Medicinal Products

AMIODARONE BIOGARAN 200 mg

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

Tablet breackable
box of 1 bottle 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.

· Supraventricular tachycardias documented 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 impairment of left ventricular function (see section 5.1 ).

Dosage AMIODARONE BIOGARAN 200 mg scored tablet box of 1 vial of 30

Prevention of recurrence of:

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

· Documented symptomatic and disabling ventricular tachycardias.

· Supraventricular tachycardias documented 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 impairment of left ventricular function (see section 5.1 ).

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).

· Atrioventricular conductive disorders of high degree not paired.

· Hyperthyroidism due to its possible aggravation by amiodarone.

· Known hypersensitivity to iodine or amiodarone or to any of the excipients.

· The 2nd and 3rd trimesters of pregnancy

· Breastfeeding

· Combinations with drugs giving torsades de pointes:

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

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

o other drugs such as: arsenious, bepridil, cisapride, diphemanil, dolasetron IV erythromycin IV, mizolastine, vincamine IV, moxifloxacin, spiramycin IV, toremifene (see section 4.5).

Adverse effects Amiodarone Biogaran

Adverse reactions were classified by organ system and frequency according to the following conventions:

Very frequently (≥10%); frequently (≥ 1%, <10%); infrequently (≥ 0.1%, <1%); rarely (≥ 0.01%, <0.1%); very rarely (<0.01%).

Eye disorders:

Very frequently:

Corneal micro-deposits, almost constant in the adult, usually remaining localized to the sub-pupillary area and not counter-indicating the continuation of the 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.

Very rarely :

Optic neuropathies (optic neuritis) with visual blur and vision loss and papillary edema at the back of the eye. 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 and subcutaneous tissue disorders:

Very frequently:

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

Frequently

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

Very rarely :

Erythema during radiotherapy.

Skin rashes, usually not very specific.

Exfoliative dermatitis, without the relationship with the product being clearly established.

Alopecia.

Endocrine disorders:

· Thyroid manifestations

Very frequently:

Apart from any clinical sign of dysthyroidism, a "dissociated" thyroid hormone (normal or slightly decreased T4, T3 increase) does not justify stopping treatment.

Frequently

Hypothyroidism has a classic form: weight gain, cautiousness, 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 antiangorous and / or antiarrhythmic efficacy); psychiatric forms of the elderly, or even thyrotoxicosis.

The collapse of the ultrasensitive 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.

· Other endocrine disorders

Very rare case of SIADH (inappropriate secretion of antidiuretic hormone) especially in case of association with drugs potentially inducing hyponatremia. See also the "biological anomaly" section.

Respiratory, thoracic and mediastinal disorders:

Frequently

Cases of interstitial or diffuse alveolar pneumopathy and organized bronchiolitis obliterans (BOOP), sometimes fatal, have been reported. The appearance of dyspnea of ​​effort or dry cough, 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, have been reported.

Very rarely :

Bronchospasm more particularly in asthmatic patients.

Acute respiratory distress syndromes, sometimes fatal, sometimes immediately following a surgical procedure (a possible interaction with high doses of oxygen has been mentioned) (see section Warnings and precautions for use ).

Not known (can not be estimated from the available data):

Cases of pulmonary hemorrhage sometimes manifesting as haemoptysis have been reported. These pulmonary manifestations often appear to be associated with amiodarone pneumonitis.

Nervous system disorders:

Frequently

Tremor or other extra-pyramidal symptoms.

Sleep disorders including nightmares.

Sensory, motor or mixed peripheral neuropathies.

Infrequently:

Myopathies.

Sensory, motor or mixed peripheral neuropathies and myopathies 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.

Very rarely :

Cerebellar ataxia.

Benign intracranial hypertension, headache. The appearance of isolated headaches requires the search for an underlying pathology.

Hepatobiliary disorders:

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

Very frequently:

Elevation of transaminases, isolated and generally moderate (1.5 to 3 times normal) regressing after dose reduction, or even spontaneously.

Frequently

Acute hepatic impairment with hypertransaminasemia and / or jaundice, sometimes fatal, requiring discontinuation of treatment.

Very rarely :

Chronic liver injury 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 treatment for more than 6 months should evoke the diagnosis of chronic liver injury. Clinical and biological disorders usually regress after stopping treatment. Some cases of irreversible evolution have been reported.

Heart conditions:

Frequently

Bradycardia generally moderate, dose-dependent.

Infrequently:

Conduction disorders (sino-atrial blocks, atrioventricular blocks of different degrees).

Very rarely :

Bradycardia marked, more exceptionally sinus arrest, reported in some cases (sinus dysfunction, elderly subjects).

Gastrointestinal disorders:

Very frequently:

Benign digestive disorders (nausea, vomiting, dysgeusia) usually present in the treatment of attack and disappearing with the reduction of dosage.

Disorders of the reproductive organs and the breast:

Very rarely :

Epididymitis. The relationship with the product does not appear to be established.

Vascular disorders:

Very rarely :

Vasculitis.

Investigations:

Rarely:

Rare hyponatraemia that may suggest SIADH.

Very rarely :

Renal impairment with moderate elevation of creatinine.

Hematological and lymphatic system disorders:

Very rarely :

Thrombocytopenia.

Immune system disorders:

Not known (can not be estimated from the available data):

Cases of angioedema have been reported.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals must report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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