HYOSCYAMINE SULFATE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hyoscyamine Sulfate Orally Disintegrating 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 Orally Disintegrating 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 parkinson

Product summary:

Hyoscyamine Sulfate Orally Disintegrating Tablets 0.125 mg are white, round, flat-faced, beveled edge, mint flavored tablets debossed with CL on one side and 12 on the other. NDC 68071-5024-8 BOTTLES OF 8 Store at controlled room temperature 20°-25°C (68°-77°F); excursion 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 To report SUSPECTED ADVERSE REACTIONS, contact County Line 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: County Line Pharmaceuticals, LLC Pine Brook, NJ 07058 USA PI-9324 Rev. 11/2017

Authorization status:

unapproved drug other

Summary of Product characteristics

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING
NUCARE 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 ORALLY DISINTEGRATING TABLETS, 0.125 MG
PI-9324
REV 11/2017 RX ONLY
DESCRIPTION
Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg
hyoscyamine sulfate
formulated for oral administration. Hyoscyamine Sulfate Orally
Disintegrating Tablets
0.125 mg disintegrate within seconds after placement on the tongue,
allowing them to
be swallowed with or without water.
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, mannitol, sorbitol and flavor.
CLINICAL PHARMACOLOGY
17
23
3
2
2
4
2
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 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 sulf