Pronunciation: IP-ra-TROE-pee-um BROE-mide/al-BUE-ter-ol SUL-fate
Class: Anticholinergic

Trade Names

Combivent
- Inhalation aerosol ipratropium bromide 18 mcg/albuterol sulfate 103 mcg per actuation

Combivent Respimat
- Inhalation spray ipratropium bromide 20 mcg/albuterol sulfate 120 mcg per actuation

DuoNeb
- Inhalation solution ipratropium bromide 0.5 mg/albuterol sulfate 3 mg per 3 mL

Combivent Inhalation Solution (Canada)
Gen-Combo Sterinebs (Canada)
ratio-Ipra Sal UDV (Canada)

Pharmacology

Albuterol

Produces bronchodilation by relaxing the bronchial smooth muscle through beta–2 receptor stimulation.

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Ipratropium

Antagonizes action of acetylcholine on the bronchial smooth muscle in the lungs, causing bronchodilation.

Indications and Usage

Treatment of bronchospasm associated with COPD in patients requiring more than 1 bronchodilator.

Contraindications

Hypersensitivity to any component of the product; hypersensitivity to atropine or any of its derivatives; hypersensitivity to soya lecithin or related food products, such as soybeans or peanuts ( Combivent only).

Dosage and Administration

Combivent
Adults

Inhalation 2 inhalations 4 times daily (max, 12 inhalations per 24 h).

Combivent Respimat

1 inhalation 4 times daily (max, 6 inhalations per 24 h).

DuoNeb
Adults

Inhalation One 3 mL vial 4 times daily via nebulization with up to 2 additional 3 mL doses daily, if needed.

General Advice

• For oral inhalation only. Avoid spraying into the nose or eyes. Administer DuoNeb only via nebulizer. Not for injection or oral use.
• Refer to manufacturer's prescribing information for priming of Combivent and Combivent Respimat .

Storage/Stability

Inhalation aerosol/spray

Store at 59° to 86°F. Protect from excessive humidity and freezing. Store pressurized canister with nozzle end down, away from heat or open flame. Do not puncture or discard pressurized canister in incinerator. Discard Combivent Respimat no later than 3 months after first use or when the locking mechanism is engaged, whichever comes first.

Inhalation solution

Store between 36° and 77°F. Protect vials from light.

Drug Interactions

Anticholinergic agents (eg, atropine)

Possible additive anticholinergic effects. Avoid coadministration.

Beta-adrenergic agonists

Risk of adverse CV effects may be increased. Coadminister with caution.

Beta-receptor blocking agents (eg, propranolol)

These agents and albuterol may inhibit the effect of each other. Coadminister with caution.

Digoxin

Albuterol component may decrease serum digoxin concentrations and therapeutic effects. Monitor digoxin serum concentrations and clinical response. Adjust the digoxin dose as needed.

MAOIs (eg, linezolid, phenelzine), tricyclic antidepressants (eg, amitriptyline)

Concomitant use of these agents or use within 2 wk of stopping such agents may potentiate the CV effects of albuterol. Coadminister with extreme caution.

Nonpotassium-sparing diuretics (eg, loop diuretics [eg, furosemide], thiazide diuretics [eg, chlorothiazide])

ECG changes and/or hypokalemia, which may result from administration of nonpotassium-sparing diuretics, can be worsened by albuterol. Although the clinical importance of these effects is not known, coadminister with caution. Monitor potassium concentrations.

Adverse Reactions

Cardiovascular

Angina, arrhythmia, hypertension, hypotension, palpitation, tachycardia (less than 2%); diastolic BP decreased, myocardial ischemia, systolic BP increased (postmarketing).

CNS

Headache (6%); asthenia, dizziness, fatigue, insomnia, nervousness, paresthesia, tremor (less than 2%); coordination difficulty, drowsiness, mental disorder, stimulation (postmarketing).

Dermatologic

Pruritus, rash (less than 2%); alopecia, angioedema, hyperhidrosis, skin reaction (postmarketing).

