HYOSCYAMINE SULFATE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)
Available from:
Proficient Rx LP
INN (International Name):
HYOSCYAMINE SULFATE
Composition:
HYOSCYAMINE SULFATE 0.125 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, 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). Hyoscyamine Sulfate Tablets, USP are 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 parkinsonism to reduce rigidity and tremors
Product summary:
Hyoscyamine Sulfate Tablets, USP, 0.125 mg are white, round, biconvex tablets debossed with “CL” on one side and “13” on the other. Bottles of 30 NDC 63187-411-30 Bottles of 60 NDC 63187-411-60 Bottles of 90 NDC 63187-411-90 Store at controlled room temperature 20°-25°C (68°-77°F); excursion 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 OUT OF REACH OF CHILDREN
Authorization status:
unapproved drug other
Authorization number:
63187-411-30, 63187-411-60, 63187-411-90

HYOSCYAMINE SULFATE- hyoscyamine sulfate tablet

Proficient Rx LP

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 Tablets, USP, 0.125 mg

PI-9326

Rev 02/09 Rx Only

DESCRIPTION

Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated 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, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester,

[3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:

Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium

stearate and microcrystalline cellulose.

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 the 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. Hyoscyamine sulfate is partly hydrolyzed to

tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12

hours. Only traces of this drug are found in breast milk. Hyoscyamine sulfate passes the blood brain

barrier and the placental barrier.

INDICATIONS AND USAGE

Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer.

They can also be used to control gastric secretions, 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). Hyoscyamine Sulfate Tablets, USP are 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 parkinsonism to reduce rigidity and tremors and to control

associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase

agents.

CONTRAINDICATIONS

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 in acute

hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia

gravis.

WARNINGS

In the presence of high environmental temperature, heat prostration can occur with drug use (fever and

heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal

obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug

would be inappropriate and possibly harmful. Like other anticholinergic agents, hyoscyamine sulfate

may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to

engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or

to perform hazardous work while taking this drug.

Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine

sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss,

hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation

and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to

48 hours after discontinuation of the drug.

PRECAUTIONS

General:

Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease,

congestive heart failure, cardiac arrhythmias, hypertension and renal disease. Investigate any

tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Use with

caution in patients with hiatal hernia associated with reflux esophagitis.

Information for Patients:

Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred

vision. In this event, the patient should be warned not to engage in activities requiring mental alertness

such as operating a motor vehicle or other machinery or to perform hazardous work while taking this

drug.

Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke;

febrile patients or those who may be exposed to elevated environmental temperatures should use

caution.

Drug Interactions:

Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is

administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines,

monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.

Antacids may interfere with the absorption of hyoscyamine sulfate. Administer Hyoscyamine Sulfate

Tablets, USP before meals; antacids after meals.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or

impairment of fertility potential of hyoscyamine sulfate; however, 40 years of marketing experience

with hyoscyamine sulfate shows no demonstrable evidence of a problem.

Pregnancy-Pregnancy Category C:

Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known

whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. Hyoscyamine Sulfate Tablets, USP should be given to a pregnant woman only if

clearly needed.

Nursing Mothers:

Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when Hyoscyamine

Sulfate Tablets, USP are administered to a nursing woman.

Geriatric Use:

Reported clinical experience has not identified differences in safety between patients aged 65 and over

and younger patients. In general, dose selection for an elderly patient should be cautious, usually

starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal,

or cardiac function and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug

may be greater in patients with impaired renal function. Because elderly patients are more likely to have

decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal

function.

ADVERSE REACTIONS

The following adverse reactions have been reported for hyoscyamine sulfate and for

pharmacologically similar drugs with anticholinergic/antispasmodic action. Adverse reactions may

include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations;

mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness;

weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation;

constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies;

urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion

and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased

sweating.

OVERDOSAGE

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot

dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation.

Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg

intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically

(tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be

managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200

mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to

paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until

effective respiratory action returns.

In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.

DOSAGE AND ADMINISTRATION

Dosage may be adjusted according to the conditions and severity of symptoms.

Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do

not exceed 12 tablets in 24 hours.

Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed

6 tablets in 24 hours.

HOW SUPPLIED

Hyoscyamine Sulfate Tablets, USP, 0.125 mg are white, round, biconvex tablets debossed with “CL” on

one side and “13” on the other.

Bottles of 30

NDC 63187-411-30

Bottles of 60

NDC 63187-411-60

Bottles of 90

NDC 63187-411-90

Store at controlled room temperature 20°-25°C (68°-77°F); excursion 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 OUT OF REACH OF CHILDREN

Manufactured for:

County Line Pharmaceuticals, LLC

Brookfield, WI 53005

For inquiries call toll free 1-866-207-5636.

PI-9326

Rev 02/09

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

HYOSCYAMINE SULFATE

hyoscyamine sulfate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 318 7-411(NDC:4319 9 -0 13)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYO SCYAMINE SULFATE (UNII: F2R8 V8 2B8 4) (HYOSCYAMINE - UNII:PX44XO8 46 X)

HYOSCYAMINE SULFATE

0 .125 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

CL;13

Contains

Packag ing

Proficient Rx LP

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 318 7-411-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 15

2

NDC:6 318 7-411-6 0

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/29 /20 20

3

NDC:6 318 7-411-9 0

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/29 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

11/0 5/20 0 9

Labeler -

Proficient Rx LP (079196022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro ficient Rx LP

0 79 19 6 0 22

REPACK(6 318 7-411) , RELABEL(6 318 7-411)

Revised: 7/2020

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