Tindamax is an antibiotic that fights bacteria in the body.

Tindamax is used to treat certain infections caused by bacteria, such as infection of the intestines or vagina. Tindamax is also used to treat certain sexually transmitted infections.

Tindamax is used to treat or giardiasis amebiasis in adults and children at least 3 years old.

You should not use Tindamax if you are in the first 3 months of pregnancy. You should not breast-feed a baby while you are taking Tindamax. However, you may begin nursing again 3 days after you take the last dose. Do not keep any milk you collect with a breast pump while you are taking Tindamax.

Before you take Tindamax, tell your doctor if you have kidney disease (or if you are on dialysis), epilepsy or other seizure disorder, a blood cell disorder such as anemia or low platelets, or a weak immune system.

Take Tindamax for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Tindamax will not treat a viral infection such as the common cold or flu. Do not drink alcohol while taking this medicine and for at least 3 days after your treatment ends.

A medicine similar to tinidazole has caused cancer in laboratory animals. It is not known if tinidazole would have the same effect in animals, or in humans. Talk with your doctor about your individual risk.

Take Tindamax exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Tindamax with food.

Some infections are treated with only one dose. Follow your doctor's instructions.

Shake the oral suspension (liquid). Measure a dose with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Do not share Tindamax with another person, even if they have the same symptoms you have.

If you are treating a sexually transmitted infection, make sure your sexual partner seeks medical attention to be treated also.

Keep using Tindamax even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Tindamax will not treat a viral infection (flu or a common cold).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Tindamax.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Trichomoniasis:

2 g orally once

Comments:
-Appropriate diagnostic procedures should be used to identify organism.
-The patient's sexual partner(s) should be treated with the same dose at the same time to prevent reinfection.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Giardiasis:

2 g orally once.

Usual Adult Dose for Amebiasis:

2 g orally once a day

Duration of Therapy:
-Intestinal: 3 days
-Amebic liver abscess: 3 to 5 days

Comments:
-This drug is not indicated to treat asymptomatic cyst passage.

Some Experts Recommend: 2 g orally once a day

Duration of Therapy:
-Mild to moderate intestinal disease: 3 days
-Severe intestinal and extraintestinal disease: 5 days

Comments:
-Treatment with a luminal amebicide should follow this 3- or 5-day therapy.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Bacterial Vaginosis:

2 g orally once a day for 2 days OR 1 g orally once a day for 5 days

Comments:
-Formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis
-Should rule out other pathogens commonly associated with vulvovaginitis (e.g., T vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, Herpes simplex virus)
-Use of this drug in pregnant women has not been studied.

Usual Adult Dose for STD Prophylaxis:

US CDC Recommendations: 2 g orally in a single dose

Comments:
-Recommended as part of a regimen for prophylaxis after sexual assault
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Giardiasis:

3 years or older: 50 mg/kg orally once
Maximum dose: 2 g/dose.

Usual Pediatric Dose for Amebiasis:

3 years or older: 50 mg/kg orally once a day
Maximum dose: 2 g/day

Duration of Therapy:
-Intestinal: 3 days
-Amebic liver abscess: 3 to 5 days

Comments:
-This drug is not indicated to treat asymptomatic cyst passage.
-Limited pediatric data on use beyond 3 days; small number of children treated for 5 days had no additional reported side effects. Close monitoring is recommended when duration of therapy exceeds 3 days.

Some Experts Recommend:
3 years or older: 50 mg/kg orally once a day
Maximum dose: 2 g/day

Duration of Therapy:
-Mild to moderate intestinal disease: 3 days
-Severe intestinal and extraintestinal disease: 5 days

Comments:
-Treatment with a luminal amebicide should follow this 3- or 5-day therapy.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Trichomoniasis:

Some Experts Recommend: 50 mg/kg orally once
Maximum dose: 2 g/dose

Comments:
-Recommended for trichomoniasis due to T vaginalis
-The patient's sexual partner(s) should be treated with the same dose at the same time.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for STD Prophylaxis:

American Academy of Pediatrics Recommendations: 2 g orally in a single dose

Comments:
-Recommended as part of a regimen for postpubertal adolescents as prophylaxis after sexual assault; recommended for trichomoniasis and bacterial vaginosis
-Current guidelines should be consulted for additional information.

You should not use Tindamax if you are allergic to tinidazole or metronidazole (Flagyl).

Do not use Tindamax to treat any condition that has not been checked by your doctor.

Do not breastfeed within 72 hours after using Tindamax. If you use a breast pump during this time, throw out the milk and do not feed it to your baby.

To make sure Tindamax is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);

• a seizure

• epilepsy or other seizure disorder;

• a blood cell disorder such as anemia or low platelets; or

• a weak immune system.

In animal studies, a medicine similar to tinidazole caused cancer. It is not known whether cancer would occur in humans using tinidazole.

It is not known if tinidazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may be harder for a man to get a woman pregnant after using this medicine.

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol while taking Tindamax and for at least 3 days after your treatment ends. You may have unpleasant side effects such as fast heartbeats, severe nausea, vomiting, sweating, and warmth or tingling under your skin.

Many products may contain alcohol, including mouthwash or cough and cold medicines. Check all label to avoid possible alcohol contained in any products you consume.

Get emergency medical help if you have signs of an allergic reaction to Tindamax (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• fever, chills, body aches, flu symptoms;

• numbness, burning pain, or tingly feeling;

• a seizure; or

• vaginal itching or discharge.

Common Tindamax side effects may include:

• nausea, vomiting, loss of appetite, indigestion;

• constipation, 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with tinidazole, especially:

• disulfiram (Antabuse, taken within the past 2 weeks);

• fluorouracil;

• lithium;

• seizure medicine - fosphenytoin, phenytoin; or

• medicine to prevent organ transplant rejection - cyclosporine, tacrolimus.

This list is not complete and many other drugs may interact with Tindamax. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.