PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
NDC 24839-699-01 UTA CAPSULE Each capsule contains: Methenamine....................................................120 mg Sodium Phosphate Monobasic..........................40.8 mg Methylene Blue...................................................10 mg Hyoscyamine Sulfate........................................0.12 mg Rx ONLY CONTENTS:100 Capsules PHARMACIST: Preserve and dispense in tight, light-resistant containers with child-resistant closures. WARNING: Keep this and all drugs out of the reach of children. Store at controlled room temperature, 150-300C (590-860F) DOSAGE AND ADMINISTRATION: Adults: One capsule 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. Distributed by:SJ Pharmaceuticals, LLC 4200 Northside Parkway NW, Building 12 Atlanta, GA 30327
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Please report Adverse Reactions to SJ Pharmaceuticals; Attention: Adverse Reactions; 4200 Northside Parkway NW, Building 12, Atlanta, GA 30327. (877) 604-7575 Cardiovascular -rapid pulse, flushing Central Nervous system -blurred vision, dizziness Respiratory -shortness of breath or trouble breathing Genitourinary -difficult micturition, acute urinary retention Gastrointestinal -dry mouth, nausea/vomiting
INDICATIONS & USAGE SECTION.
UTA CAPSULES are indicated for the treatment of symptoms of irritative voiding, the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections, and 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 UTA CAPSUSES has not been reported and due to the nature of its ingredients, abuse of UTA CAPSULES is not expected.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Adults:one capsule 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.
HOW SUPPLIED SECTION.
HOW SUPPLIED: UTA Capsules are blue/blue capsules imprinted "SJ 646" NDC 24839-699-01, bottles of 100 capsules and a unit dose pack of 1 capsule (24839-699-99).
DESCRIPTION: UTA CAPSULES for oral administration. Each capsule contains: Methenamine....................................................120 mg Sodium Phosphate Monobasic..........................40.8 mg Methylene Blue...................................................10 mg Hyoscyamine Sulfate........................................0.12 mg 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 PHOSPHATE MONOBASIC exists as a white powder. It is freely soluble in water and practically insoluble in alcohol. METHYLENE BLUE (methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. 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. UTA CAPSULES contains inactive ingredients: Microcrystalline Cellulose, Magnesium Stearate, Mannitol and Croscarmellose.
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. 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 UTA CAPSULES cause fetal harm when administered to a pregnant woman or affect reproduction capacity. UTA CAPSULES should be given to a pregnant woman with caution and only if clearly needed. Breast feeding -problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk. Accordingly UTA CAPSULES should be given to a nursing mother with caution and 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 thy may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness, or confusion. 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 methylene blue.
STORAGE AND HANDLING SECTION.
STORAGE: Dispense in a tight, light-resistant container as defined in USP. Store at controlled room temperature, 150-300C (590-860F). Keep container tightly closed. Keep this and all drugs out of the reach of children. Distributed by:SJ Pharmaceuticals, LLC 4200 Northside Parkway NW, Building 12 Atlanta, GA 30327 Rev. 08/14
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 pH5, 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 PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine. METHYLENE BLUE possesses weak antiseptic properties. it is well absorbed by the gastrointestinal tract and is srapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. HYOSCYAMINE 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 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.
CONTRADICTIONS: Hypersensitivity to any of the ingredients is possible. Risk-benefit should be carefully considered when the following medical problems exist: cardiac desease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, 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).
WARNINGS: Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.