Tozam 100/5/Tozam 100/10 Dosage/Direction for Use

The recommended dose of Losartan potassium + Amlodipine besilate is one tablet per day.
Losartan potassium + Amlodipine besilate may be administered with or without food. It is recommended to take Losartan potassium + Amlodipine besilate with water.
Losartan potassium + Amlodipine besilate may be administered with other antihypertensive agents.
Losartan is an effective treatment of hypertension in once daily doses of 50 mg to 100 mg while amlodipine is effective in doses of 5 mg to 10 mg as monotherapy. The maximum recommended dose of Losartan potassium + Amlodipine besilate is 5 mg/100 mg.
A patient whose blood pressure is not adequately controlled with losartan alone or amlodipine alone may be switched to combination therapy with Losartan potassium + Amlodipine besilate.
Losartan potassium + Amlodipine besilate 5 mg/100 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or losartan 100 mg alone.
Losartan potassium + Amlodipine besilate 10 mg/100 mg may be administered in patients whose blood pressure is not adequately controlled with losartan 100 mg or Losartan Potassium + Amlodipine.
A patient co-administered with losartan and amlodipine may be switched to Losartan potassium + Amlodipine besilate (fixed dose combination containing same dose of each ingredient) for compliance improvement.
Use in patients with renal impairment: No dosage adjustment is necessary in patients with mild renal impairment (i.e. creatinine clearance 20-50 mL/min). For patients with moderate to severe renal impairment (i.e., creatinine clearance <20 mL/min) or patients on dialysis, administration of Losartan potassium + Amlodipine besilate is not recommended.
Use in patients with intravascular volume depletion: For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg losartan once daily should be considered. Since a 25 mg dose of losartan is not available with Losartan potassium + Amlodipine besilate, this dose should be achieved with losartan monotherapy.
Use in patients with hepatic impairment: In cases where a lower dose of losartan (ie., 25 mg once daily) is required for patients with a history of hepatic impairment, administration of Losartan Potassium + Amlodipine is not recommended.
Use in the elderly: Because of decreased clearance in the elderly, amlodipine therapy should usually be initiated at 2.5 mg daily. Since a 2.5 mg dose of amlodipine is not available with Losartan potassium + Amlodipine besilate, this dose should be achieved with amlodipine monotherapy.
Use in patients ≤18 years of age: Since safety and efficacy of Losartan Potassium + Amlodipine in children ≤18 years of age has not been established, administration of Losartan Potassium + Amlodipine is not recommended.
Route of Administration: For oral administration only.