1. Name Of The Medicinal Product
Metronidazole Tablets BP 200mg
2. Qualitative And Quantitative Composition
Each tablet contains Metronidazole 200mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Tablet.
Off-white coloured, round, biconvex uncoated tablets engraved “MZ 200” & break line on one side and plain on other.
4.1 Therapeutic Indications
Metronidazole is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.
Metronidazole 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.
It is indicated in:
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).
4.2 Posology And Method Of Administration
For oral administration.
Metronidazole tablets should be swallowed, without chewing, with half a glassful of water during or after meals.
Urogenital trichomoniasis:
Adults, elderly and children over 10 years: (2 tablets in the morning and 3 tablets in the evening for 2 days). To prevent re-infection in adults the consort should receive a course of treatment concurrently.
Children (7-10 years): 100 mg three times daily for 7 days.
Children (3-7 years): 100 mg twice daily for 7 days.
Children (1-3 years): 50 mg three times daily for 7 days.
Amoebiasis:
a) Invasive intestinal disease in susceptible subject:
Adults, elderly and children over 10 years: 2 tablets three times daily for 5 days.
Children (7-10 years): 400 mg three times daily for 5 days.
Children (3-7 years): 200 mg four times daily for 5 days.
Children (1-3 years): 200 mg three times daily for 5 days.
b) Intestinal disease in less susceptible subjects and chronic amoebic hepatitis:
Adults, elderly and children over 10 years: 1 tablet three times daily for 5-10 days.
Children (7-10 years): 200 mg three times daily for 5-10 days.
Children (3-7 years): 100 mg four times daily for 5-10 days.
Children (1-3 years): 100 mg three times daily for 5-10 days.
c) Amoebic liver abscess, also forms of extra-intestinal amoebiasis:
Adults, elderly and children over 10 years: 1 tablet three times daily for 5 days.
Children (7-10 years): 200 mg three times daily for 5 days.
Children (3-7 years): 100 mg four times daily for 5 days.
Children (1-3 years): 100 mg three times daily for 5 days.
d) Symptomless cyst passers:
Adults, elderly and children over 10 years: 1-2 tablets three times daily for 5-10 days.
Children (7-10 years): 200-400 mg three times daily for 5-10 days.
Children (3-7 years): 100-200 mg four times daily for 5-10 days.
Children (1-3 years): 100-200 mg three times daily for 5-10 days.
Giardiasis
Adults, elderly and children over 10 years: 5 tablets once daily for 3 days.
Children (7-10 years): 1.0 g once daily for 3 days.
Children (3-7 years): 600-800 mg once daily for 3 days.
Children (1-3 years): 500 mg once daily for 3 days.
Acute ulcerative gingivitis:
Adults, elderly and children over 10 years: 200 mg three times daily for 3 days.
Children (7-10 years): 100 mg three times daily for 3 days.
Children (3-7 years): 100 mg twice daily for 3 days.
Children (1-3 years): 50 mg three times daily for 3 days.
Acute dental infections
Adults, elderly and children over 10 years: 200 mg three times daily for 3-7 days.
Leg ulcers and pressure sores
Adults, elderly and children over 10 years: 400 mg three times daily for 7 days
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.
4.3 Contraindications
Known hypersensitivity to metronidazole or any of the excipients.
4.4 Special Warnings And Precautions For Use
Regular clinical and laboratory monitoring are advised if administration of metronidazole for more than 10 days is considered to be necessary.
There is a possibility that after tirchomonas vaginalis has been eliminated a gonococcal infection might persist.
The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of Metronidazole. The clinical significance of this is not known at present.
In patients undergoing haemodialysis, Metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis.
No routine adjustment in the dosage of metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency.
Significant cummulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Patients should be advised not to take alcohol during therapy and for at least 48 hours afterwards because of the possibility of a disulfiram-like (antabuse effects) reaction.
Metronidazole can cause potentiation of anti-coagulant therapy when used with the Warfarin type oral anticoagulants. Dosage of the latter may require reducing. Prothrombin times should be monitored. There is no interaction with heparin
Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be tapered or withdrawn before administering Metronidazole. Plasma concentrations of lithium, creatinine and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole.
