Ethina

Ethina 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 Ethina, Ethina 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 Ethina, Ethina 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 Ethina and other antibacterial drugs, Ethina should be used only to treat or prevent 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.

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

To help clear up your tuberculosis (TB) completely, you must keep taking Ethina 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.

Ethina 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, Ethina is used in certain patients with the following medical conditions:

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

Usual Adult Dose for Tuberculosis - Active

500 mg to 1 g orally (15 to 20 mg/kg) in 1 or more divided doses per day

Maximum dose: 1 g orally per day

Duration: Treatment should continue until permanent bacteriological conversion and maximal clinical improvement have occurred, generally, 18 to 24 months.

Usual Pediatric Dose for Tuberculosis - Active

10 to 20 mg/kg orally in 2 or 3 divided doses per day or 15 mg/kg orally once per day after meals.

Maximum dose: 1 g orally per day

Duration: Treatment should continue until permanent bacteriological conversion and maximal clinical improvement have occurred, generally, 18 to 24 months.

Renal Dose Adjustments

Adults:

CrCl less than 30 mL/min: 250 to 500 mg/day.

Liver Dose Adjustments

Ethina is contraindicated in patients with severe hepatic impairment.

Precautions

Ethina is contraindicated in patients with severe hepatic impairment.

Due to rapid development of resistance, Ethina should not be used alone for the treatment of tuberculosis. It should be given with at least 1 or 2 other drugs to which the organism is susceptible.

Patient compliance is essential to the success of the antituberculosis regimen and to prevent development of resistant organisms. Patients should closely adhere to the drug regimen for the full duration of treatment. Directly-observed treatment (DOT) is recommended for all antituberculosis therapy.

Psychotic reactions have been reported with excessive alcohol ingestion during Ethina therapy.

Baseline and periodic ophthalmologic examinations are recommended. Patients should be advised to consult with their physician if they experience blurry vision, or loss of vision with or without eye pain during treatment.

Serum transaminases (SGOT, SGPT) should be measure before starting therapy and monthly thereafter. If transaminases increased, Ethina and the other antimycobacterial(s) may be temporarily discontinued until they normalize. Ethina and the other medications should then be restarted sequentially to determine which one(s) is/are responsible for the hepatotoxicity.

Blood glucose should be monitored before and during therapy. Diabetic patients may experience episodes of hypoglycemia.

Hypothyroidism has been reported. Thyroid function tests should be monitored periodically.

Antimycobacterial agents have been associated with vitamin B12 deficiency, folic acid deficiency, megaloblastic anemia, and sideroblastic anemia.

Ethina should not be administered in pediatric patients less than 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.

Dialysis

Adults: 250 to 500 mg/day.

Other Comments

Ethina should be taken with meals or at bedtime to minimize gastrointestinal intolerance.

Concomitant pyridoxine is recommended.

See also:
What is the most important information I should know about Ethina?

Take all of the Ethina that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethina may cause stomach upset, a loss of appetite, a metallic taste in your mouth, or excessive salivation (mouth watering). Notify your doctor if these side effects are persistent or severe.

Use Ethina as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Ethina may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Ethina should be taken in combination with other medicines.
• If you miss a dose of Ethina and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ethina.

Ethina is used in combination with other medicines for the treatment of active tuberculosis (infectious disease caused by Mycobacterium tuberculosis) resistant to isoniazid or rifampicin, or when there is intolerance on the part of the patient to other drugs.

See also:
What other drugs will affect Ethina?

Alcohol (Ethyl): May enhance the adverse/toxic effect of Ethina. Specifically, there may be a risk for a psychotic episode/reaction. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

CycloSERINE: Ethina may enhance the adverse/toxic effect of CycloSERINE. Monitor therapy

Isoniazid: Ethina may increase the serum concentration of Isoniazid. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

See also:
What are the possible side effects of Ethina?

Applies to Ethina: oral tablet

As well as its needed effects, Ethina (the active ingredient contained in Ethina) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Ethina, check with your doctor immediately:

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

• 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

Minor Side Effects

Some Ethina side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

• Enlargement of the breasts (in males)

An alkaloid found in opium but not closely related to the other opium alkaloids in its structure or pharmacological actions. It is a direct-acting smooth muscle relaxant used in the treatment of impotence and as a vasodilator, especially for cerebral vasodilation. The mechanism of its pharmacological actions is not clear, but it apparently can inhibit phosphodiesterases and it may have direct actions on calcium channels.