HYOSCYAMINE SULFATE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Franklin Pharmaceutical LLC

DCI (Denominação Comum Internacional):

HYOSCYAMINE SULFATE

Composição:

HYOSCYAMINE SULFATE 0.125 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, 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 t

Resumo do produto:

Hyoscyamine Sulfate Tablets, USP 0.125 mg are round, blue colored tablets that are imprinted with "AP" on one side and "112" on the other. Store at controlled room temperature 20°-25°C (68°-77°F); excursions 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 Also available as:

Status de autorização:

unapproved drug other

Características técnicas

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE TABLET
FRANKLIN PHARMACEUTICAL 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 TABLETS, USP
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: FD&C blue #1,
lactose monohydrate, magnesium
stearate, mannitol, starch and stearic acid.
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 autonomic ganglia.
Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and
decreases gastric acid secretion.
Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and
bronchlal 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 3½ hours. Hyoscyamine sulfate
is partly hydrolyzed to tropic acid and tropine but the majority of
the drug is exc