HYOSCYAMINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

County Line Pharmaceuticals, LLC

INN (International Name):

HYOSCYAMINE SULFATE

Composition:

HYOSCYAMINE SULFATE 0.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hyoscyamine Sulfate Sublingual 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 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 rigidity

Product summary:

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg are white, round, flat-faced, beveled edge, mint flavored tablets debossed with “CL” on one side and “11” on the other. Bottles of 100 NDC 43199-011-01 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.

Authorization status:

unapproved drug other

Summary of Product characteristics

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE TABLET
COUNTY LINE PHARMACEUTICALS, LLC
_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 SUBLINGUAL TABLETS, 0.125 MG
PI-9322
REV 11/2017 RX ONLY
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: colloidal silicon
dioxide, crospovidone,
magnesium stearate, mannitol, sorbitol and flavor.
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
17
23
3 2
2
4
2
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 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
su