Imigen may be available in the countries listed below.
Ingredient matches for Imigen
Sumatriptan
Sumatriptan is reported as an ingredient of Imigen in the following countries:
- South Africa
International Drug Name Search
Sunday, 26 August 2012
Nitrodur 0.6
Generic Name: nitroglycerin (Transdermal route)
nye-troe-GLIS-er-in
Commonly used brand name(s)
In the U.S.
- Minitran
- Nitrek
- Nitro-Bid
- Nitro-Dur
In Canada
- Nitrodur 0.2
- Nitro-Dur 0.2
- Nitro-Dur 0.3
- Nitrodur 0.4
- Nitro-Dur 0.4
- Nitrodur 0.6
- Nitro-Dur 0.6
- Nitro-Dur 0.8
- Transderm-Nitro
- Trinipatch 0.2
- Trinipatch 0.4
- Trinipatch 0.6
Available Dosage Forms:
- Ointment
- Patch, Extended Release
Therapeutic Class: Antianginal
Chemical Class: Nitrate
Uses For Nitrodur 0.6
Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.
Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.
This medicine is available only with your doctor's prescription.
Before Using Nitrodur 0.6
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin transdermal in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Sildenafil
- Tadalafil
- Vardenafil
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alteplase, Recombinant
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acetylcysteine
- Aspirin
- Dihydroergotamine
- Pancuronium
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cardioversion (medical heart procedure) or
- Defibrillation (medical heart procedure)—Use with caution. The patch should be removed before having these procedures.
- Congestive heart failure or
- Heart attack, recent or
- Hypertrophic cardiomyopathy (a heart disease) or
- Hypotension (low blood pressure) or
- Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.
Proper Use of nitroglycerin
This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitrodur 0.6. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.
This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.
You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
For patients using the ointment:
- Before applying a new dose of ointment, remove any ointment remaining on the skin from a previous dose. This will allow the fresh ointment to release the nitroglycerin properly.
- This medicine comes with papers to help measure the dose. Use them to measure the length of ointment squeezed from the tube and to apply the ointment to the skin. Do not rub or massage the ointment into the skin. Spread it in a thin, even layer, and cover an area of skin that is the same size each time it is applied.
- Apply the ointment to skin with little or no hair that is free of scars, cuts, or irritation.
- Apply each dose of ointment to a different area of skin to prevent irritation.
- If your doctor has ordered an airtight covering or dressing (such as plastic kitchen wrap) be placed over this medicine, make sure you know how to apply it. Airtight dressings will increase the amount of medicine absorbed through the skin and may cause more side effects. Use them only as directed and check with your doctor if you have any questions about this.
For patients using the patch system:
- Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
- Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.
- Apply the patch to a clean, dry skin area with little or no hair that is free of scars, cuts, or irritation.
- Always remove a previous patch before applying a new one.
- Apply a new patch if the first one becomes loose or falls off.
- Apply each patch to a different area to prevent skin irritation.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For angina prevention:
- For transdermal dosage form (ointment):
- Adults—At first, 7.5 milligrams (mg), one-half inch of ointment, two times a day. Apply the first dose in the morning right after you wake up, and the second dose 6 hours later. Your doctor may increase your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For transdermal dosage form (skin patch):
- Adults—Apply one patch once a day in the morning. Leave the patch in place for a total of 12 to 14 hours.
- Children—Use and dose must be determined by your doctor.
- For transdermal dosage form (ointment):
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.
Precautions While Using Nitrodur 0.6
If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.
This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.
Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.
Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.
Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.
