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Indications

Trichomoniasis: Tinizol DS 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: Tinizol DS 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: Tinizol DS 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: Tinizol DS 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 Tinizol DS and other antibacterialdrugs, Tinizol DS 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.

Pharmacology

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.

Dosage

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.
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Administration

Should be taken with food. Take during or immediately after meals.
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Interaction

The following interactions were reported with metronidazole, which is chemically-related to Tinizol DS.

Alcohol, disulfiram: Avoid during Tinizol DS 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 Tinizol DS may be decreased.

Cyclosporine, lithium, tacrolimus: Levels may be elevated by Tinizol DS, increasing the risk of toxicity.

Drugs that induce CYP3A4 (eg, fosphenytoin, phenobarbital, phenytoin, rifampin): May increase metabolism of Tinizol DS, decreasing plasma levels and therapeutic effect.

Drugs that inhibit CYP3A4 (eg, cimetidine, ketoconazole): May prolong t½ and decrease Tinizol DS Cl, increasing plasma levels and risk of adverse reactions.

Fluorouracil: Cl may be decreased by Tinizol DS, increasing the risk of adverse reactions

Fosphenytoin, phenytoin: The t½ may be prolonged and Cl reduced by Tinizol DS, increasing the risk of adverse reactions.

Oxytetracycline: Therapeutic effect of Tinizol DS may be decreased.

Contraindications

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.

Side Effects

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, Tinizol DS may produce transient leukopenia. Other rarely reported side-effects are headache, tiredness, furry tongue and dark urine.

Pregnancy & Lactation

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.

Precautions & Warnings

Compounds of similar chemical structure have produced various neurological disturbances such as dizziness, vertigo, uncoordination, and ataxia. If, during therapy with Tinizol DS, abnormal neurological signs develop, therapy should be discontinued. Use in Pregnancy & Lactation: Tinizol DS is contraindicated during the first trimester of pregnancy. While there is no evidence that Tinizol DS 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. Tinizol DS is excreted in breast milk in concentrations similar to those seen in serum. Tinizol DS can be detected in breast milk for up to 72 hours following administration. Interruption of breast-feeding is recommended during Tinizol DS therapy and for 3 days following the last dose.

Use in Special Populations

Renal Impairment: Haemodialysis: Additional dose equal to half the usual dose at the end of haemodialysis.

Therapeutic Class

Amoebicides

Storage Conditions

Store at room temperature & protected from light.