TINIDAZOL

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COMPOSITION:
Tinidazole....................... 500 mg
Excipients q.s................. 1 tablet
(Pregelatinized starch, microcrystalline cellulose M101, sodium croscarmellose, PVP K30, magnesium stearate, aerosil, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, talc, yellow ferric oxide)
DOSAGE FORM: Film coated tablet.
PRESENTATION: Box of 10 blisters x 10 tablets.
PHARMACODYNAMICS: Tinidazole is a derivative of imidazole and is active against both protozoa and obligate anaerobic bacteria e.g Bacteroides spp., Clostridium spp., Fusobacterium spp.. The mode of action of tinidazole against anaerobic bacteria and protozoa is believed to involve the penetration of tinidazole into the cell of the microorganism and subsequent damage of DNA strands or inhibition of their synthesis. Tinidazole acts on prophylaxis and treatment of biliary and gastrointestinal tract infections, abscess, and anaerobic infections e.g necrotizing fasciitis and emphysematous gangrene.
PHARMACOKINETICS: After oral administration, tinidazole is rapidly and completely absorbed; the plasma half-life of tinidazole is approximately 12 - 14 hours. Tinidazole is widely distributed and concentrations similar to those in plasma have been achieved in bile, breast milk, cerebrospinal fluid, saliva, and a variety of body tissues; it crosses the placenta readily. Only 12% is reported to be bound to plasma proteins. Unchanged drug and metabolites are excreted in the urine and, to a lesser extent, in the faeces.
INDICATIONS:
Tinidazole is often combined with other antibiotics in the following cases:
Prophylaxis of postoperative infections caused by anaerobic bacteria, especially those associated with colonic, gastrointestinal and gynecological surgery.
Treatment of the following infections due to anaerobic bacteria:
- Intraperitoneal infections: Peritonitis, abscess.
- Gynecological infections: Endometritis, endomyometritis, tubo-ovarian abscess.
- Bacterial septicemia.
- Postoperative 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.
- Amebic involvement of the liver.
CONTRAINDICATIONS: Hypersensitivity to tinidazole.
Blood dyscrasias or a known history of acute porphyria.
In patients with organic neurological disorders
PRECAUTIONS: Alcoholic beverages should be avoided during tinidazole therapy because of the possibility of a disulfiram-like reaction (flushing, abdominal cramps, vomiting, tachycardia).
PREGNANCY AND LACTATION: Tinidazole crosses the placental barrier; the use of tinidazole during the first trimester is contraindicated. There is no evidence that tinidazole is harmful during the latter stages of pregnancy, but its use during the second and third trimesters requires that the potential benefits be weighed against the possible hazards to the mother or fetus. Tinidazole is distributed into breast milk. Women should not nurse during and for at least three days after having discontinued taking the drug.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Cautions should be taken in drivers and machine users.
INTERACTIONS: Cimetidine may reduce the elimination of tinidazole because it may inhibit the hepatic metabolism of tinidazole, resulting in an enhancement of both therapeutic effects and toxicity of tinidazole.
Rifampicin may increase the clearance of tinidazole because it causes an increase in hepatic metabolism of tinidazole; so it decreases the therapeutic effect of tinidazole.
ADVERSE EFFECTS: Frequently: Nausea, poor appetite, abdominal pain. Transient change of taste.
Infrequently: Drowsiness, headache. Diarrhea,
Rarely: Allergy, fever. Reversible leukopenia. Stomatitis. Itching, skin rash. Joint pain. Peripheral nerve pathology. Chromaturia.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: 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.
DOSAGE & ADMINISTRATION: 
It is recommended that tinidazole should be orally taken during or after a meal.
Prevention of postoperative infections:
Adults: a single oral dose of 2 g approximately 12 hrs before surgery.
Treatment of anaerobic infections:
Adults: an initial oral dose of 2 g the 1st day followed by 1 g daily given as a single dose or as 500 mg twice daily.
Treatment for 5-6 days will generally be adequate, but clinical judgment must determine the duration of therapy, particularly when eradication of infection from certain sites may be difficult. It is considered necessary to continue therapy for more than 7 days.
Non-specific vaginitis:
Adults: non-specific vaginitis has been successfully treated with a single oral dose of 2 g. Higher cure rates have been achieved with 2 g single daily doses for two consecutive days (total dosage: 4 g).
Acute ulcerative gingivitis: Adults: a single oral dose of 2 g.
Urogenital trichomoniasis:
 - Adults: a single oral dose of 2 g. Simultaneous treatment of the consort is recommended.
 - Children: a single dose of 50 - 70 mg/kg of body weight. It may be necessary to repeat this dose once in some cases.
Giardiasis:
 - Adults: a single oral dose of 2 g.
 - Children: a single oral dose of 50 - 75 mg/kg of body weight. It may be necessary to repeat this dose once in some cases.
Intestinal amebiasis:
 - Adults: a single daily dose of 2 g orally for 2 - 3 days.
 - Children: a single oral dose of 50 - 60 mg/kg of body weight/day for three successive days.
Amebic involvement of the liver:
 - Adults: total dosage varies from 4.5 - 12 g, depending on the virulence of the Entamoeba histolytica. For amebic involvement of the liver, the aspiration of pus may be required in addition to therapy with tinidazole. Initiate treatment with 1.5 - 2 g orally as a single daily dose for 3 days. Occasionally, when a 3 day course is ineffective, treatment may be continued for up to 6 days.
 - Children: a single oral dose of 50 - 60 mg/kg of body weight/day for 5 successive days.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.

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