e-THAM-byoo-tole

• Active tuberculosis or other mycobacterial diseases (with at least one other drug).

• Inhibits the growth of mycobacteria.

• Tuberculostatic effect against susceptible organisms.

Absorption: Rapidly and well absorbed (80%) from the GI tract.

Distribution: Widely distributed; crosses blood-brain barrier in small amounts; crosses placenta and enters breast milk.

Protein Binding: 20–30%.

Metabolism/Excretion: 50% metabolized by the liver, 50% eliminated unchanged by the kidneys.

Half-life: 3.3 hr (increased in renal or hepatic impairment).

Contraindicated in:

• Hypersensitivity
• Optic neuritis.

Use Cautiously in:

• Renal and severe hepatic impairment (dosage reduction required)
• OB: Although safety not established, ethambutol has been used with isoniazid in pregnant women without fetal adverse effects
• Lactation: Usually compatible with breast feeding (AAP).

EENT: optic neuritis.

GI: HEPATITIS, abdominal pain, anorexia, nausea, vomiting.

Metab: hyperuricemia.

MS: joint pain.

Neuro: peripheral neuritis , confusion, dizziness, hallucinations, headache, malaise.

Resp: pulmonary infiltrates.

Misc: anaphylactoid reactions, fever.

Drug-Drug:

• Neurotoxicity may be ↑ with other neurotoxic agents.
• Aluminum hydroxide may decrease absorption (space doses 4 hr apart).

• PO (Adults and Children >13 yr): 15–25 mg/kg/day (maximum 2.5 g/day) or 50 mg/kg (up to 2.5 g) twice weekly or 25–30 mg/kg (up to 2.5 g) 3 times weekly.
• PO (Children 1 mo — 13 yr): HIV negative — 15–20 mg/kg/day once daily (maximum: 1 g/day) or 50 mg/kg/dose twice weekly (maximum: 2.5 g/dose); HIV-exposed/-infected — 15–25 mg/kg/day once daily (maximum: 2.5 g/day); MAC, secondary prophylaxis, or treatment in HIV-exposed/-infected — 15–25 mg/kg/day once daily (maximum: 2.5 g/day) with clarithromycin (or azithromycin) with or without rifabutin; Nontuberculous mycobacterial infection — 15–25 mg/kg/day once daily (maximum: 2.5 g/day).

• Ethambutol is given as a single daily dose and should be taken at the same time each day. Some regimens require dosing 2–3 times/wk. Usually administered concurrently with other antitubercular medications to prevent development of bacterial resistance.
• PO: Administer with food or milk to minimize GI irritation.
• PO: Tablets may be crushed and mixed with apple juice or apple sauce.

Myambutol

Etibi

Therapeutic Classification: antituberculars

(Generic available)

• Tablets: 100 mg; 400 mg;

(blood levels)

• Mycobacterial studies and susceptibility tests should be performed before and periodically during therapy to detect possible resistance.
• Assess lung sounds and character and amount of sputum periodically during therapy.
• Assessments of visual function should be made frequently during therapy. Advise patient to report blurring of vision, constriction of visual fields, or changes in color perception immediately. Visual impairment, if not identified early, may lead to permanent sight impairment.

• Monitor renal and hepatic functions, CBC, and uric acid levels routinely. Frequently causes elevated uric acid concentrations, which may precipitate an attack of gout.

• Risk for infection (Indications).
• Disturbed sensory perception (Side Effects).

• Instruct patient to take medication as directed. Take missed doses as soon as possible unless almost time for next dose; do not double up on missed doses. A full course of therapy may take mo to yr. Do not discontinue without consulting health care professional, even though symptoms may disappear.
• Advise patient to notify health care professional if pregnancy is suspected.
• Instruct patient to notify health care professional if no improvement is seen in 2–3 wk. Health care professional should also be notified if unexpected weight gain or decreased urine output occurs.
• Emphasize the importance of routine exams to evaluate progress and ophthalmic examinations if signs of optic neuritis occur.

• Resolution of clinical symptoms of tuberculosis.
  • Decrease in acid-fast bacteria in sputum samples.
  • Improvement seen in chest x rays. Therapy for tuberculosis is usually continued for at least 1–2 yr.

