Losartan kali; Hydroclorothiazide
Visa No.: 893110151025
Product: Pyzacar HCT 100/25mg
API: Losartan kali; Hydroclorothiazide
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 229/QĐ-QLD_22/06/2017_158
INDICATIONS
This fixed-dose combination is not indicated for initial therapy of hypertension, except in cases of severe hypertension where the benefit of achieving rapid blood pressure control outweighs the potential risks associated with initiating therapy with this combination in such patients.
DOSAGE AND ADMINISTRATION
PYZACAR HCT is administered orally, with or without food.
Hypertension
The dose should be inpidualized based on clinical response. Patients whose blood pressure is not adequately controlled with losartan or hydrochlorothiazide monotherapy may be switched to one PYZACAR HCT 50/12.5 mg tablet once daily.
For patients who do not achieve adequate blood pressure control with PYZACAR HCT 50/12.5 mg, the dose may be increased to one PYZACAR HCT 100/25 mg tablet once daily. The usual dose is one PYZACAR HCT 50/12.5 mg tablet once daily. The maximum dose is one PYZACAR HCT 100/25 mg tablet once daily.
The maximal antihypertensive effect is generally achieved within 3 weeks of initiating therapy.
CONTRAINDICATIONS
Hypersensitivity to losartan, sulfonamide-derived substances (such as hydrochlorothiazide), or any excipients of the product.
Refractory hypokalemia or hypercalcemia.
Severe hepatic impairment; cholestasis and obstructive biliary disorders.
Refractory hyponatremia.
Symptomatic hyperuricemia (gout).
Second and third trimesters of pregnancy.
Severe renal impairment (creatinine clearance <30 mL/min).
Anuria.
Concomitant use of PYZACAR HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.