Hyophen

Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate

Biocomp Pharma, Inc.
Human Prescription Drug
NDC 44523-741

Hyophen also known as Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate is a human prescription drug labeled by 'Biocomp Pharma, Inc.'. National Drug Code (NDC) number for Hyophen is 44523-741. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Hyophen drug includes Benzoic Acid - 9 mg/1 Hyoscyamine Sulfate - .12 mg/1 Methenamine - 81.6 mg/1 Methylene Blue - 10.8 mg/1 Phenyl Salicylate - 36.2 mg/1 . The currest status of Hyophen drug is Active.

Drug Information:

Drug NDC:	44523-741
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:	Hyophen
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:	Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Biocomp Pharma, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	BENZOIC ACID - 9 mg/1 HYOSCYAMINE SULFATE - .12 mg/1 METHENAMINE - 81.6 mg/1 METHYLENE BLUE - 10.8 mg/1 PHENYL SALICYLATE - 36.2 mg/1
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:	21 Sep, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Dec, 2025
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:	BioComp Pharma, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1037234 1037236
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.
NUI:	N0000175806 N0000175807
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	8SKN0B0MIM F2R8V82B84 J50OIX95QV T42P99266K 28A37T47QO
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.
Pharmacologic Class MOA:	Ammonium Ion Binding Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Nitrogen Binding Agent [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	Ammonium Ion Binding Activity [MoA] Nitrogen Binding Agent [EPC] Oxidation-Reduction Activity [MoA] Oxidation-Reduction Agent [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
44523-741-01	100 TABLET in 1 BOTTLE (44523-741-01)	21 Sep, 2010	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.

Other medicines with the same generic name

Hyophen

Methenamine & more..

Tablet
BioComp Pharma, Inc.
NDC: 44523-741

Product Elements:

Hyophen methenamine, benzoic acid, phenyl salicylate, methylene blue, and hyoscyamine sulfate crospovidone magnesium stearate cellulose, microcrystalline polyethylene glycol polyvinyl alcohol starch, rice silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide methenamine methenamine benzoic acid benzoic acid phenyl salicylate phenyl salicylate methylene blue methylene blue cation hyoscyamine sulfate hyoscyamine sat;901

Drug Interactions:

Drug interactions as a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. methylene blue inhibits a range of cyp isozymes in vitro, including 1a2, 2b6, 2c8, 2c9, 2c19, 2d6 and 3a4/5. this interaction could be more pronounced with narrow therapeutic index drugs that are metabolized by one of these enzymes (e.g., digoxin, warfarin, phenytoin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus). however, the clinical relevance of these in vitro interactions is unknown.

Indications and Usage:

Indications and usage hyophen Â® tablets are indicated for the treatment of symptoms of irritative voiding. indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Warnings:

Warnings do not exceed recommended dosage. if rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.

Dosage and Administration:

Dosage and administration adults - one tablet orally 4 times per day followed by liberal fluid intake. older children - dosage must be individualized by physician. not recommended for use in children six years of age or younger.

Contraindications:

Contraindications hypersensitivity to any of the ingredients is possible. risk benefits should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Adverse Reactions:

Adverse reactions cardiovascular: rapid heartbeat, flushing central nervous system: blurred vision, dizziness, drowsiness genitourinary: difficult micturition, acute urinary retention gastrointestinal: dry mouth, nausea and vomiting respiratory: shortness of breath or trouble breathing serious allergic reactions to this drug are rare. seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. this medication can cause urine and sometimes stools to turn blue to blue-green. this effect is harmless and will subside after medication is stopped. call your doctor or physician for medical advice about side effects. to report suspected adverse reactions, contact biocomp pharma at 1-866-762-2365 or fda at 1-800-fda-1088, www.fda.gov/medwatch. drug interactions as a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be dec Read more...

reased during concurrent use with this combination medication. methylene blue inhibits a range of cyp isozymes in vitro, including 1a2, 2b6, 2c8, 2c9, 2c19, 2d6 and 3a4/5. this interaction could be more pronounced with narrow therapeutic index drugs that are metabolized by one of these enzymes (e.g., digoxin, warfarin, phenytoin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus). however, the clinical relevance of these in vitro interactions is unknown.

