FORMULATION:

Each film-coated tablet contains:
Losartan Potassium BP……………………50mg

INDICATION:
Losartan potassium tablets are used in the management of hypertension, particularly in patients who develop cough with ACE inhibitors and to reduce the risk of stroke in patients with left ventricular hypertrophy, and in the treatment of diabetic nephropathy.

DOSAGE AND ADMINISTRATION:
The usual starting dose of losartan potassium tablets is 50mg once daily, with 25 mg used in patients with possible depletion of intravascular volume and patients with a history of hepatic impairment Losartan potassium tablets can be administered once or twice daily with total daily doses ranging from 25 mg to 100mg.

CONTRAINDICATIONS:
Losartan Potassium (ANGEL-50) tablets are contraindicated in patients who are hypersensitive to any component of the tablets.

ADVERSE EFFECTS:
Adverse effects of losartan have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion (for example those who have received high dose diuretics). Impaired renal function and, rarely rash, urticaria, pruritus, angioedema, and raised liver enzyme values may occur hyperkalaemia, myalgia, and arthralgia have been reported. Losartan appears less likely than ACE inhibitors to cause cough. Other adverse effects that have been reported with angiotensin II receptor antagonists include respiratory-tract disorders, back pain, gastrointestinal disturbances, fatigue, and neutropenia. Rhabdomyolysis has been reported rarely.

WARNINGS:
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. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme inhibitors. When pregnancy is detected, losartan potassium tablets 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.

OVERDOSAGE:
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis.

PRECAUTIONS:
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.

CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

STORAGE CONDITION:
Store at temperature not exceeding 30⁰ C.

AVAILABILITY:
Alu/Alu blister pack x 10’s (Box of 30’s and 100’s)

ADR REPORTING STATEMENT:
“For suspected adverse drug reaction report to the FDA: www.fda.gov.ph. Seek medical attention immediately at the first sign of any adverse drug reaction shall appear.”

FDA Registration No.: DRP-5307