STATIZOL (gel)
-
Chemical Name:
Metronidazole -
Therapeutic Category:
Antiprotozoal & Anthelmintic drugs -
Pharmacologic Category:
ANTI-INFECTIVE - ANTIPROTOZOAL -
Pharmaceutical Form:
Vaginal cream -
Composition:
Metronidazole 0.75 g/100 g
STATIZOL
Solution for IV Infusion
Vaginal Gel
Metronidazole
1. PHARMACOLOGY:
Metronidazole is an antiprotozoal and antianaerobic-bacterial agent; its mechanism of action is thought to involve interference with DNA by a metabolite in which the nitro group of Metronidazole has been reduced.
Metronidazole is active against several protozoa including intestinal amebiasis (acute amebic dysentery), giardia lamblia, trichomonas vaginalis, entamoeba histolytica, and entamoeba coli. And anaerobic bacteria including bacteroides species including the bacteroides fragilis group and fusobacterium species. It has also activity against gardnerella vaginalis, helicobacter pylori and spirochaetes.
2. INDICATIONS:
STATIZOL - Solution for IV Infusion is indicated for:
- Curative treatment of post – operative infections due to susceptible anaerobic bacteria.
- Preventive treatment of infections due to susceptible anaerobic bacteria during surgery.
- Severe amoebiasis.
STATIZOL – Vaginal Gel is indicated for:
- Bacterial vaginosis caused by Hemophilus, Gardnerella, Corynebacterium and anaerobic vaginosis.
- Vulvovaginosis caused by Trichomonas.
3. CONTRAINDICATIONS:
Hypersensitivity to imidazole derivatives.
4. PRECAUTIONS:
- The treatment should be discontinued in case of ataxia, vertigo or confusion.
- Possible enhancing of neurologic symptoms in patients with history of severe peripheral or central neurologic diseases.
- Alcoholic beverages should not be consumed («antabuse» effect).
- Total and differential leukocyte counts are recommended in case of high dosage and/or prolonged treatment and also in patients with history of blood dyscrasia.
- It shoud be used cautiously in the first trimester of pregnancy.
- Lactation should be discontinued during treatment.
- Vaginal intercourse is not allowed during treatment with STATIZOL – Vaginal Gel.
5. ADVERSE RECATIONS:
The adverse reactions are dose related:
- Rarely: Gastro-intestinal disorders.
- Very rarely: Cutaneo-mucosal signs, neurological sings (headache, vertigo).
- With high dosage or prolonged administration: Leucopenia, peripheral neuropathy which disappears when treatment is discontinued.
- Red-brown color of the urine.
6. DRUG INTERACTIONS:
- Do not prescribe with disulfirame.
- Metronidazole increases the serum level of warfarin sodium, phenytoin, lithium and fluorouracil with consequent potential for an increased effects.
- Metronidazole potentiates the vecuronium activity.
- Cimetidine increases the serum level of Metronidazole.
7. DOSAGE & ADMINISTRATION:
STATIZOL – Solution for IV Infusion:
It is administered by slow intravenous infusion over 30 to 60 minutes.
For curative treatment in anaerobic infections and amoebiasis:
Adults: 500 mg in a solution of 100 mL (5mg/ml) every 8 hours. The infusion rate is 5 mL per minute.
Children: 20 to 30 mg/kg daily in divided 2 - 3 intakes.
For preventive treatment in post-operative anaerobic infections in abdominal surgery and in gynecology:
Adults: 500 mg every 12 hours, 6 to 12 hours before surgery and during 3 days.
Children: 20 to 30 mg/kg daily using the same protocol.
STATIZOL – Vaginal Gel:
Dose of 5 grams intravaginally once or twice a day for 5 days. For once a day dosing it should be administered at bed time.
8. PACKAGING & COMPOSITION:
- STATIZOL – Solution for IV Infusion: A pack of 1 vial of 100 mL. Each 100 mL contains 500 mg Metronidazole.
- STATIZOL – Vaginal Gel: A pack of aluminium tube of 70 g gel. Each tube contains 0,75% Metronidazole.
9. STORAGE CONDITIONS:
- STATIZOL – Solution for IV Infusion: store between (15-30) °C, protect from light.
- STATIZOL – Vaginal Gel: store between (15-30) °C.
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