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Accuneb - Clinical Pharmacology
The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with isoproterenol. While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicate that 10% to 50% of the beta-receptors in the human heart may be beta2-receptors. The precise function of these receptors, however, is not yet established. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.
Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (IPPB) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus, and expired air. Most of the absorbed dose was recovered in urine collected during the 24 hours after drug administration. Following oral administration of 4 mg albuterol, the elimination half-life was five to six hours. Following a 3 mg dose of nebulized albuterol in adults, the mean maximum albuterol plasma level at 0.5 hours was 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). The pharmacokinetics of albuterol following administration of 0.63 mg or 1.25 mg albuterol sulfate inhalation solution by nebulization have not been determined in children 2 to 12 years old.
Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those found in whole brain.
Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown.
The safety and efficacy of Accuneb was evaluated in a 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in 349 children 6 to 12 years of age with mild-to-moderate asthma (mean baseline FEV1 60% to 70% of predicted). Approximately half of the patients were also receiving inhaled corticosteroids. Patients were randomized to receive Accuneb 0.63 mg, Accuneb 1.25 mg, or placebo three times a day administered via a Pari LC Plus™ nebulizer and a Pari PRONEB™ compressor. Racemic albuterol, delivered by a chlorofluorocarbon (CFC) metered dose inhaler (MDI) or nebulized, was used on an as-needed basis as the rescue medication.
Efficacy, as measured by the mean percent change from baseline in the area under the 6-hour curve for FEV1, was demonstrated for both active treatment regimens (n=112 [1.25 mg group] and n=110 [0.63 mg group]) compared with placebo (n=110) on day 1 and day 28. Figures 1 and 2 illustrate the mean percentage change from pre-dose FEV1 on day 1 and day 28, respectively. The mean baseline FEV1 for all patients was 1.49 L.
Figure 1 % Change from Pre-Dose FEV1 Intent-to-Treat Population Day 1
Figure 2 % Change from Pre-Dose FEV1 Intent-to-Treat Population Day 28
The onset of a 15% increase in FEV1 over baseline for both doses of Accuneb was seen at 30 minutes (the first post-dose assessment). The mean time to peak effect was approximately 30 to 60 minutes for both doses on day 1 and after 4 weeks of treatment. The mean duration of effect, as measured by a >15% increase from baseline in FEV1, was approximately 2.5 hours for both doses on day 1 and approximately 2 hours for both doses after 4 weeks of treatment. In some patients, the duration of effect was as long as 6 hours.
Clinical Trial Experience: Adverse events reported in > 1% of patients receiving AccuNeb (albuterol sulfate inhalation solution) and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.
Table 1: Adverse Events with an Incidence of > 1% of Patients Receiving AccuNeb (albuterol sulfate inhalation solution) and Greater than Placebo (expressed as % of treatment group)
|1.25 mg AccuNeb |
|0.63 mg AccuNeb |
There was one case of ST segment depression in the 1.25 mg AccuNeb (albuterol sulfate inhalation solution) treatment group.
No clinically relevant laboratory abnormalities related to AccuNeb (albuterol sulfate inhalation solution) administration were seen in this study.
Metabolic acidosis has been reported after the use of albuterol sulfate inhalation solution. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure..
Albuterol is a prescription medication used to treat bronchospasm (narrowing of airways) in people who have reversible obstructive airway disease. It may also used to prevent exercise-induced bronchospasm. Albuterol belongs to a group of drugs called beta agonists. These cause the smooth muscle of the airways to relax, making it easier to breathe.
Albuterol comes as a tablet, a syrup, and an extended release tablet to take by mouth. The tablets and syrup are usually taken three or four times a day. The extended release tablets are usually taken once every 12 hours.
Albuterol also comes as a solution to be inhaled into the mouth using a nebulizer and is usually used 3 or 4 times a day.
This medication also comes as aerosol to inhale by mouth using an inhaler. When the aerosol is used to treat or prevent symptoms of lung disease, it is usually used every 4 to 6 hours as needed. When the aerosol is used to prevent breathing difficulty during exercise, it is usually used 15 to 30 minutes before exercise.
Common side effects include fast heartbeat, shakiness, and nervousness.
