HYOSCYAMINE SULFATE ODT- hyoscyamine sulfate tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Acella Pharmaceuticals, LLC

INN (International Name):

HYOSCYAMINE SULFATE

Composition:

HYOSCYAMINE SULFATE 0.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders. Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. This product is not recommended for use in children under twelve years of age.

Product summary:

Hyoscyamine Sulfate ODT is supplied as round, green, peppermint flavored tablets with "38" debossed on one side. They are available in bottles of 100 tablets, NDC 42192-338-01. Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY . All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. Acella Pharmaceuticals, LLC Alpharetta, GA 30022 1-800-541-4802 Rev. 07/2017 500425-06

Authorization status:

unapproved drug other

Summary of Product characteristics

HYOSCYAMINE SULFATE ODT- HYOSCYAMINE SULFATE TABLET, ORALLY
DISINTEGRATING
ACELLA 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 ODT
DESCRIPTION
Each round, green, peppermint flavored, orally dispersible tablet
contains:
Hyoscyamine Sulfate, USP …… 0.125 mg.
Hyoscyamine sulfate is one of the principal anticholinergic/
antispasmodic components
of belladonna alkaloids.
(C
H
NO
)
• H
SO
• 2H
O M.W. = 712.85
INACTIVE INGREDIENTS
INACTIVE INGREDIENTS INCLUDE: Green LKB #LB-620, lactose monohydrate,
magnesium
stearate (veg), mannitol USP, peppermint flavor, starch and stearic
acid.
CLINICAL PHARMACOLOGY
Hyoscyamine has actions similar to those of atropine, but is more
potent in both its
central and peripheral effects.
This product inhibits gastrointestinal propulsive motility and
decreases gastric acid
secretions. This product controls excessive pharyngeal, tracheal, and
bronchial
secretion. This product is absorbed totally and completely by
sublingual administration
as well as oral administration.
Once absorbed, this product disappears rapidly from the blood and is
distributed
throughout the entire body.
17
23
3
2
2
4
2
The majority of hyoscyamine sulfate is excreted in the urine unchanged
within the first
12 hours and only traces of hyoscyamine sulfate are found in the
breast milk.
INDICATIONS AND USAGE
This product may be used in functional intestinal disorders to reduce
symptoms such as
those seen in mild dysenteries and diverticulitis. It can also be used
to control gastric
secretion, visceral spasm and hypermotility in cystitis, pylorospasm
and associated
abdominal cramps.
Along with appropriate analgesics, this product is indicated in
symptomatic relief of
biliary and renal colic and as a drying agent in the relief of
symptoms of acute rhinitis.
This product is effective as adjunctive therapy in the treatment of
pe