Patients receiving phenobarbital metabolise metronidazole at a much greater rate than normally, reducing the half-life to approximately 3 hours.
Metronidazole reduces the clearance of 5 fluorouracil and can therefore result in increased toxicity of 5 fluorouracil.
Patients receiving ciclosporin are at risk of elevated ciclosporin serum levels. Serum ciclosporin and serum creatinine should be closely monitored when coadministration is necessary.
Plasma levels of busulfan may be increased by metronidazole which may lead to severe busulfan toxicity.
4.6 Pregnancy And Lactation
There is inadequate evidence of the safety of metronidazole in pregnancy but it has been in wide use for many years without apparent ill consequence. Nevertheless Metronidazole, like other medicines, should not be given during pregnancy or during lactation unless the physician considers it essential; in these circumstances the short, high-dosage regimens are not recommended.
4.7 Effects On Ability To Drive And Use Machines
Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.
4.8 Undesirable Effects
The frequency of adverse events listed below is defined using the following convention:
Very common (
Blood and lymphatic system disorders:
Very rare: agranulocytosis, neutropenia, thrombocytopenia, and pancytopenia
Not known: leucopenia.
Immune system disorders:
Rare: anaphylaxis,
Not known: angioedema, urticaria.
Metabolism and nutrition disorders:
Not known: anorexia.
Psychiatric disorders:
Very rare: Psychotic disorders, including hallucinations.
Nervous system disorders:
Very rare:
• Encephalopathy (eg. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (eg. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug.
• Drowsiness, dizziness, convulsions, headaches
Not known: during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.
Eye disorders:
Very rare: diplopia, myopia.
Gastrointestinal disorders:
Not known: Taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastro-intestinal disturbances.
Hepatobiliary disorders:
Very rare: abnormal liver function tests, cholestatic hepatitis, jaundice and pancreatitis which is reversible on drug withdrawal.
Skin and subcutaneous tissue disorders:
Very rare: skin rashes, pustular eruptions, pruritis
Not known: erythema multiforme.
Musculoskeletal, connective tissue and bone disorders:
Very rare: myalgia, arthralgia.
Renal and urinary disorders:
Very rare: darkening of urine (due to metronidazole metabolite).
4.9 Overdose
There is no specific treatment for gross overdosage of metronidazole.
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Antibacterials for systemic use, ATC code: J01X D01
Metronidazole 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.
5.2 Pharmacokinetic Properties
Metronidazole is rapidly and almost completely absorbed on administration of Metronidazole tablets; peak plasma concentrations occur after 20 min to 3 hours.
The half-life of metronidazole is 8.5 ± 2.9 hours. Metronidazole can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole is excreted in milk but the intake of a suckling infant of a mother receiving normal dosage would be considerably less than the therapeutic dosage for infants.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in the other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Povidone
Magnesium Stearate
Colloidal Anhydrous Silica
Maize Starch
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
White polypropylene container with tamper evident polyethylene closure: 3 years.
Amber polypropylene bottle with polyethylene closure: 3 years.
PVC/Aluminium blisters: 2 years.
PVdC coated PVC/Aluminium blisters: 3 years.
6.4 Special Precautions For Storage
Containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Bottle: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Blisters: Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of Container
White polypropylene container with tamper evident polyethylene closure:1000, 500, 250, 100, 84, 70, 56, 42, 28, 21, 15, 14 and 7 tablets.
Amber polypropylene bottle with polyethylene closure: 50 tablets.
PVC/Aluminium blisters: 7, 14, 15, 21, 28, 42, 56, 70 and 84 tablets.
PVdC coated PVC/Aluminium blisters: 7, 14, 15, 21, 28, 42, 56, 70 and 84 tablets.
Not all pack sizes may be marketed
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Milpharm Limited,
Ares,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
8. Marketing Authorisation Number(S)
PL 16363/0025
9. Date Of First Authorisation/Renewal Of The Authorisation
27/02/2009
10. Date Of Revision Of The Text
18/05/2010
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