NDC 0225-0295 Anaspaz

Hyoscyamine Sulfate

NDC Product Code 0225-0295

NDC CODE: 0225-0295

Proprietary Name: Anaspaz What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hyoscyamine Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. It is also used to treat other conditions such as bladder and bowel control problems, cramping pain caused by kidney stones and gallstones, and Parkinson's disease. In addition, it is used to decrease side effects of certain medications (drugs used to treat myasthenia gravis) and insecticides. This medication works by decreasing acid production in the stomach, slowing down the natural movements of the gut, and relaxing muscles in many organs (such as the stomach, intestines, bladder, kidney, gallbladder). Hyoscyamine also lessens the amount of certain body fluids (e.g., saliva, sweat). This medication belongs to a class of drugs known as anticholinergics/antispasmodics.

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
0225;0295;A
Score: 2

NDC Code Structure

NDC 0225-0295-15

Package Description: 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC

NDC 0225-0295-20

Package Description: 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC

NDC Product Information

Anaspaz with NDC 0225-0295 is a a human prescription drug product labeled by Bf Ascher And Co Inc. The generic name of Anaspaz is hyoscyamine sulfate. The product's dosage form is tablet, orally disintegrating and is administered via oral; sublingual form.

Labeler Name: Bf Ascher And Co Inc

Dosage Form: Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Anaspaz Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYOSCYAMINE SULFATE .125 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • SORBITOL (UNII: 506T60A25R)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Sublingual - Administration beneath the tongue.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bf Ascher And Co Inc
Labeler Code: 0225
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-02-1973 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Hyoscyamine

Hyoscyamine is pronounced as (hye oh sye' a meen)

Why is hyoscyamine medication prescribed?
Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It works by decreasing the motion of the stomach and intestines and ...
[Read More]

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Anaspaz Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

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


17H


23NO


3)•2H


2SO


4•2H


2O.

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 the urine unchanged within the first 12 hours, with a small amount hydrolyzed to tropic acid and tropine. Only traces of this drug are found in breast milk. ANASPAZ passes the blood-brain barrier and the placental barriers.

Indications And Usage

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.

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; severe ulcerative colitis; toxic megacolon; myasthenia gravis; myocardial ischemia.

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, ANASPAZ may produce drowsiness 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.Anticholinergic psychosis has been reported in sensitive individuals given anticholinergic drugs. 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.


Elderly patients may react with excitement, agitation, drowsiness, and other unfavorable manifestations to even small doses of ANASPAZ.

General Precautions

General: Use with caution and only when clearly indicated 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

Information for Patients: ANASPAZ may produce drowsiness, dizziness or blurred vision. Patients should observe caution before operating a motor vehicle or other machinery or performing other tasks requiring mental alertness.


Use of ANASPAZ 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

Drug Interactions: Additive adverse effects resulting from cholinergic blockade may occur when ANASPAZ is administered concomitantly with other anti-muscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.


Antacids may interfere with the absorption of ANASPAZ; take ANASPAZ before meals and antacids after meals.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals have been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of ANASPAZ in either males or females.

Pregnancy

Pregnancy-Pregnancy Category C: Animal reproduction studies have not been conducted with ANASPAZ. It is also not known whether ANASPAZ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ANASPAZ should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Nursing Mothers: ANASPAZ is excreted in human milk. Caution should be exercised when ANASPAZ is administered to a nursing woman.

Pediatric Use

Pediatric Use: This product is not recommended for use in children under twelve years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications’ suppression of sweat gland activity.


A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics.

Geriatric Use

Geriatric Use: 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. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of ANASPAZ and observed closely.

Adverse Reactions

Not all of the following adverse reactions have been associated with ANASPAZ, but have been reported for drugs in the same pharmacological class, with anticholinergic/antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy, urinary retention, tachycardia, palpitations, blurred vision, mydriasis, cycloplegia, increased intraocular pressure, dry eyes, headache, nervousness, drowsiness, dizziness, weakness, mental confusion and/or excitement (especially in geriatric patients), flushing, insomnia, fever, altered sense of taste, nausea, vomiting, dysphagia, heart burn, constipation, bloated feeling, suppression of lactation, impotence, and decreased sweating. Allergic reactions or drug idiosyncrasies such as anaphylaxis, urticaria and other dermal manifestations may also occur.

Overdosage

The signs and symptoms of overdose include headache, nausea, vomiting, dizziness, dry mouth, difficulty in swallowing, dilated pupils, blurred vision, urinary retention, hot dry and flushed skin, tachycardia, hypertension, hypotension, respiratory depression, CNS stimulation, fever, ataxia, excitation, lethargy, stupor, coma, and paralysis (with large overdoses).General measures such as emesis or gastric lavage and administration of activated charcoal should be undertaken immediately. Supportive therapy is given as needed, including artificial respiration if required. Physostigmine may be given by intravenous injection to reverse severe anticholinergic symptoms.The LD


50 for hyoscyamine in rats is 375 mg/kg.


Hyoscyamine sulfate is dialyzable.

Dosage And Administration

Adults and children 12 years of age and older: 1 or 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.ANASPAZ may be taken orally (swallowed or chewed) or sublingually. The dosage of ANASPAZ should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

How Supplied

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).

Storage And Handling

Store at room temperature - 59º - 86º F (15º - 30º C) in a dry place.


Dispense in tight, amber glass or opaque PE plastic containers.


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.Manufactured for B.F. Ascher and Co., Inc.


Lenexa, KS 66219


Revised 04-17

* Please review the disclaimer below.