Mycobutol tablets

Mycobutol

  • Active Ingredient: Ethambutol
  • 800 mg, 600 mg, 400 mg
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What is Mycobutol?

The active ingredient of Mycobutol brand is ethambutol. Ethambutol is an antibiotic that prevents growth of the tuberculous bacteria in the body. Ethambutol HYDROCHLORIDE (HCL) 100 and 400 mg tablets contain the following inactive ingredients: Gelatin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Sodium Lauryl Sulfate, Sorbitol, Stearic Acid, Sucrose, Titanium Dioxide and other ingredients.

Used for

Mycobutol is used to treat diseases such as: Mycobacterium avium-intracellulare, Prophylaxis, Mycobacterium avium-intracellulare, Treatment, Tuberculosis, Active.

Side Effect

Possible side effects of Mycobutol include: numbness, tingling, burning pain, or weakness in hands or feet; Chills; skin rash; Blurred vision, eye pain, red-green color blindness, or any loss of vision (more common with high doses); pain and swelling of joints, especially big toe, ankle, or knee; Abdominal pain; nausea and vomiting; tense, hot skin over affected joints.

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Background

Mycobutol (eth am' bue tol) is a semisynthetic antibiotic which is bacteriostatic against Mycobacterium tuberculosis. Mycobutol interferes with the incorporation of mycolic acid into the mycobacterial cell wall, thus inhibiting its cell wall synthesis. Mycobutol has a broader spectrum of activity against mycobacterial species than isoniazid or rifampin and is therefore used largely in patients with suspected resistance or in atypical mycobacterial infections. Mycobutol is available in generic forms in tablets of 100 and 400 mg. The recommended dose is 15 mg/kg once daily in combination with other antituberculosis medications such as isoniazid, rifampin, pyrazinamide, and streptomycin. Higher doses are recommended for patients being retreated after a relapse. Common side effects include gastrointestinal upset, nausea, dizziness, fever, and rash. Regularly updated information on guidelines for therapy of tuberculosis is available at the Centers for Disease Control and Prevention website: http://www.cdc.gov/tb/publications/guidelines/Treatment.htm.

What should I discuss with my healthcare prov >

You should not use Mycobutol if you are allergic to it. You may not be able to take Mycobutol if you have an eye condition called optic neuritis (inflammation of nerve fibers behind your eyes). Your doctor will decide if this treatment is right for if you have an eye disorder.

Mycobutol can cause vision problems that may be a sign that you should stop taking the medicine. You may not be able to take Mycobutol if you cannot recognize or report any changes in your vision. Young children or debilitated patients may not be able to tell someone about vision problems.

To make sure Mycobutol is safe for you, tell your doctor if you have:

  • inflammatory eye disorders such as uveitis or iritis;
  • eye problems caused by diabetes;
  • cataracts;
  • liver disease;
  • k >

FDA pregnancy category C. It is not known whether Mycobutol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Mycobutol can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Mycobutol should not be given to a child younger than 13 years old.

  1. Interference with iron and copper complexes: Mycobutol might also interfere with oxidative phosphorylation and mitochondrial function by interfering with iron-containing complex 1 and copper-containing complex 4.

Mechanisms of Mycobutol-induced vision damage

The mechanisms by which Mycobutol damages the optic nerve and eyes remain unknown.

Several mechanisms have been proposed as potentially-causing Mycobutol-induced optic neuropathy and retinopathy.

  1. Metal chelation: Mycobutol is a metal chelator and functions by inhibiting arabinosyltransferase. One hypothesis suggests that Mycobutol administration chelates zinc on mitochondrial metal-containing enzymes and throughout excitotoxic pathways involving glutamate.

Before taking this medicine

You should not use Mycobutol if you are allergic to it. You may not be able to take Mycobutol if you have an eye condition called optic neuritis (inflammation of nerve fibers behind your eyes). Your doctor will decide if this treatment is right for if you have an eye disorder.

Mycobutol can cause vision problems that may be a sign that you should stop taking the medicine. You may not be able to take Mycobutol if you cannot recognize or report any changes in your vision. Young children or debilitated patients may not be able to tell someone about vision problems.

To make sure Mycobutol is safe for you, tell your doctor if you have:

eye problems caused by diabetes;

kidney disease; or

FDA pregnancy category C. It is not known whether Mycobutol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Mycobutol can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Mycobutol should not be given to a child younger than 13 years old.

Geriatric Use

There are limited data on the use of Mycobutol HCl in the elderly. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on Mycobutol HCl. No differences in safety or tolerability were observed in these patients compared with that reported in adults in general. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Generic Name: Mycobutol (eth AM bue tol)Brand Name: Myambutol

Medically reviewed by Drugs.com on Apr 15, 2019 – Written by Cerner Multum

What are the possible s >

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mycobutol can cause serious vision problems, including vision loss that may be permanent. Stop using Mycobutol and call your doctor at once if you have any problems with one or both of your eyes, such as:

  • blurred vision or trouble focusing;
  • loss of vision in one eye that lasts an hour or longer;
  • increased sensitivity of your eyes to light;
  • loss of color vision; or
  • pain with eye movement, pain behind your eyes.

