DIGOPYX Digoxin 50 mcg Syrup
COMPOSITION of DIGOPYX Digoxin 50 mcg Syrup
Each ml contains:
Digoxin……………. 50mcg
Flavoured elixir base….q.s.
DESCRIPTION
DIGOPYX (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”).
Digoxin is described chemically as (36,56,126)-3-[(0-2,6-dideoxy-6-D-ribohexopyranosyl (1-4)-0-2,6-dideoxy-p-D-ribo-hexopyranosyl-(1-4)-2,6- dideoxy-(3-D-ribohexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64014, its molecular weight is 780.95, and its structural formula is:
Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.
INDICATIONS AND USAGE of DIGOPYX Digoxin 50 mcg Syrup
-Heart Failure in Adults
DIGOPYX is indicated for the treatment of mild to moderate heart failure in adults. DIGOPYX increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, DIGOPYX should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
Heart Failure in Pediatric Patients
DIGOPYX increases myocardial contractility in pediatric patients with heart failure.
Atrial Fibrillation in Adults
DIGOPYX is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
DOSAGE AND ADMINISTRATION of DIGOPYX Digoxin 50 mcg Syrup
Important Dosing and Administration Information
In selecting a DIGOPYX dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.
Consider interruption or reduction in DIGOPYX dose prior to electrical cardioversion.
Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.
Loading Dosing Regimen in Adults and Pediatric Patients
For adults and pediatric patients if a loading dosage is to be given, administer half the total loading dose initially, then % the loading dose every 6-8 hours twice, with careful assessment of clinical response and toxicity before each dose.
CONTRAINDICATIONS
DIGOPYX is contraindicated in patients with:
- Ventricular fibrillation
- Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
WARNINGS AND PRECAUTIONS of DIGOPYX Digoxin 50 mcg Syrup
Sinus Bradycardia and Sino-atrial Block
DIGOPYX may cause severe sinus bradycardia or sinoatrial block particularly in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. Consider insertion of a pacemaker before treatment with digoxin.
Digoxin Toxicity
Signs and symptoms of digoxin toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias [first-degree, second-degree (Wenckebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation]. Toxicity is usually associated with digoxin levels greater than 2 ng/ml although symptoms may also occur at lower levels. Low body weight, advanced age or impaired renal function, hypokalemia, hypercalcemia, or hypomagnesemia may predispose to digoxin toxicity. Obtain serum digoxin levels in patients with signs or symptoms of digoxin therapy and interrupt or adjust dose if necessary. Assess serum electrolytes and renal function periodically.
The earliest and most frequent manifestation of digoxin toxicity in infants and children is the appearance of cardiac arrhythmias, including sinus bradycardia. In children, the use of digoxin may produce any arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such as atrial tachycardia (with or without block) and junctional (nodal) tachycardia. Ventricular arrhythmias are less common. Sinus bradycardia may be a sign of impending digoxin intoxication, especially in infants, even in the absence of first-degree heart block. Any arrhythmias or alteration in cardiac conduction that develops in a child taking digoxin should initially be assumed to be a consequence of digoxin intoxication.
Given that adult patients with heart failure have some symptoms in common with digoxin toxicity, it may be difficult to distinguish digoxin toxicity from heart failure. Misidentification of their etiology might lead the clinician to continue or increase DIGOPYX dosing when dosing should actually be suspended. When the etiology of these signs and symptoms is not clear, measure serum digoxin levels.
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PYXUS PHARMACEUTICALS PVT. LTD.
