Preparation
Losan® 25 tablet: Each film coated tablet contains Losartan Potassium USP 25 mg.
Losan® 50 tablet: Each film coated tablet contains Losartan Potassium USP 50 mg.
Therapeutic Class
Angiotensin Receptor Blockers
Indication
Losartan is indicated in the treatment of all grades of hypertension and heart failure. Moreover it is indicated in hypertensive patients with type II diabetes and delay the progression of renal diseases.
Contraindication
Losartan is contraindicated in pregnancy and lactation. It is also contraindicated to patients who are hypersensitive to any component of this product.
Dosage & Administration
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily. In patients who are salt depleted corrective measures should be used before starting Losartan and the initial dose should be reduced to 25 mg.
No dosage adjustment is necessary for patients up to 75 years of age. There is limited clinical experience in older patients and a lower starting dose of 25 mg once daily is recommended. Losartan may be administered with other antihypertensive agents. Losartan may be administered with or without food.
Use in elderly Patients: Patients up to 75 years: No initial dosage adjustment is necessary for this group of patients. Patients over 75 years: A lower starting dose of 25 mg once daily is recommended.
Side Effect
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 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
The usual starting dose of Losartan is 50 mg once daily. Some patients
may receive an additional benefit by increasing the dose to 100 mg
once daily. In patients with possible depletion of intravascular volume
(e.g. patients treated with diuretics) and in patients with a history of
hepatic impairment, a lower initial dose of 25 mg is recommended. No
initial dosage adjustment is necessary for elderly patients (upto 75
years) or for patients with renal impairment, including patients on
dialysis. Losartan may be administered with or without food.
Drug Interaction
No drug interaction of clinical significance has been identified. Compounds which have been studied in clinical pharmacokinetic trials include hydrochlorothiazide, digoxin, warfarin, cimetidine, ketoconazole and phenobarbital.
Presentation
Losan® 25 tablet : Each box containing 3 x 10 tablets in blister pack.
Losan® 50 tablet : Each box containing 3 x 10 tablets in blister pack.
Use Children
Losartan is not recommended in pediatric patients less than 6 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 ml/min/1.73m².
Acute Overdosage
Limited data are available regarding overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Supportive treatment should include repletion of the intravascular volume. Neither Losartan nor the active metabolite can be removed by hemodialysis.
Use 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 whether Losartan is excreted in human breast milk. However, significant level of Losartan found in rat milk which suggests that the drug should not be used in lactating mother.
Storage
Store in a cool and dry place, at below 30 ºC temperature and protected from light. Keep all medicines out of the reach of children.
