Recommended Topic Related To:

Tindamax

"An estimated 20% of travelers say that they have had casual sex with a new partner while in a foreign country. The excitement of being on vacation may encourage people to do things they would not do at home, and the inhibition-lowering effects of"...

Tindamax

INDICATIONS

Trichomoniasis

Tinidazole 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 [see CLINICAL STUDIES].

Giardiasis

Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age [see CLINICAL STUDIES].

Amebiasis

Tinidazole 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 cyst passage [see CLINICAL STUDIES].

Bacterial Vaginosis

Tinidazole 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 [see Use in Specific Populations and CLINICAL STUDIES].

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 Tindamax (tinidazole) and other antibacterial drugs, Tindamax (tinidazole) 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.

DOSAGE AND ADMINISTRATION

Dosing Instructions

It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole [see CLINICAL PHARMACOLOGY].

Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards [see DRUG INTERACTIONS].

Compounding of the Oral Suspension

For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup to be taken with food.

Procedure for Extemporaneous Pharmacy Compounding of the Oral Suspension: Pulverize four 500 mg oral tablets with a mortar and pestle. Add approximately 10 mL of cherry syrup to the powder and mix until smooth. Transfer the suspension to a graduated amber container. Use several small rinses of cherry syrup to transfer any remaining drug in the mortar to the final suspension for a final volume of 30 mL. The suspension of crushed tablets in artificial cherry syrup is stable for 7 days at room temperature. When this suspension is used, it should be shaken well before each administration.

Trichomoniasis

The recommended dose in both females and males is a single 2 g oral dose taken with food. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time.

Giardiasis

The recommended dose in adults is a single 2 g dose taken with food. In pediatric patients older than three years of age, the recommended dose is a single dose of 50 mg/kg (up to 2 g) with food.

Amebiasis

Intestinal: The recommended dose in adults is a 2 g dose per day for 3 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3 days with food.

Amebic Liver Abscess: The recommended dose in adults is a 2 g dose per day for 3-5 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. There are limited pediatric data on durations of therapy exceeding 3 days, although a small number of children were treated for 5 days without additional reported adverse reactions. Children should be closely monitored when treatment durations exceed 3 days.

Bacterial Vaginosis

The recommended dose in non-pregnant females is a 2 g oral dose once daily for 2 days taken with food or a 1 g oral dose once daily for 5 days taken with food. The use of tinidazole in pregnant patients has not been studied for bacterial vaginosis.

Dosage Forms And Strengths

  • 250 mg tablets are pink, round, scored tablets, with TM debossed on one side and 250 on the other
  • 500 mg tablets are pink, oval, scored tablets, with TM debossed on one side and 500 on the other

HOW SUPPLIED

Storage And Handling

Tindamax (tinidazole) 250 mg tablets are pink, round, scored tablets, with TM debossed on one side and 250 on the other, supplied in bottles with child-resistant caps as:

NDC 0178-8250-40 Bottle of 40

Tindamax (tinidazole) 500 mg tablets are pink, oval, scored tablets, with TM debossed on one side and 500 on the other, supplied in bottles with child-resistant caps as:

NDC 0178-8500-60 Bottle of 60

NDC 0178-8500-20 Bottle of 20

Professional Samples:

NDC 0178-8500-04 Bottle of 4

Storage: Store at controlled room temperature 20-25° C (68-77° F); excursions permitted to 15-30°C (59-86° F) [see USP]. Protect contents from light.

FDA Rev date: 5/21/2007

Last reviewed on RxList: 8/14/2007
This monograph has been modified to include the generic and brand name in many instances.

A A A

Tindamax - User Reviews

Tindamax User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tindamax sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.