NDC Code^*

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0923- Ethambutol Hydrochloride
    • 0555-0923-02- 100 TABLET, FILM COATED in 1 BOTTLE (0555-0923-02)

• 50090- A-S Medication Solutions
  • 50090-0417- Myambutol
    • 50090-0417-2- 98 TABLET, FILM COATED in 1 BOTTLE (50090-0417-2)

• 50090- A-S Medication Solutions
  • 50090-2399- Ethambutol Hydrochloride
    • 50090-2399-0- 100 TABLET, FILM COATED in 1 BOTTLE (50090-2399-0)

• 50090- A-S Medication Solutions
  • 50090-2607- Myambutol
    • 50090-2607-0- 100 TABLET, FILM COATED in 1 BOTTLE (50090-2607-0)

• 50090- A-S Medication Solutions
  • 50090-3948- Ethambutol Hydrochloride
    • 50090-3948-0- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3948-0)

• 54879- STI Pharma LLC
  • 54879-001- Ethambutol Hydrochloride
    • 54879-001-01- 12 CARTON in 1 BOX (54879-001-01) > 12 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE

• 54879- STI Pharma LLC
  • 54879-002- Ethambutol Hydrochloride
    • 54879-002-01- 12 CARTON in 1 BOX (54879-002-01) > 12 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE

• 61748- VersaPharm Inc. - An Akorn Company
  • 61748-011- Ethambutol Hydrochloride
    • 61748-011-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-011-01)

• 61748- VersaPharm Inc. - An Akorn Company
  • 61748-014- Ethambutol Hydrochloride
    • 61748-014-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-01)

• 61748- VersaPharm Inc. - An Akorn Company
  • 61748-014- Ethambutol Hydrochloride
    • 61748-014-06- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-06)

• 61748- VersaPharm Inc. - An Akorn Company
  • 61748-014- Ethambutol Hydrochloride
    • 61748-014-09- 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-09)

• 61748- VersaPharm Inc. - An Akorn Company
  • 61748-014- Ethambutol Hydrochloride
    • 61748-014-10- 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-014-10)

• 61748- VersaPharm Inc. - An Akorn Company
  • 61748-014- Ethambutol Hydrochloride
    • 61748-014-11- 10 BLISTER PACK in 1 CARTON (61748-014-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• 68084- American Health Packaging
  • 68084-280- Ethambutol Hydrochloride
    • 68084-280-01- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-280-01) > 1 TABLET in 1 BLISTER PACK (68084-280-11)

• 68180- Lupin Pharmaceuticals, Inc.
  • 68180-280- Ethambutol Hydrochloride
    • 68180-280-01- 100 TABLET in 1 BOTTLE (68180-280-01)

• 68180- Lupin Pharmaceuticals, Inc.
  • 68180-281- Ethambutol Hydrochloride
    • 68180-281-01- 100 TABLET in 1 BOTTLE (68180-281-01)

• 68180- Lupin Pharmaceuticals, Inc.
  • 68180-281- Ethambutol Hydrochloride
    • 68180-281-02- 500 TABLET in 1 BOTTLE (68180-281-02)

• 68180- Lupin Pharmaceuticals, Inc.
  • 68180-281- Ethambutol Hydrochloride
    • 68180-281-13- 4 BLISTER PACK in 1 CARTON (68180-281-13) > 14 TABLET in 1 BLISTER PACK (68180-281-11)

• 68850- STI Pharma, LLC
  • 68850-010- Myambutol
    • 68850-010-01- 100 TABLET, FILM COATED in 1 BOTTLE (68850-010-01)

• 68850- STI Pharma, LLC
  • 68850-012- Myambutol
    • 68850-012-01- 100 TABLET, FILM COATED in 1 BOTTLE (68850-012-01)

• 68850- STI Pharma, LLC
  • 68850-012- Myambutol
    • 68850-012-02- 10 BLISTER PACK in 1 BOX, UNIT-DOSE (68850-012-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• 70518- REMEDYREPACK INC.
  • 70518-0459- Ethambutol Hydrochloride
    • 70518-0459-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0459-0)

• 70518- REMEDYREPACK INC.
  • 70518-0751- Ethambutol Hydrochloride
    • 70518-0751-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0751-0)