Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street 3011, Cyprus
Klont is indicated for the prophylaxis and treatment of infection in which anaerobic bacteria have been identified or are suspected to be the cause.
Klont 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.
Klont is indicated in adults and children for the following indications:
Considerations should be given to official guidance on the appropriate use of antibacterial agents.
For oral administration only. Tablets should be swallowed whole with a little water. Dose should be taken with or after meal.
All doses are expressed as metronidazole.
Prevention against anaerobic infection: mainly in the context of abdominal (especially colorectal) and gynaecological surgery.
400 mg 8 hourly during 24 hours immediately preceding operation, followed by postoperative intravenous or rectal administration until the patient is able to take tablets.
The dose is calculated on a body weight basis: 20-30mg/kg as a single dose given 1-2 hours before surgery.
Newborns with a gestation age <40 weeks: 10mg/kg body weight as a single dose before operation.
The duration of a course of Klont treatment is about 7 days but it will depend upon the seriousness of the patient’s condition as assessed clinically and bacteriologically.
800 mg followed by 400 mg 8 hourly.
The usual daily dose is 20-30mg/kg/day as a single dose or divided into 7.5mg/kg every 8 hours. The daily dose may be increased to 40mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.
15mg/kg as a single dose daily or divided into 7.5mg/kg every 12 hours. In newborns 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 to 10 years | 3 to 7 years | 1 to 3 years | |||
| Urogenital trichomoniasis Where re-infection is likely, in adults the consort should receive a similar course of treatment concurrently | 7 or | 2000mg as a single dose or 200 mg three times daily or | 40mg/kg orally as a single dose or 15-30 mg/kg/day divided in 2-3 doses; not to exceed 2000mg/dose | ||
| 5-7 | 400mg twice daily | ||||
| Bacterial vaginosis | 5-7 or | 400 mg twice daily | |||
| 1 | 2000mg 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 |
| © 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 2400mg/day | |||||
| Giardiasis | 3 | 2000mg once daily or | 1000mg once daily | 600-800 mg once daily | 500 mg once daily |
| 5 | 400mg three times daily or | ||||
| 7-10 | 500mg 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.
As a part of a combination therapy, 20mg/kg/day not to exceed 500mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy.
The principal route of metronidazole metabolism is hepatic oxidation. Metronidazole clearance is significantly reduced in severe hepatic impairment. In severe hepatic impairment, or in patients with hepatic encephalopathy, the daily dosage should be reduced by one third, and may be administered as a single dose (see section 4.4).
Haemodialysis: an eight hour dialysis period effectively removes metronidazole and metabolites. Metronidazole should therefore be administered immediately following the completion of dialysis.
Intermittent Peritoneal Dialysis (IPD): no dosage adjustment is required.
Continuous Ambulatory Peritoneal Dialysis (CAPD): no dosage adjustment is required.
Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. The symptoms were limited to vomiting, ataxia and slight disorientation.
There is no specific antidote for metronidazole. Metronidazole and metabolites are removed by haemodialysis. Early gastric lavage would be anticipated to be beneficial. Other treatment should be symptomatic and supportive.
5 years.
Store below 25°C in the original package.
Polyvinylchloride film-aluminium foil blisters, with a patient information leaflet, in a card carton.
Cartons containing 20, 50, 60 and 100 tablets are available.
Polyvinylchloride securitainers with tamper evident closure, packs containing 100, 250, 500, and 1000 tablets are available.
Not all pack sizes may be marketed.
Any unused medicinal products or waste material should be disposed of in accordance with local requirements.
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