Lisinopril; Hydroclorothiazide
Visa No.: VD-36189-22
Product: Lisinopril /HCTZ STADA 20mg/12.5 mg
API: Lisinopril; Hydroclorothiazide
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 855/QĐ-QLD_30/12/2022_182
INDICATIONS
Indicated for the treatment of mild to moderate hypertension in patients whose blood pressure has been adequately controlled with the inpidual components given separately at the same dose ratio.
DOSAGE AND ADMINISTRATION
Patients with primary hypertension:
Liều thông thường là 1 viên x 1 lần/ngày, nên sử dụng ở cùng một thời điểm mỗi ngày.
Nếu không đạt được hiệu quả điều trị mong muốn trong vòng 2 đến 4 tuần, có thể tăng lên 2 viên x 1 lần/ngày.
Special Populations
Patients with renal impairment:
Thiazide diuretics are not suitable for patients with renal impairment and are ineffective in patients with creatinine clearance ≤30 mL/min (moderate to severe renal impairment). The fixed-dose combination of Lisinopril/Hydrochlorothiazide should not be used as initial therapy in any patient with renal impairment.
In patients with creatinine clearance >30 and <80 mL/min, the combination may be used only after dose titration of the inpidual components. The recommended lisinopril dose when used alone is 5–10 mg.
Patients previously treated with diuretics:
Symptomatic hypotension may occur after the initial dose, particularly in patients with volume and/or electrolyte depletion due to prior diuretic therapy. Diuretic treatment should be discontinued 2–3 days before initiating therapy with lisinopril/hydrochlorothiazide. If discontinuation is not possible, treatment should be initiated with lisinopril 5 mg alone.
Elderly:
No dose adjustment is required in elderly patients. Clinical studies show that the efficacy and tolerability of lisinopril and hydrochlorothiazide used together are similar in both elderly and younger patients.
Lisinopril at doses of 20–80 mg has shown comparable efficacy in elderly hypertensive patients (≥65 years) and those under 65 years. Lisinopril monotherapy provides a reduction in diastolic blood pressure comparable to hydrochlorothiazide or atenolol monotherapy. Age did not influence lisinopril tolerability in clinical studies.
Children: Safety and efficacy have not been established in children.
CONTRAINDICATIONS
Hypersensitivity to any component of the product.
Hypersensitivity to angiotensin-converting enzyme inhibitors (ACE inhibitors).
Hypersensitivity to sulfonamide-derived medicines.
Concomitant use with Sacubitril/Valsartan. Treatment with the fixed-dose combination of Lisinopril/Hydrochlorothiazide must not be initiated within 36 hours after the last dose of sacubitril/valsartan.
History of angioedema related to previous ACE inhibitor therapy.
Hereditary or idiopathic angioedema.
Second and third trimesters of pregnancy.
Severe renal impairment (creatinine clearance <30 mL/min).
Anuria.
Severe hepatic impairment.
Concomitant use 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.
