HYOSCYAMINE SULFATE elixir

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Method Pharmaceuticals, LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It 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). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is 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

Descriptif du produit:

Hyoscyamine Sulfate Elixir (0.125 mg per 5 mL) is clear colored, grape flavored and contains no alcohol or sugar. It is supplied in 16 fl. Oz. (473 mL) bottles (NDC 58657-427-16). Store at controlled room temperature, 15°-30°C (59°-86°F). Rx Only. Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev. Date: 08/2019

Statut de autorisation:

unapproved drug other

Résumé des caractéristiques du produit

HYOSCYAMINE SULFATE- HYOSCYAMINE SULFATE ELIXIR
METHOD 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
HYOSCYAMINE SULFATE ELIXIR
RX ONLY
DESCRIPTION
Hyoscyamine Sulfate Elixir contains 0.125 mg hyoscyamine sulfate per 5
mL that is
alcohol free and sugar free 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,
(a-(hydroxymethyl)-, 8-
methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, [3(S)- endo]-, sulfate
(2:1), dihydrate with the
following structure:
HYOSCYAMINE SULFATE ELIXIR also contain as inactive ingredients:
Purified Water,
Glycerin, Methylparaben Sodium, Propylparaben Sodium, Saccharin
Sodium, Xylitol, Citric
Acid, Stevia Reb-A, Natural and Artificial Grape 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 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.
Hyoscyam