Torlos-50

Torlos-50 Special Precautions

losartan

Manufacturer:

Torrent

Distributor:

Torrent
Full Prescribing Info
Special Precautions
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 potassium tablets. These conditions should be corrected prior to administration of Losartan potassium tablets, or a lower starting dose should be used.
Electrolyte Imbalance: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients with proteinuria, the incidence of hyperkalemia was higher in the group treated with Losartan potassium tablets as compared to the placebo group; however, few patients discontinued therapy due to hyperkalemia.
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 potassium tablets; in some patients, these changes in renal function were reversible upon discontinuation of therapy.
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar outcomes have been reported with Losartan potassium tablets.
In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. Similar effects have been reported with Losartan potassium tablets; in some patients, these effects were reversible upon discontinuation of therapy.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in Children: Antihypertensive effects of Losartan potassium have been established in hypertensive pediatric aged 6 to 15 years. Safety and effectiveness have not been established in pediatric patients under the age of 6 or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2.
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