Alupent

Generic Name: Metaproterenol Sulfate
Class: Selective beta-2-Adrenergic Agonists
VA Class: RE102
CAS Number: 5874-97-5

Introduction

Bronchodilator; less selective than relatively selective β₂-adrenergic agonists (e.g., albuterol).^{b c f h i j k}

Uses for Alupent

Bronchospasm in Asthma

Symptomatic management of bronchospasm in patients with reversible, obstructive airway disease (e.g., asthma).^{146 c g} Manufacturer recommends against use with other β-adrenergic bronchodilators.^{c f} (See Specific Drugs under Interactions.)

Current asthma management guidelines and most clinicians recommend anti-inflammatory therapy with an orally inhaled corticosteroid as first-line therapy for long-term control of persistent asthma, supplemented by intermittent, as-needed use of a short-acting, inhaled β₂-agonist.^{j o}

The National Asthma Education and Prevention Program (NAEPP) does not recommend nonselective β-adrenergic agonists, including metaproterenol,^{j k} for treatment of asthma because of the associated potential for excessive cardiac stimulation, particularly in high doses.^j

Bronchospasm in COPD

Symptomatic management of reversible bronchospasm in patients with COPD, including chronic bronchitis and emphysema.¹⁴⁶ Manufacturer recommends against use with other β-adrenergic bronchodilators.^{c f} (See Specific Drugs under Interactions.)

Alupent Dosage and Administration

General

• 
  

  Adjust dosage carefully according to individual requirements and response.^{146 c f g}

  
  

Administration

Administer orally^{146 f} or by oral inhalation via metered-dose inhaler or nebulizer.^{145 c}

Oral Inhalation

Metered-dose Inhaler

Oral inhalation aerosol delivers approximately 0.65 mg from mouthpiece per metered spray; 7-g or 14-g canister delivers 100 or 200 metered sprays, respectively.^c

Administer inhalation aerosol only with actuator provided by manufacturer.^d

Shake the inhaler well before use.^d

Avoid spraying aerosol into eyes.^d

Place the mouthpiece of the inhaler well into the mouth with lips closed around it.^d Exhale through nose as completely as possible.^d Inhale slowly and deeply through mouth.^d Actuate aerosol inhaler, hold breath for few seconds, withdraw mouthpiece, and exhale slowly.^d

Allow ≥2 minutes to elapse between inhalations from aerosol inhaler.^d

Clean inhalation aerosol inhaler by removing metal canister and running warm water through plastic mouthpiece.^d If soap used, rinse thoroughly with plain water.^d

Dosage

Available as metaproterenol sulfate; dosage expressed in terms of metaproterenol sulfate.^{145 c f}

Pediatric Patients

Bronchospasm in Asthma

Oral

Oral solution in children <6 years of age (limited experience): 1.3–2.6 mg/kg daily.^f

Oral solution in children 6–9 years of age or those weighing <27.3 kg: Usually, 10 mg 3 or 4 times daily.^f

Conventional tablets in children 6–9 years of age or those weighing <27.3 kg: Usually, 10 mg 3 or 4 times daily.¹⁴⁶

Oral solution in children >9 years of age or those weighing >27.3 kg: Usually, 20 mg 3 or 4 times daily.^f

Conventional tablets in children >9 years of age or those weighing >27.3 kg: Usually, 20 mg 3 or 4 times daily.¹⁴⁶

Oral Inhalation

Inhalation aerosol in children ≥12 years of age: 1.3 or 1.95 mg (2 or 3 inhalations).^c Usually no need to repeat dosing more often than every 3–4 hours.^{c d} If necessary, additional inhalations may be used, with dosage not exceeding 7.8 mg (12 inhalations) in any 24-hour period.^{c d}

0.4 or 0.6% inhalation solution for nebulization in children ≥12 years of age: 10 or 15 mg (contents of 1 vial of 0.4 or 0.6% solution for nebulization, respectively) 3 or 4 times daily.¹⁴⁵ Usually no need to repeat dosing more often than every 4 hours.^{145 g}

Adults

Bronchospasm in Asthma

Oral

Usually, 20 mg 3 or 4 times daily.^{146 f}

Oral Inhalation

Inhalation aerosol: 1.3 or 1.95 mg (2 or 3 inhalations).^c Usually no need to repeat dosing more often than every 3–4 hours.^d If necessary, additional inhalations may be used, with dosage not exceeding 7.8 mg (12 inhalations) in any 24-hour period.^{c d}

0.4 or 0.6% inhalation solution for nebulization: 10 or 15 mg (contents of 1 vial of 0.4 or 0.6% solution for nebulization, respectively) 3 or 4 times daily.¹⁴⁵ Usually no need to repeat dosing more often than every 4 hours.^{145 g}

Bronchospasm in COPD

Oral Inhalation

Inhalation aerosol: 1.3 or 1.95 mg (2 or 3 inhalations).^c Usually no need to repeat dosing more often than every 3–4 hours.^d If necessary, additional inhalations may be used, with dosage not exceeding 7.8 mg (12 inhalations) in any 24-hour period.^{c d}

