Medicinal Products

AMIODARONE ACTAVIS 200 mg

Generic drug from Cordarone
Therapeutic class: Cardiology and angiology
Active ingredients: Amiodarone
laboratory: Actavis Group Ptc Ehf

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 ACTAVIS 200 mg Breakable 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 ½ 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;

· The 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 ).

Adverse effects Amiodarone Actavis

Ocular manifestations:

Corneal micro-deposits, almost constant in adults, usually remain localized to the sub-pupillary area and do not contraindicate further 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 cases of optic neuropathy (optic neuritis) with visual blur and vision loss and papillary edema at the fundus have been reported. The evolution can be done to a more or less severe decrease in visual acuity. The relationship with amiodarone does not currently appear to be established. In the absence of other obvious etiology, however, it is recommended to discontinue treatment.

Skin manifestations:

Photosensitivity. During treatment it is advisable not to expose to the sun (and, in general, to ultraviolet rays).

Cases of erythema have also been reported during radiotherapy treatment.

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

Exceptional cases of cutaneous pigmentations, liliaceous or slate-gray, occur at high daily dosages, prescribed for a long time. After discontinuation 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 enough 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 bronchiolitis 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:

· Prolonged administration of amiodarone may result in sensory, motor, or mixed peripheral neuropathies and myopathies. They can occur only after a few months of treatment but sometimes after several years of treatment. They are usually reversible when treatment is stopped. However, this recovery may be incomplete, very slow and not appear until several months after stopping treatment.

· Other reported disorders: tremor or other extrapyramidal symptoms, cerebellar ataxia, exceptional benign intracranial hypertension, sleep disorders including nightmares.

Liver manifestations:

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

· Elevation of transaminases, isolated and generally moderate (1.5 times 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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