HYOSCYAMINE SULFATE- hyoscyamine sulfate elixir

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

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Active ingredient:
HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)
Available from:
Method Pharmaceuticals, LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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
Product summary:
Hyoscyamine Sulfate Elixir (0.125 mg per 5 mL) is clear colored, grape flavored and contains no alcohol or sugar. It is supplied in 16 fl. Oz. (473 mL) bottles (NDC 58657-427-16). Store at controlled room temperature, 15°-30°C (59°-86°F). Rx Only. Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev. Date: 08/2019
Authorization status:
unapproved drug other
Authorization number:
58657-427-16

HYOSCYAMINE SULFATE- hyoscyamine sulfate elixir

Method 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

Hyoscyamine Sulfate Elixir

Rx Only

DESCRIPTION

Hyoscyamine Sulfate Elixir contains 0.125 mg hyoscyamine sulfate per 5 mL that is alcohol free and

sugar free 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, (a-(hydroxymethyl)-, 8- methyl-8-azabicyclo[3.2.1.]oct-3-yl ester,

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

Hyoscyamine Sulfate Elixir also contain as inactive ingredients: Purified Water, Glycerin,

Methylparaben Sodium, Propylparaben Sodium, Saccharin Sodium, Xylitol, Citric Acid, Stevia Reb-A,

Natural and Artificial Grape Flavor.

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 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 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

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, 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.

Not to be used by persons having glaucoma or excessive pressure within the eye, by elderly persons

(where undiagnosed glaucoma or excessive pressure within the eye occurs most frequently), or by

children under 6 years of age, unless directed by a physician.

Discontinue use if blurring of vision, rapid pulse, or dizziness occurs. Do not exceed recommended

dosage. Not for frequent or prolonged use. If dryness of the mouth occurs, decrease dosage. If eye

pain occurs, discontinue use and see your physician immediately as this may indicate undiagnosed

glaucoma.

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 drug 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

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, 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 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

is 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

All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions

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

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

weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; 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.

To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at 1-

877-250-3427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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

Hyoscyamine Sulfate Elixir:

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

carefully.

Adults and pediatric patients 12 years of age and older: 1 to 2 teaspoonfuls every four hours or as

needed.

Do not exceed 12 teaspoonfuls in 24 hours.

HOW SUPPLIED

Hyoscyamine Sulfate Elixir (0.125 mg per 5 mL) is clear colored, grape flavored and contains no

alcohol or sugar. It is supplied in 16 fl. Oz. (473 mL) bottles (NDC 58657-427-16).

Store at controlled room temperature, 15°-30°C (59°-86°F).

Rx Only.

Distributed by:

Method Pharmaceuticals, LLC

Fort Worth, TX 76118

Rev. Date: 08/2019

PRINCIPAL DISPLAY PANEL

NDC 58657-427-16

Hyoscyamine

Sulfate Elixir

EACH 5 mL (ONE TEASPOONFUL) CONATINS:

Hyoscyamine Sulfate………0.125 mg

Rx Only

16 fl oz (473 mL)

HYOSCYAMINE SULFATE

hyoscyamine sulfate elixir

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:58 6 57-427

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 in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN SO DIUM (UNII: CR6 K9 C2NHK)

PRO PYLPARABEN SO DIUM (UNII: 6 25NNB0 G9 N)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

REBAUDIO SIDE A (UNII: B3FUD0 528 F)

Method Pharmaceuticals, LLC

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 6 57-427-16

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

0 9 /15/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED DRUG OTHER

0 9 /15/20 19

Labeler -

Method Pharmaceuticals, LLC (060216698)

Revised: 9/2019

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