Generic Name
Tinidazole
Brand Names
Tindazole, Tindamax
FDA approval date: May 17, 2004
Classification: Nitroimidazole Antimicrobial
Form: Tablet
What is Tindazole (Tinidazole)?
Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: Trichomoniasis.
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Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
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Brand Information
Tindazole (Tinidazole)
WARNING: POTENTIAL RISK FOR CARCINOGENICITY
Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent
1DOSAGE FORMS AND STRENGTHS
- 250 mg tablets are pink color, circular shaped film coated scored tablets with "250" debossed on one side and " T│P" on the other side
- 500 mg tablets are pink color, capsule shaped film coated scored tablets with "500" debossed on one side and " T│P" on the other side
2CONTRAINDICATIONS
The use of tinidazole is contraindicated:
- In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome
- In patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after intiation of metronidazole, another nitroimidazole drug, structurally related to tinidazole, in patients with Cockayne syndrome
3DRUG INTERACTIONS
Although not specifically identified in studies with tinidazole, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with tinidazole.
3.1Potential Effects of Tinidazole on Other Drugs
Warfarin and Other Oral Coumarin Anticoagulants: As with metronidazole, tinidazole may enhance the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The dosage of oral anticoagulants may need to be adjusted during tinidazole co-administration and up to 8 days after discontinuation.
Alcohols, Disulfiram: Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during tinidazole therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients using metronidazole and disulfiram concurrently. Though no similar reactions have been reported with tinidazole, tinidazole should not be given to patients who have taken disulfiram within the last two weeks.
Lithium: Metronidazole has been reported to elevate serum lithium levels. It is not known if tinidazole shares this property with metronidazole, but consideration should be given to measuring serum lithium and creatinine levels after several days of simultaneous lithium and tinidazole treatment to detect potential lithium intoxication.
Phenytoin, Fosphenytoin: Concomitant administration of oral metronidazole and intravenous phenytoin was reported to result in prolongation of the half-life and reduction in the clearance of phenytoin. Metronidazole did not significantly affect the pharmacokinetics of orally-administered phenytoin.
Cyclosporine, Tacrolimus: There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. During tinidazole co-administration with either of these drugs, the patient should be monitored for signs of calcineurin-inhibitor associated toxicities
Fluorouracil: Metronidazole was shown to decrease the clearance of fluorouracil, resulting in an increase in side-effects without an increase in therapeutic benefits. If the concomitant use of tinidazole and fluorouracil cannot be avoided, the patient should be monitored for fluorouracil-associated toxicities.
3.2Potential Effects of Other Drugs on Tinidazole
CYP3A4 Inducers and Inhibitors: Simultaneous administration of tinidazole with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin, phenytoin, and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of tinidazole, decreasing the plasma level of tinidazole. Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma concentrations of tinidazole.
Cholestyramine: Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. Thus, it is advisable to separate dosing of cholestyramine and tinidazole to minimize any potential effect on the oral bioavailability of tinidazole.
Oxytetracycline: Oxytetracycline was reported to antagonize the therapeutic effect of metronidazole.
3.3Laboratory Test Interactions
Tinidazole, like metronidazole, may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD
Tinidazole, like metronidazole, may produce transient leukopenia and neutropenia; however, no persistent hematological abnormalities attributable to tinidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended if re-treatment is necessary.
4OVERDOSAGE
There are no reported overdoses with tinidazole in humans.
Treatment of Overdosage: There is no specific antidote for the treatment of overdosage with tinidazole; therefore, treatment should be symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session.
5DESCRIPTION
Tinidazole USP is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has a molecular weight of 247.27 and the following chemical structure:
Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole USP. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, triacetin, FD&C Red 40, FD&C Yellow 6
6HOW SUPPLIED/STORAGE AND HANDLING
Tinidazole Tablets USP 250 mg are pink color, circular shaped film coated scored tablets with "250" debossed on one side and " T│P" on the other side, supplied in bottles with child-resistant caps as:
NDC 64980-426-02 Bottle of 20
Tinidazole Tablets USP 500 mg are pink color, capsule shaped film coated scored tablets with "500" debossed on one side and " T│P" on the other side, supplied in bottles with child-resistant caps as:
NDC 64980-427-12 Bottle of 12
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.
7PATIENT COUNSELING INFORMATION
Administration of Drug
Patients should be told to take Tinidazole Tablets with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole.
Patients should be told to take Tinidazole Tablets with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole.
Alcohol Avoidance
Patients should be told to avoid alcoholic beverages and preparations containing ethanol or propylene glycol during Tinidazole Tablets therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.
Lactation
Advise women not to breastfeed during treatment with Tinidazole Tablets and to discontinue breastfeeding for 72 hours following the administration of Tinidazole Tablets. Also, advise a nursing mother that she may choose to pump and discard her milk for 72 hours after administration of Tinidazole Tablets [see Use in Specific Populations (
Infertility
Advise males of reproductive potential that Tinidazole Tablets may impair fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].
Patients should be told to avoid alcoholic beverages and preparations containing ethanol or propylene glycol during Tinidazole Tablets therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.
Lactation
Advise women not to breastfeed during treatment with Tinidazole Tablets and to discontinue breastfeeding for 72 hours following the administration of Tinidazole Tablets. Also, advise a nursing mother that she may choose to pump and discard her milk for 72 hours after administration of Tinidazole Tablets [see Use in Specific Populations (
Infertility
Advise males of reproductive potential that Tinidazole Tablets may impair fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].
Drug Resistance
Patients should be counseled that antibacterial drugs including Tinidazole Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tinidazole Tablet is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Tinidazole Tablets or other antibacterial drugs in the future.
Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J.B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India
Patients should be counseled that antibacterial drugs including Tinidazole Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tinidazole Tablet is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Tinidazole Tablets or other antibacterial drugs in the future.
Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J.B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Revised: 03/2025
141037
8PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 64980-426-02
Tinidazole Tablets, USP
250 mg
R
20 Tablets
9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 64980-427-12
Tinidazole Tablets, USP
500 mg
R
12 Tablets
