Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ
Treatment of the following infections:
1. Eradication of Helicobacter pylori associated with duodenal ulcers, in the presence of antibiotic and acid suppressant therapy (see section 4.2).
2. 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.
3. Non-specific vaginitis.
4. Acute ulcerative gingivitis.
5. Urogenital trichomoniasis in both male and female patients.
6. Giardiasis.
7. Intestinal amoebiasis.
8. Amoebic involvement of the liver.
9. Prophylaxis: The prevention of post-operative infections caused by anaerobic bacteria, especially those associated with colonic, gastro-intestinal and gynaecological surgery.
Route: 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.
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.
<12 years – there is no data available.
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).
A single oral dose of 2g.
(when infection with Trichomonas vaginalis is confirmed, simultaneous treatment of the consort is recommended).
A single dose of 2g.
A single dose of 50 to 75mg/kg of body weight. It may be necessary to repeat this dose.
A single dose of 2g.
A single dose of 50 to 75mg/kg of body weight. It may be necessary to repeat this dose.
A single daily dose of 2g for 2 to 3 days.
A single daily dose of 50 to 60mg/kg of body weight on each of 3 successive days.
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.
A single dose of 50 to 60 mg/kg of body weight per day for five successive days.
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.
A single dose of 2g approximately 12 hours before surgery.
<12 years – there is no data available.
It is recommended that tinidazole be taken during or after a meal.
There are no special recommendations for this age group.
Oral administration. Swallow tablets whole with a glass of water during or after a meal.
In acute animal studies with mice and rats, the LD50 for mice was >3600mg/kg and >2300mg/kg for oral and intraperitoneal administration respectively. For rats, the LD50 was >2000mg/kg for both oral and intraperitoneal administration.
There are no reported overdoses in humans with Fasigyn.
There is no specific antidote for treatment of overdosage with tinidazole. Treatment is symptomatic and supportive. Gastric lavage may be useful. Tinidazole is easily dialysable.
2 years.
Store below 25°C in the original pack to protect from light and moisture.
Aluminium foil backed blister packs of 16 500mg tablets consisting of:
a) 250 micron PVC blister coated with 40gsm of PVdC
b) 20 micron aluminium foil backing coated with 20gsm PVdC
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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