HYOSCYAMINE SULFATE tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Alvogen Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Hyoscyamine Sulfate Extended-Release Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, 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 Extended-Release 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 rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents. Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

產品總結:

Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg are white, capsule shaped, biconvex tablets debossed with “CL” on one side and “14” on the other. Bottles of 100 NDC 47781-014-01 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursion permitted to 15° to 30°C (59° to 86°F). 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 To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of suspected adverse reactions. Distributed by: Alvogen, Inc. Morristown, NJ 07960 USA PI014-00 Revised: 08/2021

授权状态:

unapproved drug other

产品特点

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE
ALVOGEN 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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HYOSCYAMINE SULFATE EXTENDED-RELEASE TABLETS, 0.375 MG
DESCRIPTION
Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg
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 (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: Colloidal silicon
dioxide, hydroxypropyl
cellulose, magnesium stearate and microcrystalline cellulose.
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
17
23
3 2
2
4
2
sinoatrial node, the atrioventricular node and the exocrine glands. At
therapeutic doses,
it is completely devoid of any action on the 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 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 3 1/2 hours.
Hyoscyamine sulfate is partly hydrolyzed to tropic acid and t