Anaspaz

Hyoscyamine Sulfate


Bf Ascher And Co Inc
Human Prescription Drug
NDC 0225-0295
Anaspaz also known as Hyoscyamine Sulfate is a human prescription drug labeled by 'Bf Ascher And Co Inc'. National Drug Code (NDC) number for Anaspaz is 0225-0295. This drug is available in dosage form of Tablet, Orally Disintegrating. The names of the active, medicinal ingredients in Anaspaz drug includes Hyoscyamine Sulfate - .125 mg/1 . The currest status of Anaspaz drug is Active.

Drug Information:

Drug NDC: 0225-0295
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Anaspaz
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Hyoscyamine Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Bf Ascher And Co Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, Orally Disintegrating
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:HYOSCYAMINE SULFATE - .125 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
SUBLINGUAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 02 Jan, 1973
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:BF ASCHER AND CO INC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1046985
1048056
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0302250295152
UPC stands for Universal Product Code.
UNII:F2R8V82B84
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0225-0295-15100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0225-0295-15)02 Jan, 1973N/ANo
0225-0295-20500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0225-0295-20)02 Jan, 1973N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Anaspaz hyoscyamine sulfate d&c yellow no. 10 lactose magnesium stearate mannitol sorbitol starch, corn stearic acid fd&c yellow no. 6 hyoscyamine sulfate hyoscyamine light yellow 0225;0295;a

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.

Indications and Usage:

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.

Warnings:

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 sympt
oms 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.

Dosage and Administration:

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.

Contraindications:

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.

Adverse Reactions:

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.

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.

Use in 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.

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.

Overdosage:

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.

Description:

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 17 h 23 no 3 )•2h 2 so 4 •2h 2 o. hyoscyamine structure.

Clinical Pharmacology:

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 1
2 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.

Carcinogenesis and Mutagenesis and 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.

How Supplied:

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).

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.

Package Label Principal Display Panel:

The structural formula for clomipramine hydrochloride.


Comments/ Reviews:

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