OSCIMIN- hyoscyamine sulfate tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Larken Laboratories, Inc.

INN (Διεθνής Όνομα):

HYOSCYAMINE SULFATE

Σύνθεση:

HYOSCYAMINE SULFATE 0.375 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

OSCIMIN SR Tablets are supplied as green, capsule shaped tablets debossed “LL 255” on one side and plain on the opposite side. They are available in bottles of 100 tablets, NDC 68047-255-01. Store at controlled room temperature, 20°-25°C (68°-77°F), see USP Controlled Room Temperature. Dispense in tight, light-resistant containers as defined in USP/NF, with a child-resistant closure. 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 . Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Rev. 06/2017 500416-01

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

OSCIMIN- HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE
LARKEN LABORATORIES, INC.
_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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OSCIMIN SR TABLETS
DESCRIPTION
Each sustained-release tablet for oral administration contains:
Hyoscyamine Sulfate, USP …… 0.375 mg
Hyoscyamine sulfate is one of the principal anticholinergic/
antispasmodic components
of belladonna alkaloids.
Hyoscyamine sulfate is Benzeneacetic acid, α-(hydroxymethyl)-, 8-
methyl-8-
azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1),
dihydrate.
(C
H
NO
) • H
SO • 2H
O M.W. = 712.85
INACTIVE INGREDIENTS
Inactive ingredients include: calcium phosphate dibasic,
ethylcellulose, D&C Yellow #10
Aluminum Lake, FD&C Blue #1 Aluminum Lake, lactose monohydrate,
magnesium
stearate (veg.), microcrystalline cellulose, 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.
17
23
3 2
2
4
2
Once absorbed, this product disappears rapidly from the blood and is
distributed
throughout the entire body. 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.