Alupent

Name: Alupent

What should I do if I forget a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What side effects can this medication cause?

Metaproterenol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • tremor
  • nervousness
  • dizziness
  • weakness
  • headache
  • nausea

If you experience any of the following symptoms, call your doctor immediately:

  • increased difficulty breathing
  • rapid or increased heart rate
  • irregular heartbeat
  • chest pain or discomfort

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What Is Metaproterenol?

Metaproterenol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Metaproterenol is used to treat conditions such as asthma, bronchitis, and emphysema.

Metaproterenol may also be used for purposes not listed in this medication guide.

You should not use metaproterenol if you have a heart rhythm disorder that causes fast heartbeats.

You should not use metaproterenol if you are allergic to it, or if you have a heart rhythm disorder that causes fast heartbeats.

To make sure metaproterenol is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, heart rhythm disorder;
  • epilepsy or another seizure disorder;
  • low levels of potassium in your blood;
  • diabetes; or
  • an overactive thyroid.

FDA pregnancy category C. It is not known whether metaproterenol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether metaproterenol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Metaproterenol should not be given to a child younger than 6 years old.

Indications

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.

Stability

Storage

Oral

Solution and Tablets

Tight, light-resistant containers at 15–30°C.146 f Protect from moisture.146

Oral Inhalation

Oral inhalation aerosol: 15–25°C; avoid excessive humidity.c

Oral inhalation solution: ≤25°C.145 Discard solution if pinkish or darker than slightly yellow in color or if it contains a precipitate.g

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Metaproterenol Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

10 mg/5 mL*

Metaproterenol Sulfate Syrup

Novex, Par, Silarx

Tablets

10 mg*

Metaproterenol Sulfate Tablets

Par, Teva, Watson

20 mg*

Metaproterenol Sulfate Tablets

Par, Teva, Watson

Oral Inhalation

Aerosol

0.65 mg/metered spray

Alupent (with chlorofluorohydrocarbon propellants)

Boehringer Ingelheim

Solution, for nebulization

0.4%

Metaproterenol Sulfate Inhalation Solution

Dey

0.6%

Metaproterenol Sulfate Inhalation Solution

Dey

Alupent® (metaproterenol sulfate USP) Inhalation Aerosol Bronchodilator 100 and 200 Inhalations

Prescribing Information

Pharmacist:
Tear off “Instruction for Use” and dispense with container in carton.

Adverse Reactions

Adverse reactions are similar to those noted with other sympathomimetic agents. The most frequent adverse reaction to Alupent® (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.

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.

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