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FASIGYN

22-06-2009

Generic Name

Tinidazole - Amoebic infections

Drug Class Description

Tinidazole 500mg.

Presentation

Film-coated tablets. White, round, biconvex film-coated tablet embossed on one side with “FAS 500”.

Indications

Treatment of the following infections:

• Eradication of Helicobacter pylori associated with duodenal ulcers, in the presence of antibiotic and acid suppressant therapy.

• Anaerobic infections such as: Intraperitoneal infections: peritonitis, abscess. Gynaecological infections: endometritis, endomyometritis, tube-ovarian abscess. Bacterial septicaemia. Post-operative wound infections. Skin and soft tissue infections. Upper and lower respiratory tract infections: pneumonia, empyema, lung abscess.

• Non-specific vaginitis.

• Acute ulcerative gingivitis.

• Urogenital trichomoniasis in both male and female patients.

• Giardiasis.

• Intestinal amoebiasis.

• Amoebic involvement of the liver. Prophylaxis The prevention of post-operative infections caused by anaerobic bacteria, especially those associated with colonic, gastro-intestinal and gynaecological surgery.

Adult Dosage

Oral administration during or after a meal.

Eradication of H.pylori associated with duodenal ulcers

Adults The usual dose of Fasigyn is 500mg twice daily coadministered with omeprazole 20mg twice daily and clarithromycin 250mg twice daily for 7 days. Clinical studies using this 7 day regimen have shown similar H.pylori eradication rates when omeprazole 20mg once daily was used. For further information on the dosage for omeprazole see Astra data sheet.

Anaerobic infections

Adults An initial dose of 2g the first day followed by 1g daily given as a single dose or as 500mg twice daily. Treatment for 5 to 6 days will generally be adequate but clinical judgement must be used in determining the duration of therapy, particularly when eradication of infection from certain sites may be difficult. Routine clinical and laboratory observation is recommended if it is considered necessary to continue therapy for more than 7 days.

Children < 12 years -– there is no data available.

Non-specific vaginitis

Adults Non-specific vaginitis has been successfully treated with a single oral dose of 2g. Higher cure rates have been achieved with 2g single doses on 2 consecutive days (total dose 4g).

Acute ulcerative gingivitis

Adults A single oral dose of 2g.

Urogenital trichomoniasis

(when infection with Trichomonas vaginalis is confirmed, simultaneous treatment of the consort is recommended).

Adults A single dose of 2g.

Children A single dose of 50 to 75mg/kg of body weight. It may be necessary to repeat this dose.

Giardiasis

Adults A single dose of 2g.

Children A single dose of 50 to 75mg/kg of body weight. It may be necessary to repeat this dose.

·Intestinal amoebiasis

Adults A single daily dose of 2g for 2 to 3 days.

Children A single daily dose of 50 to 60mg/kg of body weight on each of 3 successive days.

Amoebic involvement in the liver

Adults Total dosage varies from 4.5 to 12g, depending on the virulence of the Entamoeba histolytica.

For amoebic involvement of the liver, the aspiration of pus may be required in addition to therapy with Fasigyn.

Initiate treatment with 1.5 to 2g as a single oral daily dose for three days. Occasionally when a three-day course is ineffective, treatment may be continued for up to six days.

Children A single dose of 50 to 60 mg/kg of body weight per day for five successive days.

Use in Renal Impairment

Dosage adjustments in patients with impaired renal function are generally not necessary. However because tinidazole is easily removed by haemodialysis, patients may require additional doses of tinidazole to compensate.1,2

Prevention of post-operative infection

Adults A single dose of 2g approximately 12 hours before surgery.

Children < 12 years – there is no data available.

Use in the elderlyThere are no special recommendations for this age group.

Child Dosage

Intestinal amoebiasis, 50 - 60 mg/kg as a single daily dose for 3 days. Liver amoebiasis, 50 - 60 mg/kg as a single daily dose for 5 days. Giardiasis, single dose of 50 - 75 mg/kg. Repeat once if necessary.

Contra Indications

As with other drugs of similar structure, tinidazole is contraindicated in patients having, or with a history of, blood dyscrasia, although no persistent haematological abnormalities have been noted in clinical or animal studies.

Tinidazole should be avoided in patients with organic neurological disorders.

Tinidazole, other 5-nitroimidazole derivatives or any of the components of this product should not be administered to patients with known hypersensitivity to the drug.

Use of tinidazole is contraindicated during the first trimester of pregnancy and in nursing mothers.

Special Precautions

As with related compounds, alcoholic beverages should be avoided during Fasigyn therapy because of the possibility of a disulfiram-like reaction (flushing, abdominal cramps, vomiting, tachycardia). Alcohol should be avoided until 72 hours after discontinuing Fasigyn.

Drugs of similar chemical structure have also produced various neurological disturbances such as dizziness, vertigo, inco-ordination and ataxia. If during therapy with Fasigyn abnormal neurological signs develop, therapy should be discontinued.

Interactions

Alcohol: Concurrent use of tinidazole and alcohol may produce a disulfiram-like reaction and should be avoided. 

Anticoagulants: Drugs of similar chemical structure have been shown to potentiate the effects of oral anticoagulants. Prothrombin times should be closely monitored and adjustments to the dose of the anticoagulant should be made as necessary.

Adverse Reactions

Reported side effects have generally been infrequent, mild and self-limiting.

Blood and lymphatic system disorders: transient leukopenia

Nervous System: ataxia, convulsions (rarely), dizziness, headache, hypesthesia, parathesia, peripheral neuropathy, sensory disturbances, vertigo, metallic taste, flushing.

Gastrointestinal disorders: abdominal pain, anorexia, diarrhoea, furry tongue, glossitis, nausea, stomatitis, vomiting

Skin and subcutaneous tissue disorders: hypersensitivity reactions, occasionally severe, may occur in rare cases in the form of skin rash, puritus, urticaria and angioneurotic edema

Renal and Urinary disorders: dark urine

General disoders and administration site conditions: fever, tiredness

Manufacturer

Pfizer

Drug Availability

(POM)