Drug Interactions:

Use in Pregnancy:

Pregnancy/reproduction fda pregnancy category c hyoscyamine and methenamine cross the placenta. studies concerning the effect of hyoscyamine and methenamine on pregnancy and reproduction have not been done in animals or humans. thus it is not known whether hyophen â¢ tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity and should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric Use:

Geriatric use use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion.

Overdosage:

Overdosage emesis or gastric lavage. slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. administration of small doses of diazepam to control excitement and seizures. artificial respiration with oxygen if needed for respiratory depression. adequate hydration. symptomatic treatment as necessary. if overdose is suspected, contact your local poison center or emergency room immediately. us residents can contact the us national poison hotline at 1-800-222-1222.

Description:

Description hyophen Â® tablets for oral administration each tablet contains: methenamine 81.6 mg benzoic acid 9.0 mg phenyl salicylate 36.2 mg methylene blue 10.8 mg hyoscyamine sulfate 0.12 mg hyoscyamine sulfate. [620-61-1][3(s)-endo]-Î±-(hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1Î±h,5Î±h-tropan-3Î±-ol(-)-tropate(ester) sulfate(2:1)(salt); 3Î±-tropanyl s-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. c 34 h 48 n 2 o 10 s. hyoscyamine sulfate is an alkaloid of belladonna. exists as a white crystalline powder. its solutions are alkaline to litmus. affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. methenamine. [100-97-0] 1,3,5,7-tetraazatricyclo [3.3.1.-1 3,7 ] decane; hexamethylenetetramine; hmt; hmta; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; uritone; urotropin. c 6 h 12 n 4 ; mol wt 140.19; c 15.40%, h 8.63%, n 39.96%. methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. its solutions are alkaline to litmus. freely soluble in water, soluble in alcohol and in chloroform. methylene blue. [61-73-4] 3,7-bis(dimethylamino) phenothiazin-5-ium chloride; c.i. basic blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. c 16 h 13 cln 3 s; mol wt 319.85, c 60.08%, h 5.67%, cl 11.08%, n 13.14%, s 10.03%. methylene blue (methylthionine chloride) exists as dark green crystals. it is soluble in water and in chloroform; sparingly soluble in alcohol. phenyl salicylate. [118-55-8] 2-hydroxybenzoic acid phenyl ester; salol. c 13 h 10 o 3 ; mol wt 214.22, c 72.89%, h 4.71%, o 22.41%. made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. phenyl salicylate exists as white crystals with a melting point of 41Â°-43Â° c. it is very slightly soluble in water and freely soluble in alcohol. benzoic acid. [65-85-0] benzenecarboxylic acid; benzeneformic acid; benzenemethanoic acid. c 7 h 6 o 2 ; mol wt 122.12, c 68.85%, h 4.95%, o 26.20%. exists as white powder or crystals, scales or needles. it has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether. hyophen Â® tablets contain inactive ingredients: crospovidone, fd&c blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, rice starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, and titanium dioxide.

Clinical Pharmacology:

Clinical pharmacology hyoscyamine sulfate is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. it is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. most is excreted in the urine within 12 hours, 13% to 50% being unchanged. its biotransformation is hepatic. its protein binding is moderate. methenamine degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. it is well absorbed from the gastrointestinal tract. 70%-90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. within 24 hours it is almost completely (90%) excreted; of this at a ph of 5, approximately 20% is formaldehyde. protein binding - some formaldehyde is bound to substances in the urine and surrounding tissues. methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at ph grea Read more...

ter than 6.8. methylene blue possesses weak antiseptic properties. it is well absorbed by the gastrointestinal tract and rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. phenyl salicylate releases salicylate, a mild analgesic for pain. benzoic acid helps maintain an acid ph in the urine necessary for the degradation of methenamine.

How Supplied:

How supplied hyophen Â® tablets are blue tablets imprinted with "sat" on one side and "901" on opposite side. ndc 44523-741-01, bottle of 100 tablets. storage dispense in a tight, light-resistant container as defined in the usp/nf with a child resistant closure. store at controlled room temperature 15Â°-30Â°c (59Â°-86Â°f). keep in a cool, dry place. keep container tightly closed. warning: keep this and all drugs out of reach of children.

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