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Eziday Tablets (Losartan Potassium)

COMPOSITION

Each tablet contains: Losartan Potassium BP/USP 25,50 & 100 mg respectively.

 DESCRIPTION

EZIDAY (Losartan Potassium) is an angiotensin Il receptor (type AT1) antagonist. EZIDAY (Losartan Potassium) is chemically described as 2-butyl-4-chloro-1-[p-(0-1H-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22CIKN60, and its molecular weight is 461.01. 

PHARMACOLOGY

 Pharmacodynamics:

Angiotensin Il is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor. Both losartan and its principal active metabolite have much greater affinity (about 1000-fold) for the AT1 receptor than for the AT2 receptor. The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT1 receptor.

Pharmacokinetics:

Losartan is an orally active agent that undergoes substantial firstpass metabolism by cytochrome P450 enzymes. It is converted, in part, to an active carboxylic acid metabolite that is responsible for most of the angiotensin Il receptor antagonism. The terminal half-life of losartan is about 2 hours and of the metabolite is about 6-9 hours. Following oral administration, losartan is well absorbed and undergoes substantial first-pass metabolism; the systemic bioavailability of losartan is approximately 33%. About 14% of an orally administered dose of losartan is converted to the active metabolite. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively. A meal slows absorption of losartan and decreases its Cmax but has only minor effects on losartan AUC or on the AUC of the metabolite (about 10% decreased). Both losartan and its active metabolite are highly bound to plasma proteins, primarily albumin, with plasma free fractions of 1.3% and 0.2%, respectively. The volume of distribution of losartan is about 34 liters and of the active metabolite is about 12 liters. When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine and about 6% is excreted in urine as active metabolite. Biliary excretion contributes to 60% of the elimination of losartan and its metabolites.

 INDICATIONS

 Hypertension: EZIDAY is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.

Hypertensive Patients with Left Ventricular Hypertrophy: EZIDAY is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. 

Nephropathy in Type 2 Diabetic Patients: EZIDAY is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio is equal to 300 or greater than 300 mg/g) in patients with type 2 diabetes and a history of hypertension.

CONTRAINDICATIONS

Losartan Potassium is contraindicated in patients who are hypersensitive to any component of this product. 

POSSIBLE ADVERSE EFFECTS

The overall incidence of adverse experiences reported with Losartan Potassium was similar to placebo. Losartan is generally well tolerated. Adverse effects, which may occur are usually mild and transient in nature and do not require discontinuation of the drug. Hepatitis, malaise, thrombocytopenia, angioedema (swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue) vasculitis, anaphylactic reactions, hyperkalemia, hyponatremia, rhabdomyolysis, dysgeusia, dry cough, erythroderma may occur.

DRUG INTERACTIONS

No significant drug-drug pharmacokinetic interactions have been found in interaction with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. Rifampin, an inducer of drug metabolism, decreased the concentrations of losartan and its active metabolite. Fluconazole, an inhibitor of P450 2C9, decreased active metabolite concentration and increased losartan concentration. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.

 Lithium: As with other drugs which affect the excretion of sodium, lithium excretion may be reduced. 

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors: NSAIDs including selective COX-2 inhibitors may diminish the antihypertensive effect of angiotensin Il receptor antagonists, including losartan.

WARNINGS

 Hypotension in Volume-Depleted Patients: In patients who are intravascularly volume-depleted (e.g., those treated with diuretics), symptomatic hypotension may occur after initiation of therapy with losartan. These conditions should be corrected prior to administration of losartan, or a lower starting dose should be used.

 Impaired Hepatic Function: A lower dose should be considered for patients with impaired liver function

Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function has been reported in susceptible individuals treated with losartan

Electrolyte Imbalance: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes. 

Potassium Supplements: A patient receiving losartan should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician

Fetal/Neonatal Morbidity & Mortality: Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, losartan should be discontinued as soon as possible. 

Nursing Mothers: Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

 DOSAGE & ADMINISTRATION

Adult Hypertensive Patients: EZIDAY may be administered with other antihypertensive agents, and with or without food. Dosing must be individualized. The usual starting dose of EZIDAY is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment. EZIDAY can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg. No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment,including patients on dialysis.

Pediatric hypertensive patients less than or equal to 6 Years of Age: The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total). Dosage should be adjusted according to blood pressure response.

 Hypertensive Patients with Left Ventricular Hypertrophy: The usual starting dose is 50 mg of EZIDAY once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of EZIDAY should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response.

Nephropathy in Type 2 Diabetic Patients: The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response. EZIDAY may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).

SPECIAL INSTRUCTIONS TO THE PHYSICIAN

Overdosage: Hypotension and tachycardia; bradycardia could occur from overdosage due to parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis. 

STORAGE/PRECAUTIONS

Store in a cool, dry and dark place between 15-30 °C. Keep all medicines out of the children’s reach.

MANUFACTURED BY  WERRICK PHARMACEUTICALS

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