albuterol/ipratropium (Rx)

Brand and Other Names:Combivent Respimat
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

albuterol (base)/ipratropium bromide

aerosol metered-dose inhaler (Combivent Respimat)

  • (100mcg/20mcg)/actuation

nebulizer solution (generic)

  • (2.5mg/0.5mg)/3mL

Chronic Obstructive Pulmonary Disease

Treatment of chronic obstructive pulmonary disease (COPD) in patients on regular bronchodilator who continue to have bronchospasm and require second bronchodilator

Aerosol: 100 mcg/20 mcg (1 actuation of metered-dose inhaler) q6hr; not to exceed 6 actuations/day

Nebulizer solution: 3 mL inhaled q6hr; not to exceed 3 mL q4hr

Dosing Considerations

Patients aged >65 years have higher steady-state systemic exposures for albuterol and ipratropium

Safety and efficacy not established

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Interactions

Interaction Checker

and albuterol/ipratropium

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Bronchitis (2-12%)

            1-10%

            Upper respiratory tract infection (1-10%)

            Lung disease (6%)

            Headache (3-6%)

            Dyspnea (2-5%)

            Nasopharyngitis (4%)

            Cough (3-4%)

            Pharyngitis (2-4%)

            Pain (1-3%)

            Chest pain (2.6%)

            Sinusitis (2.3%)

            Nausea (1-2%)

            Diarrhea (1.8%)

            Urinary tract infection (1.6%)

            Influenza (1.4%)

            Leg cramps (1.4%)

            Nausea (1.4%)

            Pneumonia (1.4%)

            Rhinitis (1.1%)

            <1%

            Allergic-type reactions, such as skin reactions (eg, rash, pruritus, urticaria [including giant urticaria]), angioedema (eg, of tongue, lips, face), laryngospasm, and anaphylaxis

            Angina

            Arrhythmia

            Arthralgia

            Dizziness

            Dry mouth

            Dyspepsia

            Dysphonia

            Edema

            Fatigue

            Hypertension

            Insomnia

            Nervousness

            Palpitation

            Paresthesia

            Tachycardia

            Tremor

            Vomiting

            Postmarketing Reports

            Cardiovascular: Palpitations, hypotension, myocardial infarction, decreased diastolic blood pressure (BP), increased systolic BP

            General: Anaphylactoid reactions, drowsiness, flushing, alopecia, edema, hypokalemia, mental disorder, hyperhidrosis, metabolic acidosis (with albuterol products), asthenia

            Gastrointestinal (GI): Mucosal ulcers, stomatitis, heartburn, distress (diarrhea, nausea, vomiting), GI motility disorder, constipation

            Muscular: Muscle spasms, muscular weakness, myalgia

            Neurologic and psychiatric: Central nervous system (CNS) stimulation, coordination difficulty

            Other: Throat irritation, dry throat, hoarseness

            Renal: Urinary retention

            Respiratory: Bronchospasm (including paradoxical bronchospasm), nasal congestion, drying of secretions, wheezing, exacerbation of COPD symptoms

            Sensory: Mydriasis, precipitation or worsening of narrow-angle glaucoma, glaucoma, increased intraocular pressure (IOP), acute eye pain, halo vision, blurred vision, accommodation disorder, ocular irritation, corneal edema, conjunctival hyperemia

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            Warnings

            Contraindications

            Hypersensitivity to albuterol, ipratropium, atropine and derivatives, soy, or peanut

            Cautions

            Paradoxical bronchospasm; discontinue immediately, and administer alternative therapy

            History of cardiovascular disorders; beta-adrenergic stimulation can result in clinically significant cardiovascular effects, myocardial ischemia, or electrocardiographic (ECG) changes

            Avoid spraying into eyes, and contact physician if visual disturbances (eg, blurred vision or halos) occur; monitor patients with narrow-angle glaucoma

            May produce clinically important hypokalemia leading to adverse cardiovascular effects in some patients

