Hyosyne
Hyoscyamine Sulfate
Lannett Company, Inc.
Human Prescription Drug
NDC 54838-506Hyosyne also known as Hyoscyamine Sulfate is a human prescription drug labeled by 'Lannett Company, Inc.'. National Drug Code (NDC) number for Hyosyne is 54838-506. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Hyosyne drug includes Hyoscyamine Sulfate - .125 mg/mL . The currest status of Hyosyne drug is Active.
Drug Information:
| Drug NDC: | 54838-506 |
| 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: | Hyosyne |
| 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: | Lannett Company, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 01 Oct, 1997 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Jan, 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, 2024 |
| 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: | Lannett Company, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1047895
|
| 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. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 54838-506-15 | 15 mL in 1 BOTTLE, PLASTIC (54838-506-15) | 01 Oct, 1997 | N/A | No |
| 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:
Hyosyne hyoscyamine sulfate hyoscyamine sulfate hyoscyamine alcohol anhydrous citric acid fd&c red no. 40 fd&c yellow no. 6 glycerin sodium benzoate sodium citrate sorbitol sucrose water
Indications and Usage:
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 âdrying agentâ in the relief of
Read more... 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.
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, 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. 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 an
Read more...d symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
Dosage and Administration:
Dosage and administration hyosyne oral drops (hyoscyamine sulfate oral solution) dosage may be adjusted according to the conditions and severity of symptoms. measuredosage very carefully. adults and pediatric patients 12 years of age and older : 1 to 2 ml every four hours or as needed. do not exceed 12 ml in 24 hours. pediatric patients 2 to under 12 years of age : 1/4 to 1 ml every four hours or as needed. do not exceed 6 ml in 24 hours. pediatric patients under 2 years of age : the following dosage guide is based upon body weight. the doses may be repeated every four hours or as needed. body weight usual dose do not exceed in 24 hours 3.4 kg (7.5 lb.) 4 drops 24 drops 5 kg (11 lb.) 5 drops 30 drops 7 kg (15 lb.) 6 drops 36 drops 10 kg (22 lb.) 8 drops 48 drops package of hyoscyamine sulfate oral drops is accompanied with a dropper having markings of 3, 4, 5 drops, and 0.25 ml. the approximate equivalent amount of hyoscyamine sulfate drops (ml) and its equivalent amount of hyoscyamine
Read more... sulfate (mg) for each marking are as follows: approximate equivalent amount marking on dropper hyoscyamine sulfate oral drops solution (ml) hyoscyamine sulfate (mg) 3 drops 0.08 ml 0.01 mg 4 drops 0.11 ml 0.01375 mg 5 drops 0.14 ml 0.0175 mg 0.25 ml 0.25 ml 0.03125 mg hyosyne elixir (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. pediatric patients 2 to under 12 years of age : please see the following dosage guide is based on body weight. the doses may be repeated every four hours or as needed. do not exceed 6teaspoonfuls in 24 hours. body weigh t usual dose 10 kg (22 lb.) 1/4 teaspoon (1.25 ml) 20 kg (44 lb.) 1/2 teaspoonful (2.5 ml) 40 kg (88 lb.) 3/4 teaspoonful (3.75 ml) 50 kg (110 lb.) 1 teaspoonful (5 ml)
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 in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.
Adverse Reactions:
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.
Overdosage:
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.
Description:
Description hyosyne oral drops (hyoscyamine sulfate oral solution) contain 0.125 mg hyoscyamine sulfate per ml with 5% v/v alcohol for oral administration. hyosyne elixir (hyoscyamine sulfate elixir) contains 0.125 mg hyoscyamine sulfate per 5 ml with 20% v/v alcohol for oral administration. hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. the empirical formula is (c 17 h 23 no 3 ) 2 ⢠h 2 so 4 ⢠2h 2 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: hyosyne oral drops also contain as inactive ingredients: alcohol, citric acid, fd&c red #40, fd&c yellow #6, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. hyosyne elixir also contain as inactive ingredients: alcohol, citric acid, fd&c red #40, fd&c yellow #6, flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. structure
Clinical Pharmacology:
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 hydro
Read more...lyzed 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.
How Supplied:
How supplied hyosyne oral drops (hyoscyamine sulfate 0.125 mg per ml) is orange colored, flavored, and contains 5% alcohol. it is supplied in a 15 ml bottle with a calibrated dropper (ndc 54838-506-15). hyosyne elixir (hyoscyamine sulfate 0.125 mg per 5 ml) is orange colored, flavored, and contains 20% alcohol. it is supplied in a pint (473 ml) bottle (ndc 54838-511-80). store at 20°-25°c (68°-77°f); excursions permitted between 15°-30°c (59°-86°f) [see usp controlled room temperature]. rx only. distributed by: lannett company, inc. philadelphia, pa 19136 revised 12/19 10-1101 cg#1101-1
Package Label Principal Display Panel:
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