Tinidazole
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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Black Box Warning
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WARNING: POTENTIAL RISK FOR CARCINOGENICITY
See full prescribing information for complete Boxed Warning.
* Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent (13.1). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE
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Overview
Tinidazole is a antiprotozoal and antibacterial agent, nitroimidazole that is FDA approved for the treatment of trichomoniasis, giardiasis, amebiasis, bacterial vaginosis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
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 (14.2)].
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.
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 (8.1) and Clinical Studies (14.5)].
- 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 and other antibacterial drugs, Tindamax 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.
Dosing Information
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 (12.3)].
- Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards.
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tinidazole in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tinidazole in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Tinidazole in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tinidazole in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tinidazole in pediatric patients.
Contraindications
- 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.
- During first trimester of pregnancy.
- In nursing mothers: Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.
Warnings
|
WARNING: POTENTIAL RISK FOR CARCINOGENICITY
See full prescribing information for complete Boxed Warning.
* Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent (13.1). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE
|
Neurological Adverse Reactions
- Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with tinidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of tinidazole therapy.
Vaginal Candidiasis
- The use of tinidazole may result in Candida vaginitis. In a clinical study of 235 women who received tinidazole for bacterial vaginosis, a vaginal fungal infection developed in 11 (4.7%) of all study subjects.
Blood Dyscrasia
- Tinidazole should be used with caution in patients with evidence of or history of blood dyscrasia.
Drug Resistance
- Prescribing Tindamax in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
Clinical Trials Experience
Clinical Studies Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Among 3669 patients treated with a single 2 g dose of tinidazole, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common (≥ 1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.)
- Other adverse reactions reported with tinidazole include:
Central Nervous System
- Two serious adverse reactions reported include convulsions and transient peripheral neuropathy including numbness and paresthesia [see Warnings and Precautions (5.1)]. Other CNS reports include vertigo, ataxia, giddiness, insomnia, drowsiness.
Gastrointestinal:
- Tongue discoloration, stomatitis, diarrhea
Hypersensitivity
- Urticaria, pruritis, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema
Renal:
- Darkened urine
Cardiovascular:
- Palpitations
Hematopoietic:
- Transient neutropenia, transient leukopenia
Other:
- Candida overgrowth, increased vaginal discharge, oral candidiasis, hepatic abnormalities including raised transaminase level, arthralgias, myalgias, and arthritis.
table
- Rare reported adverse reactions include bronchospasm, dyspnea, coma, confusion, depression, furry tongue, pharyngitis and reversible thrombocytopenia.
Adverse Reactions in Pediatric Patients:
- In pooled pediatric studies, adverse reactions reported in pediatric patients taking tinidazole were similar in nature and frequency to adult findings including nausea, vomiting, diarrhea, taste change, anorexia, and abdominal pain.
Bacterial vaginosis:
- The most common adverse reactions in treated patients (incidence >2%), which were not identified in the trichomoniasis, giardiasis and amebiasis studies, are gastrointestinal: decreased appetite, and flatulence; renal: urinary tract infection, painful urination, and urine abnormality; and other reactions including pelvic pain, vulvo-vaginal discomfort, vaginal odor, menorrhagia, and upper respiratory tract infection.
Postmarketing Experience
- The following adverse reactions have been identified and reported during post-approval use of Tindamax. Because the reports of these reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.
- Severe acute hypersensitivity reactions have been reported on initial or subsequent exposure to tinidazole. Hypersensitivity reactions may include urticaria, pruritis, angioedema, Stevens-Johnson syndrome and erythema multiforme.
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tinidazole in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tinidazole during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tinidazole with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Tinidazole with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Tinidazole with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Tinidazole with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tinidazole with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tinidazole in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tinidazole in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tinidazole in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tinidazole in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Tinidazole in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Tinidazole in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Tinidazole in the drug label.
Pharmacology
There is limited information regarding Tinidazole Pharmacology in the drug label.
Mechanism of Action
Structure
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tinidazole in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tinidazole in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tinidazole in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Tinidazole in the drug label.
How Supplied
Storage
There is limited information regarding Tinidazole Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Tinidazole in the drug label.
Precautions with Alcohol
- Alcohol-Tinidazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- TINDAMAX®
Look-Alike Drug Names
- A® — B®[1]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "http://www.ismp.org". External link in
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