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

INN (International Name):

HYOSCYAMINE SULFATE

Composition:

HYOSCYAMINE SULFATE 0.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 30 NDC 63187-411-30 Bottles of 60 NDC 63187-411-60 Bottles of 90 NDC 63187-411-90 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._
----------
HYOSCYAMINE SULFATE TABLETS, USP, 0.125 MG
PI-9326
REV 02/09 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, 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 hydrolyzed to
tropic acid and tropine but the majority of the drug is excreted in
the u