Side Effects of Accuneb
Albuterol may cause serious side effects. See "Albuterol Precautions" section.
The most common side effects of albuterol include:
- your heart feels like it is pounding or racing (palpitations)
- chest pain
- fast heart rate
- sore throat
- runny nose
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of albuterol. For more information, ask your doctor or pharmacist.
Accuneb and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Albuterol falls into category C. There are no good studies that have been done in humans with albuterol. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.
If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
For Healthcare Professionals
Applies to albuterol: compounding powder, inhalation aerosol, inhalation aerosol with adapter, inhalation capsule, inhalation powder, inhalation solution, oral syrup, oral tablet, oral tablet extended release
The most commonly reported adverse reactions are: Taste alteration (bad, unpleasant and unusual taste), mouth and throat irritation, fine tremor (usually of the hands), nausea, sweating, restlessness, headache and dizziness. These undesirable effects may subside on continuation of treatment.[Ref]
Very common (10% or more): Peripheral vasodilation, increase in heart rate
Common (1% to 10%): Palpitations, tachycardia, pallor
Rare (0.01% to 0.1%): Myocardial ischemia, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extra systoles)
Very rare (less than 0.01%): Cardiovascular collapse, thrombopenia
Frequency not reported: Angina, hypertension, hypotension, flushing[Ref]
Very common (10% or more): Headache (up to 18.8%), tremor (up to 24.2%), excitement (up to 20%), nervousness (up to 15%)
Common (1% to 10%): Migraine, dizziness, shakiness, hyperkinesia, emotional lability
Uncommon (0.1% to 1%): Somnolence, dizziness, drowsiness, restlessness, irritability
Frequency not reported: Central nervous system stimulation[Ref]
Common (1% to 10%): Skin/Appendage Infection (1.7%), pruritus, rash, erythema, urticaria, angioedema, sweating[Ref]
Common (1% to 10%): Gastroenteritis, nausea, oropharyngeal pain, vomiting, increased appetite
Uncommon (0.1% to 1%): Epigastric pain, stomach ache, loss of appetite
Rare (less than 0.1%): Sore mouth
Frequency not reported: Oropharyngeal edema, throat irritation, altered taste, glossitis, tongue ulceration, gagging, drying or irritation of the oropharynx[Ref]
Common (1% to 10%): Urinary tract infection
Rare (less than 0.1%): Nephritis
Frequency not reported: Difficulty in micturition[Ref]
Common (1% to 10%): Allergic reaction
Very rare (less than 0.01%): angioedema, urticaria, bronchospasm, hypotension and collapse[Ref]
Common (1% to 10%): Lymphadenopathy[Ref]
Common (1% to 10%): Application site reaction (mouth and throat irritation, burning sensation of the tongue)
Frequency not reported: Slight pain or stinging (IM injection)[Ref]
Common (1% to 10%): Back pain, muscles cramps
Uncommon (0.1% to 1%): Myalgia
Very rare (less than 0.01%): Fine tremor (particularly of hands)
Frequency not reported: Myoclonus[Ref]
Common (1% to 10%): Cold symptoms, flue syndrome, pain, pyrexia, hyperactivity, excitement
Uncommon (0.1% to 1%): Epistaxis, fatigue, otitis media,
Frequency not reported: Weakness[Ref]
Common (1% to 10%): Tenseness
Uncommon (0.1% to 1%): Sleepiness, sleep disturbance
Rare (0.01% to 0.1%): Hallucinations
Very rare (less than 0.01%): Insomnia[Ref]
Common (1% to 10%): Asthma exacerbation (13%), chest pain, bronchitis, sinus headache, upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough
Very rare (less than 0.01%): Paradoxical bronchospasm, bronchospasm
Frequency not reported: Aggravated bronchospasm, asthma exacerbation, chest discomfort, pulmonary edema[Ref]
Uncommon (0.1% to 1%): Dilated pupils, conjunctivitis[Ref]
Rare (less than 0.1%): Hypokalemia, hyperglycemia, increase of insulin, free fatty acids, glycerol and ketone bodies
Postmarketing reports: Metabolic acidosis, lactic acidosis[Ref]
Some side effects of AccuNeb may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
CAS Registry Number
Beta Adrenergic Agonists