ED-SPAZ- hyoscyamine sulfate tablet, orally disintegrating

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

EDWARDS PHARMACEUTICALS, INC.

INN (Միջազգային անվանումը):

HYOSCYAMINE SULFATE

Կազմը:

HYOSCYAMINE SULFATE 0.125 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

ED-SPAZ Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg are white, round, flat beveled edge tablets debossed "634" on one side and a score line on other side. Bottles of 100 NDC 0485-0082-01 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 THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Belcher Pharmaceuticals, Inc. 6911 Bryan Dairy Road Largo, FL 33777 Manufactured for: Edwards Pharmaceutical, Inc. 111 W. Mulberry St. Ripley, MS 38663 May 2010 L18I R-0510

Լիազորման կարգավիճակը:

unapproved drug other

Ապրանքի հատկությունները

ED-SPAZ- HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING
EDWARDS PHARMACEUTICALS, 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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ED-SPAZ
NDC 0485-0082-01
HYOSCYAMINE SULFATE
ORALLY DISINTEGRATING
TABLETS, 0.125 MG
RX ONLY
DESCRIPTION
Hyoscyamine sulfate orally disintegrating tablets contain 0.125 mg
hyoscyamine sulfate
formulated for oral administration.
Hyoscyamine sulfate is one of the principal
anticholinergic/antispasmodic components of
belladonna alkaloids. The molecular 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 structural formula:
Each tablet also contains as inactive ingredients: mannitol,
croscarmellose sodium and
magnesium stearate.
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
17
23
3
2
2
4
2
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 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 par