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Product Name
:
PULMO-NEB
Chemical Name
:
Salbutamol
Therapeutic Category
:
Respiratory tract drugs
Pharmacologic Category
:
Beta2 Agonist
Pharmaceutical Form
:
Ampoule
Composition
:
Salbutamol 2.5mg
Dosing
 
Dosing: Adult
Bronchospasm:
Solution for nebulization: 2.5 mg 3-4 times daily as needed; Quick relief: 1.25-5 mg every 4 to 8 hours as needed (NIH Guidelines, 2007)
Exacerbation of asthma (acute, severe) (NIH Guidelines, 2007):
Solution for nebulization: 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour by continuous nebulization

Dosing: Pediatric

Bronchospasm:
Solution for nebulization:
Manufacturer's recommendations:
Children 2-12 years (PulmoNEB®): 0.63-1.25 mg 3-4 times daily as needed
Children ≥12 years: 2.5 mg 3-4 times daily as needed
NIH Guidelines, 2007: Quick relief:
Children ≤4 years: 0.63-2.5 mg every 4-6 hours as needed
Children ≥5 years: 1.25-5 mg every 4-8 hours as needed
Exacerbation of asthma (acute, severe) (NIH Guidelines, 2007):
Solution for nebulization:
Children <12 years: 0.15 mg/kg (minimum: 2.5 mg) every 20 minutes for 3 doses, then 0.15-0.3 mg/kg (maximum: 10 mg) every 1-4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization
Children ≥12 years: 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour by continuous nebulization

Dosing: Geriatric

Inhalation: Refer to adult dosing.

Dosing: Renal Impairment

Use with caution in patients with renal impairment. No dosage adjustment required (including patients on hemodialysis, peritoneal dialysis, or CRRT; Aronoff, 2007).
Use
 
Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease; prevention of exercise-induced bronchospasm
Adverse Reactions
 
Incidence of adverse effects is dependent upon age of patient, dose, and route of administration.
Cardiovascular: Angina, atrial fibrillation, arrhythmias, chest discomfort, chest pain, extrasystoles, flushing, hyper-/hypotension, palpitation, supraventricular tachycardia, tachycardia
Central nervous system: CNS stimulation, dizziness, drowsiness, headache, insomnia, irritability, lightheadedness, migraine, nervousness, nightmares, restlessness, seizure
Dermatologic: Angioedema, rash, urticaria
Endocrine & metabolic: Hyperglycemia, hypokalemia, lactic acidosis
Gastrointestinal: Diarrhea, dry mouth, dyspepsia, gastroenteritis, nausea, unusual taste, vomiting
Genitourinary: Micturition difficulty
Local: Injection: Pain, stinging
Neuromuscular & skeletal: Muscle cramps, musculoskeletal pain, tremor, weakness
Otic: Otitis media, vertigo
Respiratory: Asthma exacerbation, bronchospasm, cough, epistaxis, laryngitis, oropharyngeal drying/irritation, oropharyngeal edema, pharyngitis, rhinitis, upper respiratory inflammation, viral respiratory infection
Miscellaneous: Allergic reaction, anaphylaxis, diaphoresis, lymphadenopathy
Postmarketing and/or case reports: Anxiety, glossitis, hoarseness, metabolic acidosis, myocardial ischemia, pulmonary edema, throat irritation, tongue ulceration
Contraindications
 
Hypersensitivity to albuterol or any component of the formulation
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response.
• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.
Disease-related concerns:
• Asthma: Appropriate use: Optimize anti-inflammatory treatment before initiating maintenance treatment with albuterol. Do not use as a component of chronic therapy without an anti-inflammatory agent. Only the mildest forms of asthma (Step 1 and/or exercise-induced) would not require concurrent use based upon asthma guidelines.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia or hypertension or HF); beta-agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias.
• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose.
• Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure.
• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium.
• Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.
Special populations:
• Pediatrics: Face masks should be used in children <4 years of age.
Dosage form specific issues:
• Chlorofluorocarbons: Patient response may vary between inhalers that contain chlorofluorocarbons and those which are chlorofluorocarbon-free.
Other warnings/precautions:
• Appropriate use: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.
• Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed. A spacer device or valved holding chamber is recommended when using a metered-dose inhaler.
Interactions
 
Alpha-/Beta-Blockers: May diminish the therapeutic effect of Beta2-Agonists. Risk D: Consider therapy modification
Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy
Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk D: Consider therapy modification
Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy
MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Avoid or limit caffeine (may cause CNS stimulation).
Herb/Nutraceutical: Avoid ephedra, yohimbe (may cause CNS stimulation). Avoid St John's wort (may decrease the levels/effects of albuterol).
Pregnancy
 
C
Pregnancy Implications
Albuterol crosses the placenta; tocolytic effects, fetal tachycardia, fetal hypoglycemia secondary to maternal hyperglycemia with oral or intravenous routes reported. Available evidence suggests safe use as an inhalation during pregnancy, and albuterol is the preferred short-acting beta agonist for use in asthma according to the NHLBI 2007 Guidelines for the Diagnosis and Management of Asthma.
Lactation
 
Excretion in breast milk unknown/use caution
Monitoring Parameters
 
FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium; asthma symptoms; arterial or capillary blood gases (if patients condition warrants)
Mechanism of Action
 
Relaxes bronchial smooth muscle by action on beta2-receptors with little effect on heart rate
Pharmacodynamics / Kinetics
 
Onset of action: Peak effect:
Nebulization/oral inhalation: 0.5-2 hours
Oral: 2-3 hours
Duration: Nebulization/oral inhalation: 3-4 hours; Oral: 4-6 hours
Metabolism: Hepatic to an inactive sulfate
Half-life elimination: Inhalation: 3.8 hours; Oral: 3.7-5 hours
Excretion: Urine (30% as unchanged drug)
 
   
 
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