HYOSCYAMINE SULFATE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Alvogen Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Hyoscyamine Sulfate Tablets, USP 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 Tablets, USP 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.

Prehľad produktov:

Hyoscyamine Sulfate Tablets, USP, 0.125 mg are white, round, biconvex tablets debossed with “CL” on one side and “13” on the other. Bottles of 100 NDC 47781-013-01 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.

Stav Autorizácia:

unapproved drug other

Súhrn charakteristických

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE TABLET
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 TABLETS, USP, 0.125 MG
RX ONLY
DESCRIPTION
Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate
formulated for
oral administration.
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, crospovidone,
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
sinoatrial node, the atrioventricular node and the exocrine glands. At
therapeutic doses,
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