DRUGS & SUPPLEMENTS

Ethide

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Published: 2021-11-11T10:10:10+00:00

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Ethide uses

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
References
Ethide reviews

INDICATIONS AND USAGE

Ethide is primarily indicated for the treatment of active tuberculosis in patients with M. tuberculosis resistant to isoniazid or rifampin, or when there is intolerance on the part of the patient to other drugs. Its use alone in the treatment of tuberculosis results in the rapid development of resistance. It is essential, therefore, to give a suitable companion drug or drugs, the choice being based on the results of susceptibility tests. If the susceptibility tests indicate that the patient's organism is resistant to one of the first-line antituberculosis drugs (i.e., isoniazid or rifampin) yet susceptible to Ethide, Ethide should be accompanied by at least one drug to which the M. tuberculosis isolate is known to be susceptible.3 If the tuberculosis is resistant to both isoniazid and rifampin, yet susceptible to Ethide, Ethide should be accompanied by at least two other drugs to which the M. tuberculosis isolate is known to be susceptible.3

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ethide and other antibacterial drugs, Ethide should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Patient nonadherence to prescribed treatment can result in treatment failure and in the development of drug-resistant tuberculosis, which can be life-threatening and lead to other serious health risks. It is, therefore, essential that patients adhere to the drug regimen for the full duration of treatment. Directly observed therapy is recommended for all patients receiving treatment for tuberculosis. Patients in whom drug-resistant M. tuberculosis organisms are isolated should be managed in consultation with an expert in the treatment of drug-resistant tuberculosis.

CONTRAINDICATIONS

Ethide is contraindicated in patients with severe hepatic impairment and in patients who are hypersensitive to the drug.

WARNINGS

The use of Ethide alone in the treatment of tuberculosis results in rapid development of resistance. It is essential, therefore, to give a suitable companion drug or drugs, the choice being based on the results of susceptibility testing. However, therapy may be initiated prior to receiving the results of susceptibility tests as deemed appropriate by the physician. Ethide should be administered with at least one, sometimes two, other drugs to which the organism is known to be susceptible (see INDICATIONS AND USAGE ). Drugs which have been used as companion agents are rifampin, ethambutol, pyrazinamide, cycloserine, kanamycin, streptomycin, and isoniazid. The usual warnings, precautions, and dosage regimens for these companion drugs should be observed.

Patient compliance is essential to the success of the antituberculosis therapy and to prevent the emergence of drug-resistant organisms. Therefore, patients should adhere to the drug regimen for the full duration of treatment. It is recommended that directly observed therapy be practiced when patients are receiving antituberculous medication. Additional consultation from experts in the treatment of drug-resistant tuberculosis is recommended when patients develop drug-resistant organisms.

PRECAUTIONS

General

Prescribing Ethide in the absence of a proven or strongly suspected bacterial infection indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Ethide may potentiate the adverse effects of the other antituberculous drugs administered concomitantly. Ophthalmologic examinations (including ophthalmoscopy) should be performed before and periodically during therapy with Ethide.

Information For Patients

Patients should be advised to consult their physician should blurred vision or any loss of vision, with or without eye pain, occur during treatment.

Excessive ethanol ingestion should be avoided because a psychotic reaction has been reported.

Patients should be counseled that antibacterial drugs including Ethide should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ethide is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Ethide or other antibacterial drugs in the future.

Laboratory Tests

Determination of serum transaminases should be made prior to initiation of therapy and should be monitored monthly. If serum transaminases become elevated during therapy, Ethide and the companion antituberculosis drug or drugs may be discontinued temporarily until the laboratory abnormalities have resolved. Ethide and the companion antituberculosis medication(s) then should be reintroduced sequentially to determine which drug (or drugs) is (are) responsible for the hepatotoxicity.

Blood glucose determinations should be made prior to and periodically throughout therapy with Ethide. Diabetic patients should be particularly alert for episodes of hypoglycemia.

