Trecator-SC

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.

This product is available in the following dosage forms:

• Tablet

In the U.S.

• Trecator
• Trecator-SC

Available Dosage Forms:

• Tablet

Therapeutic Class: Antitubercular

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.

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.

Pediatric

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

Geriatric

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.

Pregnancy

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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.

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:

• Clumsiness or unsteadiness
• confusion
• mental depression
• numbness, tingling, burning, or pain in the hands and feet
• yellow eyes or skin

• 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
• 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
• tightness in the chest
• troubled breathing or swallowing
• weakness in the hands or feet
• weight gain

• Chills
• cold sweats
• coma
• cool, pale skin
• dark urine
• dizziness
• general tiredness and weakness
• headache
• light-colored stools
• nausea and vomiting
• nightmares
• seizures
• slurred speech
• 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:

• Abdominal or stomach pain
• diarrhea
• increased watering of the mouth
• loss of appetite
• metallic taste
• swelling or inflammation of the mouth
• weight loss

• 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.

Applies to ethionamide: oral tablet

Along with its needed effects, ethionamide (the active ingredient contained in Trecator-SC) 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 while taking ethionamide:

• Clumsiness or unsteadiness
• confusion
• mental depression
• numbness, tingling, burning, or pain in the hands and feet
• yellow eyes or skin

• 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
• 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
• tightness in the chest
• troubled breathing or swallowing
• weakness in the hands or feet
• weight gain

• Chills
• cold sweats
• coma
• cool, pale skin
• dark urine
• dizziness
• general tiredness and weakness
• headache
• light-colored stools
• nausea and vomiting
• nightmares
• seizures
• slurred speech
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects of ethionamide 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:

• Abdominal or stomach pain
• diarrhea
• increased watering of the mouth
• loss of appetite
• metallic taste
• swelling or inflammation of the mouth
• weight loss

• 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