EENT

Nasopharyngitis, pharyngitis (4%); dysphonia, eye pain (less than 2%); accommodation disorder, acute eye pain, blurred vision, conjunctival hyperemia, corneal edema, dry throat, drying of secretions, halo vision, hoarseness, increased IOP, mucosal ulcers, mydriasis, nasal congestion, ocular irritation, pharyngeal edema, precipitation or worsening of narrow-angle glaucoma, throat irritation (postmarketing).

GI

Diarrhea, nausea (2%); constipation, dry mouth, dyspepsia, taste perversion, vomiting (less than 2%); GI distress, GI motility disorder, mouth edema, stomatitis (postmarketing).

Genitourinary

UTI (2%); dysuria (less than 2%); urinary retention (postmarketing).

Metabolic

Hypokalemia (less than 2%).

Musculoskeletal

Arthralgia, muscle spasm, myalgia (less than 2%); back pain, muscular weakness (postmarketing).

Respiratory

Bronchitis (12%); upper respiratory tract infection (11%); cough, lung disease (6%); dyspnea (5%); respiratory disorders (3%); sinusitis (2%); pharyngolaryngeal pain, wheezing (less than 2%); pneumonia, rhinitis (1%); exacerbation of COPD symptoms, paradoxical bronchospasm (postmarketing).

Miscellaneous

Chest pain, pain (3%); chest discomfort, influenza-like illness (less than 2%); influenza, leg cramps (1%); allergic-type reactions (including anaphylaxis, laryngospasm; angioedema of tongue, lips, and face; skin rash), edema, increased sputum (less than 2%); aching, flushing, heartburn, metabolic acidosis (postmarketing).

Precautions

Monitor Respiratory status Monitor respiratory status. Periodically monitor BP and pulse rate.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hypersensitivity

Immediate hypersensitivity reactions may occur.

Renal Function

Use with caution.

Hepatic Function

Use with caution.

Special Risk Patients

Use with caution in patients with narrow-angle glaucoma, convulsive disorders, hyperthyroidism, diabetes mellitus, prostatic hypertrophy, or bladder neck obstruction, and in patients who are unusually responsive to sympathomimetic amines.

CNS effects

CNS stimulation may occur; use cautiously in patients with history of seizures or hyperthyroidism.

CV effects

Toxic symptoms may occur in patients with CV disorders. Use with caution in patients with coronary insufficiency, arrhythmias, or hypertension.

Diabetes

Dosage adjustment of insulin may be required.

Excessive use

Death may occur with excessive use of inhaled sympathomimetic drugs in patients with asthma.

Hypokalemia

Transient decreases in potassium levels may occur.

Paradoxical bronchospasm

Life-threatening bronchospasms can occur, usually with the first use of a new container.

Overdosage

Symptoms

Angina, arrhythmia, cardiac arrest, dizziness, dry mouth, fatigue, headache, hypertension or hypotension, hypokalemia, insomnia, malaise, nausea, nervousness, palpitations, seizures, tachycardia, tremor.

Patient Information

• Advise patients to continue taking other medications for the same condition as prescribed by their health care provider.
• Advise patients using the nebulizer to read the patients' instructions for use before starting therapy and again with each refill.
• Ensure that patients using inhalation solution can prepare, use, and clean the nebulizer without difficulty.
• Review proper administration technique for patients using inhalation aerosol/spray. Have patients demonstrate technique to ensure effective use of the metered-dose inhaler.
• Instruct patients not to exceed prescribed dose. Advise patients to inform their health care provider if symptoms do not improve or if they worsen, if treatments are needed more often than usual, or if the medication appears to become less effective.
• Instruct patients not to stop the medication once symptoms have been controlled. Continued daily use is necessary to control symptoms.
• Advise patients to carry medical identification (eg, card, bracelet) indicating COPD.
• Caution patients about engaging in activities requiring balance and visual acuity (eg, driving a car, operating appliances or machinery) because dizziness, accommodation disorder, mydriasis, and blurred vision can occur.
• Inform patients to notify their health care provider if they experience changes in vision, difficulty with urination, palpitations, chest pain, rapid heart rate, tremor, or nervousness.
• Inform patients that paradoxical bronchospasm can occur and to discontinue use if this reaction occurs.

Copyright © 2009 Wolters Kluwer Health.