Trecator-SC (Oral)

Ethionamide is used along with other medicines to treat tuberculosis (TB). Ethionamide is an antibiotic that helps to kill or stop the growth of bacteria. However, it will not work for colds, flu, or other viral infections.

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

It is very important for your doctor to check your progress during regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking 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 get worse, contact 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 happen with this medicine. Contact your doctor immediately if you or your child experience 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 this medicine affects you before you drive, use machines, or do anything else that could be dangerous if you cannot see well.

Avoid drinking 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 having surgery or medical tests.

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

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a decision for you and your doctor to make. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional if you have 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 for children younger than 12 years old.

Geriatric

There is no information available on how age affects the effects of ethionamide in elderly patients. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution when taking ethionamide.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may need to change the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and are not necessarily a complete list.

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

• Cycloserine
• Pyrazinamide
• Rifampin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and are not necessarily a complete list.

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

• Ethanol

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

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

• Severe liver disease—Should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Trecator
• Trecator-SC

Available Dosage Forms:

• Tablet

Therapeutic Class: Antitubercular

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.