Nitrodur 0.6 Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Lightheadedness
- Arm, back, or jaw pain
- blurred vision
- chest pain or discomfort
- chest tightness or heaviness
- confusion
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- fainting
- fast or irregular heartbeat
- nausea
- shortness of breath
- sweating
- unusual tiredness or weakness
- Bluish-colored lips, fingernails, or palms
- dark urine
- difficulty with breathing
- fever
- headache
- pale skin
- rapid heart rate
- sore throat
- unusual bleeding or bruising
- Blistering, burning, crusting, dryness, or flaking of the skin
- cough
- difficulty with swallowing
- hives
- itching, scaling, severe redness, soreness, or swelling of the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash
- wheezing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred or loss of vision
- bulging soft spot on the head of an infant
- change in consciousness
- change in the ability to see colors, especially blue or yellow
- cold, clammy skin
- disturbed color perception
- double vision
- feeling of constant movement of self or surroundings
- halos around lights
- headache, severe and throbbing
- loss of consciousness
- night blindness
- overbright appearance of lights
- paralysis
- sensation of spinning
- tunnel vision
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Rare
- Burning, itching, redness, skin rash, swelling, or soreness at the application site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Nitrodur 0.6 side effects (in more detail)
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More Nitrodur 0.6 resources
- Nitrodur 0.6 Side Effects (in more detail)
- Nitrodur 0.6 Use in Pregnancy & Breastfeeding
- Nitrodur 0.6 Drug Interactions
- Nitrodur 0.6 Support Group
- 0 Reviews for Nitrodur 0.6 - Add your own review/rating
Compare Nitrodur 0.6 with other medications
- Angina
- Angina Pectoris Prophylaxis
- Heart Attack
- Heart Failure
- High Blood Pressure
Saturday, 25 August 2012
Vi-Daylin with Iron
Generic Name: multivitamin with iron (MUL tee VYE ta mins with i ron)
Brand Names:
What is Vi-Daylin with Iron (multivitamin with iron)?
Multivitamin are a combination of many different vitamins that are normally found in foods and other natural sources.
Iron is normally found in foods like red meat. In the body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.
Multivitamin and iron are used to provide vitamins and iron that are not taken in through the diet. They are also used to treat iron or vitamin deficiencies caused by illness, pregnancy, poor nutrition, digestive disorders, and many other conditions.
Multivitamin and iron may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Vi-Daylin with Iron (multivitamin with iron)?
Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects. Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms if you take too much.
Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).
Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin with iron.
What should I discuss with my healthcare provider before taking Vi-Daylin with Iron (multivitamin with iron)?
Iron and certain vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.
If you have any medical conditions, ask your doctor before taking a multivitamin with iron. If you have certain conditions, you may need a certain vitamin formulation or special tests while taking this product.
Do not take multivitamin with iron without telling your doctor if you are pregnant or plan to become pregnant. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. Multivitamin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Vi-Daylin with Iron (multivitamin with iron)?
Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.
Never take more than the recommended dose of multivitamin with iron. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.
Many multivitamin products also contain minerals such as calcium, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.
Take your multivitamin with a full glass of water. You may take the multivitamin with food if it upsets your stomach.
The chewable tablet must be chewed or allowed to dissolve in the mouth before swallowing.
Measure the liquid form of this multivitamin using a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Liquid multivitamin may sometimes be mixed with water, fruit juice, or infant formula (but not milk or other dairy products). Follow the directions on the medicine label.
Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.
It is important to take multivitamin with iron regularly to get the most benefit.
Store this medication at room temperature away from moisture and heat. Keep the liquid medicine from freezing.
Store multivitamin in their original container. Storing multivitamin in a glass container can ruin the medication.
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, skip the missed dose and take the medicine at the next regularly scheduled time. 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. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms.
Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).
What should I avoid while taking Vi-Daylin with Iron (multivitamin with iron)?
Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.
Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.
Avoid taking an antibiotic medicine within 2 hours before or after you take multivitamin with iron. This is especially important if you are taking an antibiotic such as ciprofloxacin (Cipro), demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), norfloxacin (Noroxin), ofloxacin (Floxin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).
Certain foods can also make it harder for your body to absorb iron. Avoid taking this multivitamin within 1 hour before or 2 hours after eating fish, meat, liver, and whole grain or "fortified" breads or cereals.
Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.
Vi-Daylin with Iron (multivitamin with iron) 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 serious side effects such as:
bright red blood in your stools; or
pain in your chest or throat when swallowing a ferrous fumarate tablet.
When taken as directed, multivitamin are not expected to cause serious side effects. Less serious side effects may include:
constipation, diarrhea;
nausea, vomiting, heartburn;
stomach pain, upset stomach;
black or dark-colored stools or urine;
temporary staining of the teeth;
headache; or
unusual or unpleasant taste in your mouth.
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 Vi-Daylin with Iron (multivitamin with iron)?
Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking multivitamin with iron, tell your doctor if you also use:
acetohydroxamic acid (Lithostat);
cimetidine (Tagamet);
deferoxamine (Desferal);
etidronate (Didronel);
diuretics (water pills);
heart or blood pressure medications;
tretinoin (Vesanoid);
isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);
dimercaprol (an injection used to treat poisoning by arsenic, lead, or mercury);
penicillamine (Cuprimine);
pancrelipase (Cotazym, Creon, Ilozyme, Pancrease, Ultrase);
trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Septra, TMP/SMX); or
an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.
This list is not complete and there may be other medications that can interact with or be affected by multivitamin with iron. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More Vi-Daylin with Iron resources
- Vi-Daylin with Iron Side Effects (in more detail)
- Vi-Daylin with Iron Use in Pregnancy & Breastfeeding
- Vi-Daylin with Iron Drug Interactions
- Vi-Daylin with Iron Support Group
- 0 Reviews for Vi-Daylin with Iron - Add your own review/rating
- Multivitamin with Iron Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
- Anemagen MedFacts Consumer Leaflet (Wolters Kluwer)
- BiferaRx MedFacts Consumer Leaflet (Wolters Kluwer)
- Chromagen Forte MedFacts Consumer Leaflet (Wolters Kluwer)
- Ferocon MedFacts Consumer Leaflet (Wolters Kluwer)
- Ferotrin Prescribing Information (FDA)
- Ferralet 90 Prescribing Information (FDA)
- Ferralet 90 MedFacts Consumer Leaflet (Wolters Kluwer)
- Ferrex 150 Forte Prescribing Information (FDA)
- Ferrex 150 Forte Plus Prescribing Information (FDA)
- Ferrex 150 Forte Plus MedFacts Consumer Leaflet (Wolters Kluwer)
- Ferrex 28 Prescribing Information (FDA)
- FerroGels Forte MedFacts Consumer Leaflet (Wolters Kluwer)
- FerroGels Forte Prescribing Information (FDA)
- FoliTab 500 MedFacts Consumer Leaflet (Wolters Kluwer)
- Fumatinic MedFacts Consumer Leaflet (Wolters Kluwer)
- Hematogen Forte Prescribing Information (FDA)
- Integra MedFacts Consumer Leaflet (Wolters Kluwer)
- Integra F MedFacts Consumer Leaflet (Wolters Kluwer)
- Integra F Prescribing Information (FDA)
- Integra Plus MedFacts Consumer Leaflet (Wolters Kluwer)
- Integra Plus Prescribing Information (FDA)
- Irospan 24/6 MedFacts Consumer Leaflet (Wolters Kluwer)
- Irospan 24/6 Prescribing Information (FDA)
- NovaFerrum Prescribing Information (FDA)
- NovaFerrum MedFacts Consumer Leaflet (Wolters Kluwer)
- Proferrin-Forte MedFacts Consumer Leaflet (Wolters Kluwer)
- Tricon Prescribing Information (FDA)
Compare Vi-Daylin with Iron with other medications
- Anemia
- Vitamin/Mineral Supplementation and Deficiency
Where can I get more information?
- Your pharmacist can provide more information about multivitamin with iron.
See also: Vi-Daylin with Iron side effects (in more detail)
Cambia
Generic Name: diclofenac (dye KLOE fen ak)
Brand Names: Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor
What is diclofenac?
Diclofenac is a non steroidal anti inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain inflammation.
Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis.
Diclofenac powder (Cambia) is used to treat a migraine headache attack. Do not use this medication to treat a cluster headache.
Cambia will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.
Diclofenac may also be used for purposes not listed in this medication guide.
What is the most important information I should know about diclofenac?
This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use diclofenac just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac, especially in older adults.
Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Ask a doctor or pharmacist before using any cold, allergy, or other pain medicine. Medicines similar to diclofenac are contained in many combination medicines. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid drinking alcohol. It may increase your risk of stomach bleeding.
What should I discuss with my healthcare provider before taking diclofenac?
Do not use diclofenac just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.
This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac, especially in older adults.
You should not use this medication if you are allergic to diclofenac, or if you have a history of allergic reaction to aspirin or other NSAIDs.
To make sure you can safely take diclofenac, tell your doctor if you have any of these other conditions:
a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
a history of stomach ulcers or bleeding;
- liver or kidney disease,
asthma;
polyps in your nose;
a bleeding or blood clotting disorder; or
if you smoke.
FDA pregnancy category D. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking diclofenac during the last 3 months of pregnancy may harm the unborn baby. Do not take diclofenac during pregnancy unless your doctor has told you to. It is not known whether diclofenac passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using diclofenac. Do not give this medicine to a child younger than 18 years old without medical advice.
