Source: Registered Drug Product Database (NG) Publisher: Unique Pharmaceuticals Limited, 11, Fatai Atere Way, Matori-Mushin Lagos, Tel: +234 8097421000, Email: mail@uniquepharm.com Manufacturer: Unique Pharmaceuticals Limited, Km 38, Abeokuta Road, Sango-Ota, Ogun State, Nigeria, Tel: +234 8097421000, Email: mail@uniquepharm.com
Metronidazole tablets 200 mg is indicated in prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.
Metronidazole tablets 200 mg is active against a wide range of pathogenic micro- organisms, notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis.
It is also active against Trichomonas vaginalis and other species of trichomonads, Entamoeba histolytica, Giardia lamblia, Balantidium coli and the causative organisms of acute ulcerative gingivitis.
Metronidazole tablets 200 mg is indicated in the oral treatment of:
The prevention of post-operative infections due to anaerobic bacteria, particularly species of Bacteroides and anaerobic streptococci.
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated.
Urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male. The male consort of females suffering from urogenital trichomoniasis should be treated concurrently.
Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis).
All forms of amoebiasis (intestinal and extra-intestinal disease, and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections (e.g. acute pericoronitis and acute apical infections). Considerations should be given to official guidance on the appropriate use of antibacterial agents.
Anaerobic infections: The duration of a course of Metronidazole Tablets 200 mg treatment is about 7 days but it will depend upon the seriousness of the patient's condition as assessed clinically and bacteriologically.
Prophylaxis against anaerobic infection: Chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.
Adults:
400 mg 8-hourly for 24 hours immediately preceding operation followed by postoperative intravenous or rectal administration until the patient is able to take the tablets.
Children:
<12 years: 20-30 mg/kg as a single dose given 1-2 hours before surgery.
Newborns with a gestation age of <40 weeks: 10 mg/kg body weight as a single dose before operation.
Treatment of established anaerobic infection:
Adults:
800 mg followed by 400 mg 8-hourly.
Children:
Children >8 weeks to 12 years of age: The usual 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 <40 weeks, accumulation of metronidazole can occur during the first week of life, therefore the concentrations of metronidazole in serum should preferably be monitored after a few days therapy.
Protozoal and other infections:
| Dosage is given in terms of metronidazole or metronidazole equivalent | |||||
| Duration of dosage in days | Adults and children over 10 years | Children | |||
| 7 to 10 years | 3 to 7 years | 1 to 3 years | |||
| Urogenital Trichomoniasis Where infection is likely in adults the consort should receive similar course of treatment concurrently | 7 or 5-7 | 2000 mg as a single dose or 200 mg three times daily or 400 mg twice 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/day | ||
| 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 daily mg times | 200 mg four daily mg times | 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 extra-intestinal 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 50mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400 mg/day | |||||
| Giardiasis | 3 | 2000 mg once daily or | 1000 mg once daily | 600-800 mg once daily | 500 mg once daily |
| 5 | 400 mg three times daily or | ||||
| 7-10 | 500 mg twice daily | ||||
| Alternatively, as expressed in mg per kg of body weight: 15-40mg/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 daily |
| Acute dental infections | 3-7 | 200 mg three times daily | |||
| Leg ulcers and pressure sores | 7 | 400 mg three times daily | |||
| Children and infants weighing less than 10 kg should receive proportionally smaller dosages. Elderly: Metronidazole is well tolerated by the elderly, but a pharmacokinetic study suggests cautious use of high dosage regimens in this age group. | |||||
Eradication of Helicobacter pylori in paediatric patients:
As a part of a combination therapy, 20 mg/kg/day not to exceed 50 0mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy.
For oral use.
Metronidazole Tablets 200 mg should be swallowed without chewing, with half a glass of water, during or after meals.
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms are limited to vomiting, ataxia and slight disorientation. There is no specific treatment for gross over dosage of metronidazole. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.
36 months.
Store in a dry place, below 30°C.
Keep the container tightly closed, protect from light.
a. Blisters consisting of hard tempered aluminum foil, compatible with PVC or PVDC, Thermo-sealed. 10 tablets per blister and 10 blisters per cardboard box.
b. Low density polyethylene jars with lid containing 1000 tablets in sealed polyethylene bags.
None.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.