Resounding Health: Medicine: Alupent

Basic Drug Info

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Drug Name:	Alupent
Manufacturer:	Boehringer Ingelheim Pharmaceuticals, Inc.
Other Info:	Insert metal canister into clear end of mouthpiece.Remove protective cap, invert canister and shake well before each use.Avoid spraying in eyes. Enclose mouthpiece with the lips. The base of the canister should be held vertically. The Alupent® canister is to be used only with the white Alupent® Inhalation Aerosol mouthpiece. This mouthpiece should not be used with other aerosol medications.Exhale deeply, then inhale slowly through the mouth and at the same time firmly press once on the upended canister base; continue to inhale deeply. Hold your breath for a few seconds and then remove the mouthpiece from the mouth and exhale slowly.One inhalation is often enough to obtain relief. The inhalation can be repeated once or twice, if necessary, or as your physician directs. Wait at least two minutes before repeating the inhalation. In most cases, the dose should not be repeated more often than every 3 to 4 hours. No more than 12 inhalations should be taken in one day.Replace protective cap after use.WARNING: Do not exceed the dose prescribed by your physician. If difficulty in breathing persists, contact your physician immediately.Note: When full, the container holds enough medication for at least 200 inhalations: at least 100 inhalations are in the sample unit. Check regularly, by shaking the cylinder or container, to determine whether it contains any medication. When it first seems empty, there are still about ten doses left. Refill containers for the plastic mouthpiece are available when prescribed by your physician.Keep the mouthpiece clean. Wash with hot water. If soap is used, rinse thoroughly with plain water.Never open the container holding the medication. Opening it is dangerous and renders the contents useless.Caution: Contents Under Pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F. Keep out of reach of small childrenNote: The indented statement below is required by the Federal government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs): This product contains trichloromonofluoromethane (CFC-11), dichlorodifluoromethane (CFC-12) and dichlorotetrafluoroethane (CFC-114), substances which harm the environment by destroying ozone in the upper atmosphere.Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.Distributed byBoehringer Ingelheim Pharmaceuticals, Inc.,Ridgefield, CT 06877Licensed from Boehringer Ingelheim International GmbHPrinted in U.S.A2/99

Clinical Trials:	NIH - Clinical Trials

Indications and Usage

Alupent® (metaproterenol sulfate USP) is indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Bronchial spasm -- Spasmodic contraction of the smooth muscle of the bronchi.

Acute bronchitis -- sudden inflammation of the tracheobronchial tree, which comprises the trachea, or windpipe, and the bronchi; typically associated with a viral upper respiratory tract infection, such as the common cold, and is usually mild; in patients with chronic lung or heart disease, acute bronchitis is more severe, and can become chronic and progress to pneumonia.

Bronchitis -- Inflammation of the large airways in the lung including any part of the BRONCHI, from the PRIMARY BRONCHI to the TERTIARY BRONCHI.

Pathological accumulation of air in tissues -- A pathological accumulation of air in tissues or organs.

Pulmonary Emphysema -- Enlargement of air spaces distal to the TERMINAL BRONCHIOLES where gas-exchange normally takes place. This is usually due to destruction of the alveolar wall. Pulmonary emphysema can be classified by the location and distribution of the lesions.

Contraindications

Use in patients with cardiac arrhythmias associated with tachycardia is contraindicated.Although rare, immediate hypersensitivity reactions can occur.

Therefore, Alupent® (metaproterenol sulfate USP) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to any of its components.

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

Tachycardia -- Abnormally rapid heartbeat, usually with a HEART RATE above 100 beats per minute for adults. Tachycardia accompanied by disturbance in the cardiac depolarization (cardiac arrhythmia) is called tachyarrhythmia.

Immediate hypersensitivity -- Hypersensitivity reactions which occur within minutes of exposure to challenging antigen due to the release of histamine which follows the antigen-antibody reaction and causes smooth muscle contraction and increased vascular permeability.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Fatalities have been reported following excessive use of Alupent® (metaproterenol sulfate USP) as with other sympathomimetic inhalation preparations, and the exact cause is unknown.

Cardiac arrest was noted in several cases.Alupent, 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 can produce paradoxical bronchospasm (which can be life threatening).

If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.Alupent 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.