País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
METAPROTERENOL SULFATE (UNII: GJ20H50YF0) (METAPROTERENOL - UNII:53QOG569E0)
Lannett Company, Inc.
METAPROTERENOL SULFATE
METAPROTERENOL SULFATE 10 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Metaproterenol sulfate syrup is indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema. 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 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
Abbreviated New Drug Application
METAPROTERENOL SULFATE- METAPROTERENOL SULFATE SYRUP LANNETT COMPANY, INC. ---------- METAPROTERENOL SULFATE SYRUP, USP DESCRIPTION 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: CLINICAL PHARMACOLOGY _In vitro_ studies and _in vivo_ pharmacologic studies have demonstrated that metaproterenol sulfate has a preferential effect on beta adrenergic receptors compared with isoproterenol. While it is recognized that beta adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicate that there is a population of beta receptors in the human heart existing in a concentration between 10 to 50%. The precise function of these, however, is not yet established (see WARNINGS section). 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 cat Leia o documento completo