acebutolol

Absorption: Well absorbed following oral administration but rapidly undergoes metabolism.

Distribution: Minimal penetration of the CNS. Crosses the placenta and enters breast milk in small amounts.

Metabolism/Excretion: Mostly metabolized to diacetolol, which is also a beta blocker.

Half-Life: 3–4 hr (8–13 hr for diacetolol).

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO (effect on BP)	1–1.5 hr	2–8 hr	12–24 hr
PO (antiarrhythmic)	1 hr	4–6 hr	up to 10 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Uncompensated HF;
Pulmonary edema;
Cardiogenic shock;
Bradycardia or heart block;
Obstructive airway disease including asthma;
Lactation: Lactation.

Use Cautiously in:

Renal or hepatic impairment (↓ dosage if CCr <50 mL/min/1.73 m²);
Thyrotoxicosis (may mask symptoms);
Diabetes mellitus (may mask symptoms of hypoglycemia);
History of severe allergic reactions (intensity of reactions may be ↑);
OB: Use during pregnancy may result in neonates with reduced birth weight, hypotension, and bradycardia; use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may have sensitivity to adverse reactions.

Adv. Reactions/Side Effects ⬆ ⬇

CV: HF, BRADYCARDIA, hypotension, PULMONARY EDEMA

Derm: rash

EENT: blurred vision, stuffy nose

Endo: hyperglycemia, hypoglycemia

GI: constipation, diarrhea, nausea, vomiting

GU: erectile dysfunction, ↓libido, urinary frequency

MS: arthralgia, joint pain

Neuro: fatigue, weakness, anxiety, depression, dizziness, drowsiness, insomnia, memory loss, nervousness, nightmares

Resp: bronchospasm, wheezing

Misc: drug-induced lupus syndrome

Interactions ⬆ ⬇

Drug-drug:

General anesthetics, IV phenytoin, and verapamil may cause additive myocardial depression.
↑risk of bradycardia when used with digoxin, verapamil, diltiazem, or clonidine.
Antihypertensives, acute ingestion of alcohol, or nitrates may cause additive hypotension.
Use with epinephrine may result in unopposed alpha-adrenergic stimulation.
Concurrent use with thyroid preparations may ↓ effectiveness.
Concurrent use with insulin may result in prolonged hypoglycemia.
May ↓ effectiveness of theophylline.

Route/Dosage ⬆ ⬇

PO (Adults ): 400–800 mg/day in 1–2 divided doses (may ↑ up to 1200 mg/day; max = 800 mg/day in older adults).

Renal Impairment

PO (Adults ): CCr 26–50 mL/min/1.73 m²: ↓dose by 50%. CCr <25 mL/min/1.73 m²: ↓dose by 75%.

Availability ⬆ ⬇

(Generic available)

Capsules: 200 mg; 400 mg
Tablets: 100 mg; 200 mg; 400 mg

Assessment ⬆ ⬇

Monitor BP, ECG, and pulse frequently during dose adjustment period and periodically during therapy.
Assess routinely for signs and symptoms of HF (dyspnea, rales/crackles, weight gain, peripheral edema, jugular venous distention). Monitor intake and output ratios and daily weights.
Monitor frequency of prescription refills to determine compliance.

Lab Test Considerations:

May cause increased BUN, serum lipoprotein, potassium, triglyceride, and uric acid levels.
- May cause increased serum alkaline phosphatase, LDH, AST, and ALT levels.
- May cause increased ANA titers.
- May cause increase in blood glucose levels.

Implementation ⬆ ⬇

PO: Take apical pulse prior to administering. If <50 bpm or if arrhythmia occurs, withhold medication and health care professional.
- May be administered with food or on an empty stomach.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed, at the same time each day, even if feeling well; do not skip or double up on missed doses. Take missed doses as soon as possible up to 4 hr before next dose. Abrupt withdrawal may precipitate life-threatening arrhythmias, hypertension, or myocardial ischemia.Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any Rx, OTC, or herbal products, especially cold preparations, concurrently with this medication. Patients on antihypertensive therapy should also avoid excessive amounts of coffee, tea, and cola.
- Advise patient to make sure enough medication is available for weekends, holidays, and vacations. A written prescription may be kept in wallet in case of emergency.
- Teach patient and family how to check pulse and BP. Instruct them to check pulse daily and BP biweekly and to report significant changes to health care professional.
- May cause drowsiness or dizziness. Caution patients to avoid driving or other activities that require alertness until response to the drug is known.
- Caution patient that this medication may increase sensitivity to cold.
- Caution diabetic patients to closely monitor blood glucose, especially if weakness, malaise, irritability, or fatigue occurs. May mask tachycardia and BP changes as signs of hypoglycemia, but dizziness and sweating may still occur.
- Advise patient to notify health care professional if slow pulse, difficulty breathing, wheezing, cold hands and feet, dizziness, light-headedness, confusion, depression, rash, fever, sore throat, unusual bleeding, or bruising occurs.
- Instruct patient to inform health care professional of medication regimen prior to treatment or surgery.
- Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.
- Advise patient to carry identification describing disease process and medication regimen at all times.
Hypertension: Reinforce the need to continue additional therapies for hypertension (weight loss, sodium restriction, stress reduction, regular exercise, moderation of alcohol consumption, and smoking cessation). Acebutolol controls but does not cure hypertension.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in BP.
Decreased heart rate.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-1200- Acebutolol Hydrochloride
  - 0378-1200-01- 100 CAPSULE in 1 BOTTLE (0378-1200-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-1400- Acebutolol Hydrochloride
  - 0378-1400-01- 100 CAPSULE in 1 BOTTLE (0378-1400-01)

42291- AvKARE, Inc.
- 42291-101- Acebutolol Hydrochloride
  - 42291-101-90- 90 CAPSULE in 1 BOTTLE (42291-101-90)

50268- AvPAK
- 50268-050- Acebutolol Hydrochloride
  - 50268-050-15- 50 BLISTER PACK in 1 BOX (50268-050-15) > 1 CAPSULE in 1 BLISTER PACK (50268-050-11)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-669- Acebutolol Hydrochloride
  - 53746-669-01- 100 CAPSULE in 1 BOTTLE (53746-669-01)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-669- Acebutolol Hydrochloride
  - 53746-669-05- 500 CAPSULE in 1 BOTTLE (53746-669-05)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-670- Acebutolol Hydrochloride
  - 53746-670-01- 100 CAPSULE in 1 BOTTLE (53746-670-01)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-670- Acebutolol Hydrochloride
  - 53746-670-05- 500 CAPSULE in 1 BOTTLE (53746-670-05)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-670- Acebutolol Hydrochloride
  - 53746-670-30- 30 CAPSULE in 1 BOTTLE (53746-670-30)

65162- Amneal Pharmaceuticals LLC
- 65162-669- Acebutolol Hydrochloride
  - 65162-669-10- 100 CAPSULE in 1 BOTTLE (65162-669-10)

65162- Amneal Pharmaceuticals LLC
- 65162-669- Acebutolol Hydrochloride
  - 65162-669-50- 500 CAPSULE in 1 BOTTLE (65162-669-50)

65162- Amneal Pharmaceuticals LLC
- 65162-670- Acebutolol Hydrochloride
  - 65162-670-03- 30 CAPSULE in 1 BOTTLE (65162-670-03)

65162- Amneal Pharmaceuticals LLC
- 65162-670- Acebutolol Hydrochloride
  - 65162-670-10- 100 CAPSULE in 1 BOTTLE (65162-670-10)

65162- Amneal Pharmaceuticals LLC
- 65162-670- Acebutolol Hydrochloride
  - 65162-670-50- 500 CAPSULE in 1 BOTTLE (65162-670-50)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