- Approval Id
- c24bddb4c4b33ae6
- Drug Name
- IRBETAS 300 FILM COATED TABLET 300 MG
- Product Name
- IRBETAS 300 FILM COATED TABLET 300 MG
- Approval Number
- SIN16192P
- Approval Date
- 2021-05-14
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
Posology
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan Tablets at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Tablets can be increased to 300 mg, or other anti-hypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan Tablets. (See section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
The demonstration of renal benefit of Irbesartan Tablets in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other anti-hypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Special Populations
**Renal impairment:** no dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Intravascular volume depletion:** Volume and/or sodium depletion should be corrected prior to administration of Irbesartan Tablets.
**Hepatic impairment:** no dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
**Older People:** Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for Older People.
**Paediatric population:** the safety and efficacy of irbesartan in children aged 0 to 18 has not been established. Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Method of Administration
For oral use.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
Irbesartan is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen. (See sections 4.3, 4.4, 4.5 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Irbesartan can be used alone or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Second and third trimester of pregnancy (see sections 4.4 and 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
The concomitant use of Irbesartan Tablets with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Do not administer Irbesartan Tablets with angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetic nephropathy (see sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- C09CA04
- Atc Item Name
- irbesartan
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
- Company Detail Path
- /organization/7b2062edde9ff0f1/accord-healthcare-private-limited
