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Ethionamide (Oral route)

Pronunciation:

e-thye-ON-a-mide

Brand Names:

  • Trecator
  • Trecator-SC

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Antitubercular

Uses of This Medicine:

Ethionamide is used with other medicines to treat tuberculosis (TB). Ethionamide may also be used for other problems as determined by your doctor.

To help clear up your tuberculosis (TB) completely, you must keep taking this medicine for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.

Ethionamide is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, ethionamide is used in certain patients with the following medical conditions:

  • Atypical mycobacterial infections, such as Mycobacterium avium complex (MAC)
  • Leprosy (Hansen's disease)

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—

Although there is no specific information comparing use of ethionamide in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ethionamide in the elderly with use in other age groups.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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.

  • Pyrazinamide
  • Rifampin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Isoniazid

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 mellitus (sugar diabetes)—Diabetes may be harder to control in patients taking ethionamide
  • Liver disease (severe)—Patients with severe liver disease may have an increased chance of side effects

Proper Use of This Medicine:

Ethionamide may be taken with 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 (e.g., Hexa-Betalin; vitamin B 6) 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 and teenagers—250 milligrams (mg) every eight to twelve hours. Ethionamide must be taken with other medicines to treat tuberculosis.
      • Children—Dose is based on body weight. The usual dose is 4 to 5 mg per kilogram of body weight every eight hours. Ethionamide must be taken with other medicines to treat tuberculosis.

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.

Precautions While Using This Medicine:

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

It is very important that your doctor check your progress at regular visits. Also, check with your doctor immediately if blurred vision or any loss of vision, with or without eye pain, occurs during treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Since this medicine may cause blurred vision or loss of vision, 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.

If this medicine causes clumsiness; unsteadiness; or numbness, tingling, burning, or pain in the hands and feet, check with your doctor immediately. These may be early warning symptoms of more serious nerve problems that could develop later.

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
mood or other mental changes
numbness, tingling, burning, or pain in hands and feet
yellow eyes or skin
Rare
Blurred vision or loss of vision, with or without eye pain
changes in menstrual periods
coldness
decreased sexual ability (in males)
difficulty in concentrating
dry, puffy skin
faster heartbeat
increased hunger
nervousness
shakiness
skin rash
swelling of front part of neck
weight gain

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
Dizziness (especially when getting up from a lying or sitting position)
loss of appetite
metallic taste
nausea or vomiting
sore mouth
Less common or rare
Enlargement of the breasts (in males)

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.


Last Updated: 4/4/2014

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