ethambutol

Contraindicated in:

Hypersensitivity;
Optic neuritis.

Use Cautiously in:

Renal impairment (↓ dose);
Severe hepatic impairment (↓ dose);
OB: Although safety not established, ethambutol has been used with isoniazid in pregnant women without fetal adverse effects;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

Adv. Reactions/Side Effects ⬆ ⬇

EENT: optic neuritis

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

Metab: hyperuricemia

MS: joint pain

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

Resp: pulmonary infiltrates

Misc: anaphylactoid reactions, fever

Interactions ⬆ ⬇

Drug-drug:

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

Availability ⬆ ⬇

(Generic available)

Tablets: 100 mg; 400 mg

Route/Dosage ⬆ ⬇

PO (Adults and Children >13 yr): 15–25 mg/kg/day (max = 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 (max = 1 g/day) or 50 mg/kg/dose twice weekly (max = 2.5 g/dose); HIV-exposed/-infected: 15–25 mg/kg/day once daily (max = 2.5 g/day); MAC, secondary prophylaxis, or treatment in HIV-exposed/-infected: 15–25 mg/kg/day once daily (max = 2.5 g/day) with clarithromycin (or azithromycin) with or without rifabutin; Nontuberculous mycobacterial infection: 15–25 mg/kg/day once daily (max = 2.5 g/day).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits the growth of mycobacteria.

Therapeutic effects:

Tuberculostatic effect against susceptible organisms.

Classifications ⬆ ⬇

Therapeutic Classification: antituberculars

Pharmacokinetics ⬆ ⬇

Absorption: 80% absorbed following oral administration.

Distribution: Widely distributed to tissues; crosses blood-brain barrier in small amounts.

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

Half-Life: 3.3 hr (↑ in renal or hepatic impairment).

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	2–4 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of ethambutol. Instruct patient to take as directed without regard to food, but food or milk may prevent GI upset. 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 read Patient Information before starting and with each Rx refill in case of changes.
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 ↓ urine output occurs.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests will be needed. Emphasize the importance of routine ophthalmic examinations, especially if signs of optic neuritis occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. Advise patient to avoid aluminum hydroxide-containing antacids within 4 hr of taking ethambutol; may ↓ absorption.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

42806- Epic Pharma, LLC
- 42806-101- ETHAMBUTOL HYDROCHLORIDE
  - 42806-101-01- 100 TABLET, FILM COATED in 1 BOTTLE (42806-101-01)

42806- Epic Pharma, LLC
- 42806-102- ETHAMBUTOL HYDROCHLORIDE
  - 42806-102-01- 100 TABLET, FILM COATED in 1 BOTTLE (42806-102-01)

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

60592- Kalchem International inc
- 60592-243-
  - 60592-243-10- 1000 g in 1 BOTTLE (60592-243-10)

65691- Cadila Pharmaceuticals Limited
- 65691-0014-
  - 65691-0014-1- 25 kg in 1 DRUM (65691-0014-1)

66406- Patheon Inc.
- 66406-0224-
  - 66406-0224-0- 18215 TABLET, FILM COATED in 1 CONTAINER (66406-0224-0)

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)

70518- REMEDYREPACK INC.
- 70518-2966- Ethambutol Hydrochloride
  - 70518-2966-0- 30 TABLET in 1 BLISTER PACK (70518-2966-0)

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Indications ⬇

Contraind./Precautions ⬆ ⬇