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Indopril 5
Rx

Imidapril has hypotensive effect in hypertension appears to result primarily from the suppression of the plasma renin-angiotensin-aldosterone system.

Pack size Box of 30 tablets
Shelf-life 24 months
Composition Imidapril hydrochloride
Dosage forms and strengths Tablet: 5 mg
Product code :

PRESCRIBING INFORMATION

Indication:

Treatment of essential hypertension.

Dosage:

  • Adults: Start with 5 mg daily; if control of blood pressure has not been achieved after at least 3 weeks, increased to 10 mg/day; maximum 20 mg/day; consider combination with a diuretic.
  • Elderly (≥ 65 years old): Start with 2.5 mg once a day, titrate according to response, maximum 10 mg/day.
  • Renal impairment: Clcr 30 – 80 ml/min: Initiate with 2.5 mg/day; Clcr 10 – 29 ml/min: Should not use.
  • Hepatic impairment: Start with 2.5 mg/day.
  • Patients at increased risk for first dose hypotension: Correction in salt and/or body fluids deficiencies and discontinuation of an existing diuretic therapy for 2 – 3 days before imidapril. If this is not possible, initial dose should be imidapril 2.5 mg/day, then careful dose titration.
  • Cardiac failure: Start with 2.5 mg/day; should be closely monitored.
  • Children: The safety and efficacy have not been established.

Usage:

The tablets should be taken once a day at the same time about 15 minutes before meals. The first dose should be given preferably at bedtime.

  • Hypersensitivity to any of the ingredients or Angiotensin-converting enzyme (ACE) inhibitors.
  • History of angioneurotic oedema associated with previous ACE inhibitors therapy.
  • Hereditary/idiopathic angioedema.
  • Second and third trimesters of pregnancy.
  • Severe renal failure with or without haemodialysis (Clcr < 10 m/min).

Common: Headache, dizziness, fatigue, somnolence; cough; nausea.

Use with caution in the following cases:

  • Ischaemic heart or cerebrovascular disease.
  • Aortic or mitral valve stenosis, hypertrophic cardiomyopathy.
  • Collagen vascular disease.
  • Severe cardiac failure or underlying renal disease, including bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney.
  • Undergoing LDL lipid apheresis with dextrane sulfate, under-going haemodialysis with high-flux membranes, undergoing desensitising treatment with hymenoptera venom.
  • Previously treated with oral antidiabetic drugs or insulin in the first month treating with imidapril.
  • Driving/ operating machinery.
  • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
  • Imidapril is not recommended during the first trimester of pregnancy and during breast-feeding.

Possible risks:

  • Hyperkalaemia.
  • Proteinuria.
  • Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx.
  • Cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death.
  • Severe hypotension.