0.4 or 0.6% inhalation solution for nebulization: 10 or 15 mg (contents of 1 vial of 0.4 or 0.6% solution for nebulization, respectively) 3 or 4 times daily.¹⁴⁵ Usually no need to repeat dosing more often than every 4 hours.^{145 g}

Prescribing Limits

Pediatric Patients

Bronchospasm

Asthma

Oral Inhalation

Inhalation aerosol in children ≥12 years of age: Maximum ≤7.8 mg (≤12 inhalations) total daily dosage.^c

Adults

Bronchospasm in Asthma

Oral Inhalation

Inhalation aerosol: Maximum ≤7.8 mg (≤12 inhalations) total daily dosage.^d

Bronchospasm in COPD

Oral Inhalation

Inhalation aerosol: Maximum ≤7.8 mg (≤12 inhalations) total daily dosage.^d

Cautions for Alupent

Contraindications

Arrhythmias associated with tachycardia.^{145 146 c f}

Known hypersensitivity to metaproterenol or any ingredients in formulation.^{145 146 c f}

Warnings/Precautions

Warnings

Acute or Worsening Asthma

Oral inhalation therapy intended for acute symptomatic relief of bronchospasm.^{126 134 135}

Failure to respond to previously effective dosage of metaproterenol may indicate seriously worsening asthma.^{112 126 134 135} Contact a clinician if control of mild asthma deteriorates. Reevaluate asthma therapy and institute alternative regimens or therapy.^{112 126 134 135}

Excessive Doses

Fatalities have been associated with excessive use of inhaled sympathomimetic drugs; cardiac arrest occurred in several cases.^{145 c}

Paradoxical Bronchospasm

Possible life-threatening, acute paradoxical bronchospasm.^{b c} Occasionally occurs after repeated or excessive use of orally inhaled sympathomimetic amines.^{b g}

Discontinue therapy immediately if bronchoconstriction occurs and institute alternative therapy.^{b c}

Cardiovascular Effects

Possible clinically important cardiovascular effects, including cardiac arrhythmias (e.g., tachycardia), changes in BP, and related symptoms.^{146 b c f}

Cautious use recommended in patients with cardiovascular disorders (e.g., ischemic heart disease, CAD, cardiac arrhythmias, hypertension, CHF).^{145 146 c f}

Sensitivity Reactions

Rarely, immediate hypersensitivity reactions can occur.^{c f}

Possible acute bronchospasm.^{b c} (See Paradoxical Bronchospasm under Cautions.)

General Precautions

Nervous System Effects

In high doses, possible CNS stimulation.^b

Cautious use recommended in patients with seizure disorders and those with sensitivity to sympathomimetic amines.^{146 c}

Metabolic Effects

Possible hypokalemia, which may increase risk of adverse cardiovascular effects.^{k l m}

Cautious use recommended in patients with diabetes mellitus or hyperthyroidism.^{145 146 c f}

Specific Populations

Pregnancy

Category C.^{c f g}

Lactation

Not known whether metaproterenol is distributed into milk.^{c f g} With oral inhalation solution, use caution.^g Administer oral solution or inhalation aerosol to nursing women only if potential benefits to the woman outweigh the possible risk to infant.^{c f}

Pediatric Use

Safety and efficacy of oral inhalation aerosol or solution for nebulization not established in children <12 years of age.^{c g}

Safety and efficacy of oral tablets not established in children <6 years of age.^{146 b} Safety and efficacy of oral solution demonstrated in limited number of pediatric patients <6 years of age.^f

Common Adverse Effects

Inhalation aerosol: Nervousness, ^c headache,^c dizziness,^c palpitations,^c GI distress,^c tremor,^c throat irritation,^c nausea,^c vomiting,^c cough,^c asthma exacerbation.^c

Inhalation solution: Nervousness,^g tachycardia,^g tremor,^g nausea.^g

Oral tablets: Nervousness,¹⁴⁶ tachycardia,¹⁴⁶ tremor,¹⁴⁶ headache,¹⁴⁶ palpitations,¹⁴⁶ nausea,¹⁴⁶ GI distress,¹⁴⁶ dizziness,¹⁴⁶ asthma exacerbation, ¹⁴⁶ insomnia,¹⁴⁶ fatigue,¹⁴⁶ diarrhea,¹⁴⁶ bad taste,¹⁴⁶ vomiting,¹⁴⁶ drowsiness,¹⁴⁶ syncope,¹⁴⁶ hypertension,¹⁴⁶ pruritus,¹⁴⁶ appetite changes,¹⁴⁶ dry throat,¹⁴⁶ fever.¹⁴⁶

