Tindamax

Last updated on RxList: 10/27/2020
Tindamax Side Effects Center

What Is Tindamax?

Tindamax (tinidazole tablets) is a nitroimidazole antimicrobial used to treat trichomoniasis, giardiasis in patients age 3 and older, amebiasis in patients age 3 and older, and bacterial vaginosis in adult women.

What Are Side Effects of Tindamax?

Side effects of Tindamax include:

Dosage for Tindamax

The dose of Tindamax to treat trichomoniasis is a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time. The dose of Tindamax to treat giardiasis in adults is a single 2 g dose taken with food. The dose of Tindamax to treat giardiasis in pediatric patients older than three years of age is a single dose of 50 mg/kg (up to 2 g) with food. The dose of Tindamax to treat intestinal amebiasis in adults is 2 g per day for 3 days with food. The dose of Tindamax to treat intestinal amebiasis in pediatric patients older than three years of age is 50 mg/kg/day (up to 2 g per day) for 3 days with food. dose of Tindamax to treat amebic liver abscess in adults is 2 g per day for 3- 5 days with food. Tindamax to treat amebic liver abscess in pediatric patients older than three years of age is 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. The dose of Tindamax to treat bacterial vaginosis in adult women is 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food.

Tindamax In Children

Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of Tindamax in pediatric patients have not been established.

Pediatric administration: For those unable to swallow tablets, Tindamax tablets may be crushed in artificial cherry syrup, to be taken with food.

What Drugs, Substances, or Supplements Interact with Tindamax?

Tindamax may interact with other medicines such as:

  • warfarin and other oral coumarin anticoagulants,
  • alcohol-containing beverages/preparations,
  • lithium,
  • cyclosporine,
  • tacrolimus, and
  • CYP3A4 inducers (such as phenobarbital, rifampin, phenytoin, and fosphenytoin),
  • CYP3A4 inhibitors (such as cimetidine and ketoconazole),
  • cholestyramine, and
  • oxytetracycline

Tell your doctor all medications and supplements you use.

Tindamax During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tindamax; it is unknown how it would affect a fetus. Tindamax passes into breast milk. Breastfeeding while using Tindamax is not recommended. Discontinue breastfeeding during and for 72 hours after the last dose of Tindamax.

Additional Information

Our Tindamax (tinidazole tablets), for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21618s007lbl.pdf

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Tindamax Consumer Information

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • numbness, burning pain, or tingly feeling; or
  • seizure (convulsions).

Less serious side effects may include:

  • vaginal itching or discharge;
  • nausea, vomiting, loss of appetite, indigestion;
  • constipation, diarrhea, stomach cramps;
  • feeling weak or tired;
  • headache, dizziness; or
  • a metallic or bitter taste in your mouth;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tindamax (Tinidazole)

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Tindamax Professional Information

SIDE EFFECTS

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]. 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 1: Adverse Reactions Summary of Published Reports

  2 g single dose Multi-day dose
GI: Metallic/bitter taste 3.7% 6.3%
  Nausea 3.2% 4.5%
  Anorexia 1.5% 2.5%
  Dyspepsia/cramps/epigastric discomfort 1.8% 1.4%
  Vomiting 1.5% 0.9%
  Constipation 0.4% 1.4%
CNS: Weakness/fatigue/malaise 2.1% 1.1%
  Dizziness 1.1% 0.5%
Other: Headache 1.3% 0.7%
Total patients with adverse reactions 11.0% (403/3669) 13.8% (244/1765)

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 [See Clinical Studies].

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.

Read the entire FDA prescribing information for Tindamax (Tinidazole)

© Tindamax Patient Information is supplied by Cerner Multum, Inc. and Tindamax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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