Teveten 300mg Tablets (Eprosartan)- Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Eprosartan, Teveten 

Date published: 08/02/2012 09:27

Type of SPC Change: Revised SPC

Generic drug name: Eprosartan

Drug brand name: Teveten

Legal status: POM

Pharmaceutical manufacturer: Abbott Laboratories Limited

Summary
by: Atisha Sharma

There have been significant updates to several sections of the SPC, including the following:

 

Change to section 4.2 - Posology and method of administration

 

Eprosartan may be used alone or in combination with other anti-hypertensives. In particular, addition of a thiazide-type diuretic such as hydrochlorothiazide or a calcium channel blocker such as sustained release nifedipine has been shown to have an additive effect with Eprosartan.

 

No dose adjustment is required in the elderly.

 

There is limited experience in patients with hepatic insufficiency (see section 4.3).

 

In patients with moderate or severe renal impairment (creatinine clearance <60 ml/min), the daily dose should not exceed 600 mg.

 

Teveten is not recommended for use in children and adolescents due to lack of data on safety and efficacy

 

Change to section 4.3 - Contraindications

 

Haemodynamically significant bilateral renovascular disease or severe stenosis of a solitary functioning kidney

 

Change to section 4.4 - Special warnings and precautions for Use

 

Caution is recommended for use in patients with creatinine clearance < 30 ml/min or in patients undergoing dialysis.

 

Please refer to SPC link below for full information on all changes.

SPC

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