How should I take diclofenac?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
If you switch brands of diclofenac, your dose needs may change. Follow your doctor's instructions about how much medicine to take.
Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Dissolve the diclofenac powder (Cambia) with 1 to 2 ounces of water. Do not use any other type of liquid. Stir this mixture and drink all of it right away. Diclofenac powder works best if you take it on an empty stomach.
Call your doctor if your headache does not completely go away after taking Cambia. Do not take a second dose of diclofenac powder without your doctor's advice.
Do not crush, chew, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating.
If you use this medication long-term, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, and fainting.
What should I avoid while taking diclofenac?
Ask a doctor or pharmacist before using any cold, allergy, or other pain medicine. Medicines similar to diclofenac are contained in many combination medicines. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid drinking alcohol. It may increase your risk of stomach bleeding. Avoid exposure to sunlight or tanning beds. Diclofenac can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Diclofenac 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. Stop using diclofenac and call your doctor at once if you have a serious side effect such as:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
swelling or rapid weight gain, urinating less than usual or not at all;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
bruising, severe tingling, numbness, pain, muscle weakness;
neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
upset stomach, mild heartburn or stomach pain, diarrhea, constipation bloating, gas;
dizziness, headache, nervousness;
skin itching or rash;
blurred vision; or
ringing in your ears.
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 diclofenac?
Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Tell your doctor about all other medications you use, especially:
a blood thinner such as warfarin (Coumadin, Jantoven);
cyclosporine (Gengraf, Neoral, Sandimmune);
isoniazid (for treating tuberculosis);
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexall);
pronbenecid (Benemid);
rifampin (Rifadin, Rifater, Rifamate);
secobarbital (Seconal);
sertraline (Zoloft);
sulfamethoxazole (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);
teniposide (Vumon);
zafirlukast (Accolate);
a diuretic (water pill) such as furosemide (Lasix).
steroids (prednisone and others);
antifungal medication such as fluconazole (Diflucan) or voriconazole (Vfend);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), indomethacin (Indocin), meloxicam (Mobic), and others;
cholesterol-lowering medicine such as fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, TriCor, Triglide), fluvastatin (Lescol), or lovastatin (Mevacor, Altoprev, Advicor); or
heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.
This list is not complete and other drugs may interact with diclofenac. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Cambia resources
- Cambia Side Effects (in more detail)
- Cambia Use in Pregnancy & Breastfeeding
- Cambia Drug Interactions
- Cambia Support Group
- 2 Reviews for Cambia - Add your own review/rating
- Cambia Advanced Consumer (Micromedex) - Includes Dosage Information
- Cambia Prescribing Information (FDA)
- Cambia Consumer Overview
- Cambia Powder Packets MedFacts Consumer Leaflet (Wolters Kluwer)
- Diclofenac MedFacts Consumer Leaflet (Wolters Kluwer)
- Diclofenac Prescribing Information (FDA)
- Diclofenac Professional Patient Advice (Wolters Kluwer)
- Cataflam Prescribing Information (FDA)
- Cataflam Immediate-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Cataflam Consumer Overview
- Voltaren Prescribing Information (FDA)
- Voltaren Drops MedFacts Consumer Leaflet (Wolters Kluwer)
- Voltaren Consumer Overview
- Zipsor Prescribing Information (FDA)
- Zipsor Consumer Overview
- diclofenac epolamine Monograph (AHFS DI)
Compare Cambia with other medications
- Migraine
Where can I get more information?
- Your pharmacist can provide more information about diclofenac.
See also: Cambia side effects (in more detail)
Friday, 24 August 2012
Juveacne Zinc
Juveacne Zinc may be available in the countries listed below.
Ingredient matches for Juveacne Zinc
Erythromycin
Erythromycin is reported as an ingredient of Juveacne Zinc in the following countries:
- Peru
Zinc Acetate
Zinc Acetate is reported as an ingredient of Juveacne Zinc in the following countries:
- Peru
International Drug Name Search
Xolair Solution for Injection
1. Name Of The Medicinal Product
Omalizumab
Omalizumab
2. Qualitative And Quantitative Composition
Xolair 75 mg solution for injection:
Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab*.
Xoliar 150 mg solution for injection:
Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab*.
*Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
Clear to opalescent, slightly yellow to brown solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).
Adults and adolescents (12 years of age and older)
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Children (6 to <12 years of age)
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
4.2 Posology And Method Of Administration
Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma.
Posology
The appropriate dose and frequency of Xolair is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to administration of the initial dose, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment. Based on these measurements, 75 to 600 mg of Xolair in 1 to 4 injections may be needed for each administration.
Patients with IgE lower than 76 IU/ml were less likely to experience benefit (see section 5.1). Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to < 12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts in adults, adolescents and children (6 to <12 years of age).
Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given Xolair.
The maximum recommended dose is 600 mg omalizumab every two weeks.
Table 1: Conversion from dose to number of syringes, number of injections and total injection volume for each administration
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Table 2: ADMINISTRATION EVERY 4 WEEKS. Xolair doses (milligrams per dose) administered by subcutaneous injection every 4 weeks
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Table 3: ADMINSTRATION EVERY 2 WEEKS. Xolair doses (milligrams per dose) administered by subcutaneous injection every 2 weeks
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Treatment duration, monitoring and dose adjustments
Xolair is intended for long-term treatment.Clinical trials have demonstrated that it takes at least 12
Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms. Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.
Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).
Special populations
Elderly (65 years of age and older)
There are limited data available on the use of Xolair in patients older than 65 years but there is no evidence that elderly patients require a different dose from younger adult patients.
Renal or hepatic impairment
There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of Xolair. Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment. While no particular dose adjustment is recommended for these patients, Xolair should be administered with caution (see section 4.4).
Paediatric population
The safety and efficacy of Xolair in children below age 6 have not been established. No data are available.
Method of administration
For subcutaneous administration only. Do not administer by the intravenous or intramuscular route.
The injections are administered subcutaneously in the deltoid region of the arm. Alternatively, the injections can be administered in the thigh if there is any reason precluding administration in the deltoid region.
There is limited experience with self-administration of Xolair. Therefore treatment is intended to be administered by a healthcare provider only (see section 6.6 and also information for the healthcare professional section of the package leaflet).
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special Warnings And Precautions For Use
General
Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis, or allergic rhinitis. Xolair is not indicated for the treatment of these conditions.
Xolair therapy has not been studied in patients with autoimmune diseases, immune complex-mediated conditions, or pre-existing renal or hepatic impairment (see section 4.2). Caution should be exercised when administering Xolair in these patient populations.
Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of Xolair therapy is not recommended. Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually.
Immune system disorders
• Allergic reactions type I
Type I local or systemic allergic reactions, including anaphylaxis and anaphylactic shock, may occur when taking omalizumab, also with onset after a long duration of treatment. Most of these reactions occurred within 2 hours after the first and subsequent injections of Xolair but some started beyond 2 hours and even beyond 24 hours after the injection. Therefore medicinal products for the treatment of anaphylactic reactions should always be available for immediate use following administration of Xolair. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.
Anaphylactic reactions were rare in clinical trials (see section 4.8).
Antibodies to omalizumab have been detected in a low number of patients in clinical trials trials (see section 4.8). The clinical relevance of anti-Xolair antibodies is not well understood.
• Serum sickness
Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab. The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab. The onset has typically been 1
• Churg-Strauss syndrome and hypereosinophilic syndrome
Patients with severe asthma may rarely present systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), both of which are usually treated with systemic corticosteroids.
In rare cases, patients on therapy with anti-asthma medicinal products, including omalizumab, may present or develop systemic eosinophilia and vasculitis. These events are commonly associated with the reduction of oral corticosteroid therapy.
In these patients, physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications, and/or neuropathy.
Discontinuation of omalizumab should be considered in all severe cases with the above mentioned immune system disorders.
Malignancies
During clinical trials in adults and adolescents 12 years of age and older, there was a numerical imbalance in cancers arising in the Xolair (0.5%; 25 cancers in 5,015 patients) treatment group compared with the control (0.18%; 5 cancers in 2,854 patients) group. Malignancies were uncommon (<1/100) in both the active and the control group. The diversity in the type of cancers observed, the relatively short duration of exposure and the clinical features of the individual cases render a causal relationship unlikely. The overall observed incidence rate of malignancy in the Xolair clinical trial programme was comparable to that reported in the general population.
