albuterol sulfate


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Related to albuterol sulfate: budesonide, salbutamol, Ventolin

albuterol sulfate (salbutamol sulfate)

AccuNeb, Gen-Salbutamol (CA), Nu-Salbutamol (CA), ProAir HFA, Proventil HFA, Ventolin HFA, Vospire-ER

Pharmacologic class: Sympathomimetic (beta2-adrenergic agonist)

Therapeutic class: Bronchodilator, antiasthmatic

Pregnancy risk category C

Action

Relaxes smooth muscles by stimulating beta2-receptors, thereby causing bronchodilation and vasodilation

Availability

Aerosol: 90 mcg/actuation, 108 mcg/inhalation

Oral solution: 2 mg/5 ml

Solution for inhalation: 0.083% (3 ml), 0.5% (0.5 and 20 ml), 0.63 mg/3 ml, 1.25 mg/3 ml

Syrup: 2 mg/5 ml

Tablets: 2 mg, 4 mg

Tablets (extended-release): 4 mg, 8 mg

Indications and dosages

To prevent and relieve bronchospasm in patients with reversible obstructive airway disease

Adults and children ages 12 and older:Tablets-2 to 4 mg P.O. three or four times daily, not to exceed 32 mg daily. Extended-release tablets-4 to 8 mg P.O. q 12 hours, not to exceed 32 mg daily in divided doses. Syrup-2 to 4 mg (1 to 2 tsp or 5 to 10 ml) three or four times daily, not to exceed 8 mg q.i.d.

Aerosol-one to two inhalations q 4 to 6 hours to relieve bronchospasm; two inhalations q.i.d. to prevent bronchospasm. Solution for inhalation-2.5 mg three to four times daily by nebulization, delivered over 5 to 15 minutes.

Children ages 6 to 12:Tablets-2 mg P.O. three or four times daily; maximum daily dosage is 24 mg, given in divided doses. Extended-release tablets-4 mg q 12 hours; maximum daily dosage is 24 mg/kg given in divided doses. Syrup-2 mg (1 tsp or 5 ml) three or four times daily, not to exceed 24 mg.

Adults and children age 4 and older (with ProAir HFA): Two inhalations q 4 to 6 hours to treat acute bronchospasm

Children ages 2 to 12 weighing more than 15 kg (33 lb):Solution for inhalation-2.5 mg three to four times/day by nebulization

Children ages 2 to 6:Syrup-Initially, 0.1 mg/kg P.O. t.i.d., not to exceed 2 mg (1 tsp) t.i.d. Maximum dosage is 4 mg (2 tsp) t.i.d.

To prevent exercise-induced bronchospasm

Adults and children older than age 4 (older than age 12 with Proventil): Two inhalations 15 minutes before exercise

Adults and children age 4 and older (with ProAir HFA): Two inhalations q 15 to 30 minutes before exercise

Dosage adjustment

• Sensitivity to beta-adrenergic stimulants
• Elderly patients

Off-label uses

• Chronic obstructive pulmonary disease
• Hyperkalemia with renal failure
• Preterm labor management

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• cardiac disease, hypertension, diabetes mellitus, glaucoma, seizure disorder, hyperthyroidism, exercise-induced bronchospasm, prostatic hypertrophy
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

• Give extended-release tablets whole; don't crush or mix with food.
• Administer solution for inhalation by nebulization over 5 to 15 minutes, after diluting 0.5 ml of 0.5% solution with 2.5 ml of sterile normal saline solution.
• Know that children weighing less than 15 kg (33 lb) who require less than 2.5 mg/dose should receive 0.5% inhalation solution.

