Suppository
Metronidazole
Composition
Flagyl 0.5 g suppository: each contains 500 mg metronidazole
Flagyl 1 g suppository: each contains 1 g metronidazole.
Mechanism
Trichomoniacide, Anaerobicide
Indications
- Treatment of infections in which anaerobic bacteria have been identified: septicaemia, bacteremia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic cellulitis.
- Prevention of post operative infections due to anaerobic bacteria, particularly species of bacteroides and anerobic streptococci.
Dosage and Administration
- Treatment of infections in which anaerobic bacteria have been identified.
- Adults: 1 gram suppository at 8 hourly intervals until oral medication becomes possible. If the suppository administration is more than 3 days, reduced the further doses into 1 gram at 12 hourly intervals.
- Children: 7.5 mg/kg body-weight at 8 hourly intervals.
- Prevention of post operative infections due to anaerobic bacteria:
- Adults: 1 gram suppository 2-4 hours before surgery, then at 8 hourly intervals until oral medication becomes possible.
- Children: ½ or ¼ of 500 mg suppository at 8 hourly intervals.
- Care must be taken for: Lactating woman as metronidazole is secreted in breast milk. Second and third trimesters of pregnancy as metronidazole can pass the placenta barrier.
- FLAGYL should be administered with caution to patients with CNS diseases. The CNS interference has been reported in some cases, but will disappear on the withdrawn or on the reduced doses of metronidazole.
- When taken together with alcohol, metronidazole can provoke a disulfiram-like reaction.
- Count the blood examination is recommended for a long term treatment.
- For patients with hepatic insufficiency, doses below those usually recommended should be administered caustiously.
- Safety in children has not been established, except in amoebiasis.
Side Effects
- Sometimes appear nausea, anorexia, epigatris distress.
- Serious adverse reactions are reported: convulsive seizures and peripheral neuropathy.
- An unpleasant taste in the mouth, furred tongue, nausea, vomiting or other gastro intestinal disturbance have been most common reported.
- Urticaria, skin rash, pruritus, angiodema and rarely anaphylaxis have occured.
- Drowsiness, dizziness, headache, ataxia and darkening of the urine (due to metabolites) have been reported rarely.
- A moderate, reversible leucopenia has been reported in some patients.
Contra Indications
- Metronidazole should not be used in patients with an established history of bone marrow depresion.
- Patients who are known to be hypersensitive to metronidazole.
- First trimester of pregnancy.
Drug Interactions
- FLAGYL may be given alone. In combination with other antibiotic: both should be given in full normal therapeutic doses.
- Prior to simultaneous administration with Warfarin, the anticoagulant should be checked and if possible to be suitably reduced.
- Cimetidine prolongs the plasma clearance of metronidazole, presumably by inhibiting metabolic enzymes, toxic concentrations of metronidazole may be produced.
Storage
Store below 25°C
Protect from Light
Presentation
Flagyl 0.5 g suppository :
Box of 2 Blisters @ 5 suppositories. Reg. No. DKL0121201453A1
Flagyl1 g suppository :
Box of 2 Blisters @ 5 suppositories. Reg. No. DKL0121201453B1
HARUS DENGAN RESEP DOKTER
ON MEDICAL PRESCRIPTION ONLY
Manufactured by
PT Aventis Pharma,
Jakarta - Indonesia
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