Call your doctor at once if you have:

  • new or worsening cough with fever, trouble breathing;
  • numbness of tingling in your hands or feet;
  • confusion, hallucinations;
  • fever, swollen glands, painful mouth sores, skin sores, cold or flu symptoms, general ill feeling;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • chest pain or shortness of breath with mild exertion;
  • little or no urinating;
  • liver problems --upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • itching or rash;
  • joint pain;
  • headache, dizziness; or
  • nausea, vomiting, stomach pain, indigestion, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Is ocular damage from Mycobutol reversible?

Sometimes. The reversibility of Mycobutol ocular damage is subject to significant individual variation. Some medical doctors are more confident about the reversibility of ocular damage resulting from Mycobutol than others.

According to Chamberlain et al. (2017), 30% to 64% of people with Mycobutol ocular damage will experience visual improvement within 3 months if they stop Mycobutol as soon as visual symptoms are noticed or detected. (R)

Few patients will experience full visual recovery of vision in the aftermath of Mycobutol optic neuropathy. The average improvement is 2 lines on the Snellen chart.

Elderly patients are less likely to recover than younger patients. A case series of 10 patients by Tsai and Lee (1997) reported that the recovery rate in visual function for patients 60 and older was 20% (1 of 5) versus 80% (4 of 5) for patients under 60. (R)

If optic nerve atrophy is present at the time of diagnosis – recovery of visual function is unlikely.

According to Woung et al. (1995), patients visual function recovers in the following order: visual acuity, visually evoked potentials, color vision, critical flicker frequency, visual field, contrast sensitivity, pupil cycle time. (R)

The case series of 10 patients by Tsai and Lee (1997) reported that only 50% of patients with Mycobutol optic neuropathy experienced visual improvement within 1-to-3 years of stopping the medication. Furthermore, all of these patients had used clinically “safe dosages” of Mycobutol.

Although improvements were attained by some patients, full visual recovery was not reported. Authors emphasized that there is no “safe dosage” of Mycobutol. (R)

Mycobutol

Mycobutol generally is considered to have a bacteriostatic effect on M. tuberculosis, especially at lower dosages. Easily administered and well absorbed, Mycobutol penetrates poorly into CSF even in the presence of inflammation. 164,165 Mycobutol primarily is used when there is a possibility of initial drug resistance to other first-line drugs. Retrobulbar neuritis is the most serious adverse effect; 160 symptoms are blurred vision, central scotoma, and red-green color blindness. Neuritis is exceedingly rare in children and all persons with normal renal function. 166 Complications appear to be dose-related and rarely occur with a daily dose of 20 mg/kg per day.

A prospective study of ocular toxicity in patients receiving Mycobutol as a part of directly observed treatment strategy therapy.

  • Authors: Garg et al. (2015) (Source)
  • Aim: Evaluate rates of Mycobutol-induced ocular toxicity among 64 patients enrolled in India’s revised National Tuberculosis Control Program who received intermittent doses of Mycobutol and rifampicin.
  • Category 1: Mycobutol (1200 mg), rifampicin (450 mg), isoniaz >Why did ocular toxicity occur among patients in this study?

Likely the Mycobutol dose. Garg et al. noted that patients in this study received Mycobutol at a dose that exceeded 20 mg/kg body weight. The exact body weight of each patient was not provided so we are unable to know the degree of excess dosing for each patient.

Additionally, it’s known that isoniazid can contribute to ocular toxicity. In this study, it’s possible that some of the adverse ocular effects were partially attributable to isoniazid.

Contraindications—hypersensitivity, optic neuritis

Caution—renal dysfunction, ophthalmologic disorders

Maternal Considerations There are no adequate reports or well-controlled studies of Mycobutol in pregnant women. The published experience consists of relatively small to moderate-sized series and case reports. However, untreated tuberculosis poses a significant threat to the mother, fetus, and family. Adherence to treatment can be made difficult because of a general fear of any medication and pregnancy-related nausea. What information exists suggests that all four first-line drugs for the treatment of tuberculosis (isoniazid, rifampin, Mycobutol, and pyrazinamide) have excellent safety records in pregnancy.Side effects include thrombocytopenia, neuropathy (optic, peripheral), anorexia, N/V, joint pain, abdominal pain, fever, headache, hallucinations, pruritus, and elevated LFTs. Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Mycobutol reportedly crosses the human placenta, achieving an F:M ratio approximating unity. There are no reports suggesting an adverse fetal effect. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. In case reports, only small quantities of Mycobutol were reported in human breast milk, providing a relative infant dose of Drug Interactions Antacids may reduce absorption if given within 4 h. References Bothamley G. Drug Saf 2001; 24:553-65.Brost BC, Newman RB. Obstet Gynecol Clin North Am 1997; 24:659-73.Holdiness MR. Early Hum Dev 1987; 15:61-74.Shneerson JM, Francis RS. Tubercle 1979; 60:167-9.Tripathy SN. Int J Gynaecol Obstet 2003; 80:247-53.Tran JH, Montakantikul P. J Hum Lact 1998; 14:337-40. Summary Pregnancy Category: BLactation Category: S •

Pregnancy does not alter the importance of treating mycobacterial infection.

Mycobutol is considered safe and effective during pregnancy and lactation.

Mycobutol Interactions

Avoid taking an antacid containing aluminum hydroxide (Alternagel, Maalox, Mi-Acid, Mylanta, Rulox) within 4 hours after you take Mycobutol. Some antacids can make it harder for your body to absorb Mycobutol.

Other drugs may interact with Mycobutol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.


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