Tindamax

Tindamax is used to treat infections caused by protozoa (tiny, one-celled animals). It works by killing the protozoa. This medicine is also used to treat vaginal infections caused by bacteria.

Tindamax is available only with your doctor's prescription. This product is available in the following dosage forms:

• Tablet

Before using Tindamax, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of tinidazole in children below 3 years of age. Safety and efficacy have not been established. It is only used in children three years of age and older for the treatment of giardiasis and amebiasis .

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of tinidazole in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require adjustment of dosage in patients receiving tinidazole .

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. 

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Capecitabine
• Disulfiram
• Doxifluridine
• Fluorouracil
• Tegafur

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disease or a history of blood disease—Tinidazole may make this condition worse.
• Central nervous system (CNS) disease, including epilepsy—Tinidazole may increase the chance of seizures (convulsions) or other CNS side effects.
• Liver disease, severe—Patients with severe liver disease may have an increase in side effects.
• Oral thrush or vaginal yeast infection—Tinidazole may make yeast infections worse.

To use Tindamax properly, you must follow all instructions given by your doctor. If this medicine upsets your stomach, it may be taken with meals or a snack. If stomach upset (nausea, vomiting, stomach pain, or diarrhea) continues, check with your doctor.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

In some kinds of infections, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. 

For example, if you are to take one dose a day, the doses should be spaced about 24 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Some types of infections are treated with one dose of Tindamax. If you cannot swallow the tablet, it may be crushed in artificial cherry syrup. Shake this mixture well before drinking .

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

• For intestinal amebiasis:
  • Adults—2 grams per day for three days.
  • Children 3 years of age and older—50 milligrams per kilogram of body weight per day (up to to 2 grams per day) for three days.
  • Children below 3 years old—Use and dose must be determined by your doctor .
• For amebic liver abscess:
  • Adults—2 grams per day for 3 to 5 days.
  • Children 3 years of age and older—50 milligrams per kilogram of body weight per day (up to to 2 grams per day) for 3 to 5 days.
  • Children below 3 years old—Use and dose must be determined by your doctor .
• For bacterial vaginosis:
  • Adults— 2 grams per day for two days or 1 gram per day for five days.
  • Children—Use and dose must be determined by your doctor .
• For giardiasis:
  • Adults—2 grams given once as a single dose.
  • Children 3 years of age and older—50 milligrams per kilogram of body weight (up to to 2 grams) given once as a single dose.
  • Children below 3 years old—Use and dose must be determined by your doctor .
• For trichomoniasis:
  • Adults— 2 grams given once as a single dose.
  • Children—Use and dose must be determined by your doctor .

Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Before using Tindamax, there are some precautions you must take. If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

You should not take this medicine during the first trimester (3 months) of pregnancy. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. 

If you think you have become pregnant while using the medicine, tell your doctor right away. Also, do not breastfeed while using this medicine. Wait at least three days after you stop taking this medicine before you breastfeed .

Tinidazole may cause a vaginal yeast infection. Check with your doctor right away if you are having itch of the vagina or outside genitals; pain during sexual intercourse; or thick, white curd-like vaginal discharge without odor or with a mild odor .

Drinking alcoholic beverages or using preparations that contain propylene glycol while taking this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (for example, elixirs, cough syrups, tonics) may also cause problems. 

These problems may last for at least 3 days after you stop taking tinidazole. Also, this medicine may cause alcoholic beverages to taste different. Therefore, you should not drink alcoholic beverages or use other alcohol or propylene glycol-containing preparations while you are taking this medicine and for at least 3 days after stopping it.

If you are taking this medicine for trichomoniasis (an infection of the sex organs in males and females), your doctor may want to treat your sexual partner at the same time you are being treated, even if he or she has no symptoms. 

Also, it may be desirable to use a condom (prophylactic) during intercourse. These measures will help keep you from getting the infection back again from your partner. If you have any questions about this, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine .

As with many medications, there are several potential side effects associated with Tindamax. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare:

• change in consciousness
• cough
• difficulty breathing
• loss of consciousness
• noisy breathing
• shortness of breath
• tightness in the chest
• wheezing

Incidence unknown:

• black, tarry stools
• bleeding gums
• blood in urine or stools
• burning, numbness, tingling, or painful sensations
• chest pain
• chills
• difficulty swallowing
• fast, irregular, pounding or racing heartbeat or pulse
• fever
• hives
• increased transaminase levels
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• reddening of the skin, especially around ears
• seizures
• sore throat
• sores, ulcers, or white spots on lips or in the mouth
• swelling of eyes, face, or inside of the nose
• swollen glands
• ulcers
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

• bitter taste
• metallic taste

Less common:

• acid or sour stomach
• belching
• cramps
• difficulty having a bowel movement (stool)
• dizziness
• the general feeling of discomfort or illness
• headache
• heartburn
• indigestion
• loss of appetite
• pain or discomfort in chest, upper stomach, or throat
• vomiting
• weight loss

Rare:

• body aches or pain
• the coating on the tongue
• congestion
• depression
• dryness or soreness of throat
• hoarseness
• mood or mental changes
• runny nose
• tender, swollen glands in neck
• voice changes

Incidence unknown:

• abnormal liver
• darkened urine
• diarrhea
• difficulty in moving
• the feeling of constant movement of self or surroundings
• giddiness
• lightheadedness
• muscle pain or stiffness
• pain, swelling, or redness in joints
• the sensation of spinning
• shakiness and unsteady walk
• sleepiness
• sleeplessness
• swelling or inflammation of the mouth
• tongue discoloration
• trembling, or other problems with muscle control or coordination
• trouble sleeping
• unable to sleep
• white or brownish vaginal discharge
• white patches in the mouth or throat or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.