Pronunciation:

tye-NYE-da-zole

Brand Names:

• Tindamax

Dosage Forms:

• Tablet

Warnings:

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent . Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of tinidazole to approved indication only. Avoid chronic use .

Classifications:

Therapeutic—

Antibiotic

Uses of This Medicine:

Tinidazole is used to treat infections caused by protozoa (eg, trichomoniasis, giardiasis, and amebiasis). It is also used to treat adult women with vaginal infections (bacterial vaginosis).

Tinidazole belongs to the group of medicines called antiprotozoals. These medicines are used to treat infections caused by protozoa (tiny, one-celled animals).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-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 an adjustment in the dose for patients receiving tinidazole.

Breast-feeding—

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.

Other medicines—

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 or
• Peripheral neuropathy (nerve problem), history of or
• Seizures, history of or
• Vaginal yeast infection (Candida infection)—Use with caution. May make these conditions worse.

• Cockayne syndrome (genetic disorder)—Should not be used in patients with this condition.

• Kidney disease, including dialysis patients or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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.

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 during the day. If you need help planning the best times to take your medicine, check with your doctor.

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 amebic liver abscess:
    • Adults—2 grams (g) once a day for 3 to 5 days.
    • Children older than 3 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 50 milligrams (mg) per kilogram (kg) of body weight per day (up to 2 g per day) for 3 to 5 days.
    • Children 3 years of age and younger—Use and dose must be determined by your doctor.
  • For bacterial vaginosis:
    • Adults— 2 grams (g) once a day for 2 days or 1 g once a day for 5 days.
    • Children—Use and dose must be determined by your doctor.
  • For giardiasis:
    • Adults—2 grams (g) given as a single dose.
    • Children older than 3 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 50 milligrams (mg) per kilogram (kg) of body weight (up to 2 g) given as a single dose.
    • Children 3 years of age and younger—Use and dose must be determined by your doctor.
  • For intestinal amebiasis:
    • Adults—2 grams (g) once a day for 3 days.
    • Children older than 3 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 50 milligrams (mg) per kilogram (kg) of body weight per day (up to 2 g per day) for 3 days.
    • Children 3 years of age and younger—Use and dose must be determined by your doctor.
  • For trichomoniasis:
    • Adults— 2 grams (g) 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—

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the oral liquid (crushed tablets in artificial cherry syrup) at room temperature up to 7 days.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Do not use this medicine if you have taken disulfiram (Antabuse®) within the last two weeks. Also, do not take alcohol or alcoholic products (eg, propylene glycol) during treatment with this medicine and for at least 3 days after your last dose.

This medicine may increase your risk for cancer. Talk to your doctor about this risk.

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause a vaginal yeast infection. Check with your doctor right away if you have itching of the vagina or genitals or thick, white vaginal discharge with mild or no odor.

If you are taking this medicine for trichomoniasis (an infection of the sex organs in men or women), 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 (rubber) during intercourse. These measures will help to keep you from getting the infection back again from your partner. If you have any questions about this, talk with your doctor.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. 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

Chest tightness

change in consciousness

cough

loss of consciousness

trouble breathing

Incidence not known

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, itching, rash

large, hive-like swelling on the 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 the 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 the 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

dizziness

general feeling of discomfort or illness

headache

heartburn

indigestion

loss of appetite

pain or discomfort in the chest, upper stomach, or throat

vomiting

weight loss

Rare

Body aches or pain

coating on tongue

depression

hoarseness

mood or mental changes

runny nose

tender, swollen glands in the neck

voice changes

Incidence not known

Darkened urine

diarrhea

difficulty in moving

feeling of constant movement of self or surroundings

giddiness

lightheadedness

muscle pain or stiffness

pain, swelling, or redness in joints

sensation of spinning

shakiness and unsteady walk

sleepiness

swelling 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.