METAPROTERENOL SULFATE syrup

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

METAPROTERENOL SULFATE (UNII: GJ20H50YF0) (METAPROTERENOL - UNII:53QOG569E0)

Διαθέσιμο από:

Lannett Company, Inc.

INN (Διεθνής Όνομα):

METAPROTERENOL SULFATE

Σύνθεση:

METAPROTERENOL SULFATE 10 mg in 5 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

METAPROTERENOL SULFATE- METAPROTERENOL SULFATE SYRUP
LANNETT COMPANY, INC.
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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