Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRIMETHOPRIM; SULPHAMETHOXAZOLE
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
TRIMETHOPRIM; SULPHAMETHOXAZOLE
1000 Tablets
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ 1 CO-TRIMOXAZOLE ‘MPI’ TABLETS Sulphamethoxazole/Trimethoprim (400mg/80mg) WHAT IS IN THIS LEAFLET: 1. What Co-Trimoxazole ‘MPI’ Tablets is used for 2. How Co-Trimoxazole ‘MPI’ Tablets works 3. Before you use Co-Trimoxazole ‘MPI’ Tablets 4. How to use Co-Trimoxazole ‘MPI’ Tablets 5. While you are using Co- Trimoxazole ‘MPI’ Tablets 6. Side Effects 7. Storage and Disposal of Co- Trimoxazole ‘MPI’ Tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CO-TRIMOXAZOLE ‘MPI’ TABLETS IS USED FOR Co-Trimoxazole is used for the treatment of urinary tract infections, pneumocystitis carinii pneumonia (inflammation of lungs), intra- abdominal infections, genitourinary tract infections, burn wound infections, acute otitis media (inflammation of the ear), respiratory tract infections and various lung infections. Your doctor may have prescribed Co- Trimoxazole ‘MPI’ Tablets for another purpose. Ask your doctor if you have any questions why Co-Trimoxazole ‘MPI’ Tablets has been prescribed for you. HOW CO-TRIMOXAZOLE ‘MPI’ TABLETS WORKS Co-Trimoxazole belongs to a group of medicines called antibiotics. Co- Trimoxazole works by stopping the growth of the bacteria causing the infection. BEFORE YOU USE CO-TRIMOXAZOLE ‘MPI’ TABLETS -_When you must not use it _ If you are allergic (hypersensitive) to trimethoprim or sulphonamide or any other ingredient of Co- Trimoxazole ‘MPI’ Tablets. If you have acute porphyria (a genetic metabolic disorder). If you have G6PD deficiency. If you are going to deliver or a nursing mother. If it is for your child and they are less than 2 months of birth. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Co- Trimoxazole ‘MPI’ Tablets. -_Before you start to use it _ You must tell your doctor or pharmacist if: You have allergies to any medicine which you have taken previ Soma hati kamili
7044-05 CO-TRIMOXAZOLE ‘MPI’TABLETS NAME AND STRENGTH OF ACTIVE INGREDIENT(S): Each tablet contains: Sulphamethoxazole ………………………………………………400mg Trimethoprim………………………………………………………80mg PRODUCT DESCRIPTION: A white, round, scored of diameter 12.5mm flat tablet with ‘MPI’ marking. PHARMACODYNAMICS: The antimicrobial activity of the combination of trimethoprim and sulphamethoxazole results from its actions on two steps of the enzymatic pathway for the synthesis of tetrahydrofolic acid. Sulphonamide inhibits the incorporation of PABA into folic acid, and trimethoprim prevents the reduction of dihydrofolate to tetrahydrofolate. PHARMACOKINETICS: After a single oral dose of the combined preparation, trimethoprim is absorbed more rapidly than sulphamethoxazole. Peak blood concentrations of trimethoprim usually occur by 2 hours, and that of sulphamethoxazole are seen by 4 hours. The half-lives of trimethoprim and sulphamethoxazole are 16 and 10 hours, respectively. Trimethoprim is rapidly distributed and concentrated in tissues, and relatively small quantities are bound to plasma protein in the presence of sulphamethoxazole. The drug enters cerebrospinal fluid and sputum readily. High concentrations of each component of the mixture are also found in bile. About 65% of sulphamethoxazole is bound to plasma protein. Up to 60% of administered trimethoprim and from 25% to 50% of sulphamethoxazole are excreted in the urine in 24 hours. Two third of the sulphamethoxazole is unconjugated. Metabolites of trimethoprim are also excreted. INDICATIONS: Co-Trimoxazole is used for the treatment of: • Urinary tract infections caused by E.coli, Klebsiella, Enterobacter, P. mirabilis, P. vulgaris and Morganella morganii. • Acute otitis media in children caused by H. influenzae and Streptococcus pneumoniae. • Acute exacerbations of chronic bronchitis in adults caused by H. influenzae and Streptococcus pneumoniae. • Enteritis caused by Shigella flexner Soma hati kamili