T-zol

Trichomoniasis : T-zol is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners ... Read more Trichomoniasis : T-zol is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection. Giardiasis : T-zol is indicated for the treatment of giardiasis caused by Giardia duodenalis in both adults and pediatric patients older than three years of age. Sections or subsections omitted from the full prescribing information are not listed. Amebiasis : T-zol is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cystpassage. Bacterial Vaginosis : T-zol is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women. Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out. To reduce the development of drug-resistant bacteria and maintain the effectiveness of T-zol and other antibacterialdrugs, T-zol should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Tinidazole, a 5-nitroimidazole derivative with antimicrobial actions similar to metronidazole, is active against both protozoa (e.g. Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia) and obligate anaerobic bacteria. It damages DNA strands or inhibits DNA synthesis in microorganism.

Prevention of Postoperative Infections :

Adult : A single oral dose of 2g approximately 12 hours before surgery.

Children less than 12 years : Data are not available to allow dosage recommendations for children below the age of 12 years in the prophylaxis of anaerobic infections.

Trichomoniasis : a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time Giardiasis:

Adults : a single 2 g dose taken with food.

Pediatric patients older than three years of age : a single dose of 50 mg/kg (up to 2 g) with food

Amebiasis, Intestinal:

Adults : 2 g per day for 3 days with food.

Pediatric patients older than three years of age : 50 mg/kg/day (up to 2 g per day) for 3 days with food

Amebic liver abscess:

Adults : 2 g per day for 3-5 days with food.

Pediatric patients older than three years of age : 50 mg/kg/day (up to 2 g per day) for 3-5 days with food

Bacterial vaginosis : Non-pregnant, adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food. Should be taken with food. Take during or immediately after meals.

The following interactions were reported with metronidazole, which is chemically-related to T-zol. Alcohol, disulfiram : Avoid during T-zol use and for 3 days afterward because cramps, nausea, vomiting, headaches, and flushing may occur. Anticoagulants, oral (eg, warfarin) : Anticoagulant effects may be increased. Anticoagulant dose may need to be adjusted during coadministration and for up to 8 days after discontinuation. Cholestyramine: Bioavailability of T-zol may be decreased. Cyclosporine, lithium, tacrolimus : Levels may be elevated by T-zol, increasing the risk of toxicity. Drugs that induce CYP3A4 (eg, fosphenytoin, phenobarbital, phenytoin, rifampin) : May increase metabolism of T-zol, decreasing plasma levels and therapeutic effect. Drugs that inhibit CYP3A4 (eg, cimetidine, ketoconazole) : May prolong t½ and decrease T-zol Cl, increasing plasma levels and risk of adverse reactions. Fluorouracil : Cl may be decreased by T-zol, increasing the risk of adverse reactions Fosphenytoin, phenytoin : The t½ may be prolonged and Cl reduced by T-zol, increasing the risk of adverse reactions. Oxytetracycline : Therapeutic effect of T-zol may be decreased.

As with other compounds of similar structure, tinidazole, is contraindicated in patients having, or with a history of, blood dyscrasias although no persistent haematological abnormalities have been noted in clinical or animal studies. Tinidazole should be avoided in patients with organic neurological disorders. Tinidazole should not be administered to patients with known hypersensitivity to the compound.

Reported side effects have generally been infrequent, mild and self-limiting. Side effects from the gastrointestinal tract include nausea, vomiting, anorexia, diarrhoea and metallic taste. Hypersensitivity reactions, occasionally severe, may occur in rare cases in the form of skin rash, pruritis, urticaria and angioneurotic oedema. As with related compounds, T-zol may produce transient leukopenia. Other rarely reported side-effects are headache, tiredness, furry tongue and dark urine.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Compounds of similar chemical structure have produced various neurological disturbances such as dizziness, vertigo, uncoordination, and ataxia. If, during therapy with T-zol, abnormal neurological signs develop, therapy should be discontinued. Use in Pregnancy & Lactation: T-zol is contraindicated during the first trimester of pregnancy. While there is no evidence that T-zol is harmful during the late stages of pregnancy, its use during the last two trimesters requires that the potential benefits outweigh the possible risk to mother and foetus. T-zol is excreted in breast milk in concentrations similar to those seen in serum. T-zol can be detected in breast milk for up to 72 hours following administration. Interruption of breast-feeding is recommended during T-zol therapy and for 3 days following the last dose.

Store at room temperature & protected from light.