Source: Registered Drug Product Database (NG) Revision Year: 2025 Publisher: Unique Pharmaceuticals Limited, 11, Fatai Atere Way, Matori-Mushin Lagos, Tel: +234 8097421000, Email: mail@uniquepharm.com Drug product manufacturer: Unique Pharmaceuticals Limited, Km 38, Abeokuta Road, Sango-Ota, Ogun State, Nigeria, Tel: +234 8097421000, Email: mail@uniquepharm.com
Unigyl Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected as the pathogen.
Metronidazole Oral Suspension is active against a wide range of pathogenic micro-organisms, notably Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia, Balantidium coli and other species of bacteroides, fusobacteria, eubacteria, clostridia, gardnerella vaginalis and anaerobic cocci.
It is indicated in Adults, Children and Newborns with a gestation age of over 40 weeks for:
Adults and Children over 10 years only for:
Adults and Children for:
Children for
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
A: Prophylaxis: against anaerobic infection-chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.
Dosage: 400 mg at 8 hourly intervals during the 24 hours preceding the operation followed by postoperative intravenous or rectal administration until the patient is able to take Metronidazole Oral Suspension by mouth.
Children <12 years: 20 - 30 mg/kg as a single dose given 1 - 2 hours before surgery.
Newborns with a gestation age <40 weeks: 10 mg/kg body weight as a single dose before operation.
Elderly: Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of drug.
Anaerobic infections: The duration of a course of Metronidazole treatment is about 7 days but it will depend upon the seriousness of the patient's condition as assessed clinically and bacteriologically.
B: Treatment of established anaerobic infection:
800 mg followed by 400mg at 8 hourly intervals.
Children >8 weeks to 12 years of age: The usual daily dose is 20 - 30 mg/kg/day as a single dose or divided into 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection. The duration of treatment is usually 7 days.
Children <8 weeks of age: 15 mg/kg as a single dose daily or divided into 7.5 mg/kg every 12 hours.
In newborns with a gestation age <40 weeks, accumulation of metronidazole can occur during the first week of life, which is why the concentrations of metronidazole in serum should preferably be monitored after a few days therapy.
C: Treatment of Protozoal and Other Infections:
(See Table).
| Duration of dosage in days | Adults and children over 10 years** | Children* | |||
|---|---|---|---|---|---|
| 7 - 10 years | 3 - 7 years | 1 - 3 years | |||
| Urogenital Trichomoniasis Where re-infection is likely, in adults the consort should receive a similar course of treatment concurrently | 7 or | 200 mg three times daily | 40 mg/kg orally as a single dose or 15 - 30 mg/kg/day divided in 2 - 3 doses not to exceed 2000 mg/dose | ||
| 5 - 7 or | 400 mg twice daily | ||||
| 1 | 2000 mg as a single dose | ||||
| Bacterial Vaginosis | 5 - 7 or | 400 mg twice daily | |||
| 1 | 2000 mg as a single dose | ||||
| Amoebiasis (a) Invasive intestinal disease in susceptible subjects | 5 | 800 mg three times daily | 400 mg three times daily | 200 mg four times daily | 200 mg three times daily |
| (b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis | 5 - 10 | 400 mg three times daily | 200 mg three times daily | 100 mg four times daily | 100 mg three times daily |
| (c) Amoebic liver abscess also other forms of extraintestinal amoebiasis | 5 | 400 mg three times daily | 200 mg three times daily | 100 mg four times daily | 100 mg three times daily |
| (d) Symptomless cyst passers | 5 - 10 | 400-800 mg three times daily | 200 - 400 mg three times daily | 100 - 200 mg four times daily | 100-200 mg three times daily |
| Alternatively, doses may be expressed by body weight 35 to 50 mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400 mg/day | |||||
| Giardiasis | 3 or | 2000 mg once daily | 1000 mg once daily | 600-800 mg once daily | 500 mg once daily |
| 5 or | 400 mg three times daily | ||||
| 7-10 | 500 mg twice daily | ||||
| Alternatively, as expressed in mg per kg of body weight: 15 - 40 mg/kg/day divided in 2 - 3 doses. | |||||
| Acute Ulcerative Gingivitis | 3 | 200 mg three times daily | 100 mg three times daily | 100 mg twice daily | 50 mg three times |
| Acute Dental Infections | 3 - 7 | 200 mg three times daily | |||
| Leg Ulcers and Pressure Sores | 7 | 400 mg three times daily | |||
Dosage is given in terms of metronidazole or metronidazole equivalent.
* Children and babies weighing less than 10Kg should receive proportionally smaller doses.
** Metronidazole is well tolerated by the elderly, but a pharmacokinetic study suggests cautious use of high dosage regimen in this age group.
Eradication of Helicobacter pylori in paediatric patients:
As a part of combination therapy, 20 mg/kg/day not to exceed 500mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy.
For oral administration only.
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole over dosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.
3 years.
Do not store above 30°C.
60 ml amber PET bottle with tamper evident ROPP cap.
Keep out of the reach of children.
Shake the bottle well before use.
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