DRUGS & SUPPLEMENTS

Metaproterenol

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Metaproterenol uses


DESCRIPTION

Metaproterenol sulfate syrup is an oral bronchodilator.

Each teaspoonful, 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:


Structure

CLINICAL PHARMACOLOGY

In vitro studies and in vivo pharmacologic studies have demonstrated that Metaproterenol sulfate has a preferential effect on beta2 adrenergic receptors compared with isoproterenol. While it is recognized that beta2 adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicate that there is a population of beta2 receptors in the human heart existing in a concentration between 10 to 50%. The precise function of these, however, is not yet established.

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: Absorption, biotransformation and excretion studies in humans following oral administration have indicated that an average of less than 10% of the drug is absorbed intact; it is not metabolized by catechol-0-methyltransferase nor converted to glucuronide conjugates but is excreted primarily as the sulfate conjugate formed in the gut.

Pulmonary function tests performed after the administration of Metaproterenol usually show improvement, e.g., an increase in the one-second forced expiratory volume (FEV1), 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 FEV1) 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.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

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.

WARNINGS

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.

PRECAUTIONS

General: 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.

Information For Patients: Appropriate care should be exercised when considering the administration of additional sympathomimetic agents. A sufficient interval of time should elapse prior to administration of another sympathomimetic agent. Metaproterenol should not be used more often than prescribed. If symptoms persist, patients should consult a physician promptly.

Drug Interactions: Other beta adrenergic bronchodilators should not be used concomitantly with Metaproterenol because they may have additive effects. Beta adrenergic agonist should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists on the vascular system may be potentiated.

Pregnancy: Teratogenic Effects: PREGNANCY CATEGORY C: Metaproterenol sulfate has been shown to be teratogenic and embryotoxic in rabbits when given in doses corresponding to 62 times the maximum recommended dose. These effects included skeletal abnormalities, hydrocephalus and skull bone separation. Results of other studies in rabbits, rats or mice have not revealed any teratogenic, embryotoxic or fetotoxic effects. There are no adequate and well-controlled studies in pregnant women. Metaproterenol sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether Metaproterenol is excreted in human milk; therefore, Metaproterenol should be used during nursing only if the potential benefit justifies the possible risk to the newborn.

Pediatric Use: Safety and effectiveness in children below the age of 6 have been demonstrated in a limited number of patients. See DOSAGE AND ADMINISTRATION section.

ADVERSE REACTIONS

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
Adverse Experience

Incidence

Number of Patients

%
Cardiovascular


Tachycardia

68

6.1

Central Nervous System


Headache

12

1.1

Nervousness

54

4.8

Gastrointestinal


Nausea

15

1.3

Musculoskeletal


Tremor

18

1.6

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.

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

DOSAGE AND ADMINISTRATION

Metaproterenol sulfate syrup contains 10 mg of Metaproterenol sulfate per teaspoonful.

Children: Aged six to nine years or weight under 60 lb - one teaspoonful (5 mL) three or four times a day. Children over nine years or weight over 60 lb - two teaspoonfuls (10 mL) three or four times a day. Clinical trial experience in children under the age of six is limited. Of 40 children treated with Metaproterenol sulfate syrup for at least one month, daily doses of approximately 1.3 to 2.6 mg/kg were well tolerated.

Adults: Two teaspoonfuls (10 mL) three or four times a day.

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

HOW SUPPLIED

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 Ave

Carmel, NY 10512


Container Label

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Metaproterenol pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Metaproterenol available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


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Metaproterenol destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Metaproterenol Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Metaproterenol pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."METAPROTERENOL SULFATE SYRUP [SILARX PHARMACEUTICALS, INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."METAPROTERENOL SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "metaproterenol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Metaproterenol?

Depending on the reaction of the Metaproterenol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Metaproterenol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Metaproterenol addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Metaproterenol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Metaproterenol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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