ANGIOTEN Tablet

For the treatment of hypertension.

Dosage and Administration

- In patients with essential hypertension, starting and maintenance the recommended dose is 50mg once daily. Some patients may benefits from receiving 100mg once daily.

- For patients with hepatic impairment or volume depletion or who are otherwise at high risk of hypotension, a lower dose of 25mg once daily is recommended.

No initial dosage adjustment is necessary for elderly patients or those with renal impairment, including patients undergoing dialysis. Losartan and it metabolite are not removed by dialysis.

ANGIOTEN may be given with or without food.

ANGIOTEN may be administered with other antihypertensive agents.

Patients who are hypersensitive to Losartan or any component of this drug.

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, occurring at least 1% patients.

- Thiazide type diuretics: If losartan is administered together with thiazide type diuretic, the blood-pressure-lowering effect are additive.

- ANGIOTEN should not be used with potassium-sparing diuretic.

Pregnancy

ANGIOTEN is not recommended in pregnant women because of the risk of fetal and neonatal morbidity and death.

Lactation

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.

- 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 in children: Safety and effectiveness in children have not been established.

ANGIOTEN is the first of a new class of antihypertensive, a nonpeptide angiotensinⅡ(AⅡ) receptor antagonist. This novel agent binds competitively and selectively to the AⅡsubtype 1 (AT1 receptor) thereby blocking AⅡ-induced physiological effect. The active metabolite, E3174, bind to the AT1 receptor with 10-fold greater affinity than the parent compound, and is about 15-20 times more potent in inhibiting angiotensinⅡ-induced pressor and contractile responses.

ANGIOTEN is orally active. In patients with hypertension, once-daily administration of losartan decrease blood pressure throughout a 24-hour period without affecting the heart rate.

Losartan potassium in dose 50-100mg daily as monotherapy has reduces diastolic blood pressure (DBP) by about 8-13mmHg 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.