Albuterol Sulfate Inhalation Solution (Page 3 of 5)

Labor and Delivery

Oral albuterol has been shown to delay pre-term labor in some reports. There are presently no well-controlled studies that demonstrate that it will stop pre-term labor or prevent labor at term. Because of the potential for beta agonist interference with uterine contractility, use of Albuterol Sulfate Inhalation Solution for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Albuterol has not been approved for the management of pre-term labor. The benefit:risk ratio when albuterol is administered for tocolysis has not been established. Serious adverse reactions, including pulmonary edema, have been reported following administration of albuterol to women in labor.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of Albuterol Sulfate Inhalation Solution 1.25 mg and 0.63 mg have been established in pediatric patients between the ages of 2 and 12 years. The use of Albuterol Sulfate Inhalation Solution in these age groups is supported by evidence from adequate and well-controlled studies of Albuterol Sulfate Inhalation Solution in children age 6 to 12 years and published reports of albuterol sulfate trials in pediatric patients 3 years of age and older. The safety and effectiveness of Albuterol Sulfate Inhalation Solution in children below 2 years of age have not been established.

ADVERSE REACTIONS

Clinical Trial Experience

Adverse events reported in >1% of patients receiving 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 Albuterol Sulfate Inhalation Solution and Greater than Placebo (expressed as % of treatment group)
1.25 mg Albuterol Sulfate Inhalation Solution (N=115) 0.63 mg Albuterol Sulfate Inhalation Solution (N=117) Placebo (N=117)
Asthma Exacerbation 13 11.1 8.5
Otitis Media 4.3 0.9 0
Allergic Reaction 0.9 3.4 1.7
Gastroenteritis 0.9 3.4 0.9
Cold Symptoms 0 3.4 1.7
Flu Syndrome 2.6 2.6 1.7
Lymphadenopathy 2.6 0.9 1.7
Skin/Appendage Infection 1.7 0 0
Urticaria 1.7 0.9 0
Migraine 0.9 1.7 0
Chest Pain 0.9 1.7 0
Bronchitis 0.9 1.7 0.9
Nausea 1.7 0.9 0.9

There was one case of ST segment depression in the 1.25 mg Albuterol Sulfate Inhalation Solution treatment group.

No clinically relevant laboratory abnormalities related to Albuterol Sulfate Inhalation Solution administration were seen in this study.

Post-marketing Experience

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.

OVERDOSAGE

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of the pharmacological effects listed in ADVERSE REACTIONS. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Albuterol Sulfate Inhalation Solution. Treatment consists of discontinuation of Albuterol Sulfate Inhalation Solution together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Albuterol Sulfate Inhalation Solution.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 580 times the maximum recommended daily inhalation dose of Albuterol Sulfate Inhalation Solution on a mg/m 2 basis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 mg/kg and 2000 mg/kg, respectively (approximately 260 and 1200 times the maximum recommended daily inhalation dose of Albuterol Sulfate Inhalation Solution on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of Albuterol Sulfate Inhalation Solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 1.25 mg or 0.63 mg inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver Albuterol Sulfate Inhalation Solution over 5 to 15 minutes.

The use of Albuterol Sulfate Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV 1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol Sulfate Inhalation Solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of Albuterol Sulfate Inhalation Solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of Albuterol Sulfate Inhalation Solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of Albuterol Sulfate Inhalation Solution when administered with other nebulizer systems have not been established.

Albuterol Sulfate Inhalation Solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol Sulfate Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg/3 mL and 1.25 mg/3 mL, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 1, 5, or 25unit-dose LDPE vials. Each strength of Albuterol Sulfate Inhalation Solution is available in a shelf carton containing a single or multiple foil pouches.

Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configurations.
NDC 76204-010-01 30 foil pouches, each containing 1 vial, total 30 vials per carton
NDC 76204-010-55 5 foil pouches, each containing 5 vials, total 25 vials per carton
NDC 76204-010-25 1 foil pouch, containing 25 vials, total 25 vials per carton

Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL (potency expressed as albuterol) contains 1.5 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configurations.
NDC 76204-011-01 30 foil pouches, each containing 1 vial, total 30 vials per carton
NDC 76204-011-55 5 foil pouches, each containing 5 vials, total 25 vials per carton
NDC 76204-011-25 1 foil pouch, containing 25 vials, total 25 vials per carton

Rx only.

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