Tinidazole

Tinidazole is a prescription medication used to treat Intestinal Amebiasis, Amebic Liver Abscess, Giardiasis or Trichomoniasis, and Bacterial Vaginosis (nonpregnant). 

• Tinidazole is available under the following different brand names: Tindamax.

Adult and pediatric dosage

Tablet

• 250mg
• 500mg

Amebiasis, Intestinal

Adult dosage

• 2 g/day orally for 3 days

Pediatric dosage

• Children younger than 3 years of age: Safety and efficacy not established
• Children older than 3 years of age: 50 mg/kg/day orally for 3 days; 2 g maximum

Amebic Liver Abscess

Adult dosage

• 2 g/day orally for 3-5 days

Pediatric dosage

• Children younger than 3 years of age: Safety and efficacy not established
• Children older than 3 years of age: 50 mg/kg/day orally for 5 days; 2 g maximum

Giardiasis or Trichomoniasis

Adult dosage

• 2 g orally once

Pediatric dosage

• Children younger than 3 years of age: Safety and efficacy not established
• Children older than 3 years of age: 50 mg/kg/day orally once; 2 g maximum

Bacterial Vaginosis (Nonpregnant)

• 2 g orally once daily for 2 days or 1 g orally once daily for 5 days

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Tinidazole include:

• skin flushing or redness 

Serious side effects of Tinidazole include:

• injection site reactions, 
• hives, 
• itching, 
• wheezing, 
• shortness of breath, 
• allergic reactions, 
• inadequate musculoskeletal block, 
• severe dizziness,
• low blood pressure, and 
• fast or slow heart rate

Rare side effects of Tinidazole include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Tinidazole has unknown severe interactions with the following drugs:
  • dronabinol
  • lopinavir
  • ritonavir
  • Tinidazole has serious interactions with at least 11 other drugs.
• Tinidazole has moderate interactions with at least 209 other drugs.
• Tinidazole has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• 1st trimester of pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tinidazole?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tinidazole?”

Cautions

• Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole drugs, which are structurally related to tinidazole; although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects; however, it is unclear if positive tumor findings in lifetime rodent studies indicate a risk to patients taking a short course or single dose of the drug; use should be limited to approved indications only; avoid chronic use
• Caution in patients with history of blood dyscrasias or history of hepatic impairment
• Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, reported; appearance of abnormal neurologic signs demands the prompt discontinuation of therapy
• Prescribing drug in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria
• Risk of bacterial overgrowth with prolonged treatment
• No safety & efficacy data on pediatric patients younger than 3 years of age
• Therapy may result in Candida vaginitis, a fungal infection, when used to treat bacterial vaginosis

Pregnancy and Lactation

• Available published data from a case-control study and case report with use in pregnant women are insufficient to identify risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks associated with untreated lower genital tract infections during pregnancy. 
• Limited published literature, based on breast milk sampling, reports that drug is present in human milk; there are no reports of adverse effects on breastfed infant and no information on effects on milk production
• Because of potential for serious adverse reactions, including tumorigenicity, breastfeeding is not recommended during treatment and for 72 hours (based on half-life) after last dose

A nursing mother may choose to pump and discard her milk during treatment and for 72 hours after last dose to minimize exposure to breastfeeding infant