ANASPAZ- 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:

BF ASCHER AND CO INC

INN (International Name):

HYOSCYAMINE SULFATE

Composition:

HYOSCYAMINE SULFATE 0.125 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ANASPAZ is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), acute entercolitis and other functional gastrointestinal disorders. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. ANASPAZ is indicated (along with appropriate analgesics) in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus; intestinal atony of elderly or debilitated patients; unstable cardiovascular status; severe ulcerative colitis; toxic megacolon; myasthenia gravis; my

Product summary:

ANASPAZ (l-hyoscyamine sulfate orally disintegrating tablets) 0.125mg is available as a compressed, light yellow, scored tablet, imprinted with the Ascher logo and 225/295 in bottles of 100 tablets (NDC 0225-0295-15) and 500 tablets (NDC 0225-0295-20).

Authorization status:

unapproved drug other

Summary of Product characteristics

ANASPAZ - HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING
BF ASCHER AND CO 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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ANASPAZ
l-hyoscyamine sulfate
0.125 mg tablets
Rx only
DESCRIPTION
Each ANASPAZ tablet contains l-hyoscyamine sulfate 0.125mg. ANASPAZ
may be taken orally
(swallowed or chewed) or sublingually. ANASPAZ tablets are compressed,
light yellow, and scored
with the Ascher logo on one side and 225/295 on the other. Inactive
ingredients: FD&C yellow #6,
FD&C yellow #10, lactose monohydrate NF, magnesium stearate NF,
mannitol USP, starch 1500 NF,
stearic acid NF purified powder.
ANASPAZ is chemically pure l-hyoscyamine sulfate, one of the principal
anticholinergic/antispasmodic components of belladonna alkaloids.
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 chemical formula (C
H
NO
)•2H
SO
•2H
O.
CLINICAL PHARMACOLOGY
ANASPAZ 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
smooth muscle, cardiac muscle, the sino-atrial node, the
atrioventricular node and the exocrine glands.
At therapeutic doses, it is completely devoid of any action on
autonomic ganglia. ANASPAZ inhibits
gastrointestinal propulsive motility and decreases gastric acid
secretion. ANASPAZ also controls
excessive pharyngeal, tracheal and bronchial secretions. ANASPAZ is
absorbed totally and completely
by sublingual administration as well as oral administration. Once
absorbed, ANASPAZ disappears
rapidly from the blood and is distributed throughout the entire body.
The half-life of ANASPAZ is 3.5
hours and the majority of the drug is excreted in