HYOSCYAMINE ER- hyoscyamine sulfate tablet, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Wallace Pharmaceuticals Inc.

INN (Nama Internasional):

HYOSCYAMINE SULFATE

Komposisi:

HYOSCYAMINE SULFATE 0.375 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Hyoscyamine sulfate extended-release 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 andmneurogenic 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 re

Ringkasan produk:

Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg are white, capsule-shaped tablets. They are coded “AP” on one side and “115” on the other. Bottles of 100 tablets          NDC 51525-0115-1 Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-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 Also available as: Dosage Strength Package Size NDC Hyoscyamine Sulfate Tablets, USP 0.125 mg 100 51525-0112-1 Hyoscyamine Sulfate Sublingual Tablets 0.125 mg 100 51525-0113-1 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-1151-03                 Rev. 3/2018 Printed in USA 70011278

Status otorisasi:

unapproved drug other

Karakteristik produk

HYOSCYAMINE ER- HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE
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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HYOSCYAMINE SULFATE EXTENDED-RELEASE TABLETS, 0.375 MG
RX ONLY
DESCRIPTION
Hyoscyamine sulfate 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 (C
H NO ) •H SO •2H O and the molecular weight is 712.85.
Chemically, it is benzeneacetic acid,
-(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: calcium phosphate
dibasic, ethylcellulose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose 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, 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.
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 3½ hours. Hyoscyamine
sulfate is partly hyd