Medicinal Products

AMIODARONE RATIOPHARM 200 mg

Generic drug from Cordarone
Therapeutic class: Cardiology and angiology
Active ingredients: Amiodarone
laboratory: Ratiopharm Gmbh

Tablet breackable
Box of 30
All forms

Indication

Prevention of recurrence of:

· Life-threatening ventricular tachycardias: Treatment should be initiated in a hospital setting under monitoring;

· Documented symptomatic and disabling ventricular tachycardias;

· Documented supraventricular tachycardias when the need for treatment is established in the event of resistance or contraindication to other therapies;

· Ventricular fibrillations

Treatment of supraventricular tachycardias: slowing or reducing atrial fibrillation or atrial flutter.

Amiodarone may be used in the presence of coronary artery disease and / or impaired left ventricular function (see section 5.1 ).

Dosage AMIODARONE RATIOPHARM 200 mg scored tablet Box of 30

Attack treatment

The usual dosing schedule is 3 tablets daily, for 8 to 10 days.

In some cases the treatment of attack could use higher doses (4 to 5 tablets per day), always on short periods and under electrocardiographic monitoring.

Maintenance treatment

Look for the minimum effective dose, variable according to the patients, of 1/2 tablet per day (1 tablet every two days) to 2 tablets every day.

Against indications

This medicine is contraindicated in the following situations:

Sinus bradycardia and non-paired sino-atrial blocks

· Sinus disease not fitted (risk of sinus arrest);

· Unconditioned high-grade conductive disorders;

· Hyperthyroidism due to its possible aggravation by amiodarone;

· Known hypersensitivity to iodine or amiodarone;

· 2nd and 3rd trimesters of pregnancy

· Breastfeeding

· Combinations with drugs giving torsades de pointes:

class Ia antiarrhythmic agents (quinidine, hydroquinidine, disopyramide, etc.),

o class III antiarrhythmics (sotalol, dofetilide, ibutilide ...),

o certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol ...),

o other drugs such as: bepridil, cisapride, diphemanil, erythromycin IV, mizolastine, sparfloxacin, vincamine IV ...
(see section Interactions with other medicines and other forms of interaction ).

This medicine is usually not recommended in combination with diltiazem injection and halofantrine and pentamidine (see section 4.5 ).

Side effects Amiodarone Ratiopharm

Ocular manifestations: Corneal micro-deposits, almost constant in adults, usually remain localized to the sub-pupillary area and do not contraindicate the continuation of treatment. Exceptionally, they can be accompanied by perception of colored halos in dazzling light, or sensation of fog.

Corneal micro-deposits consist of complex lipid deposits and are always completely reversible when the treatment is stopped.

Some observations of optic neuropathy (optic neuritis) with visual blur and decreased vision and papillary edema at the fundus have been reported. The evolution can be done towards a more or less severe reduction of the visual acuity. The relationship with amiodarone does not currently appear to be established. However, it is recommended, in the absence of any other obvious etiology, to suspend treatment.

Skin manifestations: photosensitization. It is advisable not to expose yourself to the sun (and, in general, to ultraviolet rays) during treatment.

Cases of erythema have also been reported during radiotherapy.

Skin rash observations, usually not very specific, some exceptional cases of exfoliative dermatitis have been reported without the relationship with the product seems clearly established.

Exceptional cutaneous, liliaceous or slate-gray pigmentations occur at high daily dosages, prescribed for a long time; after cessation of treatment, the disappearance of these pigments is slow (10 to 24 months).

Thyroid manifestations:

· Apart from any clinical signs of dysthyroidism, a "dissociated" thyroid hormone (normal or slightly lowered T 4, T 3 increase ) does not justify stopping treatment.

· Hypothyroidism has a classic form: weight gain, apathy, somnolence; the clear elevation of the TSH signifies the diagnosis. Stopping administration leads to gradual return to euthyroidism within 1 to 3 months; this judgment is not mandatory: if the indication justifies it, amiodarone can be continued by combining L-thyroxine-based ophthalmic therapy, TSH constituting a dosing guide.

