Medicinal Products

AMIODARONE ZENTIVA 200 mg

Generic drug from Cordarone
Therapeutic class: Cardiology and angiology
Active ingredients: Amiodarone
laboratory: Sanofi-Aventis France

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 disease and / or impairment of left ventricular function (see pharmacodynamic properties).

Dosage AMIODARONE ZENTIVA 200 mg Breakable Tablet 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 or to any of the excipients;
- sinus bradycardia and sino-atrial blocks not paired;
- sinus disease not fitted (risk of sinus arrest);
high-grade atrioventricular conductive disorders not matched;
- 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:
. the anti-arrhythmic class la (quinidine, hydroquinidine, disopyramide),
. class III anti-arrhythmics (sotalol, dofetilide, ibutilide),
. other drugs such as: bepridil, cisapride, diphemanil, erythromycin IV, mizolastine, moxifloxacin, spiramycin IV, vincamine IV,
. sultopride,
(see interactions).
- In children, the safety and efficacy of amiodarone have not been evaluated in controlled clinical trials.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
Associations advised against : ciclosporin; injectable diltiazem; injectable verapamil; antiparasitic agents capable of giving torsades de pointes (halofantrine, lumefantrine, pentamidine); neuroleptics capable of giving torsades de pointes [certain phenothiazinic neuroleptics (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, tiapride, véralipride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide)]; methadone.

Side effects Amiodarone Zentiva

Adverse reactions were classified by organ system and frequency according to the following conventions:
Very frequently (> = 10%); frequently (> = 1%, = 0.1%, = 0.01%, <0.1%); very rarely (<0.01%).
EYE MANIFESTATIONS:
- Very frequently :
Corneal micro-deposition, almost constant in adults, usually remaining localized to the sub-pupillary area and not indicative of continued 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.
- 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 MANIFESTATIONS:
- Very frequently :
photosensitivity. It is advisable not to expose yourself to the sun (and, in general, to ultraviolet rays) during treatment.
- Frequently :
cutaneous pigmentations, liliaceous or slate-gray, occurring for long daily dosages, 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.
THYROID MANIFESTATIONS:
- Very frequently :
apart from any clinical sign of dysthyroidism, a "dissociated" thyroid hormone (increase of T4, normal or slightly lowered T3) does not justify stopping treatment.
- Frequently :
. hypothyroidism takes 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 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 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:
- Frequently :
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 warnings and precautions for use).
NEUROLOGICAL EFFECTS:
- Frequently :
. tremors or other extrapyramidal symptoms,
. sleep disorders including nightmares,
. sensory, motor, or mixed peripheral neuropathies.
- Uncommonly :
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.
HEPATIC MANIFESTATIONS:
- cases of liver damage 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 liver injury 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 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:
- Frequently :
generally moderate, dose-dependent bradycardia.
- Uncommonly :
conduction disorders (sino-atrial blocks, atrioventricular blocks of different degrees).
- Very rarely :
marked bradycardia, more exceptionally sinus arrest, reported in some cases (sinus dysfunction, elderly subjects).
GASTROINTESTINAL EFFECTS:
Very frequently :
Benign digestive disorders (nausea, vomiting, dysgeusia) usually contemporaneous with the attack treatment and disappearing with the reduction of dosage.
EFFECTS ON THE REPRODUCTION SYSTEM:
Very rarely :
epididymitis. The relationship with the product does not appear to be established.
VASCULAR EFFECTS:
Very rarely :
vasculitis.
BIOLOGICAL ANOMALIES:
Very rarely :
renal impairment with moderate elevation of creatinine.
EFFECTS ON THE BLOOD AND LYMPHATIC SYSTEM:
Very rarely :
thrombocytopenia.

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