RENICARD Film-coated tablet Ref.[115263] Active ingredients: Losartan

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Unichem SA (Pty) Ltd, San Domenico, Ground Floor, Unit G4, 10 Church Street, Durbanville, 7551 Cape Town, Tel: +27 21 531 0436

Therapeutic indications

RENICARD 50 is indicated for:

  • The treatment of hypertension.
  • Renal protection in type 2 diabetic patients with hypertension and proteinuria.

Posology and method of administration

Posology

Hypertension

The usual starting and maintenance dose is 50 mg once daily for most patients. The maximum antihypertensive effect is achieved 3–6 weeks after initiation of therapy. The dose may be increased to 100 mg once daily.

For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).

No initial dosage adjustment is necessary for the elderly patients or for patients with renal impairment, including patients on dialysis. A lower dose should be considered for patients with a history of hepatic impairment (see section 4.4).

Renal protection in type 2 diabetic patients with hypertension and proteinuria

The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on blood pressure response.

RENICARD 50 may be administered with other antihypertensive medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting medicines) as well as with insulin and other commonly used hypoglycaemic medicines (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

Method of administration

RENICARD 50 may be administered with or without food.

Overdose

The symptoms of an overdosage of RENICARD 50 would be hypotension and tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither RENICARD 50 nor the active metabolite can be removed by haemodialysis.

Shelf life

36 months.

Special precautions for storage

Store at or below 25°C in a dry place.

Protect from light.

Keep the blister strips in outer carton until required for use.

Nature and contents of container

Aluminium/PVC blister strips of 10 tablets. Three strips will be packed in an outer carton.

Special precautions for disposal and other handling

Not applicable.

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