COMPOSITIONS :
Thiamphenicol Capsule 500 mg, each capsule contains : Thiamphenicol 500 mg.
DESCRIPTIONS :
Thiamphenicol contain Thiamphenicol as active ingredient is available in dry syrup 125 mg/5 ml and capsule 500 mg.
INDICATIONS :
Thiamphenicol is indicated for infections caused by :
- Salmonella sp.
- H. influenzae, especially meningeal infections.
- Rickettsia.
- Lymphogranuloma-psittacosis.
- Gram negative bacteria which cause bacteremia-meningitis.
Not for hepatobilier and gonorrhoeae.
DOSAGE AND ADMINISTRATIONS :
- Adults, children, infants > 2 weeks : 50 mg/kgBW a day in divided doses, 3 – 4 times daily.
- Premature infants : 25 mg/kgBW a day in divided doses, 4 times daily.
- Newborn babies < 2 weeks : 25 mg/kgBW a day in divided doses, 4 times daily.
CONTRAINDICATIONS :
- Patients who known to be hypersensitive to Thiamphenicol or Chloramphenicol.
- Patients with severe renal or liver impairment.
WARNINGS AND PRECAUTIONS :
- Not recommended for infections of unknown cause.
- Not recommended for mild infections, e.g. cough, flu, influenza, throat infection.
- Should not be used for prophylaxis of bacterial infections.
- Blood cell counts must be done before Thiamphenicol therapy.
- In prolonged treatments and when high doses are needed, it is advisable to perform periodical blood examination.
- Should not be used for pregnancy and lactating women, because Thiamphenicol may across the placenta and excreted in breast milk.
- Caution should be taken when given to patients with renal impairment (dose should be reduced).
- Care should be taken for possibility of superinfection from bacteria and yeasts.
- Caution should be exercised when prescribing to premature and newborn babies (< 4 weeks).
- Treatment should be discontinued if reticulocytopenia, leucopenia, thrombocytopenia or anemia occurs.
- Duration of use should not exceed the specified time limit.
DRUG INTERACTIONS :
- Phenobarbital reduces therapeutic efficacy of Thiamphenicol.
- Thiamphenicol may inhibit metabolism of Warfarin, anticonvulsant and Sulphonylurea.
- Avoid concomitant administration with other drugs which can cause bone marrow depression.
- Concomitant use with Chloramphenicol may cause cross-resistance.
- Care should be taken when co-administering with drugs which are metabolized by liver enzymes e.g., Dicumarol, Phenytoin, Tolbutamide, Phenobarbital.
ADVERSE REACTIONS :
- Blood dyscrasia e.g., aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia, particularly irreversible and fatal aplastic anemia.
- Bone marrow depression with high dose administration and reversible if treatment is discontinued.
- Hypersensitive reactions, e.g., rash, urticaria, fever, angioedema and anaphylactic reaction (rare).
- Gastrointestinal disturbances, e.g., nausea, vomiting, glossitis, stomatitis and diarrhoea.
- Gray syndrome may occur in premature or newborn babies (< 4 weeks).
- Bacterial and fungal superinfection may occur during prolonged therapy with Thiamphenicol.
- Other adverse reactions e.g., headache, mental depression and optic neuritis.
PRESENTATIONS :
| Thiamphenicol Capsule 500 mg | Box, 10 strips @ 10 capsules | Reg. No. GKL1202345501A1 |
STORAGE :
Thiamphenicol Capsule :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
