Eseflah 50mg

50 mg Film Coated Tablet
ANGIOTENSIN 2 RECEPTOR BLOCKER

FORMUATION: Each film-coated tablet contains: Losartan potassium 50 mg
MECHANISM OF ACTION: Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininsae II)], is a potent vasoconstrictor, the primary vasoactive hormone of the rennin-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 AT, receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT, 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 AT, receptor.
INDICATIONS: Losartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
DOSAGE AND ADMINISTRATION: Usual starter dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g, Patients treated with diuretics) and patients with history of hepatic impairment.
Losartan can be administered once or twice daily with total dosage ranging from 25 mg to 100 mg.
If the antihypertensive effect measured at trough using a once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.
Losartan may be administered with other antihypertensive agents.
It may be administered with or without food.
CONTRAINDICATIONS: Losartan is contraindicated in patients who are hypersensitive to any component of this product.
WARNINGS:
Fetal/Neonatal Morbidity and Mortality
Drugs that act directly on the rennin-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. The use of drugs that act directly on the rennin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported.
Hypotension
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. This condition should be corrected prior to administration of Losartan.
PRECAUTIONS:
General
Impaired Hepatic Function
Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of Losartan in cirrhotic patients, a lower dose should be considered for patients with impaired liver function.
Impaired Renal Function
As a consequence of inhibiting the rennin-angiotensin-aldosterone system, changes in renal function have been reported in susceptible individuals treated with losartan; in some patients, these changes in renal function were reversible upon discontinuation of therapy.
ADVERSE EFFECTS:
General: Facial edema, fever, orthostatic effects, syncope
Cardiovascular: angina pectoris, second degree AV block, CVA, hypotension, myocardial infarction, arrhythmias including atrial fibrillation, palpitation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation
Digestive: anorexia, constipation, dental pain, dry mouth, flatulence, gastritis, vomiting
Hematologic: anemia
Metabolic: gout
Musculoskeletal: arm pain, hip pain, joint swelling, knee pain, musculosketetal pain, shoulder pain , stiffness, arthralgia, arthritis, fibrmyalgia, muscle weakness
Nervous System / Psychiatric: anxiety, anxiety disorder, ataxia, confusion, depression, dream abnormality, hypesthesia, decreased libido, memory disorder, sleep disorder, somnolence, tremor, vertigo
Respiratory: dyspnea, bronchitis, pharyngeal, discomfort, epistaxis, rhinitis, respiratory congestion
Skin: alopecia, dermatitis, dry skin, ecchymosis, erythema, flushing, photosensitivity, pruiritis, rash, sweating, urticaria
Special senses: blurred vision, burning/stinging in the eye, conjunctivitis, taste perversion, tinnitus, decrease in visual acuity
Urogenital: impotence, nocturia, urinary frequency, urinary tract infection
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 0.1 per cent of patients with essential hypertension treated with losartan potassium alone.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.11 grams percent 0.09 volume per cent, respectively) occurred frequently in patients treated with losartan potassium alone, but were rarely of clinical importance. No patients were discontinued due to anemia.
Liver Function Tests: Occasional elevations of liver enzymes and/or other serum bilirubin have occurred.
DRUG INTERACTIONS: Losartan, administered for 12 days, did not affect the pharmacokinetics of pharmacodynamics of a single dose of warfarin. Losartan did not affect the pharmacokinetics of oral or intravenous digoxin. Coadministration of losartan and cimetidine led to an increase of about 18% in AUC of losartan but did not affect the pharmacokinetic interaction between losartan and hydrochlorothiazide.
No significant drug-drug pharmacokinetic interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, cimetidine and Phenobarbital.
Storage: Store at a temperature not exceeding 30°C. Protect from light. Keep out of reach of children.
Caution: Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Availability: Blister/Strip of 10 tablets. Box of 100 tablets.

Manufactured by:
Flamingo Pharmaceuticals Limited
Factory: Rabale, Navi Mumbai 400 701. India
Office: P.O. Box No. 27257, Mumbai 400 071. India

Imported by:
Pasteur Pharmaceutical Sales
1335 G. Araneta Ave., SMH, Quezon City, Philippines

Distributed by:
Planetarium Enterprises
Lagazo Village, Calinan, Davao City, Philippines

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