Metaproterenol Sulfate

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Overview

What is Metaproterenol Sulfate?

Metaproterenol sulfate syrup is an oral bronchodilator.

Each teaspoonful (5 mL), for oral administration, contains metaproterenol sulfate 10 mg. In addition, each teaspoonful (5 mL) contains the following inactive ingredients:

citric acid, edetate disodium, FD&C Red No. 40, glycerin, hydroxyethyl cellulose, black cherry flavor, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution, sodium citrate and purified water.

Metaproterenol sulfate, 1- (3, 5 dihydroxyphenyl) -2-isopropyl - aminoethanol sulfate, is a white, crystalline, racemic mixture of two optically active isomers. It has the following structural formula:

What does Metaproterenol Sulfate look like?

What are the available doses of Metaproterenol Sulfate?

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What should I talk to my health care provider before I take Metaproterenol Sulfate?

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How should I use Metaproterenol Sulfate?

Metaproterenol sulfate syrup is indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema.

Metaproterenol sulfate syrup contains 10 mg of metaproterenol sulfate per teaspoonful (5 mL).

Children

Adults

It is recommended that the physician titrate the dosage according to each individual patient’s response to therapy.

What interacts with Metaproterenol Sulfate?

Use in patients with cardiac arrhythmias associated with tachycardia is contraindicated.

Although rare, immediate hypersensitivity reactions can occur. Therefore, metaproterenol sulfate syrup is contraindicated in patients with a history of hypersensitivity to any of its components.

What are the warnings of Metaproterenol Sulfate?

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What are the precautions of Metaproterenol Sulfate?

General

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.

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Information For Patients

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Drug Interactions

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Pregnancy

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Nursing Mothers

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Pediatric Use

What are the side effects of Metaproterenol Sulfate?

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

The following table of adverse experiences is derived from 44 clinical trials involving 1,120 patients treated with metaproterenol sulfate syrup:

**Metaproterenol Sulfate Syrup Incidence of Adverse Events Occurring in at least 1% of Patients**

	Number of Patients

Tachycardia	68	6.1

Headache	12	1.1
Nervousness	54	4.8

Nausea	15	1.3

Tremor	18	1.6

What should I look out for while using Metaproterenol Sulfate?

Use in patients with cardiac arrhythmias associated with tachycardia is contraindicated.

Although rare, immediate hypersensitivity reactions can occur. Therefore, metaproterenol sulfate syrup is contraindicated in patients with a history of hypersensitivity to any of its components.

Metaproterenol, 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.

What might happen if I take too much Metaproterenol Sulfate?

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.

The treatment consists of discontinuation of metaproterenol together with appropriate symptomatic therapy.

How should I store and handle Metaproterenol Sulfate?

Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .Metaproterenol Sulfate Syrup, USP is available as a red, cherry-flavored syrup containing 10 mg of metaproterenol sulfate per teaspoonful (5 mL) in 473 mL (one pint) bottles.Store below 86°F (30°C). Protect from light. Manufactured by: Silarx Pharmaceuticals, Inc.1033 Stoneleigh AveCarmel, NY 10512Metaproterenol Sulfate Syrup, USP is available as a red, cherry-flavored syrup containing 10 mg of metaproterenol sulfate per teaspoonful (5 mL) in 473 mL (one pint) bottles.Store below 86°F (30°C). Protect from light. Manufactured by: Silarx Pharmaceuticals, Inc.1033 Stoneleigh AveCarmel, NY 10512Metaproterenol Sulfate Syrup, USP is available as a red, cherry-flavored syrup containing 10 mg of metaproterenol sulfate per teaspoonful (5 mL) in 473 mL (one pint) bottles.Store below 86°F (30°C). Protect from light. Manufactured by: Silarx Pharmaceuticals, Inc.1033 Stoneleigh AveCarmel, NY 10512Metaproterenol Sulfate Syrup, USP is available as a red, cherry-flavored syrup containing 10 mg of metaproterenol sulfate per teaspoonful (5 mL) in 473 mL (one pint) bottles.Store below 86°F (30°C). Protect from light. Manufactured by: Silarx Pharmaceuticals, Inc.1033 Stoneleigh AveCarmel, NY 10512

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Clinical Information

Chemical Structure

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Clinical Pharmacology

In vitro

in vivo

The pharmacologic effects of beta adrenergic agonist drugs, including metaproterenol, 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.

PHARMACOKINETICS

Pulmonary function tests performed after the administration of metaproterenol usually show improvement, e.g., an increase in the one-second forced expiratory volume (FEV), maximum expiratory flow rate, peak expiratory flow rate, forced vital capacity, and/or a decrease in airway resistance. The resultant decrease in airway obstruction may relieve the dyspnea associated with bronchospasm.

Pulmonary function has been monitored in controlled single- and multiple-dose studies. The duration of effect of a single dose of metaproterenol sulfate syrup (that is, the period of time during which there is a 15% or greater increase in mean FEV) was up to 4 hours. Recent studies in laboratory animals (minipigs, rodents and dogs) recorded the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta agonists and methylxanthines were administered concurrently. The significance of these findings when applied to humans is currently unknown.

Non-Clinical Toxicology

Use in patients with cardiac arrhythmias associated with tachycardia is contraindicated.

Although rare, immediate hypersensitivity reactions can occur. Therefore, metaproterenol sulfate syrup is contraindicated in patients with a history of hypersensitivity to any of its components.

Metaproterenol, 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.

Drug Interactions

General

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.

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

The following table of adverse experiences is derived from 44 clinical trials involving 1,120 patients treated with metaproterenol sulfate syrup:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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