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:

Proficient Rx LP

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 10 NDC 63187-058-10 Bottle of 15 NDC 63187-058-15 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

Authorization status:

unapproved drug other

Summary of Product characteristics

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE TABLET
PROFICIENT RX LP
_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 04/09 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
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 sulfate is 2
to 3 1/2 hours. Hyoscyamin