Colixtan Dosage/Direction for Use

Posology and method of administration: The recommended dose of Losartan and Amlodipine is one tablet per day. It may be administered with or without food. It is recommended to take the tablets with water. It 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 and Amlodipine is 100 mg/5 mg. A patient whose blood pressure is not adequately controlled with Losartan alone or Amlodipine alone may be switched to combination therapy with Fixed-dose combination of Losartan and Amlodipine. Fixed-dose combination of Losartan and Amlodipine 50 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Losartan 50 mg alone. A patient co-administered with Losartan and Amlodipine may be switched to Fixed-dose combination of Losartan and Amlodipine (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 Fixed-dose combination of Losartan and Amlodipine 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 Fixed-dose combination of Losartan and Amlodipine, this dose should be achieved with Losartan monotherapy.
Use in patients with hepatic impairment: A lower dose of losartan (i.e. 25 mg once daily) is required for patients with a history of hepatic impairment, administration of Fixed-dose combination of Losartan and Amlodipine is not recommended.
Use in the elderly: There was no age-related difference in the efficacy or safety profile of Losartan. 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 Fixed-dose combination of Losartan and Amlodipine, this dose should be achieved with Amlodipine monotherapy.
Use in patients ≤18 years of age: Since safety and efficacy of Fixed-dose combination of Losartan and Amlodipine in children ≤18 years of age has not been established, administration of Fixed-dose combination of Losartan and Amlodipine is not recommended.