For the use of a Registered Medical Practitioner or a Hospital or 1aboratory
AMICOR
COMPOSITION :
Each ml contains:
Amrinone Lactate USP equivalent to Amrinone 5 mg Water for Injection IP q.s.
DESCRIPTION
Amicor represent a new class of cardiac inotropic agents distinct from digitalis glycosides or catecholamines. Amicor is designated chemically as 5-Amino (3,4 bipyridin)-6 (1 H)-one 2 hydroxypropanate. Amicor injection is available as a sterile solution in 20 ml. ampoules for intravenous administration. Each ml contains Amrinone lactate equivalent to 5 mg of Amrinone.
CLINICAL PHARMACOLOGY:
Amicor injection is a positive inotropic agent with vasodilator activity, different in structure and the mode of action from either digitalis glycosides or catecholamines with respect to its inotropic effect, experimental evidence indicate that it is not a beta-adrenergic agonist. It inhibits myocardial cyclic adenosine monophosphate (c-AMP) phosphodiesterase activity and increase cellular levels of cAMP. Unlike digitalis, it does not inhibit sodium-potassium adenosine triphosphate activity. With respect to its vasodilatory activity, Amicor reduces after load and preload by its direct relaxant effect on vascular smooth muscle.
DOSAGE AND ADMINISTRATION :
Loading doses of Amicor injection should be administered as supplied (undiluted). Infusion of Amicor injection may be administered in normal, or half normal saline solution to concentration of 1mg/ml to 3mg/ml. Diluted solution should be used within 24 hours.
Amicor injection may be infected into running dextrose(glucose) infusion through a Y-Connector or directly into the tubing where preferable. A chemical interaction occurs slowly over a 24 hours period when the intravenous solution of Amicor Injection is mixed directly with dextrose containing solutions. THEREFORE , AMICOR SHOULD NOT BE DILUTED WITH SOLUTIONS THAT CONTAIN DEXTROSE (GLUCOSE) PRIOR TO INJECTION.
A chemical interaction occurs immediately, which is evidenced by the formation of a precipitate when furosemide should not be administrated in intravenous lines containing amrinone.
AMRINONE INJECTION USP
INDICATION AND USAGE :
Amicor Injection is indicated for the short-term management of congestive heart failure. Because of limited experience and potential for serious adverse effects.
Amicor should be used only in patient who can be closely monitored and who have not responded adequately to digitalis, diuretics, and/or vasodilators. Althrough most patients have been studied hemodynamically for periods only up to 24 hours, some patients were studied for longer periods and demonstrated consistent hemodynamic and clinical effects. The duration of therapy should depend on patient responsiveness.
CONTRAINDICATIONS :
Amicor Injection is contraindicated in patients who are hypersensitive to it. It is also contraindicated in those patients known to be hypersensitive to bisufites.
WARNING :
Contains sodium metabisulfite, a sulfite that may cause allergic-type reaction including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently is asthmatic than in nonasthmatic people.
PRECAUTIONS :
Amicor Injection should not be used in patients with severe aortic or pulmonic valvular disease in lieu of surgial relife of the obstruction. Like other inotropic agents, it may aggravate outflow obstruction in hypertrophic subaortic stenosis. During intravenous therapy with Amicor Injection, blood pressure and heart rate should be monitored and the rate of infusion slowed or stopped in patients showing excessive decreases in blood pressure. Patients who have received vigorous diuretic therapy may have insufficient cardiac filling pressure to respond adequately to Inocor lactate injection, in which case cautious liberalization of fluid and electrolyte intake may be indicated. Supraventricular and ventricular arrhythmias have been observed in the very high risk population treated. While amrione per se has not been shown to be arrhythmogenic, the potential for arrhythmia, present in congestive heart failure itself, may be increased by any drug or combination of drugs. Parenteral drug products should be inspected visually and should not be used if particulate matter or discoloration is observed.
PRESENTATION :
Amicor in 20 ml ampoule. STORAGE:
Store at a room temperature. Protect from light. Manufactured by :
SAMARTH LIFE SCIENCES PVT. LTD.
Nangal Uparla, Swarghat Road, Nalagarh, Solan, Himachal Pradesh 174101 D4^ H.O.: Ram Mandir Road, Goregaon (W), Mumbai - 400 104.
