Amiodarone-ELSaad (amp)
-
Chemical Name:
Amiodarone -
Therapeutic Category:
Cardiovascular drugs -
Pharmacologic Category:
Antiarrhythmic Agent, Class III -
Pharmaceutical Form:
Ampoule -
Composition:
amiodarone 150mg
AMIODARONE
Ampoule & Tablet
Amiodarone HCl
1-PHARMACOLOGY:
Amiodarone HCl is a class III anti-arrhythmic agent. It is used in the control of ventricular and supraventricular arrhythmias, including arrhythmias associated with Wolf-Parkinson-White syndrome.
Amiodarone HCl has been used in the treatment of angina pectoris.
2-INDICATION:
AMIODARONE is indicated only for the treatment of life-threatening recurrent ventricular arrhythmias when these have not responded to adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.
1-Recurrent ventricular fibrillation.
2-Recurrent hemodynamically unstable ventricular tachycardia.
AMIODARONE should be used only by physicians familiar with the product and with access to appropriate monitoring facilities (electrocardiographic and electrophysiologic techniques).
Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy and potential exacerbation of the arrhythmia, initiation of therapy with AMIODARONE should be carried out in the hospital.
3-CONTRAINDICATIONS:
Amiodarone HCl is contraindicated in severe sinus-node dysfunction, causing marked sinus bradycardia; second-or third-degree atrioventricular block; and when episodes of bradycardia have caused syncope (except when used in conjunction with a pacemaker).
Amiodarone HCl is contraindicated in patients with a known hypersensitivity to the drug or to any of its components, including iodine.
4-ADVERSE REACTION:
Few undesirable adverse effects associated with the use of Amiodarone HCl including severe bradycardia, conduction disturbances, severe hypotension.
Amiodarone HCl is reported to reduce the peripheral transformation of (T4) to (T3); it can affect thyroid function and may induce hypo-or hyperthyroidism.
Some other adverse reactions:
Gastrointestinal disorders: nausea, vomiting, constipation, anorexia.
Optical disorders: optic neuropathy, optic neuritis, corneal precipitation, iris pigmentations.
Dermal effects: photosensitivity, long-term amiodarone usage may produce dermal pigmentations.
Rarely hepatic disfunction, peripheral neuropathy and few rare cases of pulmonary neurological disorders.
It has been suggested that Amiodarone HCl induced phospholipidosis may explain some of its adverse effects; it also affects the hepatic enzymes.
5-WARNINGS:
- Amiodarone HCl is intended for use only in patients with the indicated life-threatening arrhythmias because amiodarone use is accompanied by substantial toxicity.
- Amiodarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity
- Liver injury is common with amiodarone, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases.
- Like other antiarrhythmics, amiodarone can exacerbate the arrhythmia
- Patients with the indicated arrhythmias must be hospitalized while the loading dose of Amiodarone HCl is given, and a response generally requires at least one week, usually two or more. Because absorption and elimination of Amiodarone HCl are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment.
- When Amiodarone HCl must be stopped it poses the risk of an interaction with whatever subsequent treatment is tried.
- Medsafe advices prescribers to conduct baseline lung, liver and thyroid function tests, an ECG, serum potassium levels and an ophthalmological examination before patients start treatment with amiodarone.
- In addition, medsafe recommended regular monitoring of patients receiving long-term amiodarone therapy, and continued monitoring of thyroid function for several months after amiodarone discontinuation.
6-PREGNANCY AND LACTATION:
Pregnancy Category D: Amiodarone can cause fetal harm when administered to a pregnant woman. Although amiodarone use during pregnancy is uncommon, there have been a small number of published reports of congenital goiter/hypothyroidism and hyperthyroidism. If amiodarone is used during pregnancy, or if the patient becomes pregnant while taking amiodarone, the patient should be apprised of the potential hazard to the fetus.
In general, amiodarone should be used during pregnancy only if the potential benefit to the mother justifies the unknown risk to the fetus.
Amiodarone and one of its major metabolites, are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug. Therefore, when amiodarone therapy is indicated, the mother should be advised to discontinue nursing.
7-DRUG INTERACTION:
- Amiodarone may alter the thyroid function tests.
- Amiodarone increases the anticoagulant effects of warfarine.
- Amiodarone increases the plasma concentration of digoxin and phenytoin
- Phenytoin reduces the plasma concentration of amiodarone
- Cimetidine increases the plasma concentration of amiodarone HCl
- Should be used with caution in patients under calcium channel-blockers treatment, and other arrhythmias and beta adrenergic-receptors antagonists.
- Grapefruit juice should not be taken during treatment with oral amiodarone. Grapefruit juice inhibits the metabolism of oral amiodarone in the intestinal mucosa, resulting, in increased plasma levels of amiodarone.
8-DOSAGE AND ADMINISTRATION:
AMIODARONE SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFETHREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT.
AMIODARONE Tablet:
In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of AMIODARONE has not been determined. Because of the food effect on absorption, AMIODARONE should be administered consistently with regard to meals. Individual patient titration is suggested according to the following guidelines:
For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of AMIODARONE in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced.
Grapefruit juice should not be taken during treatment with oral amiodarone.
Upon starting AMIODARONE therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs. When adequate arrhythmia control is achieved, or if side effects become prominent, AMIODARONE dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. AMIODARONE may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose.
| Loading Dose (Daily) |
Adjustment and Maintenance (Daily) |
Adjustment and Maintenance (Daily) |
|
| Ventricular Arrhythmias | 1 to 3 Weeks | ~1 month | Usual maintenance |
| 800 to 1,600 mg | 600 to 800 mg | 400 mg |
AMIODARONE Ampoule:
Intravenous injection: AMIODARONE may be given intravenously where facilities for close monitoring of cardiac function and resuscitation are available.
In emergencies it may be given in doses of (150-300) mg in (10-20) ml of 5 % glucose injection by slow I.V. injection.
A second injection should not be given until at least 15 minutes after the first dose.
Intravenous infusion: Usually in a dose of 5 mg per kg body-weight in 250 ml of 5 % glucose injection infused over 20 minutes to 2 hours, and repeated tree times in 24 hours to a maximum of 1.2 g/day.
9-PACKAGING AND COMPOSITION:
Amiodarone - Ampoule
Pack of 5 or 25 Ampoules
Each Ampoule 3 ml contains Amiodarone HCl 150 mg
Amiodarone - Tablet
Box contains 20 Tablets
Each tablet contains Amiodarone HCl 200 mg
Store AMIODARONE at room temperature protected from light
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