SPL UNCLASSIFIED SECTION.
Tamper evident by heat seal under cap. Do not use if there is evidence of tampering. WARNING: Patient should be advised that urine may be colored blue while taking this medication
HOW SUPPLIED SECTION.
HOW SUPPLIED URIN D/S is a oval, purple tablet embossed with LLORENS on one side, available in bottles of 100 tablets NDC 54859-701-10 and professional sample bottles of 4 tablets NDC 54859-701-04.
WARNINGS Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.
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.
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, flushing Central Nervous System - blurred vision, dizziness, drowsiness Respiratory - shortness of breath or trouble breathing Genitourinary - difficult micturition, acute urinary retention Gastrointestinal - dry mouth, nausea and vomiting
DOSAGE & ADMINISTRATION SECTION.
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.
DESCRIPTION Each tablet contains: Methenamine.............................81.6 mg Sodium Biphosphate..................40.8 mg Phenyl Salicylate.......................36.2 mg Methylene Blue..........................10.8 mg Hyoscyamine Sulfate...................0.12 mg Inactive 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. 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. C6H12N4; mol wt 140.19; C 51.40%, 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. 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, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100 C 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, 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. 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, 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. 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 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.
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.
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.
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 C (59-86 degrees F)
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-C Tablets should be given to a 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 excitement, agitation, drowsiness, or confusion.
TERATOGENIC EFFECTS SECTION.
Pregnancy Category C - Hyoscyamine Sulfate and Methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether Utira-C Tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Utira-C Tablets should be given to a pregnant woman only if clearly needed.
DRUG INTERACTIONS SECTION.
DRUG INTERACTIONS Drug Interactions - 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.
CLINICAL PHARMACOLOGY SECTION.
CLINICAL PHARMACOLOGY 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. SODIUM BIPHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine. PHENYL SALICYLATE releases salicylate, a mild analgesic for pain. METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and rapidly reduced to leukomethylene blue which is stabilizied in some combination form in the urine. 75% is excreted unchanged. 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.
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).