Parasitic (helminth) infections
IgE may be involved in the immunological response to some helminth infections. In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered. The helminth infection rate in the overall clinical programme, which was not designed to detect such infections, was less than 1 in 1,000 patients. However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic. If patients do not respond to recommended anti-helminth treatment, discontinuation of Xolair should be considered.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions. Medicinal product or vaccine interaction studies have not been performed with Xolair. There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma will interact with omalizumab.
In clinical studies Xolair was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short-acting and long-acting beta agonists, leukotriene modifiers, theophyllines and oral antihistamines. There was no indication that the safety of Xolair was altered with these other commonly used anti-asthma medicinal products. Limited data are available on the use of Xolair in combination with specific immunotherapy (hypo-sensitisation therapy). In a clinical trial where Xolair was co-administered with immunotherapy, the safety and efficacy of Xolair in combination with specific immunotherapy were found to be no different to that of Xolair alone.
Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
4.6 Pregnancy And Lactation
Pregnancy
There are no adequate data from the use of omalizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Omalizumab crosses the placental barrier and the potential for harm to the foetus is unknown. Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals (see section 5.3). Xolair should not be used during pregnancy unless clearly necessary.
Breast-feeding
It is not known whether omalizumab is excreted in human breast milk. Omalizumab is excreted into non-human primate breast milk and risk to the suckling child cannot be excluded. Women should not breast-feed during Xolair therapy.
Fertility
There are no human fertility data for omalizumab. In specifically-designed non-clinical fertility studies, including mating studies, no impairment of male or female fertility was observed following repeated dosing with omalizumab at dose levels up to 75 mg/kg. Furthermore, no genotoxic effects were observed in separate non-clinical genotoxicity studies (see section 5.3).
4.7 Effects On Ability To Drive And Use Machines
Xolair has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable Effects
Over 4,400 allergic asthma patients were randomised in controlled efficacy trials with Xolair.
During clinical trials in adult and adolescent patients 12 years of age and older, the most commonly reported adverse reactions were injection site reactions, including injection site pain, swelling, erythema and pruritus, and headaches. In clinical trials in children 6 to <12 years of age, the most commonly reported adverse reactions suspected of being related to the medicinal product were headache, pyrexia and upper abdominal pain. Most of the reactions were mild or moderate in severity.
Table 4 lists the adverse reactions recorded in clinical studies in the total safety population treated with Xolair by MedDRA system organ class and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequency categories are defined as: very common (
Table 4: Adverse reactions
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*: Very common in children 6 to <12 years of age
**: In children 6 to <12 years of age
Immune system disorders
For further information, see section 4.4.
Malignancies
The overall observed incidence rate of malignancy in adults and in adolescents 12 years of age and older in the Xolair clinical trial programme was comparable to that reported in the general population (see section 4.4).
There were no cases of malignancy with omalizumab in the clinical trials in children 6 to <12 years of age; there was a single case of malignancy in the control group.
Arterial thromboembolic events (ATE)
In controlled clinical trials and an ongoing observational study, a numerical imbalance of ATEs was observed. ATE included stroke, transient ischaemic attack, myocardial infarction, unstable angina, and cardiovascular death (including death from unknown cause). The rate of ATE in patients in the controlled clinical trials was 6.29 for Xolair-treated patients (17/2703 patient years) and 3.42 for control patients (6/1755 patient years). In Cox proportional hazards model, Xolair was not associated with ATE risk (hazard ratio 1.86; 95% confidence interval 0.73
Platelets
In clinical trials few patients had platelet counts below the lower limit of the normal laboratory range. None of these changes were associated with bleeding episodes or a decrease in haemoglobin. No pattern of persistent decrease in platelet counts, as observed in non-human primates (see section 5.3), has been reported in humans (patients above 6 years of age), even though isolated cases of idiopathic thrombocytopenia have been reported in the post-marketing setting.
Parasitic infections
In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight numerical increase in infection rate with omalizumab that was not statistically significant. The course, severity, and response to treatment of infections were unaltered (see section 4.4).
4.9 Overdose
Maximum tolerated dose of Xolair has not been determined. Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities. The highest cumulative dose administered to patients was 44,000 mg over a 20
If an overdose is suspected, the patient should be monitored for any abnormal signs or symptoms. Medical treatment should be sought and instituted appropriately.
5. Pharmacological Properties
5.1 Pharmacodyna
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