|Dosage and administration||
Hypersensitivity to losartan or any excipients of the drug.
|Warnings and precautions for use||
Special monitoring and/or dose reduction should be considered in patients with volume depletion, being treated with diuretics and patients with other factors that may lead to hypotension. Patients with either unibilateral or bilateral renal artery stenosis, or stenosis of the artery to a solitary kidney are also at increased risk of unwanted effects (elevated creatinine and urea) and the treatment should be monitored closely.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
As other antihypertensive drugs, caution should be taken when driving a vehicle and operating machines because losartan may cause headache, dizziness, fatigue, especially at the beginning of treatment or when the dose is increased.
|Interactions, incompatibilities of medicine||
Losartan does not affect the pharmacokinetics of oral or intravenous digoxin.
|Undesirable effects (ADRs)||
Most side effects are mild and may go away on their own over time.
|Overdose and management||
Limited data are available regarding overdosage in humans.
Losartan potassium, an angiotensin II receptor antagonist (Type AT1), is the first of a new class of agents to be introduced for the treatment of hypertension.
Following oral administration, losartan is well absorbed and undergoes substantial first-pass hepatic metabolism by cytochrome P450 enzymes (CYP2C9 và CYP3A4). Bioavailability of losartan is approximately 33%. Approximately 14% of the oral dose of losartan is converted to an active metabolite that is responsible for most of the angiotensin II receptor antagonism. The terminal half-life of losartan is about 2 hours and of the metabolite is about 6-9 hours. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each tablet contains:
Losartan potassium . . . . . . . . . . . . . . . . 100 mg
Cardboard box with 3 or 10 blisters of 10 film coated tablets.
Treatment of essential hypertension in adults and in children over 6 years old: It may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan should be administered to patients who are intolerant to angiotensin-converting enzyme inhibitors (ACEs).
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day.
Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy.