bisoprolol

REMS

Hypertension.

Contraindicated in:

Uncompensated HF;
Pulmonary edema;
Cardiogenic shock;
Bradycardia or heart block.

Use Cautiously in:

Renal impairment (dosage ↓ recommended);
Hepatic impairment (dosage ↓ recommended);
Pulmonary disease (including asthma; beta₁ selectivity may be lost at higher doses); avoid use if possible;
Diabetes mellitus (may mask signs of hypoglycemia);
Thyrotoxicosis (may mask symptoms);
History of severe allergic reactions (intensity of reactions may be ↑);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may have ↑ sensitivity to beta blockers (initial dosage ↓ recommended).

CV: BRADYCARDIA, HF, hypotension, peripheral vasoconstriction

Derm: rash

EENT: blurred vision, stuffy nose

Endo: hyperglycemia, hypoglycemia

GI: ↑liver enzymes, constipation, diarrhea, nausea, vomiting

GU: erectile dysfunction, ↓libido, urinary frequency

MS: arthralgia, back pain, joint pain

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

Resp: bronchospasm, PULMONARY EDEMA, wheezing

Misc: drug-induced lupus syndrome

Drug-drug:

General anesthetics, phenytoin, and verapamil may cause additive myocardial depression.
Additive bradycardia may occur with clonidine, digoxin, diltiazem, ivabradine, or verapamil.
Additive hypotension may occur with other antihypertensives, acute ingestion of alcohol, or nitrates.
Concurrent use with amphetamine, cocaine, ephedrine, epinephrine, norepinephrine, phenylephrine, or pseudoephedrine may result in unopposed alpha-adrenergic stimulation (excessive hypertension, bradycardia).
Concurrent thyroid preparation administration may ↓ effectiveness.
May alter the effectiveness of insulins or oral hypoglycemic agents (dose adjustments may be necessary).
May ↓ the effectiveness of theophylline.
May ↓ the beta₁-cardiovascular effects of dopamine or dobutamine.
Use cautiously within 14 days of MAO inhibitor therapy (may result in hypertension).

(Generic available)

Tablets: 5 mg; 10 mg
In combination with: hydrochlorothiazide (Ziac). See Appendix [not included in this PDA edition].

PO (Adults ): 5 mg once daily, may be ↑ to 10 mg once daily (range 2.5–20 mg/day).

Renal Impairment

PO (Adults ): CCr <40 mL/min: Initiate therapy with 2.5 mg/day, titrate cautiously.

Hepatic Impairment

PO (Adults ): Hepatitis/Cirrhosis: Initiate therapy with 2.5 mg/day, titrate cautiously.

Blocks stimulation of beta₁(myocardial)-adrenergic receptors. Does not usually affect beta₂(pulmonary, vascular, uterine)-receptor sites.

Therapeutic effects:

Decreased BP and heart rate.

Therapeutic Classification: antihypertensives

Pharmacologic Classification: beta blockers

Absorption: Well absorbed after oral administration, but 20% undergoes first-pass hepatic metabolism.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: 50% excreted unchanged by the kidneys; remainder renally excreted as metabolites; 2% excreted in feces.

Half-Life: 9–12 hr.

(antihypertensive effect)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–4 hr	24 hr

Instruct patient to take medication exactly as directed, at the same time each day, even if feeling well; do not skip or double up on missed doses. If a dose is missed, it should be taken as soon as possible up to 4 hr before next dose. Abrupt withdrawal may precipitate life-threatening arrhythmias, hypertension, or myocardial ischemia.
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. Caution patients to avoid driving or other activities that require alertness until response to the drug is known.
Advise patients to change positions slowly to minimize orthostatic hypotension.
Caution patient that this medication may increase sensitivity to cold.
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.
Diabetics should closely monitor blood glucose, especially if weakness, malaise, irritability, or fatigue occurs. Medication does not block dizziness or sweating as signs of hypoglycemia.
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 before treatment or surgery.
Advise patient to carry identification describing disease process and medication regimen at all times.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
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). Medication controls but does not cure hypertension.

NDC Code

0185- Eon Labs, Inc.
- 0185-0771- bisoprolol fumarate
  - 0185-0771-01- 100 TABLET, COATED in 1 BOTTLE (0185-0771-01)

0185- Eon Labs, Inc.
- 0185-0771- bisoprolol fumarate
  - 0185-0771-30- 30 TABLET, COATED in 1 BOTTLE (0185-0771-30)

0185- Eon Labs, Inc.
- 0185-0774- bisoprolol fumarate
  - 0185-0774-01- 100 TABLET, COATED in 1 BOTTLE (0185-0774-01)

0185- Eon Labs, Inc.
- 0185-0774- bisoprolol fumarate
  - 0185-0774-30- 30 TABLET, COATED in 1 BOTTLE (0185-0774-30)

0378- Mylan Pharmaceuticals Inc.
- 0378-0523- Bisoprolol Fumarate
  - 0378-0523-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0523-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0523- Bisoprolol Fumarate
  - 0378-0523-93- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0523-93)

0378- Mylan Pharmaceuticals Inc.
- 0378-0524- Bisoprolol Fumarate
  - 0378-0524-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0524-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0524- Bisoprolol Fumarate
  - 0378-0524-93- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0524-93)

15955- ORIT LABORATORIES LLC
- 15955-373- BISOPROLOL FUMARATE
  - 15955-373-30- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-373-30)

15955- ORIT LABORATORIES LLC
- 15955-373- BISOPROLOL FUMARATE
  - 15955-373-50- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-373-50)

15955- ORIT LABORATORIES LLC
- 15955-374- BISOPROLOL FUMARATE
  - 15955-374-30- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-374-30)

15955- ORIT LABORATORIES LLC
- 15955-374- BISOPROLOL FUMARATE
  - 15955-374-50- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-374-50)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-126- Bisoprolol Fumarate
  - 29300-126-01- 100 TABLET in 1 BOTTLE, PLASTIC (29300-126-01)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-126- Bisoprolol Fumarate
  - 29300-126-05- 500 TABLET in 1 BOTTLE, PLASTIC (29300-126-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-126- Bisoprolol Fumarate
  - 29300-126-13- 30 TABLET in 1 BOTTLE, PLASTIC (29300-126-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-127- Bisoprolol Fumarate
  - 29300-127-01- 100 TABLET in 1 BOTTLE, PLASTIC (29300-127-01)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-127- Bisoprolol Fumarate
  - 29300-127-05- 500 TABLET in 1 BOTTLE, PLASTIC (29300-127-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-127- Bisoprolol Fumarate
  - 29300-127-13- 30 TABLET in 1 BOTTLE, PLASTIC (29300-127-13)

52817- TruPharma, LLC
- 52817-270- Bisoprolol
  - 52817-270-10- 100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10)

52817- TruPharma, LLC
- 52817-270- Bisoprolol
  - 52817-270-30- 30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30)

52817- TruPharma, LLC
- 52817-271- Bisoprolol
  - 52817-271-10- 100 TABLET, FILM COATED in 1 BOTTLE (52817-271-10)

52817- TruPharma, LLC
- 52817-271- Bisoprolol
  - 52817-271-30- 30 TABLET, FILM COATED in 1 BOTTLE (52817-271-30)

61919- DIRECTRX
- 61919-787- BISOPROLOL FUMARATE
  - 61919-787-90- 90 TABLET in 1 BOTTLE (61919-787-90)

63187- Proficient Rx LP
- 63187-871- Bisoprolol Fumarate
  - 63187-871-30- 30 TABLET in 1 BOTTLE, PLASTIC (63187-871-30)

63187- Proficient Rx LP
- 63187-871- Bisoprolol Fumarate
  - 63187-871-60- 60 TABLET in 1 BOTTLE, PLASTIC (63187-871-60)

63187- Proficient Rx LP
- 63187-871- Bisoprolol Fumarate
  - 63187-871-90- 90 TABLET in 1 BOTTLE, PLASTIC (63187-871-90)

65862- Aurobindo Pharma Limited
- 65862-086- Bisoprolol Fumarate
  - 65862-086-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-086-01)

65862- Aurobindo Pharma Limited
- 65862-086- Bisoprolol Fumarate
  - 65862-086-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-086-30)

65862- Aurobindo Pharma Limited
- 65862-087- Bisoprolol Fumarate
  - 65862-087-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-087-01)

65862- Aurobindo Pharma Limited
- 65862-087- Bisoprolol Fumarate
  - 65862-087-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-087-30)

68071- NuCare Pharmaceuticals,Inc.
- 68071-1582- Bisoprolol Fumarate
  - 68071-1582-3- 30 TABLET in 1 BOTTLE (68071-1582-3)

68071- NuCare Pharmaceuticals,Inc.
- 68071-5097- Bisoprolol
  - 68071-5097-3- 30 TABLET, FILM COATED in 1 BOTTLE (68071-5097-3)

68788- Preferred Pharmaceuticals, Inc.
- 68788-6775- Bisoprolol Fumarate
  - 68788-6775-1- 100 TABLET in 1 BOTTLE, PLASTIC (68788-6775-1)

68788- Preferred Pharmaceuticals, Inc.
- 68788-6775- Bisoprolol Fumarate
  - 68788-6775-3- 30 TABLET in 1 BOTTLE, PLASTIC (68788-6775-3)

68788- Preferred Pharmaceuticals, Inc.
- 68788-6775- Bisoprolol Fumarate
  - 68788-6775-6- 60 TABLET in 1 BOTTLE, PLASTIC (68788-6775-6)

68788- Preferred Pharmaceuticals, Inc.
- 68788-6775- Bisoprolol Fumarate
  - 68788-6775-9- 90 TABLET in 1 BOTTLE, PLASTIC (68788-6775-9)

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

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