Saturday, September 14, 2013


Amiodarone hydrochloride 
Composition: Amiodarone hydrochloride 200 mg 
Excipients: Lactose, corn starch, povidone, colloidal silica anhydrous, magnesium stearate for one scored tablet 
When this medicine should be used: It is used in preventing and treating certain cardiac rhythm disorders 
Attention: In what cases not to be used: 
Contraindications: Not to be used in the following cases: - Known allergy to iodine of amiodarone or one of the other constituents of the product - Hyperthyroidism - some troubles of arrhythmias and / or cardiac conduction - Very slow cardiac rhythm - Starting from the 1st trimester of the pregnancy - Lactation - In combination with drugs that can give torsades de pointes 
(serious heart rhythm disturbances): Antiarrhythmics clss I 
(quinidine, hydroquinidine, disopyramide), Antiarrhythmics class 
Ill (sotalol, dofetilide, ibutilide) 
- Suttopride (Neuroleptic) - Other drugs such as (bepridil, cisapride, diphernanhl, erythromycin IV, Spiramycin IV) (Drug interactions and other interactions). 
Special warning: 
- Using Amiodarone with Simvastatin in dose more than 20mg: 
may increase risk of Rhabdoniyolysis 
- Tell your doctor In case of acute shortness of breath, difficulty of breathing, dry cough which could be isolated or associated with an alteration of general condition, fatigue, persistent fever, __________ unexplained diarrhea, weight loss, muscle pain, reduced vision, or in case of recurrence of too fast heart beats. - Due to presence of lactose, this drug should not be used in case of congenital galactosemia, malabsorption of glucose and galactose or lactase deficiency (rare metabolic diseases) 
for use: - Protect yourself from the sun for the whole duration of treatment to avoid the occurrence of “sunburn”. - During treatment, blood tests should be applied to monitor your thyroid or liver functions. - Before surgery inform your Anesthesiologist that you have been treated with Amiodarone. - Tolerance and efficacy is not known in children. Drug interactions & other interactions: - To avoid possible interactions between multiple drugs you should report any ongoing treatment to your doctor. - This drug should not be used in association with susceptible drugs which may induce torsades de polities (serious heart rhythm disturbances) such as drags indicated to treat rhythm disorders (quinidine. hydroquinidine, disopyramide, dofetilide, ibutilide, sotalol) and other drugs such as (bepridil, cisapride, diphemanil, erythromycin IV, Spiramycin IV). - These contraindications are not applicable in ease of cardiac failure associated with ventricular fibrillation resistant to external shock. - This drug should be avoided in association with cyclosporine, diltiazem injection, verapamil, some antiparasites (halofantrine, lumefantrine, pentamidine) some neuroleptics (chlorpromazinc, cyamemazine, levomepromazine, thioridazine, trifluoperuzine, amisuipride, sulpride, tiapride, veralipride, droperidol, haloperidol, pimozide) and with methadone. Pregnancy & Lactation: - Due to the presence of iodine, use of this drug is contraindicated starting from the 1st trimester of pregnancy. - In ease of treatment by this drug breastfeeding is contraindicated.
- In general, you should inform your doctor or your pharmacist before using this drug during pregnancy and Lactation. Dose: The usual dose is highly variable from one person to another but the usual dose is: Acute Attack treatment: 3 tablets per day for 8 to 10 days Maintenance treatment: 1/2 tablet to 2 tablets per day In all cases, you must not change or stop the dose without medical advice. Route of administration: Oral Frequency and time at which the drug should be administrated: Tablets can be swallowed before, during or between meals, the fact of crushing the tablets does not alter their properties. Treatment duration: Seek strictly the order of your doctor. In case of overdose: 
In case you took an excessive dose, call your doctor as soon as possible or call any poison control center in your area What to do if you forgot to take your dose? 
In case you forgot to take a dose, there is no particular risk. Do not take a double dose to make up the single dose you have missed. 
Undesirable effects: As other active products, this drug may cause some undesirable effects for some people. 
This should be reported to your doctor who will advise whether you should continue or stop your treatment 
Very frequently: 
- Visual disturbances (colored halos around objects) - Skin reaction to sunlight - Changes in thyroid hormones without clinical signs of thyroid disease - Increase liver enzymes levels in the blood (transaminase) - Benign digestive symptoms (nausea, vomiting, dysphagia) - Thyroid disease (weight gain, nervousness and fatigue, or contrary, excessive weight loss and diarrhea) - Respiratory problems (shortness of breath, breathlessness, fever, dry cough) - Tremors - Sleep disturbances including nightmares - Difficulty walking (damage of nerves endings) - Acute liver damage and / orjaundice, which can be very serious - Slow heart rate Little frequently: - Cardiac conduction disturbances - Injury of limb muscles 
Very rarely: 
- Blurred vision or decreased vision - Skin reactions with redness and itching - Hair Loss - Breathing problems in asthmatic patients and / or during surgical procedure which can be very serious - Chronic hepatitis - Slowing of heart rate - Decrease of blood platelets 
• Kidney damage 
- Headache (at the onset of headache, see your doctor). 
Inform your doctor or pharmacist about any undesirable effects not 
mentioned in this Icatlet 
Storage: Do not exceed the cxpiry date mentioned on the pack. 
Store at temperature ‘not exceeding 25’C, in a dry place. 
Presentation: Carton box containing 3 blisters of 10 scored tablets each. Keep out of reach of children  GLOBAL NAPI PHARMACEUTICALS _... 2’ Irrdastriol Zone, 6’of October City. Egypt 
I aVenhlS Under license of Sanofi Aventis - France

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