Medicinal Products

AMIODARONE AGUETTANT 50 mg / ml solution for injection (IV) box of 10 ampoules of 3 ml

Generic drug of Cordarone 150 MG / 3 ML
Therapeutic class: Cardiology and angiology
Active ingredients: Amiodarone
laboratory: Aguettant

IV injectable solution
All forms

Indication

- Severe rhythm disturbances when the oral route is inappropriate, including:
. atrial rhythm disorders, with fast ventricular rhythm;
. tachycardias of Wolf Parkinson White Syndrome;
. documented symptomatic and disabling ventricular arrhythmias.
- Cardiopulmonary resuscitation in case of cardiac arrest related to ventricular fibrillation resistant to external electric shocks.

Dosage AMIODARONE AGUETTANT 50 mg / ml solution for injection (IV) box of 10 ampoules of 3 ml

- Severe rhythm disturbances when the oral route is inappropriate, including:
. atrial rhythm disorders, with fast ventricular rhythm;
. tachycardias of Wolf Parkinson White Syndrome;
. documented symptomatic and disabling ventricular arrhythmias.
- Cardiopulmonary resuscitation in case of cardiac arrest related to ventricular fibrillation resistant to external electric shocks.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following situations:
- Known hypersensitivity to iodine, amiodarone or any of the excipients.
- Sinus bradycardia and sino-auricular blocks not paired.
- Sinus disease not fitted (risk of sinus arrest).
- Conductive disorders atrioventricular high degree not paired.
- Hyperthyroidism due to its possible aggravation by amiodarone.
- Cardiovascular collapse.
- Severe hypotension.
- In children under 3 years of age due to the presence of benzyl alcohol.
- 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.
- Breast-feeding: 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 (see section on interactions),
. sultopride.
- These contraindications do not apply when amiodarone is used in cardiopulmonary resuscitation in case of cardiac arrest related to ventricular fibrillation resistant to external electrical shocks.
NOT RECOMMENDED :
Associations advised against : ciclosporin; injectable diltiazem; halofantrine, pentamidine, lumefantrine; neuroleptics capable of giving torsades de pointes [certain phenothiazine neuroleptics (chlorpromazine, cyamémazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, tiapride, véralipride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide)].

Adverse effects Amiodarone Aguettant

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%).
CARDIAC EFFECTS:
- Frequently : bradycardia.
- Very rarely :
. marked bradycardia, more rarely sinus arrest, reported in some cases, particularly in the elderly,
. pro-arrhythmic effect.
GASTROINTESTINAL EFFECTS:
Very frequently : nausea.
REACTIONS TO THE INJECTION SITE:
Frequently : Possible venous inflammatory reaction in case of direct peripheral venous administration, injection site reactions such as pain, erythema, edema, necrosis, extravasation, infiltration, inflammation, phlebitis and cellulitis.
HEPATIC MANIFESTATIONS:
- Cases of liver damage have been reported. These cases have been diagnosed by elevated serum transaminases.
Indeed, have been reported:
Very rarely :
- Elevation of transaminases, isolated and generally moderate (1.5 times to 3 times normal) regressing after dose reduction, or even spontaneously.
- Acute hepatic impairment with hypertransaminasemia and / or jaundice, sometimes fatal, requiring discontinuation of treatment.
- Chronic liver injury during prolonged treatment (oral).
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.
EFFECTS ON THE IMMUNE SYSTEM:
Very rarely : anaphylactic shock.
NEUROLOGICAL EFFECTS:
Very rarely : benign intracranial hypertension (pseudo tumor cerebri).
PULMONARY MANIFESTATIONS:
Very rarely :
- Acute respiratory distress syndromes, generally associated with interstitial pneumonitis, sometimes fatal, sometimes immediately following a surgical procedure (a possible interaction with high doses of oxygen was mentioned). The discontinuation of amiodarone should be considered and the interest of corticosteroids taken into consideration.
- Bronchospasm and / or apnea in case of severe respiratory failure, especially in asthmatics.
SKIN MANIFESTATIONS:
Very rarely : sweating, alopecia.
VASCULAR EFFECTS:
- Frequently : blood pressure drop, usually moderate and transient. Cases of severe hypotension or collapse have been reported particularly after overdose or too fast administration.
- Very rarely : hot flashes.

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