Relief of local symptoms such as inflammation, hypermotility,
and pain, which accompany lower urinary tract infections.
Relief of urinary tract symptoms caused by diagnostic procedures.
Manage Discomfort
UTA Capsules may be used to manage discomfort and reduce symptoms
associated with such procedures as:
Catheter use
Pre- and post-laproscopy
Endometrial biopsy
Post-Caesarean section
Honeymoon cystitis
Patient Advantages
UTA Capsules have a clear advantage. It's easy to see when
you look at what UTA Capsules have to offer your patients:
Easy to swallow
Encapsulated
Will not stain hands, teeth or clothing
Sugar-free, suitable for diabetics
Fast relief, often within 30 minutes
Ease spasm
Alleviate pain and irritation
Economically priced
Blue urine indicator
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.
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 (hexamethyleneteramine)
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 (methylthionine chloride) exists as dark green crystals.
It is soluble in water and in chloroforrn; sparingly soluble
in alcohol.
PHENYL SALICYLATE exists as white crystals with
a melting point of 40°- 43° C. It is very slightly
soluble in water; freely soluble in alcohol.
SODIUM PHOSPHATE
MONOBASIC exists as a white powder. It is freely soluble
in water and practically insoluble in alcohol.
UTA® CAPSULES
contain inactive ingredients: Dicalcium Phosphate, Gelatin,
Microcrystalline Cellulose, Magnesium Stearate, Stearic Acid,
Silica, FD&C Blue #1 Lake, D&C Red # 28 Lake
and FD&C Red #40 Lake.
Clinical Pharmacology
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.
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 pH 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 is rapidly reduced to leukornethylene
blue which is stabilized in some combination form in the urine.
75% is
excreted unchanged.
PHENYL SALICYLATE releases salicylate, a
mild analgesic for pain.
SODIUM PHOSPHATE MONOBASIC an acidificr,
helps to maintain an acid pH in the urine necessary for the
degradation of methenamine.
Indications and Usage
UTA® CAPSULES - 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.
CONTRAINDICATIONS - Hypersensitivity to any of the
ingredients is possible. Risk-benefit should be carefully considered
when the following medical problems exist: cardiac disease
(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 they 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 I hour apart from
doses of hyoscyamine; antimyasthenics (concurrent use with
byoscyamine 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
A dependence on the use of UTA® CAPSULES 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 ing (0.5 to 1mg 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.
Dosing and Administration
Adults: One capsule orally 4 times per day followed
by liberal fluid intake.
Children - Above 6 years of age: 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.
Storage
Dispense in a tight, light-resistant container as defined
in the USP. Store at controlled room temperature 20°- 25°C
(68° - 77°F) with allowable excursions 15° - 30°C
(59° - 86° F). Keep container tightly closed.