            May cause immediate hypersensitivity reaction (urticaria, angioedema, rash, bronchospasm, anaphylaxis, or oropharyngeal edema); discontinue immediately, and administer alternative therapy

            Use cution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus, prostatic hyperplasia, or bladder-neck obstruction

            May cause dizziness and blurred vision; patients should use caution when performing tasks requiring mental alertness

            Do not exceed recommended dosage; fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma

            Keep out of reach of children

            Avoid freezing

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            Pregnancy & Lactation

            Pregnancy

            There are no randomized clinical studies of the drug combination, or its individual components, ipratropium bromide and albuterol sulfate, in pregnant women; ipratropium is negligibly absorbed systemically following oral inhalation; therefore, maternal use is not expected to result in fetal exposure to drug

            Published literature, including cohort studies, case-control studies and case series, over several decades have not identified drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes with ipratropium bromide

            Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or, miscarriage; there are clinical considerations with use of therapy in pregnant women; animal reproduction studies have not been conducted with drug

            Because of potential for beta-agonist interference with uterine contractility, use of drug for the treatment of COPD during labor should be restricted to those patients in whom the benefits clearly outweigh risk; serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol

            Animal data

            • Animal studies are available with its individual components, ipratropium bromide and albuterol sulfate
            • Based on oral reproduction studies, no evidence of structural alterations was observed when ipratropium bromide was administered to pregnant mice, rats, and rabbits during organogenesis at doses approximately 340, 68,000 and 17,000 times, respectively, the maximum recommended human daily inhalation dose (MRHDID) in adults on a mg/m2 basis
            • When albuterol was administered to pregnant mice during organogenesis there was evidence of cleft palate at doses approximately equivalent to maximum recommended human daily inhalation

            Lactation

            There are no available data on presence of drug, or components, ipratropium bromide or albuterol, in human milk, effects on breastfed infant, or on milk production; although lipid-insoluble quaternary cations pass into breast milk, ipratropium concentrations in plasma after inhaled therapeutic doses are low

            Plasma levels of albuterol after inhaled therapeutic doses are low in humans; therefore, ipratropium and albuterol concentrations in human breast milk are likely to be correspondingly low; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for albuterol and any potential adverse effects on breastfed child from albuterol or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Albuterol: Beta2-adrenergic bronchodilator

            Ipratropium: Anticholinergic (parasympatholytic) agent; inhibits vagally mediated reflexes by antagonizing acetylcholine action; prevents increase in intracellular calcium concentration caused by interaction of acetylcholine with muscarinic receptors on bronchial smooth muscle

            Absorption

            Peak plasma time: Albuterol, 3 hr (from portion swallowed)

            Peak plasma concentration: Albuterol, 419-802 pg/mL (from portion swallowed)

            Distribution

            Protein bound: Ipratropium, 0-9%

            Metabolism

            Albuterol: Conjugatively metabolized to albuterol 4'-O-sulfate

            Ipratropium: Partially metabolized to inactive ester hydrolysis products

            Elimination

            Half-life: Albuterol, 3.6 hr (after 30-min infusion of 1.5 mg); ipratropium, 2 hr (after inhalation or IV administration)

            Mean clearance: Albuterol, 439 mL/min/1.73 m²

            Excretion: Albuterol, urine (27%); ipratropium, urine (4%)

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            Administration

            Instructions

            See individual package inserts for instructions on use

            Avoid freezing

            Aerosol metered-dose inhalers

            • Insert cartridge into metered-dose inhaler, and prime unit before initial use; actuate inhaler toward ground until aerosol cloud is visible, then repeat 3 more times
            • If inhaler has not been used for >3 days, actuate it once before using it again
            • If inhaler has not been used for ≥21 days, repeat priming process for initial use (ie, actuate until aerosol cloud is observed, then repeat 3 more times)

            Nebulizer solution

            • Administer via jet nebulizer connected to air compressor with adequate air flow
            • Equip with mouthpiece or suitable air mask
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.