Hyperthyroidism is more misleading: pauci-symptomatic (slight unexplained weight loss, attenuation of anti-anginal and / or antiarrhythmic efficacy); psychiatric forms of the elderly, or even thyrotoxicosis. The collapse of the ultra-sensitive TSH makes it possible to affirm the diagnosis.

Stopping amiodarone is imperative: it is usually sufficient to initiate, within 3-4 weeks, the clinical cure. Severe cases that may lead to the death of the patient require urgent treatment with appropriate treatment. When thyrotoxicosis is of concern, in itself or because of its impact on a precarious myocardial balance, the inconsistent efficacy of synthetic antithyroid drugs leads to the recommendation of a frank corticosteroid (1 mg / kg) and sufficiently prolonged (3 months).

Cases of hyperthyroidism have been reported up to several months after stopping amiodarone.

Pulmonary manifestations

Cases of diffuse interstitial or alveolar pneumopathy and organized broncholitis obliterans (BOOP) have been reported.

The appearance of a dyspnea of ​​effort, isolated or associated with an alteration of the general state (fatigue, slimming, feverishness) imposes a radiological control and if necessary, the stop of the treatment. These pneumopathies can indeed evolve into pulmonary fibrosis.

Early discontinuation of amiodarone, with or without corticosteroid therapy, leads to regression of the disorders. The clinical signs usually disappear in 3 or 4 weeks, the radiological and functional improvement is slower (several months).

Some cases of pleurisy, usually associated with interstitial lung disease and some cases of bronchospasm have been reported.

Some cases of acute respiratory distress syndromes have been observed, usually immediately following a surgical procedure (a possible interaction with high doses of oxygen has been evoked) (see section Interactions with other medicinal products and other forms interactions ).

Neurological effects

They are rare:

Peripheral sensitivo-motor neuropathies and / or myopathies, usually reversible upon discontinuation of treatment;

· Other disorders reported: extra-pyramidal tremor, cerebellar ataxia, exceptional benign intracranial hypertension, nightmares.

Liver manifestations

Cases of liver disease have been reported; these cases were diagnosed by elevated serum transaminases. Indeed, have been reported:

· Transaminase elevation, isolated and generally moderate (1.5 to 3 times normal) regressing after dose reduction, or even spontaneously.

· Exceptional acute hepatopathy (some isolated cases) with hypertransaminasemia and / or jaundice, sometimes fatal, requiring discontinuation of treatment.

· Rare cases of chronic liver disease during prolonged treatment.
The histology is that of a pseudo-alcoholic hepatitis. Discretion of the clinical and biological picture (inconsistent hepatomegaly, hypertransaminasemia between 1.5 and 5 times normal) justifies regular monitoring of liver function. Hypertransaminasemia, even moderate, occurring after a treatment of more than 6 months should evoke the diagnosis of chronic liver disease. Clinical and biological disorders usually regress after stopping treatment. Some cases of irreversible evolution have been reported.

Cardiac effects

· Bradycardia generally moderate, dose-dependent. In some cases (sinus dysfunction, elderly), marked bradycardia, more rarely sinus arrest, have been reported.
Rarely: conduction disturbances (sinoatrial block, atrioventricular blocks of different degrees).
The arrhythmogenic effect of amiodarone is low, lower than that of most anti-arrhythmic drugs and usually occurs with certain combinations (see section Interactions with other medicinal products and other forms of interaction ) or with electrolyte disturbances.

Various effects

· Benign digestive disorders (nausea, vomiting, dysgeusia) usually contemporaneous with the attack treatment and disappearing with the reduction of dosage. Some observations of epididymitis have been reported. The relationship with the product does not appear to be established. Some cases of alopecia have been observed.

· A few isolated cases, of different expression, have been observed in a context suggestive of a hypersensitivity reaction: vasculitis, renal damage with moderate elevation of creatinine, thrombocytopenia.

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