Oral solution: Tachycardia,^f nervousness,^f tremor,^f nausea,^f headache.^f

Interactions for Alupent

Specific Drugs

Drug	Interaction	Comments
Antidepressants, tricyclic	Increased effect on vascular system146 c f	Use caution146 c f
β-Adrenergic blocking agents	Antagonism of pulmonary effects, bronchospasmb n	If concomitant use necessary, use cardioselective β-adrenergic blocker without intrinsic sympathomimetic activity (e.g., metoprolol, atenolol, esmolol); use low dosages initially and titrate upward with cautionn
MAO inhibitors	Increased effect on vascular system 146 c f	Use caution146 c f
Methylxanthine derivatives	Pharmacokinetic interaction unlikelye Potential for increased cardiotoxic effects (e.g., arrhythmias)100 101 102 146 c g
Sympathomimetic agents	Additive effects and possible toxicityb c f	Concomitant use not recommendedc f Exercise extreme care and allow sufficient time to elapse prior to administration of another sympathomimetic agent146 c (See Duration under Pharmacokinetics)

Alupent Pharmacokinetics

Absorption

Bioavailability

Oral bioavailability about 10%.^{f h}

Onset

Oral inhalation aerosol: ≤1 minute.^b

Oral: ≤15–30 minutes.^{146 b}

Oral inhalation solution: ≤5–30 minutes.^{b g}

Oral or oral inhalation: Peak effect ≤1 hour.^b

Duration

Oral: ≤4 hours for oral solution and ≥4 hours for tablets.^{146 f}

Oral inhalation aerosol: About 1–2.5 hours.^c

Oral inhalation solution: 4–6 hours.^g

Bronchodilating effect of metaproterenol persists for ≥1 hour longer than that of equipotent doses of isoproterenol.^b

Distribution

Extent

Not known if metaproterenol is distributed into milk.^c

Plasma Protein Binding

Approximately 10–15%.ⁱ

Elimination

Metabolism

Following oral administration, extensively metabolized in GI tract to sulfate conjugate.^{c i} Following oral inhalation, may be excreted as glucuronic acid conjugates.^{145 147}

Elimination Route

Oral: Excreted in urine (approximately 40%) mostly as sulfate metabolite.^{147 f i}

Half-life

Biphasic: Terminal half-life 1.5–6 hours.^{h i}

Stability

Storage

Oral

Solution and Tablets

Tight, light-resistant containers at 15–30°C.^{146 f} Protect from moisture.¹⁴⁶

Oral Inhalation

Oral inhalation aerosol: 15–25°C; avoid excessive humidity.^c

Oral inhalation solution: ≤25°C.¹⁴⁵ Discard solution if pinkish or darker than slightly yellow in color or if it contains a precipitate.^g

ActionsActions

• 
  

  Stimulates β-adrenergic receptors with little or no effect on α-adrenergic receptors.^b

  
  


• 
  

  Less selectivity for β₂-receptors than albuterol.^{b j} More selectivity for β₂-receptors than isoproterenol.^{c f i}

  
  


• 
  

  Stimulates the production of cyclic adenosine-3′,5′-monophosphate (cAMP),^{146 b f} which mediates bronchial smooth muscle relaxation and inhibition of release of proinflammatory mediators from mast cells in airways.^{146 b c f}

  
  


• 
  

  Decreases airway resistance.^{c f g}

  
  


• 
  

  In high doses, may cause CNS stimulation and some cardiostimulatory effects, which may result in tachycardia and hypertension.^b

  
  


• 
  

  Possible development of tolerance to bronchodilatory effects with prolonged therapy exceeding recommended dosages.^b

  
  

Advice to Patients

• 
  

  Importance of adherence to dosing schedules of metaproterenol and concomitant therapy, including not exceeding recommended dosage or frequency of use unless otherwise instructed by a clinician.^{b f}

  
  


• 
  

  Importance of using extreme care when considering administration of additional sympathomimetic agents.^f Importance of allowing a sufficient interval of time to elapse before administering another sympathomimetic agent.^f (See Specific Drugs under Interactions.)

  
  


• 
  

  Importance of contacting clinician if asthmatic symptoms worsen or adverse reactions or diminished response occurs with usual dosage;^{b f g} do not increase dose or frequency of administration.^{c f}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^c

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^c

  
  


• 
  

  Importance of advising patients of other important precautionary information.^{146 c f g} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Metaproterenol Sulfate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	10 mg/5 mL*	Metaproterenol Sulfate Syrup	Novex, Par, Silarx
	Tablets	10 mg*	Metaproterenol Sulfate Tablets	Par, Teva, Watson
		20 mg*	Metaproterenol Sulfate Tablets	Par, Teva, Watson
Oral Inhalation	Aerosol	0.65 mg/metered spray	Alupent (with chlorofluorohydrocarbon propellants)	Boehringer Ingelheim
	Solution, for nebulization	0.4%	Metaproterenol Sulfate Inhalation Solution	Dey
		0.6%	Metaproterenol Sulfate Inhalation Solution	Dey

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

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