Source: Registered Drug Product Database (NG) Revision Year: 2021 Publisher: Nemel Pharmaceuticals Limited, Plot 35, Emene Industrial Layout, Enugu, Neigeria
Nemegyl is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.
Nemegyl 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, Entamoeba histolytica, Giardia lamblia and Balantidium coli.
Nemegyl is indicated in adults and children for the following indications:
1. The prevention of post-operative infections due to anaerobic bacteria, particularly species of Bacteroides and anaerobic streptococci.
2. 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.
3. Urogenital trichomoniasis in the female (Trichomonal vaginitis) and in the male.
4. Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginitis).
5. All forms of amoebiasis (intestinal and extra-intestinal disease and that of symptomless cyst passers).
6. Giardiasis.
7. Acute ulcerative gingivitis.
8. Anaerobically-infected leg ulcers and pressure sores.
9. 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.
Chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.
Adults:
400 mg 8 hourly during 24 hours immediately preceding operation followed by post-operative intravenous or rectal administration until the patient is able to take tablets.
Paediatric population:
Children <12 years: 20–30 mg/kg as a single dose given 1–2 hours before surgery.
New-borns with a gestation age <40 weeks: 10 mg/kg body weight as a single dose before operation.
The duration of a course of Nemegyl treatment is about 7 days but it will depend upon the seriousness of the patient’s condition as assessed clinically and bacteriologically.
Adults:
800 mg followed by 400 mg 8 hourly.
Paediatric population:
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. 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.
New-borns with a gestation age <40 weeks: accumulation of metronidazole can occur during the first week of life, therefore the concentrations of metronidazole in serum should preferable be monitored after a few days therapy.
| Dosage is given in terms of metronidazole or metronidazole equivalent | |||||
| 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 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/kg dose | |||
| Bacterial vaginosis | |||||
| 5 – 7 Or 1 | 400 mg twice daily Or 2000 mg as a single dose | N/A | |||
| 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 extra- intestinal amoebiasis | 5 | ||||
| (d) Symptomless cyst passers | 5 – 10 | 400 – 800 mg three times daily | 200 – 400 mg three times daily | 100 – 200 mg our 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 5 Or 7 – 10 | 2000 mg once daily Or 400 mg three times daily Or 500 mg twice daily | 1000 mg once daily | 600 – 800 mg once daily | 500 mg once 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 daily | |
| Acute dental infections | |||||
| 3 – 7 | 200 mg three times daily | N/A | |||
| Leg ulcers and pressure sores | |||||
| 7 | 400 mg three times daily | N/A | |||
| 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. | |||||
As a part of a combination therapy, 20 mg/kg/day not to exceed 500 mg twice daily for 7–14 days. Official guidelines should be consulted before initiating therapy.
Oral administration, Nemegyl tablets should be swallowed with water (not chewed). It is recommended that the tablets be taken during or after a meal.
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 overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.
4 years.
Store below 30°C in the original packaging (protect from light).
Nemegyl tablets are packed in PVC/Aluminium foil blister pack.
No special requirements.
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