SEPTRIN Tablet Ref.[108385] Active ingredients: Sulfamethoxazole Trimethoprim

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Septrin 80 mg/400 mg Tablets.

Pharmaceutical Form

Tablet.

White, round, biconvex tablets, debossed with S2 on one side and scored on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole.

Contains 2.25 mg of sodium per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sulfamethoxazole

Sulfamethoxazole competitively inhibits the utilisation of para-aminobenzoic acid in the synthesis of dihydrofolate by the bacterial cell resulting in bacteriostasis.

Trimethoprim

Trimethoprim is a dihydrofolate reductase inhibitor, inhibiting the conversion of bacterial dihydrofolic acid to tetrahydrofolic acid, required for the synthesis of some amino acids. Its effects are considerably greater on the cells of micro-organisms than on the mammalian cells.

List of Excipients

Sodium starch glycolate type A
Povidone K30
Docusate sodium
Magnesium stearate

Pack sizes and marketing

PVC/Aluminium foil blister packs.

Packs of 100 and 500 tablets.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA1691/010/001

Date of first authorisation: 14th November 1975
Date of last renewal: 14th November 2005

Drugs

Drug Countries
SEPTRIN Australia, Spain, Ireland, Malta, Turkey

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.