Label: HYOPHEN- methenamine, benzoic acid, phenyl salicylate, methylene blue, and hyoscyamine sulfate tablet
- NDC Code(s): 0076-0901-01
- Packager: Star Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated January 5, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Hyophen ™ 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]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. 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 6H 12N 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 16H 13ClN 3S; 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 13H 10O 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 41°-43° 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 7H 6O 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 ™ 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.Close
- 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 greater 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.Close
- INDICATIONS AND USAGE
Hyophen ™ 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.Close
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).Close
Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.Close
Cross sensitivity and/or related problems
patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication is also. Delay in gastric emptying could complicate the management of gastric ulcers.
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 ™ 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.
problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk. Accordingly, Hyophen ™ tablets should be given to a nursing mother with caution and only if clearly needed.
there have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.
infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.
use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion.
- 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 Stellar Pharmacal at 1-800-845-7827 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.
because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine; antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). Patients should be advised that the urine may become blue to blue-green and the feces may be discolored as a result of the excretion of the Methylene blue.
- DRUG ABUSE AND DEPENDENCE
A dependence on the use of Hyophen ™ tablets has not been reported and due to the nature of its ingredients, abuse of Hyophen ™ tablets is not expected.Close
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.Close
- 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.Close
- HOW SUPPLIED
Hyophen ™ tablets are blue tablets imprinted with "SAT" on one side and "901" on opposite side. NDC 0076-0901-01, Bottle of 100 Tablets.
Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.
Store at controlled room temperature 15°-30°C (59°-86°F).
Keep in a cool, dry place.
Keep container tightly closed.
WARNING: Keep this and all drugs out of reach of children.
- SPL UNCLASSIFIED SECTION
Hyophen™ is a registered trademark licensed to Star Pharmaceuticals, LLC
BIOCOMP PHARMA, INC.
San Antonio, Texas 78230
Ft. Lauderdale, FL 07726
Rev. 90101-23 -07/12Close
- SPL UNCLASSIFIED SECTION
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
Hyophen™ is a registered trademark licensed to Star Pharmaceuticals. LLC
Distributed by: BIOCOMP PHARMA, INC. San Antonio, Texas 78230
Manufactured for: STELLAR PHARMACAL Ft. Lauderdale, FL 33306Close
- INGREDIENTS AND APPEARANCE
methenamine, benzoic acid, phenyl salicylate, methylene blue, and hyoscyamine sulfate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0076-0901 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE 81.6 mg BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 9 mg PHENYL SALICYLATE (UNII: 28A37T47QO) (PHENYL SALICYLATE - UNII:28A37T47QO) PHENYL SALICYLATE 36.2 mg METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE 10.8 mg HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X) HYOSCYAMINE SULFATE 0.12 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) STARCH, RICE (UNII: 4DGK8B7I3S) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 11mm Flavor Imprint Code SAT;901 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0076-0901-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/21/2010 Labeler - Star Pharmaceuticals, LLC (962184003)