Pronunciation:

e-thye-ON-a-mide

Brand Names:

• Trecator
• Trecator-SC

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antitubercular

Uses of This Medicine:

Ethionamide is used together with other medicines to treat tuberculosis (TB). Ethionamide belongs to the class of medicines called antibiotics and works to kill or prevent the growth of bacteria. However, it will not work for colds, flu, or other virus infections.

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—

Use of ethionamide is not recommended in children younger than 12 years of age.

Older adults—

No information is available on the relationship of age to the effects of ethionamide in geriatric patients. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving ethionamide.

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.

• Cycloserine
• Pyrazinamide
• Rifampin

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:

• Diabetes or
• Thyroid problems—Use with caution. May make these conditions worse.

• Liver disease, severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly 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. To do so may increase the chance for side effects.

Ethionamide may be taken with meals or after meals, if it upsets your stomach.

To help clear up your tuberculosis (TB) completely, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks. You may have to take it every day for 1 to 2 years or more. It is important that you do not miss any doses.

Your doctor may also want you to take pyridoxine (eg, Hexa-Betalin, vitamin B6) every day to help prevent or lessen some of the side effects of ethionamide. If so, it is very important to take pyridoxine every day along with this medicine. Do not miss any doses.

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 the treatment of tuberculosis (TB):
    • Adults—Dose is based on body weight and must determined by your doctor. The starting dose is usually 250 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg per day.
    • Children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day, divided in 2 or 3 doses taken after meals or 15 mg per kg of body weight per day, taken as a single dose.
    • Children younger than 12 years of age—Use is not recommended.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.

If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Since this medicine may cause blurred vision or loss of vision, with or without eye pain, make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

Avoid taking alcohol while using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.

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:

Less common

Clumsiness or unsteadiness

confusion

mental depression

numbness, tingling, burning, or pain in the hands and feet

yellow eyes or skin

Rare

Blindness or vision changes

blue-yellow color blindness

blurred vision or loss of vision, with or without eye pain

burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

changes in menstrual periods

chest tightness

coldness

decreased sexual ability (in males)

decreased vision

difficulty in concentrating

dry, puffy skin

fast heartbeat

fever

hives, itching, or rash

hoarseness

increased hunger

increased sensitivity of the skin to sunlight

irritation

joint pain, stiffness, or swelling

redness or other discoloration of the skin

severe sunburn

shakiness

swelling of the eyelids, face, lips, hands, or feet

swelling of the front part of the neck

trouble breathing or swallowing

weakness in the hands or feet

weight gain

Incidence not known

Black, tarry stools

blistering, peeling, or loosening of the skin

chest pain

chills

cold sweats

coma

cool, pale skin

cough

dark urine

diarrhea

dizziness

general tiredness and weakness

headache

joint or muscle pain

light-colored stools

nausea and vomiting

nightmares

painful or difficult urination

red irritated eyes

red skin lesions, often with a purple center

seizures

slurred speech

sore throat

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

yellow eyes and skin

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

Increased watering of the mouth

loss of appetite

metallic taste

stomach pain

swelling or inflammation of the mouth

weight loss

Incidence not known

Blemishes on the skin

decreased interest in sexual intercourse

enlargement of the breasts (in males)

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

pimples

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.