection.a c


Distribution


Extent


Following topical application to the eye in rabbits, highest concentrations in tissues and fluids other than the eye occurred in the pituitary gland, with lower concentrations in the intestine, fat, adrenal gland, kidney, heart, lung, spleen, ovary, pancreas, liver, uterus, muscle, brain, and serum.a


Systemically absorbed epinephrine crosses the placenta but not the blood-brain barrier.a e


Systemically absorbed epinephrine distributes into milk.a


Elimination


Metabolism


Circulating epinephrine is metabolized in the liver and other tissues by a combination of reactions involving the enzymes catechol-O-methyltransferase (COMT) and MAO.b


The major metabolites are metanephrine and 3-methoxy-4-hydroxymandelic acid (vanillylmandelic acid, VMA), both of which are inactive.


Elimination Route


Pharmacologic actions are terminated mainly by uptake and metabolism in sympathetic nerve endings.a


Epinephrine and its metabolites are excreted by the kidneys.


Stability


Storage


Ophthalmic, Nasal, and Parenteral Solutions


Epinephrine, epinephrine salts, and solutions containing the drugs gradually darken on exposure to light and air and must be stored in tight, light-resistant containers.a b d


Discard solutions with a color that is pinkish or darker than slightly yellow or that contain a precipitate.a b d g


Follow the manufacturer’s directions with respect to storage requirements for each product.a


Injection

15–25°C; protect from light and freezing.d g


In some commercially available injections, air has been replaced with nitrogen to avoid oxidation.a


Withdrawal of doses from multiple-dose vials introduces air into the vials, subjecting the remaining epinephrine to oxidation.a Oxidation of epinephrine imparts first a pink, then a brown color.a


Nasal Solution

15–25°C; protect from light and freezing.h


Ophthalmic Solution

Protect from light and excessive heat.b


ActionsActions



  • An endogenous catecholamine that is a mydriatic and vasoconstrictor.a c




  • Lowers IOP and causes brief mydriasis and vasoconstriction in open-angle glaucoma;a c slight effect on IOP in the normal eye.a Appears to lower IOP principally by stimulating α- and/or β2-adrenergic receptors, resulting in an increase in both pressure-independent (uveoscleral) and, to a lesser extent, pressure-dependent (trabecular) aqueous humor outflow.a




  • Constricts arterioles in the skin and mucous membranes by its effect on α-adrenergic receptors.a




  • Constricts conjunctival blood vessels, contracts the dilator muscle of the pupil, and may dilate the pupil after topical application to the conjunctiva or injection into the anterior chamber of the eye.a c




  • Induces mydriasis poorly in normal eyes; however, effective mydriasis occurs when the permeability of the eye is increased during surgery or trauma, after postganglionic sympathetic denervation (as in Horner’s syndrome or Raeder’s syndrome), and in patients with chronic renal hypertension, hyperthyroidism, or certain cases of glaucoma.a c




  • Produces only slight relaxation of the ciliary muscle so that cycloplegia does not occur.a



Advice to Patients



  • Do not use solutions that are pinkish or darker than slightly yellow or if they contain a precipitate.a g




  • Advise that ocular discomfort and conjunctival irritation (burning, stinging) are common with topical application to the conjunctiva.a c




  • Advise that soft contact lenses generally should not be worn during ocular instillation because of risk of black discoloration, particularly during chronic use of epinephrine ophthalmic solutions.a b c




  • Advise glaucoma patients that mydriasis, blurred vision, and light sensitivity may occur and can be minimized by administering at bedtime or after a miotic, when possible.a




  • Advise glaucoma patients of the possibility of ocular pigmentary changes during prolonged therapy.a c




  • Importance of aphakic patients reporting visual changes (e.g., loss of visual acuity, blurring and visual distortation) during chronic therapy since these may be signs of maculopathy.a b c




  • Importance of discontinuing use of epinephrine and consulting a clinician if signs of sensitivity develop or if irritation persists or increases during therapy with the drug.a




  • Importance of warning patients of possible systemic sympathomimetic effects if epinephrine is used prior to ocular surgery, especially for injection with a local anesthetic.a




  • Importance of contacting a clinician if prompt relief is not obtained with intranasal therapy.h




