| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | For oral administration |
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Indication:
Cotrimoxazole is a type of antibacterial medicine, which works by killing bacteria. Cotrimoxazole tablets are used to treat:
or prevent lung infections caused by Pneumocystis jiroveci (P.carinii)
or prevent toxoplasmosis (passed through undercooked meat or cat faeces)
nocardiosis (bacterial infection causing abscesses)
urinary tract infections (e.g. cystitis) or worsening of long-term bronchitis
ear infections ( acute otitis media).
Contra-indication:
Do not take Cotrimoxazole tablets and tell your doctor if you:
are allergic (hypersensitive) to trimethoprim, sulphonamides or any of the other ingredients
have sever liver damage or jaundice
have any blood disorder or porphyria (a genetic disease)
have severe kidney disease
are pregnant or planning to become pregnant
Cotrimoxazole should not be given to newborn babies under 6 weeks old except for Pneumocystis jiroveci (P.carinii) infection.
Adverse Effects:
Stop taking the tablets and contact a doctor at once if you get a skin rash, or severe allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing, fever, inflamed heart or blood vessels (chest pain, fever, a fast heartbeat, tiredness), systemic lupus erythematosus (SLE-skin rash, hair loss, difficulty breathing and joint pains), Stevens-Johnson syndrome (severe skin rash with flushing, fever, blisters or ulcers) or toxic epidermal necrolysis (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns).
Aseptic meningitis can occur in some patients as a combination of symptoms such as headache, fever, stiff neck, tiredness, feeling ill and sensitivity of eyes to bright light.
Pregnancy and breast-feeding
Cotrimoxazole should not be used in pregnancy. If you are breast-feeding, ask your doctor for advice before taking this medicine.
Storage instructions:
Store below 25ºC. Protect from moisture and light. Keep out of reach of children
| Testing terms | Standards | Results |
| Appearance | White or almost white round tablets | Complies |
| Average mass | 516.8mg-571.2mg | 536.5mg |
| Friability | NMT 1.0% | 0.2% |
| Disintegration Time | Not more than 15 minutes | Complies |
| Trimethoprim | NLT 80% of the labeled amount of trimethoprim is dissolved 60 minutes |
95% |
| Sulfamethoxazole | NLT 80% of the labeled amount of sulfamethoxazole is dissolved 60 minutes |
96% |
| Total aerobic | Not more than 1000 cfu/g | <10cfu/g |
| Moulds & Yeasts | Not more than 100 cfu/g | <10cfu/g |
| Assay | Trimethoprim: 93.0%-107.0% of the labeled amount Sulfamethoxazole: 93.0%-107.0% of the labeled amount |
97.9% 98.2% |
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