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Cardiovascular Agents

Irbesartan STADA® 150 mg

 

Pack size:

Box of 2 blisters x 14 film-coated tablets.

 

Composition: 

Each film-coated tablet contains irbesartan 150 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Adminstration
  • Contraindications
  • Adverse reactions
  • Precautions

Administered orally without regard to meals.

  • Hypertension:
    Irbesartan is used alone or in combination with other classes of antihypertensive agents in the management of hypertension. Angiotensin II receptor antagonists, such as irbesartan, are considered one of several preferred antihypertensive drugs for the initial management of hypertension in patients with chronic renal failure, diabetes mellitus, and/or heart failure.
    Adult dosage:
    The usual initial dosage of irbesartan in adults is 150 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. Irbesartan also can be used concomitantly with other antihypertensive agents.
    A lower initial 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 hemodialysis.
  • 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.
    For the treatment of renal disease in hypertensive type 2 diabetics, irbesartan should be given in an initial dose of 75 mg once daily, increased to 300 mg once daily for maintenance.
    Dosage in renal and hepatic impairment
    The dosage adjustment is not necessary in patients with renal and hepatic impairment.
  • Pediatric dosage
    The usual initial dosage of irbesartan in children 6 - 12 years of age or adolescents 13 - 16 years of age with hypertension is 75 or 150 mg once daily, respectively. If blood pressure response is inadequate with the initial dosage, dosage may be increased to 150 or 300 mg once daily in children or adolescents, respectively; higher dosages in children or adolescents are not recommended.
     

Or as prescribed by physicians.

 

  • Patients who are hypersensitive to irbesartan or to any ingredient of the drug.
  • Pregnancy.
  • Lactation.

     

  • Adverse effects of irbesartan have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion (for example those who have received high-dose diuretics). Impaired renal function and, rarely, rash, urticaria, pruritus, angioedema, and raised liver enzyme values may occur. Hyperkalaemia, myalgia, and arthralgia have been reported.
  • Other adverse effects that have been reported with angiotensin II receptor antagonists include respiratory-tract disorders, back pain, gastrointestinal disturbances, fatigue and neutropenia. Rhabdomyolysis has been reported rarely.

     

  • Initiation of antihypertensive therapy may cause symptomatic hypotension in patients with intravascular volume-or sodium-depletion, e.g., in patients treated vigorously with diuretics or in patients on dialysis. Such volume depletion should be corrected prior to administration of the drug, or a low starting dose should be used.
  • In 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), treatment with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists that effect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
  • Pregnancy: Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and mortality when used in pregnancy during the second and third trimesters. Irbesartan should be discontinued as soon as possible when pregnancy is detected.
  • Lactation: It is not known whether irbesartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug.
  • No studies on the effects on the ability to drive and use machines have been performed. Based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability. When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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