Lisiplus HCT 10/12.5

Rx

Indications:

Treatment of essential hypertension in patients where combination therapy is appropriate.

Dosage:

The usual dosage is one tablet, administered once daily.

Lisiplus HCT 10/12.5 should be taken at approximately the same time each day. If the desired therapeutic effect cannot be achieved in a period of 2 to 4 weeks at this dose level, the dose can be increased to two tablets administered once daily.

• Renal insufficiency: Lisiplus HCT 10/12.5 is not to be used as initial therapy in any patient with renal insufficiency. In patients with creatinine clearance of > 30 and < 80 ml/min, Lisiplus HCT 20/12.5 may be used, but only after titration of the individual components.
• Prior diuretic therapy: The diuretic therapy should be discontinued for 2 – 3 days prior to initiation of therapy with Lisiplus HCT 10/12.5. If this is not possible, treatment should be started with lisinopril alone, in a 5 mg dose.
• Elderly: No adjustment of dosage is required in the elderly.
• Paediatric use: Safety and effectiveness have not been established.

Usage:

Lisiplus HCT 10/12.5 is administered orally.

Hypersensitivity to lisinopril, to any of the excipients or any other angiotensin converting enzyme (ACE) inhibitor; Hypersensitivity to hydrochlorothiazide or other sulphonamide-derived drugs.

History of angioedema with previous ACE inhibitor therapy; Hereditary or idiopathic angioedema; Gout; Hyperuricaemia; Anuria; Addition’s disease; Hypercalcemia; Severe hepatic impairment; Severe renal impairment.

Second and third trimesters of pregnancy

Common:

• Lisinopril: Headache, persistent and nonproductive cough.
• Hydrochlorothiazide: Fatigue, dizziness, vertigo, headache, hypokalaemia, hyperuricaemia, hyperglycaemia, hyperlipaemia (high dose).

• Lisinopril should be administered with caution in patients with obstruction in the outflow tract of the left ventricle (e.g., aortic stenosis, hypertrophic cardiomyopathy).
• Renal function should be monitored during the first few weeks of therapy.
• Hyperkalemia can develop, especially in those with renal impairment or diabetes mellitus and those receiving drugs; Hypoglycemia can develop in patients receiving concomitant therapy with ACE inhibitors and insulin or oral antidiabetic agents.
• Persistent and nonproductive cough reported with all ACE inhibitors; resolves after drug discontinuance.
• Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension.
• Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease.
• Thiazides may result in hypomagnesemia; increase in cholesterol and triglyceride levels.
• Lisiplus HCT 10/12.5 discontinued as soon as possible after detection of pregnancy.
• Product is not recommended for breast-feeding women.
• Products may have an effect on the ability to drive and use machines.