Hexagon Pharma


Full Prescribing Info
Losartan potassium.
Each film-coated tablet contains: Losartan potassium 50 mg.
Pharmacology: Pharmacodynamics: Mechanism of Action: Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)), 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 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 AT1 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.
Losartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Dosage/Direction for Use
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 daily 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 our without food.
Losartan is contraindicated in patients who are hypersensitive to any component of this product.
Fetal/Neonatal Morbidity and 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. The use of drugs that act directly on the renin-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.
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.
Special 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 renin-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.
Use In Pregnancy & Lactation
When pregnancy is deleted, Losartan should be discontinued as soon as possible.
Adverse Reactions
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, fibromyalgia, 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 percent, 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, adminstered 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 pharmacokinetics of its active metabolite. Coadministration of losartan and phenobarbital led to a reduction of about 20% in the AUC of losartan and that of its active metabolite. There is no pharmacokinetic interaction between losartan and hydrochlorothiazide.
Store at a temperatures not exceeding 30°C. Protect from light.
ATC Classification
C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
FC tab 50 mg x 100's.
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