Periodic monitoring of thyroid function tests is recommended as hypothyroidism, with or without goiter, has been reported with Ethide therapy.

Drug Interactions

Ethide has been found to temporarily raise serum concentrations of isoniazid. Ethide may potentiate the adverse effects of other antituberculous drugs administered concomitantly. In particular, convulsions have been reported when Ethide is administered with cycloserine and special care should be taken when the treatment regimen includes both of these drugs. Excessive ethanol ingestion should be avoided because a psychotic reaction has been reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Teratogenic Effects

Animal studies conducted with Ethide indicate that the drug has teratogenic potential in rabbits and rats. The doses used in these studies on a mg/kg basis were considerably in excess of those recommended in humans. There are no adequate and well-controlled studies in pregnant women. Because of these animal studies, however, it must be recommended that Ethide be withheld from women who are pregnant, or who are likely to become pregnant while under therapy, unless the prescribing physician considers it to be an essential part of the treatment.

Labor and Delivery

The effect of Ethide on labor and delivery in pregnant women is unknown.

Nursing Mothers

Because no information is available on the excretion of Ethide in human milk, Ethide should be administered to nursing mothers only if the benefits outweigh the risks. Newborns who are breast-fed by mothers who are taking Ethide should be monitored for adverse effects.

Pediatric Use

Due to the fact that pulmonary tuberculosis resistant to primary therapy is rarely found in neonates, infants, and children, investigations have been limited in these age groups. At present, the drug should not be used in pediatric patients under 12 years of age except when the organisms are definitely resistant to primary therapy and systemic dissemination of the disease, or other life-threatening complications of tuberculosis, is judged to be imminent.

ADVERSE REACTIONS

Gastrointestinal: The most common side effects of Ethide are gastrointestinal disturbances including nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia and weight loss. Adverse gastrointestinal effects appear to be dose related, with approximately 50% of patients unable to tolerate 1 gm as a single dose. Gastrointestinal effects may be minimized by decreasing dosage, by changing the time of drug administration, or by the concurrent administration of an antiemetic agent.

Nervous System: Psychotic disturbances (including mental depression), drowsiness, dizziness, restlessness, headache, and postural hypotension have been reported with Ethide. Rare reports of peripheral neuritis, optic neuritis, diplopia, blurred vision, and a pellagra-like syndrome also have been reported. Concurrent administration of pyridoxine has been recommended to prevent or relieve neurotoxic effects.

Hepatic: Transient increases in serum bilirubin, SGOT, SGPT; Hepatitis (with or without jaundice).

Other: Hypersensitivity reactions including rash, photosensitivity, thrombocytopenia and purpura have been reported rarely. Hypoglycemia, hypothyroidism, gynecomastia, impotence, and acne also have occurred. The management of patients with diabetes mellitus may become more difficult in those receiving Ethide.

OVERDOSAGE

No specific information is available on the treatment of overdosage with Ethide. If it should occur, standard procedures to evacuate gastric contents and to support vital functions should be employed.

DOSAGE AND ADMINISTRATION

In the treatment of tuberculosis, a major cause of the emergence of drug-resistant organisms, and thus treatment failure, is patient nonadherence to prescribed treatment. Treatment failure and drug-resistant organisms can be life-threatening and may result in other serious health risks. It is, therefore, important that patients adhere to the drug regimen for the full duration of treatment. Directly observed therapy is recommended when patients are receiving treatment for tuberculosis. Consultation with an expert in the treatment of drug-resistant tuberculosis is advised for patients in whom drug-resistant tuberculosis is suspected or likely. Ethide should be administered with at least one, sometimes two, other drugs to which the organism is known to be susceptible (see INDICATIONS AND USAGE ).

Ethide is administered orally. The usual adult dose is 15 to 20 mg/kg/day, administered once daily or, if patient exhibits poor gastrointestinal tolerance, in divided doses, with a maximum daily dosage of 1 gram.

