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.


Thursday, 20 September 2012

Boots Nirolex Night Time Cough Relief Linctus or Cough Nurse Night Time Liquid or Almus Night Time Cough Relief Linctus





1. Name Of The Medicinal Product



Boots Nirolex Night Time Cough Relief Linctus or Cough Nurse Night Time Liquid or Almus Night Time Cough Relief Linctus


2. Qualitative And Quantitative Composition










Active ingredient




mg/5ml




Diphenhydramine hydrochloride Ph Eur




12.5




Pholcodine Ph Eur




3.75



3. Pharmaceutical Form



Oral liquid



4. Clinical Particulars



4.1 Therapeutic Indications



For the symptomatic relief of dry, ticklish and unproductive coughs.



4.2 Posology And Method Of Administration



Adults and Children over 12 years: 20ml (4 teaspoonfuls) at bedtime.



Children under 12 years: Not recommended.



Elderly: There is no need for dosage reduction.



For oral administration.



4.3 Contraindications



Hypersensitivity to any of the ingredients, liver disease, ventilatory failure and porphyria.



4.4 Special Warnings And Precautions For Use



Children under 12 years should not be given this medicine.



Cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis.



This medicine should be used with care in conditions such as closed angle glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction. Caution should also be observed in patients with epilepsy and severe cardiovascular disorders.



As pholcodine is a sedative, caution is needed in those patients who have airway disease e.g. asthma, chronic obstructive pulmonary disease (COPD) and ventilatory insufficiency, as respiratory depression may occur. Caution is also needed in patients with kidney disease or a history of drug abuse.



Warning: May cause drowsiness. If affected do not drive or operate machinery.



Avoid alcoholic drink.



Do not exceed the stated dose.



If symptoms persist for longer than 5 days talk to your doctor.



Keep all medicines out of the reach of children.



Information related specifically to the excipients in this formulation (see section 6.1)



Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Each 20ml dose contains 9g sucrose.



Ethanol: Each 20ml dose contains 0.8g alcohol (ethanol), equivalent to 20ml beer or 8ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.



Sodium: Each 20ml dose contains 41mg of sodium. To be taken into consideration by patients on a controlled sodium diet.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Diphenhydramine



CNS depressants: may enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.



Antimuscarinic drugs: may have an additive antimuscarinic action with other drugs, such as atropine and some antidepressants.



MAOIs: not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome.



Pholcodine



Not to be used in patients taking MAOIs or within 14 days of stopping treatment.



Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.



The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect. Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).



4.6 Pregnancy And Lactation



The safety of pholcodine in pregnancy has not been fully established but its use has not revealed any direct evidence of teratogenicity. However, in view of the possible association of foetal abnormalities with first trimester exposure to diphenhydramine, use of the product during pregnancy should be avoided. The safety of this product during lactation has not been established and use during this period should be avoided.



4.7 Effects On Ability To Drive And Use Machines



May cause drowsiness. If affected do not drive or operate machinery.



4.8 Undesirable Effects



May occasionally cause nausea, vomiting, drowsiness, skin rashes and anticholinergic side effects such as dryness of the mouth, constipation, urinary retention and blurred vision. May also cause elation or depression, irritability and nightmares.



Immune system disorders: hypersensitivity reactions, anaphylaxis.



4.9 Overdose



Symptoms of overdosage may include nausea, vomiting, drowsiness, restlessness excitement, ataxia, respiratory depression and occasionally convulsions and hyperpyrexia. In cases of severe overdosage, the stomach should be emptied by aspiration and lavage. The patient should be kept quiet to minimise excitation which occurs particularly in children. The specific narcotic antagonist naloxone may be used to reverse any respiratory depression. Convulsions may be controlled with intravenous diazepam. Otherwise treatment should be symptomatic and supportive.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pholcodine is a cough suppressant with mild sedative but little analgesic action.



Diphenhydramine has antihistamine properties with a pronounced sedative action.



5.2 Pharmacokinetic Properties



Pholcodine is readily absorbed from the gastrointestinal tract. It can relieve local irritation of the respiratory tract for about 4 to 5 hours.



Peak plasma levels of diphenhydramine hydrochloride occur 2 to 4 hours after administration. Diphenhydramine is about 85 - 98% bound to plasma proteins. The plasma half life ranges form 2.4 to 8 hours.



Diphenhydramine undergoes extensive pre-systemic metabolism which results in 50% metabolism of an oral dose. The major route of elimination is in the urine, largely as metabolites with very little unchanged drug present.



5.3 Preclinical Safety Data



Not applicable.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Hyetellose



Glycerol



Liquid sugar



Citric acid monohydrate



Sodium citrate



Sodium benzoate



Quinoline yellow



Blue 12401



Alcohol



Grenadine flavour 514485E GIV (contains propylene glycol)



Purified water



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



36 months



6.4 Special Precautions For Storage



Do not store above 25°C.



6.5 Nature And Contents Of Container



1. A 50ml, 100ml, 125ml, 150ml, 200ml or 250ml glass bottle either with a child resistant polypropylene cap without a liner or a roll on pilfer proof cap with a liner.



2. A 50ml, 100ml, 125ml, 150ml, 200ml, or 250ml amber glass bottle either with a child resistant polypropylene cap without a liner or a roll on pilfer proof cap with a liner.



3. A 50ml, 100ml, 125ml, 150ml, 200ml or 250ml amber PET bottle fitted with a child resistant polypropylene cap and an expanded polyethylene liner.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



The Boots Company PLC



1 Thane Road West



Nottingham



NG2 3AA



Trading as: BCM



8. Marketing Authorisation Number(S)



PL 00014/0230



9. Date Of First Authorisation/Renewal Of The Authorisation



February 1981



10. Date Of Revision Of The Text



November 2009