Adverse reactions

CNS: dizziness, excitement, headache, hyperactivity, insomnia

CV: hypertension, palpitations, tachycardia, chest pain

EENT: conjunctivitis, dry and irritated throat, pharyngitis

GI: nausea, vomiting, anorexia, heartburn, GI distress, dry mouth

Metabolic: hypokalemia

Musculoskeletal: muscle cramps

Respiratory: cough, dyspnea, wheezing, paradoxical bronchospasm

Skin: pallor, urticaria, rash, angioedema, flushing, sweating

Other: tooth discoloration, increased appetite, hypersensitivity reaction

Interactions

Drug-drug.Beta-adrenergic blockers: inhibited albuterol action, possibly causing severe bronchospasm in asthmatic patients

Digoxin: decreased digoxin blood level

MAO inhibitors: increased cardiovascular adverse effects

Oxytoxics: severe hypotension

Potassium-wasting diuretics: ECG changes, hypokalemia

Theophylline: increased risk of theophylline toxicity

Drug-food.Caffeine-containing foods and beverages (such as coffee, tea, chocolate): increased stimulant effect

Drug-herbs.Cola nut, ephedra (ma huang), guarana, yerba maté: increased stimulant effect

Patient monitoring

Stay alert for hypersensitivity reactions and paradoxical bronchospasm. Stop drug immediately if these occur.
• Monitor serum electrolyte levels.

Patient teaching

• Tell patient to swallow extended-release tablets whole and not to mix them with food.
• Follow manufacturer's directions supplied with inhalation drugs.

Teach patient signs and symptoms of hypersensitivity reaction and paradoxical bronchospasm. Tell him to stop taking drug immediately and contact prescriber if these occur.

Instruct patient to notify prescriber immediately if prescribed dosage fails to provide usual relief, because this may indicate seriously worsening asthma.
• Advise patient to limit intake of caffeine-containing foods and beverages and to avoid herbs unless prescriber approves.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Advise patient to establish effective bedtime routine and to take drug well before bedtime to minimize insomnia.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and herbs mentioned above.

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References in periodicals archive ?
Authors of the study found that use of AFECTAIR resulted in an increased delivery of albuterol sulfate at the patient interface compared with the method currently used to introduce aerosolized medication into the ventilator circuit.
5% Albuterol Sulfate Inhalation Solution is the first FDA approved packaging of this medication in 0.
Food and Drug Administration (FDA) for albuterol sulfate HFA inhalation aerosol, the generic version of ProAir HFA.
In clinical studies, ProAir HFA, the market leading albuterol sulfate inhaler,1 exhibited significant bronchodilator efficacy in pediatric asthmatics aged 4 to 11 years.
According to this study conducted in an in vitro model of neonatal mechanical ventilation conditions, when compared with a conventional wye connector, use of the AFECTAIR neonatal device resulted in improved delivery of aerosolized albuterol sulfate, including:
ProAir([R])HFA is the number-one branded hydrofluroalkane (HFA) albuterol sulfate inhaler in the U.
The objective of this study was to compare the dose of aerosolized albuterol sulfate delivered to lung simulator under various neonatal ventilator settings using the AFECTAIR ventilator circuit patient interface connector versus current SoC delivery system.
Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after administration of ipratropium bromide or albuterol sulfate.
IVAX' branded respiratory product, albuterol sulfate HFA (CFC-free) in a standard metered dose inhaler, launched in the fourth quarter of 2004, is presently vying for the number one market share position among HFA albuterol products.
or Europe; that sales of QVAR in Europe may not accelerate due to its launch in Easi-Breathe(R); that IVAX may not receive final approval for HFA albuterol sulfate in its aerosol breath operated inhaler or that its launch will be delayed; market acceptance and demand for IVAX' respiratory products may not be as anticipated; that CFC propellants may not be removed from the market when anticipated or at all; that IVAX may not be able to achieve a significant share of the albuterol inhaler market with its breath operated aerosol device; that our worldwide marketing and sales network may not continue to strengthen and may not help to leverage our investments in development; and that IVAX may not be able to increase efficiency or reduce costs in 2005.
that IVAX will not receive final approval for albuterol sulfate using a non-ozone depleting HFA propellant in its breath-activated inhaler or that its launch may be delayed; the difficulty of predicting the timeliness or outcome of product development efforts and regulatory applications; market acceptance and demand for IVAX' respiratory products may not be as anticipated; changing market conditions; the impact of competitive products and pricing; and the impact of foreign currency exchange rates and fluctuations in those rates.
Except for the historical matters contained herein, statements in this press release, including statements relating to IVAX' approvable letter for albuterol sulfate using a non-ozone depleting HFA (hydrofluoroalkane) propellant in a metered dose inhaler (MDI), are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.