Levbid Tablets

Generic name:hyoscyamine sulfate
Dosage form: tablet
Drug class:Anticholinergics / antispasmodics

Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:

Levbid® extended-release tablets contain 0.375 mg of hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage.

Hyoscyamine sulfate is one of the principal anticholinergic/ antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2•H2SO4•2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:

Each Levbid® extended-release tablet also contains as inactive ingredients: calcium phosphate dibasic, ethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and stearic acid.

CLINICAL PHARMACOLOGY:

Levbid® inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, the cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Levbid® inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Levbid® also controls excessive pharyngeal, tracheal, and bronchial secretions.

Hyoscyamine sulfate is absorbed totally and completely by oral administration. Once absorbed, it disappears rapidly from the blood and is distributed throughout the entire body: the half-life is 2 to 3 ½ hours. Hyoscyamine...