COMPOSITION
Each film-coated tablet contains Losartan Potassium BP 50 mg.
PHARMACOLOGY
Carlos 50 (Losartan Potassium) is the first of new class of antihypertensives and angiotensin-II receptor (type AT1) antagonist. Angiotensin-II is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. Losartan and its principal active metabolite block the vasoconstriction and aldosterone secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT1 receptor found in many tissues. Carlos 50 is now regarded as the first-line therapy option for treating high blood pressure.
INDICATIONS
Hypertension (including reduction of stroke risk in hypertension with Left ventricular hypertrophy); chronic heart failure when ACE inhibitors are unsuitable or contra-indicated; diabetic nephropathy in type 2 Diabetes mellitus.
DOSAGE AND ADMINISTRATION
- Hypertension, diabetic nephropathy in type 2 diabetes mellitus, usually 50 mg once daily (intravascular volume depletion, initially 25 mg once daily); if necessary increased after several weeks to 100 mg once daily; elderly over 75 years initially 25 mg daily.
- Chronic heart failure, initially 12.5 mg once daily, increased at weekly intervals to max. 150 mg once daily if tolerated.
CONTRAINDICATIONS
Losartan potassium is contraindicated in patients who are hypersensitive to the active ingredient or any component of the drug.
SIDE EFFECTS
In controlled clinical trials in patients with essential hypertension, dizziness was the only side effect reported that occurred with an incidence greater than placebo in 1% or more of patients treated with losartan. Rarely, rash was reported, although the incidence in controlled clinical trials was less than placebo. Angioedema, involving swelling of the face, lips and/or tongue has been reported rarely in patients treated with losartan. Serious hypotension (particularly on initiating treatment in salt-depleted patients) or renal failure (mainly in patients with renal artery stenosis) may be encountered during losartan treatment.
PRECAUTION
In patients who are intravenously volume in depleted (e.g. those treated with high-dose diuretics), symptomatic hypotension may occur. These conditions should be corrected prior to the administration of losartan or a lower starting dose should be used. A lower dose should be considered for patients with a history of hepatic impairment. Losartan should not be used with potassium-sparing diuretics.
HEPATIC IMPAIRMENT
Consider dose reduction in mild to moderate impairment.
DRUG INTERACTIONS
No drug interactions of clinical significance have been identified. Drugs which have been studied in clinical pharmacokinetic trials including- Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine, Ketoconazole and Phenobarbital.
USE IN PREGNANCY & LACTATION
Although there is no experience with the use of losartan in pregnant women, animal studies with losartan potassium have demonstrated fetal and neonatal injury and death, the mechanism of which is believed to be pharmacologically mediated through effects on the renin – angiotensin – aldosterone system. Losartan should not be used in pregnancy and if pregnancy is detected, losartan should be discontinued as soon as possible. It is not known if losartan is excreted in human breast milk. It is found in rat milk. The drug should not therefore be used while breastfeeding.
STORAGE
Protect from light & moisture. Store in a cool & dry place (below 30°C) temperature. Keep out of the reach of children.
PACKAGING
Each box contains 10 x 3 tablets in Alu-Alu blister pack
