DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION Adults one tablet orally 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.
DRUG ABUSE AND DEPENDENCE SECTION.
DRUG ABUSE AND DEPENDENCE A dependence on the use of URIN D/S has not been reported and due to the nature of its ingredients, abuse of URIN D/S is not expected.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Cardiovascular rapid heartbeat, flushingCentral Nervous System blurred vision, dizziness, drowsinessRespiratory shortness of breath or trouble breathingGenitourinary difficult micturition, acute urinary retention Gastrointestinal dry mouth, nausea and vomiting.
CLINICAL PHARMACOLOGY SECTION.
CLINICAL PHARMACOLOGY. METHENULLMINE degrades in an acidic urine environment releasingformaldehyde which provides bactericidal or bacteriostatic action. Itis well absorbed from the gastrointestinal tract. 70%-90% reaches theurine unchanged at which point it is hydrolyzed if the urine is acidic.Within 24 hours it is almost completely (90%) excreted; of this at pHof 5, approximately 20% is formaldehyde. Protein binding someformaldehyde is bound to substances in the urine and surroundingtissues. Methenamine is freely distributed to body tissue and fluidsbut is not clinically significant as it does not hydrolyze at pHgreater than 6.8.SODIUM BIPHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine.PHENYL SALICYLATE releases salicylate, mild analgesic for pain.METHYLENE BLUE possesses weak antiseptic properties. It is wellabsorbed by the gastrointestinal tract and rapidly reduced toleukomethylene blue which is stabilizied in some combination form inthe urine. 75% is excreted unchanged. HYOSCYAMINE SULFATE is 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.
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).
DESCRIPTION. Each tablet contains: Methenamine.............................81.6 mgSodium Biphosphate..................40.8 mgPhenyl Salicylate.......................36.2 mgMethylene Blue..........................10.8 mgHyoscyamine Sulfate...................0.12 mgInactive Ingredients: Carbopol 934P, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, dicalcium phosphate, polydextrose, hypromellose, D&C Red 27, titanium dioxide, FD&C Blue 2, triacetin, FD&C Red 40, macrogol, talc. METHENULLMINE. [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. C6H12N4; mol wt 140.19; 51.40%, 8.63%, 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.SODIUM BIPHOSPHATE. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H2NaO4P; mol wt 119.98, 1.68%, Na 19.16%, 53.34%, 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100 loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25 C: 4.5.PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C13H10O3; mol wt 214.22, 72.89%, 4.71%, 22.41%. Made by the action of phosphorus oxy-chloride on mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with melting point of 41-43 C. It is very slightly soluble in water and freely soluble in alcohol.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. C16H18ClN3S; mol wt 319.85, 60.08%, 5.67%, Cl 11.08%, 13.14%, 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]--(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1H,5H-tropan-3-ol(-)-tropate(ester) sulfate(2:1)(salt);3-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C34H48N2O10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as 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.
DRUG INTERACTIONS SECTION.
DRUG INTERACTIONS Drug Interactions because of this products effect on gastrointestinal motility andgastric emptying, it may decrease the absorption of other oralmedications during concurrent use such as: urinary alkalizers; thiazidediuretics (may cause the urine to become alkaline reducing theeffectiveness of methenamine by inhibiting its conversion toformaldehyde); antimuscarinics (concurrent use may intensifyantimuscarinic effects of hyoscyamine because of secondaryantimuscarinic 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 toformaldehyde). Doses of these medications should be spaced hour apartfrom doses of hyoscyamine; antimyasthenics (concurrent use withhyoscyamine may further reduce intestinal motility); ketoconazole(patients should be advised to take this combination at least hoursafter ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent usemay intensify antimuscarinic side effects), opioid (narcotic analgesicsmay result in increased risk of severe constipation); sulfonamides(these drugs may precipitate with formaldehyde in the urine, increasingthe danger of crystalluria). Patients should be advised that the urinemay become blue to blue-green and the feces may be discolored as aresult of the excretion of the Methylene blue.
HOW SUPPLIED SECTION.
HOW SUPPLIED URIN D/S is oval, purple tablet embossed with LLORENS on one side, available in bottles of 100 tablets NDC 54859-701-10 and professional sample bottles of tablets NDC 54859-701-04.
INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE. 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.
NONTERATOGENIC EFFECTS SECTION.
Breast-feeding Problems in humans have not been documented, however, Methenamine and traces of Hyoscyamine Sulfate are excreted in breast milk. Accordingly, Utira(TM)-C Tablets should be given to nursing woman only if clearly needed. Prolonged Use 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.Pediatric Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.Geriatric Use with caution in elderly patients as they may respond to usual doses of Hyoscyamine Sulfate with exctextent, agitation, drowsiness, or confusion.
OVERDOSAGE Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of to mg (0.5 to mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam to control exctextent and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRECAUTIONS Cross sensitivity and/or related problems patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.
SPL UNCLASSIFIED SECTION.
URIN D/SRX ONLYUrinary antisepticNDC 54859-701-10.
STORAGE AND HANDLING SECTION.
STORAGE PHARMACIST: Preserve and dispense in tight-light resistant package as defined in the USP. Store at controlled room temperature between 15-30 degrees (59-86 degrees F).
TERATOGENIC EFFECTS SECTION.
Pregnancy Category - Hyoscyamine Sulfate and Methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether Utira(TM)-C Tablets cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Utira(TM)-C Tablets should be given to pregnant woman only if clearly needed.
WARNINGS Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.