Metaproterenol

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain, fast heart rate;
• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• tremors; or
• worsening or no improvement in your symptoms.

Common side effects may include:

• nervousness;
• headache;
• dizziness, drowsiness;
• nausea, diarrhea, upset stomach, dry mouth;
• tired feeling; or
• sleep problem (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Metaproterenol is a prescription medication used to treat asthma, chronic bronchitis, and emphysema. Metaproterenol belongs to a group of medications called bronchodilators which help by relaxing airways in the lungs, making it easier to breathe.

Metaproterenol is available as a tablet and an oral liquid and are usually taken 3 to 4 times per day. Metaproterenol is also available as an oral inhalation and is usually given every 3 to 4 hours.

Common side effects of metaproterenol include tremor, nervousness, and headache.

Metaproterenol is part of the drug class:

• Inhaled Selective beta 2 adrenoreceptor agonists

Serious side effects have been reported with Metaproterenol. See "Metaproterenol Precautions" section.

Common side effects of metaproterenol include:

• nausea
• tremor
• nervousness
• increased heart rate
• headache

This is not a complete list of metaproterenol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Alupent

In Canada

• Alti-Orciprenaline

Available Dosage Forms:

• Syrup
• Tablet

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

Metaproterenol Sulfate Inhalation Solution USP is a unit-dose bronchodilator administered by oral inhalation with the aid of an intermittent positive pressure breathing apparatus (IPPB). It contains 0.4% or 0.6% Metaproterenol sulfate in a sterile, acidic, aqueous solution containing edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide for pH adjustment.

Chemical, metraproterenol sulfate is 3,5 dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol sulfate (2:1), a white crystalline, racemic mixture of two optically active isomers. It differs from isoproterenol hydrochloride by having two hydroxyl groups attached at the meta positions on the benzene ring rather than one at the meta and one at the para position.

                                                                                                  (C11H17NO3)2•H2SO4
                                                                                                  M.W. 520.59

Metaproterenol Sulfate

General

Because Metaproterenol Sulfate Inhalation Solution is a sympathomimetic drug, it should be used with great caution in patients with hypertension, coronary artery disease, congestive heart failure, hyperthyroidism or diabetes, or when there is sensitivity to sympathomimetic amines.

Information for Patients

Extreme care must be exercised with respect to the administration of additional sympathomimetic agents. A sufficient interval of time should elapse prior to administration of another sympathomimetic agent such as epinephrine or isoproterenol.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in mice and rats to evaluate the oral carcinogenic potential of Metaproterenol sulfate have not been completed. Studies of Metaproterenol sulfate have not been conducted to determine mutagenic potential or effect on fertility.

Pregnancy

Teratogenic Effects

Metaproterenol sulfate has been shown to be teratogenic and embryocidal in rabbits when given orally in doses 620 times the human inhalation dose; the teratogenic effects included skeletal abnormalities and hydrocephalus with bone separation. Oral reproduction studies in mice, rats and rabbits showed no teratogenic or embryocidal effect at 50 mg/kg, or 310 times the human inhalation dose. There are no adequate and well-controlled studies in pregnant women. Metaproterenol Sulfate Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Metaproterenol Sulfate Inhalation Solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 have not been established.

Adverse reactions are similar to those noted with other sympathomimetic agents.

The most frequent adverse reactions to Metaproterenol sulfate are nervousness and tachycardia which occur in about 1 in 7 patients, tremor which occurs in about 1 in 20 patients, and nausea which occurs in about 1 in 50 patients. Less frequent adverse reactions are hypertension, palpitations, vomiting and bad taste which occur in approximately 1 in 300 patients.

(met a proe TER e nol)

Refer to adult dosing.

Adverse events were observed in some animal reproduction studies. Beta agonists, including metaproterenol, may interfere with uterine contractility if administered during labor; maternal and fetal tachycardia have been observed (Baillie, 1970; Tyack, 1971).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, pre-eclampsia, preterm birth, low birth weight infants). Oral beta2-receptor agonists are not recommended to treat asthma during pregnancy (NAEPP, 2005).