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UTA Capsules

Generic Name: methenamine, sodium phosphate, monobasic, phenyl salicylate, methylene blue and hyoscyamine sulfate
Dosage Form: capsule

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.

UTA Capsules

DESCRIPTION:

UTA Capsules for oral administration.
Each capsule contains:
Methenamine....................................................120 mg
Sodium Phosphate Monobasic..........................40.8 mg
Phenyl Salicylate................................................36 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.

PHENYL SALICYLATE exists as white crystals with a melting point of 40o-43oC.  It is very slightly soluble in water and freely soluble 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: Dicalcium Phosphate, Gelatin, Microcrystalline Cellulose, Magnesium Stearate, Stearic Acid, Silica, FDC Blue #1 Lake, DC Red #28 Lake and FDC Red #40 Lake.

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.

PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.

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.
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.

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.

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.

ADVERSE REACTIONS:

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

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.

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.

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:

UTA Capsules are blue/blue capsules imprinted "SJ 646" NDC 45985-646-01, bottles of 100 capsules and a unit dose pack of 1 capsule (45985-646-99).

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.

Manufactured by:
Contract Pharmacal Corporation
Hauppauge, NY 11788

Distributed by:
Stewart-Jackson Pharmacal
4200 Northside Parkway NW, Building 12
Atlanta, GA 30327

Rev. 05/09

NDC 45985-646-01

UTA CAPSULE

Each capsule contains:

Methenamine....................................................120 mg
Sodium Phosphate Monobasic..........................40.8 mg
Phenyl Salicylate................................................36 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.

Manufactured by:
Contract Pharmacal Corporation
Hauppauge, NY 11788

Distributed by:
Stewart-Jackson Pharmacal
4200 Northside Parkway NW,
Building 12
Atlanta, GA 30327





UTA 
methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, hyoscyamine sulfate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45985-646
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methenamine (Methenamine) Methenamine 120 mg  in 206.92 mg
Sodium Phosphate, Monobasic (PHOSPHORIC ACID) Sodium Phosphate, Monobasic 40.8 mg  in 206.92 mg
Phenyl Salicylate (Phenyl Salicylate) Phenyl Salicylate 36 mg  in 206.92 mg
Methylene Blue (Methylene Blue) Methylene Blue 10 mg  in 206.92 mg
Hyoscyamine Sulfate (Hyoscyamine) Hyoscyamine Sulfate .12 mg  in 206.92 mg
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code SJ;646
Contains         
Packaging
# Item Code Package Description
1 NDC:45985-646-01 10020692 mg in 1 BOTTLE
2 NDC:45985-646-99 206.92 mg in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2002
Labeler - STEWART-JACKSON PHARMACAL, INC (101802361)
Establishment
Name Address ID/FEI Operations
CONTRACT PHARMACAL CORPORATION 057795122 manufacture
Revised: 11/2009
 
STEWART-JACKSON PHARMACAL, INC



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