Alupent Information
Alupent (Orciprenaline) Description
Alupent (Orciprenaline) (metaproterenol sulfate USP) Inhalation Aerosol is a bronchodilator administered by oral inhalation. The Alupent (Orciprenaline) Inhalation Aerosol containing 75 mg of metaproterenol sulfate as micronized powder is sufficient medication for 100 inhalations. The Alupent (Orciprenaline) Inhalation Aerosol containing 150 mg of metaproterenol sulfate as micronized powder is sufficient medication for 200 inhalations. Each metered dose delivers through the mouthpiece 0.65 mg of metaproterenol sulfate (each ml contains 15 mg). The inert ingredients are dichlorodifluoromethane, dichlorotetrafluoroethane and trichloromonofluoromethane as propellants, and sorbitan trioleate.Alupent (Orciprenaline) , 1-(3,5-dihydroxyphenyl)-2-isopropylaminoethanol sulfate, is a white, crystalline, racemic mixture of two optically active isomers. It has the following chemical structure:
Alupent (Orciprenaline) Clinical Pharmacology
The pharmacologic effects of beta adrenergic agonist drugs, including Alupent (Orciprenaline) , are at least in part attributable to stimulation through beta adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Alupent (Orciprenaline) Indications And Usage
Alupent (Orciprenaline) (metaproterenol sulfate USP) is indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema.
Alupent (Orciprenaline) Contraindications
Use in patients with cardiac arrhythmias associated with tachycardia is contraindicated.Although rare, immediate hypersensitivity reactions can occur. Therefore, Alupent (Orciprenaline) (metaproterenol sulfate USP) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to any of its components.
Alupent (Orciprenaline) Warnings
Fatalities have been reported following excessive use of Alupent (Orciprenaline) (metaproterenol sulfate USP) as with other sympathomimetic inhalation preparations, and the exact cause is unknown. Cardiac arrest was noted in several cases.
Alupent (Orciprenaline) , like other beta adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or ECG changes. As with other beta adrenergic aerosols, Alupent (Orciprenaline) can produce paradoxical bronchospasm (which can be life threatening). If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.
Alupent (Orciprenaline) should not be used more often than prescribed. Patients should be advised to contact their physician in the event that they do not respond to their usual dose of a sympathomimetic amine aerosol.
Alupent (Orciprenaline) Precautions
Extreme care must be exercised with respect to the administration of additional sympathomimetic agents.
Since metaproterenol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension or cardiac arrhythmias, in patients with hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients after use of any beta adrenergic bronchodilator.
Alupent (Orciprenaline) Adverse Reactions
Adverse reactions are similar to those noted with other sympathomimetic agents. The most frequent adverse reaction to Alupent (Orciprenaline) (metaproterenol sulfate USP) administered by metered-dose inhaler among 251 patients in 90-day controlled clinical trials was nervousness. This was reported in 6.8% of patients. Less frequent adverse experiences, occurring in 1-4% of patients were headache, dizziness, palpitations, gastrointestinal distress, tremor, throat irritation, nausea, vomiting, cough and asthma exacerbation. Tachycardia occurred in less than 1% of patients.
Alupent (Orciprenaline) Overdosage
The expected symptoms with overdosage are those of excessive beta-stimulation and/or any of the symptoms listed under adverse reactions, e.g. angina, hypertension or hypotension, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise and insomnia.
Treatment consists of discontinuation of metaproterenol together with appropriate symptomatic therapy.
Alupent (Orciprenaline) Dosage And Administration
The usual single dose is two to three inhalations. With repetitive dosing, inhalation should usually not be repeated more often than about every three to four hours. Total dosage per day should not exceed 12 inhalations.
Alupent (Orciprenaline) (metaproterenol sulfate USP) Inhalation Aerosol is not recommended for children under 12 years of age.
It is recommended that the physician titrate dosage according to each individual patient’s response to therapy.
Alupent (Orciprenaline) How Supplied
Each 100 inhalations of Alupent (Orciprenaline) (metaproterenol sulfate USP) Inhalation Aerosol contains 75 mg of metaproterenol sulfate as a micronized powder in inert propellants. Each metered dose delivers through the mouthpiece 0.65 mg metaproterenol sulfate (each ml contains 15 mg). Alupent (Orciprenaline) Inhalation Aerosol with Mouthpiece (NDC 0597-0070-08), net contents 7g (5 ml). The mouthpiece is white with a clear, colorless sleeve and a blue protective cap.
Each 200 inhalations of Alupent (Orciprenaline) Inhalation Aerosol contains 150 mg of metaproterenol sulfate as a micronized powder in inert propellants. Each metered dose delivers through the mouthpiece 0.65 mg metaproterenol sulfate (each ml contains 15 mg). Alupent (Orciprenaline) Inhalation Aerosol with Mouthpiece (NDC 0597-0070-17), net contents 14g (10ml). The mouthpiece is white with a clear, colorless sleeve and a blue protective cap. Alupent (Orciprenaline) Inhalation Aerosol Refill (NDC 0597-0070-18), net contents 14g (10 ml).Note: The indented statement below is required by the Federal government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):
A notice similar to the above WARNING has been placed in the information for the patient of this product under the Environmental Protection Agency’s (EPA’s) regulations. The patient’s warning states that the patient should consult his or her physician if there are questions about alternatives.
Store between 59°F (15°C) and 77°F (25°C). Avoid excessive humidity.
Alupent (Orciprenaline)
Alupent (Orciprenaline) Patient’s Instructions For Use
