HYOSCYAMINE SL- hyoscyamine sulfate tablet, orally disintegrating

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)

Verfügbar ab:

Wallace Pharmaceuticals Inc.

INN (Internationale Bezeichnung):

HYOSCYAMINE SULFATE

Zusammensetzung:

HYOSCYAMINE SULFATE 0.125 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Hyoscyamine sulfate sublingual tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine sulfate sublingual tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidit

Produktbesonderheiten:

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “113” on the other. Bottles of 100 tablets NDC 51525-0113-1 Store at controlled room temperature 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). Please refer to current USP. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP OUT OF REACH OF CHILDREN Also available as: Dosage Strength Package Size NDC Hyoscyamine Sulfate Tablets, USP 0.125 mg 100 51525-0112-1 Hyoscyamine Sulfate Extended-Release Tablets 0.375 mg 100 51525-0115-1 Distributed by: Wallace Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 © 2018 Mylan Pharmaceuticals Inc. WALLACE and     are trademarks of Wallace Pharmaceuticals Inc., a Mylan company. IN-1131-03 Rev. 3/2018 Printed in USA 70011275

Berechtigungsstatus:

unapproved drug other

Fachinformation

HYOSCYAMINE SL- HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING
WALLACE PHARMACEUTICALS INC.
_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._
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DESCRIPTION
Hyoscyamine sulfate sublingual tablets contain 0.125 mg hyoscyamine
sulfate formulated for sublingual
administration. However, the tablets may be chewed or taken orally.
Hyoscyamine sulfate is one of the principal
anticholinergic/antispasmodic components of belladonna
alkaloids. The empirical formula is (C
H NO ) •H SO •2H O 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 tablet also contains as inactive ingredients: FD&C blue #1,
lactose monohydrate, magnesium
stearate, mannitol, starch and stearic acid.
CLINICAL PHARMACOLOGY
Hyoscyamine sulfate 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, 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.
Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and
decreases gastric acid secretion.
Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and
bronchial secretions.
Hyoscyamine sulfate is absorbed totally and completely by sublingual
administration as well as oral
administration. Once absorbed, hyoscyamine sulfate disappears rapidly
from the blood and is distributed
throughout the entire body. The half-life of hyoscyamine sulfate is 2
to 3ó hours. Hyoscyamine sulfate
is partly hydrolyzed to tropic acid and tr