Utira-C Tablets

Name: Utira-C Tablets

Utira-C Tablets - Clinical Pharmacology

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.

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.

METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and rapidly reduced to leukomethylene 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 acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

Adverse Reactions

Cardiovascular: rapid heartbeat, flushing
Central Nervous System: blurred vision, dizziness, drowsiness
Genitourinary: difficult micturition, acute urinary retention
Gastrointestinal: dry mouth, nausea and vomiting
Respiratory: shortness of breath or trouble breathing

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal at 1-800-845-7827 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug interactions - As a result of hyoscyamine’s effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication.

Urinary alkalizers and 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: Concurrent use may reduce absorption of hyoscyamine resulting in decreased therapeutic effectiveness. 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, therefore caution is recommended.

Ketoconazole and hyoscyamine may cause increased gastrointestinal pH. Concurrent administration with hyoscyamine may result in marked reduction in the absorption of ketaconazole. Patients should be advised to take this combination at least 2 hours after ketoconazole.

Monoamine oxidase (MAO) inhibitors: Concurrent use with hyoscyamine 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.

Drug Abuse and Dependence

A dependence on the use of Utira®-C tablets has not been reported and due to the nature of its ingredients, abuse of Utira®-C tablets 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.

If overdose is suspected, contact your local Poison Control Center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

Utira-C Tablets 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.

How is Utira-C Tablets Supplied

Utira®-C tablets are blue tablets and imprinted with “SAT” on one side and “902” on the opposite side. NDC 0178-0513-01, bottle of 100 Tablets.

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