Medicinal Products

AMIODARONE IREX 200 mg

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

Tablet breackable
Case 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 down 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 IREX 200 mg Tablet breakable Case 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

CONTRAINDICATED:
This medicine is contraindicated in the following situations:
- known hypersensitivity to iodine or amiodarone;
- sinus bradycardia and sino-atrial blocks not paired;
- sinus disease not fitted (risk of sinus arrest);
- high-order unconditioned conductive disorders;
- hyperthyroidism due to its possible aggravation by amiodarone;
- the 2nd and 3rd trimesters of pregnancy: the fetal thyroid starting to fix iodine from 14 weeks of amenorrhea, no repercussion on the fetal thyroid is expected in case of prior administrations. An iodized overload with the use of this product past this term, can lead to fetal hypothyroidism, biological or even clinical (goiter). As a result, the use of this drug is contraindicated from the 2nd trimester.
- breastfeeding: Amiodarone and its metabolite, as well as iodine, pass into milk at concentrations higher than maternal plasma. Because of the risk of hypothyroidism in infants, breastfeeding is contraindicated when treated with this drug.
- in combination with drugs that can induce torsades de pointes:
. anti-arrhythmic class la (quinidine, hydroquinidine, disopyramide ...),
. class III anti-arrhythmics (sotalol, dofetilide, ibutilide ...),
. sultopride,
. other drugs such as: bepridil, cisapride, diphemanil, erythromycin IV, mizolastine, sparfloxacin, vincamine IV ... (see section on interactions).
Take into account the presence of lactose, in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
In children, the safety and efficacy of amiodarone have not been evaluated in controlled clinical trials.
NOT RECOMMENDED :
This medicine IS GENERALLY NOT RECOMMENDED in association with:
injectable diltiazem,
halofantrine, pentamidine, moxifloxacin,
- certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, tiapride, pimozide, haloperidol, droperidol),
- as well as with beta-blockers other than sotalol and esmolol (see interactions section).

Adverse effects Amiodarone Irex

- Ocular manifestations: Corneal microdeposits, almost constant in adults, usually remain localized to the subdupillary area and do not contra-indicate the continuation of treatment. Exceptionally, they can be accompanied by perception of colored halos in dazzling light, or sensation of fog. Corneal microdepositions consist of complex lipid deposits and are always completely reversible when 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 sign of dysthyroidism, a "dissociated" thyroid hormone (increase of T4, normal or slightly lowered T3) does not justify stopping treatment.
. Hypothyroidism takes a classic form: weight gain, apathy, drowsiness; 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 anti-arrhythmic 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 precarious myocardial balance, the inconsistent efficacy of synthetic antithyroid drugs leads to the recommendation of steroidal corticosteroids (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 pneumonitis.
Some cases of bronchospasm have been reported, especially in asthmatic patients.
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 on interactions).
- Neurological effects:
They are rare :
. prolonged administration of amiodarone may cause peripheral sensory, motor or mixed 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 can 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 to 3 times normal) regressing after dose reduction, or even spontaneously,
. exceptional 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 disorders (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 drug combinations (see section interactions) or electrolyte disturbances.
- Various effects:
. Benign digestive disorders (nausea, vomiting, dysgeusia) usually present in the treatment of attack 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 diverse 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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