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a b




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b




  • Importance of informing patients of other important precautionary information.a b d h (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
















































Epinephrine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Nasal



Solution



0.1% (1:1000) (of epinephrine)



Adrenalin Chloride



Monarch



Ophthalmic



Solution



0.5% (of epinephrine)



Epifrin (with benzalkonium chloride, edetate disodium, and sodium metabisulfite)



Allergan



1% (of epinephrine)



Epifrin (with benzalkonium chloride, edetate disodium, and sodium metabisulfite)



Allergan



Glaucon (with benzalkonium chloride, edetate disodium, and sodium metabisulfite)



Alcon



2% (of epinephrine)



Epifrin (with benzalkonium chloride, edetate disodium, and sodium metabisulfite)



Allergan



Glaucon (with benzalkonium chloride, edetate disodium, and sodium metabisulfite)



Alcon



Parenteral



Injection



0.1 mg/mL (0.01% or 1:10,000) (of epinephrine)*



Epinephrine Hydrochloride Injection



Hospira, IMS



1 mg/mL (0.1% or 1:1000) (of epinephrine)*



Adrenalin Chloride Solution (with sodium bisulfite in ampuls and with chlorobutanol and sodium bisulfite in multiple-dose vials)



Monarch





















































Epinephrine Bitartrate Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Ophthalmic



Solution



1% (approximately equivalent to epinephrine 0.5%) with Pilocarpine Hydrochloride 1%



E-Pilo-1 (with benzalkonium chloride, edetate disodium, and sodium bisulfite)



Novartis



P1E1 (with benzalkonium chloride and sodium bisulfite)



Alcon



1% (approximately equivalent to epinephrine 0.5%) with Pilocarpine Hydrochloride 2%



E-Pilo-2 (with benzalkonium chloride, edetate disodium, and sodium bisulfite)



Novartis



P2E1 (with benzalkonium chloride and sodium bisulfite)



Alcon



1% (approximately equivalent to epinephrine 0.5%) with Pilocarpine Hydrochloride 3%



P3E1 (with benzalkonium chloride and sodium bisulfite)



Alcon



1% (approximately equivalent to epinephrine 0.5%) with Pilocarpine Hydrochloride 4%



E-Pilo-4 (with benzalkonium chloride, edetate disodium, and sodium bisulfite)



Novartis



P4E1 (with benzalkonium chloride and sodium bisulfite)



Alcon



1% (approximately equivalent to epinephrine 0.5%) with Pilocarpine Hydrochloride 6%



E-Pilo-6 (with benzalkonium chloride, edetate disodium, and sodium bisulfite)



Novartis



P6E1 (with benzalkonium chloride and sodium bisulfite)



Alcon


















Epinephryl Borate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Ophthalmic



Solution



0.5% (of epinephrine)



Epinal (with benzalkonium chloride)



Alcon



1% (of epinephrine)



Epinal (with benzalkonium chloride)



Alcon



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



a. AHFS Drug Information 2004. McEvoy, GK, ed. Epinephrine (52:24 and 52:32). Bethesda, MD: American Society of Health-System Pharmacists; 2004:2712-5,2720-2.



b. Allergan. Epifrin (epinephrine) sterile ophthalmic solution prescribing information. Irvine, CA: 2002 May.



c. Mauger TF, Craig EL, eds. Havener's ocular pharmacology. 6th ed. St. Louis: Mosby; 1994:46-7,56-67,189-95,210-1,436-8.



d. Monarch. Adrenalin chloride solution (epinephrine injection, USP) 1:1000 prescribing information. Bristol, TN: 2002 Oct.



e. AHFS Drug Information 2004. McEvoy, GK, ed. Epinephrine. Bethesda, MD: American Society of Health-System Pharmacists; 2004:1250-6.



f. AHFS Drug Information 2004. McEvoy, GK, ed. Dipivefrin. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2710-2



g. The United States pharmacopeia, 27th rev, and The national formulary, 22nd ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 2004:710-2.(



h. Monarch. Adrenalin chloride solution (epinephrine nasal solution, USP) 1:1000 prescribing information. Bristol, TN: undated.



i. Epinephrine. In: Briggs GG, Freeman RK, Yaffe SJ. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2002:483-4.