Losartan potassium
film coated tablet
Composition
Each film coated tablet contains:
Losartan potassium .................................................. 50 mg
Pharmacology
ANGIOTEN® (losartan potassium) is the first of a new class of antihypertensive, a nonpeptide angiotensin II (AII) receptor antagonist.
This novel agent binds competitively and selectively to the AII subtype 1 (AT1 receptor) thereby blocking All-induced physiological effect.
The active metabolite. E3174, bind to the AT1 receptor with 10-fold greater affinity than the parent compound, and is about 15 to 20 times more potent in inhibiting angiotensin II-induced pressor and contractile responses.
ANGIOTEN® (losartan potassium) is orally active In patients with hypertension, once-daily administration of losartan decrease blood pressure throughout a 24-hour period without affecting the hear) rate.
Losartan potassium in dose 50 to 100 mg daily as mono-therapy has reduces diastolic blood pressure (DBP) by about 8 to 13 mmHg in patients with mild to moderate hypertension, and has shown equivalent effectiveness to enalapril, atenolol or extended release felodipine. The addition of thiazide diuretic to losartan reduces larger blood pressure reductions than occur with either drug alone.
The oral bioavailability of losartan is about 33 % indicating a considerable first-pass metabolism. Losartan and its metabolism, E3174 are more than 98 % bound to plasma protein. The terminal elimination half-life of E3174 is slightly longer than that of losartan (6 to 9 h vs 2 h, respectively). The pharmacokinetic properties of losartan potassium and E3174 are not affected by renal dysfunction to any clinically important extent.
Indication
ANGIOTEN® is indicated for the treatment of hypertension.
Contraindication
Patients who are hypersensitive to losartan potassium.
Warnings and precautions
- Symptomatic hypotension may occur in patients who are intravascularly volume depleted : so a lower starting dose of losartan should be used.
- In patients with renal impairment and in the elderly, serum potassium should be monitored.
- Use in patients with hepatic dysfunction . Plasma concentration of losartan and its metabolite might be are increased, dose of losartan should be adjusted.
- Use during pregnancy ANGIOTEN® is not recommended in pregnant women because of the risk of fetal and neonatal morbidity and death.
- Use in nursing mother: It is not known whether losartan is excreted in human milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
- Use in children : Safety and effectiveness in children have not been established
Dizziness, headache, asthenia/fatigue, cough, diarrhea, dyspepsia, cramp muscle, myalgia, pain back. pain leg, insomnia, nasal congestion, upper respiratory infection, serious disorder and sinusitis. These adverse events, whether or not attributed to the treatment, occuring at least 1 % patients.
Dosage and administration
In patients with essential hypertension, starting and maintenance the recommended dose is 50 mg once daily. Some patients may benefits from receiving 100 mg once daily.
For patients with hepatic impairment or volume depletion or who are otherwise at high risk of hypotension, a lower dose of 25 mg once daily is recommended.
No initial dosage adjusment is necessary for elderly patients or those with renal impairment, including patients undergoing dialysis. ANGIOTEN® and its metabolite are not removed by dialysis.
ANGIOTEN® may be given with or without food.
ANGIOTEN® may be administered with other antihypertensive agents.
Presentation
Film coated tablet 50 mg: Box of 3 strips x 10 tablets
Reg. No. DKL9911630217A1
Store below 30°C.
ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER.
PT KALBE FARMA Tbk.
Bekasi - Indonesia
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