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Irbesartan STELLA 300 mg
Rx

Irbesartan is a potent, orally active, selective angiotensin II receptor (AT1 subtype) antagonist.

Pack size Box of 28 tablets
Shelf-life 36 months
Composition Irbesartan
Dosage forms and strengths Film-coated tablet: 300 mg
Product code :

PRESCRIBING INFORMATION

Indications:

Hypertension: Irbesartan is used alone or in combination with other classes of antihypertensive agents in the management of hypertension.

Diabetic nephropathy: Irbesartan is used in the management of diabetic nephropathy manifested by elevated serum creatinine and proteinuria (urinary protein excretion exceeding 300 mg daily) in patients with type 2 diabetes mellitus and hypertension.

Dosage:

Hypertension

  • Adult: The initial dosage is 300 mg once daily in patients without depletion of intravascular volume. If blood pressure response is inadequate with the initial dosage, dosage may be increased as tolerated to 300 mg once daily or a diuretic may be added. A dose of 75 mg once daily may be considered in elderly patients over 75 years, for patients with intravascular volume depletion, and for those receiving haemodialysis.
  • Children 6 – 12 years of age or adolescents 13 – 16 years of age: An initial dosage is 75 or 300 mg once daily, respectively. If blood pressure response is inadequate, dosage may be increased to 150 or 300 mg once daily, respectively; higher dosages are not recommended.

Renal and hepatic impairment: The dosage adjustment is not necessary.

Diabetic nephropathy

An initial dose of 75 mg once daily, increased to 300 mg once daily for maintenance.

Usage:

Irbesartan STELLA 300 mg is administered orally and without regard to meals.

Known hypersensity to any of the active substance or excipients.

Pregnancy and lactation.

Adverse effects are usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension. Impaired renal function and, urticaria, pruritus, angioedema, and raised liver enzyme values; hyperkalaemia, myalgia, and arthralgia. Respiratory-tract disorders, back pain, gastrointestinal disturbances, fatigue and neutropenia.

  • Caution when use irbesartan in patients with intravascular volume or sodium-depletion, patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), patients with ischaemic cardiopathy.
  • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take Irbesartan STELLA 300 mg.
  • Irbesartan should be discontinued as soon as possible when pregnancy is detected. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug.
  • Patients should be aware of how they react to drug before driving or operating machinery.