Ethide tablets have been reformulated from a sugar-coated tablet to a film-coated tablet. Patients should be monitored and have their dosage retitrated when switching from the sugar-coated tablet to the film-coated tablet (see CLINICAL PHARMACOLOGY ).

Therapy should be initiated at a dose of 250 mg daily, with gradual titration to optimal doses as tolerated by the patient. A regimen of 250 mg daily for 1 or 2 days, followed by 250 mg twice daily for 1 or 2 days with a subsequent increase to 1 gm in 3 or 4 divided doses has been reported.4,5 Thus far, there is insufficient evidence to indicate the lowest effective dosage levels. Therefore, in order to minimize the risk of resistance developing to the drug or to the companion drug, the principle of giving the highest tolerated dose (based on gastrointestinal intolerance) has been followed. In the adult this would seem to be between 0.5 and 1.0 gm daily, with an average of 0.75 gm daily.

The optimum dosage for pediatric patients has not been established. However, pediatric dosages of 10 to 20 mg/kg p.o. daily in 2 or 3 divided doses given after meals or 15 mg/kg/24 hrs as a single daily dose have been recommended.1,2 As with adults, Ethide may be administered to pediatric patients once daily. It should be noted that in patients with concomitant tuberculosis and HIV infection, malabsorption syndrome may be present. Drug malabsorption should be suspected in patients who adhere to therapy, but who fail to respond appropriately. In such cases, consideration should be given to therapeutic drug monitoring (see CLINICAL PHARMACOLOGY ).

The best times of administration are those which the individual patient finds most suitable in order to avoid or minimize gastrointestinal intolerance, which is usually at mealtimes. Every effort should be made to encourage patients to persevere with treatment when gastrointestinal side effects appear, since they may diminish in severity as treatment proceeds.

Concomitant administration of pyridoxine is recommended.

Duration of treatment should be based on individual clinical response. In general, continue therapy until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

HOW SUPPLIED

Ethide^® (ethionamide tablets, USP) are supplied in bottles of 100 tablets as follows:

250 mg, orange film-coated tablet marked "W" on one side and "4117" on reverse side, NDC 0008-4117-01.

Store at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in a tight container.

REFERENCES

Feigin, R.D., and Cherry, J.D.: Textbook of Pediatric Infectious Diseases, 2nd Edition. Philadelphia, W.B. Saunders Co., 1987, pp. 1371-1372.
Nelson, W.E., Behrman, R.E., Vaughan, V.C. (eds.): Nelson Textbook of Pediatrics, 13th edition. Philadelphia, W.B. Saunders Co., 1987, p.636.
Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, Am J Respiratory and Critical Care Medicine, 149:1359-1374, 1994.
Peloquin, CA: Pharmacology of the Antimycobacterial Drugs, Med Clin North Am 77(6): 1230-1262, 1993.
American Thoracic Society. Am J Respir Crit Care Med 1997;156:S1-S25.

This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.

LAB-0685-4.0

September 2016

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Pfizer

NDC 0008-4117-01

Ethide ^®

(ethionamide tablets, USP)

tablets

250 mg

SEALED FOR

YOUR PROTECTION

100 Tablets

Rx only

Ethide pharmaceutical active ingredients containing related brand and generic drugs:

Ethionamide

Ethide available forms, composition, doses:

Tablets, Film-Coated; Oral; Ethionamide 250 mg

Ethide destination | category:

Human:
Anti-TB agents
Antileprotics

Ethide Anatomical Therapeutic Chemical codes:

J04AD03 - Ethionamide

Ethide pharmaceutical companies:

Lupin Pharmaceuticals

References

Dailymed."TRECATOR (ETHIONAMIDE) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."ETHIONAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"ethionamide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Ethide?

Depending on the reaction of the Ethide after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ethide not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Ethide addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Ethide, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Ethide consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.