COMPOSITIONS :
Thiamphenicol Dry syrup 125 mg/5 ml, each 5 ml (a measurement spoonful) suspension contains : Thiamphenicol 125 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.
Preparation of dry syrup :
Add 50 ml water to the bottle and shake well until evenly suspended. Keep container tightly closed. After reconstitution, store suspension below 30oC and use within 10 days. Shake well before use.
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 Dry syrup 125 mg/5 ml | Bottle @ 60 ml | Reg. No. GKL1202345638A1 |
STORAGE :
Thiamphenicol Dry syrup :
STORE BELOW 30ºC, PROTECT FROM LIGHT
Thiamphenicol Dry syrup : After reconstitution, store suspension below 30OC and use within 10 days. Shake well before use.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
