Utira-C

UTIRA-C- hyoscyamine sulfate, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methenamine and methylene blue tablet, sugar coated
Hawthorn Pharmaceuticals

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.

DESCRIPTION

Each tablet for oral administration contains:

Hyoscyamine Sulfate………12 mg

Methenamine…..81.6 mg

Phenyl Salicylate…..36.2 mg

Sodium Phosphate Monobasic…..40.8 mg

Methylene Blue…..10.8 mg

Other Ingredients: Calcium Sulfate, Carnauba Wax, D & C Red # 27 lake, Dicalcium Phosphate, FD&C Blue #1 Lake, Gelatin, Hypromellose, Kaolin, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Pharmaceutical Glaze, Polyethylene Glycol, Polyvinylpyrrolidone, Sugar and Titanium Dioxide.

Hyoscyamine Sulfate. [101- 31-5] [3(s)-endo)-α(Hydroxymethyl benzeneacetlc acid 8- methyl-8-azabicyclo [3.2.1] oct- 3-yl ester; 1αH,5 αH-tropan-3 α-ol(-)-tropate (ester);3 α-tropanyIS-(-)-tropate; I-tropic acid ester with tropine; 1- tropine tropate. 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.

C17 H23 N03 • H2 S04 • 2H2 0

MW = 712.85

Methenamine. [100-97-0] 1,3,5,7- Tetraazatricyclo [3.3.1.137 ] decane; hexamethyenetetramine; HMT; HMTA; hexamine. 1,3,5,7- tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C6 H12 N4 ; 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.

Phenyl Salicylate. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C13 H10 O3 ; mol wt 214.22, C 72.89%, H 4.70%, 0 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 40-43° C. It is very slightly soluble in water and freely soluble in alcohol.

Sodium Phosphate Monobasic. [7558-80-7] Sodium biphosphate; sodium dihyrdogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; [H2 Na04 P:] mol wt 119.98. H 1.68%, Na 19.16%, 0 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100º loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aq soln is acid. PH of 0.1 molar aq soln at 25°: 4.5.

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. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

C16 H18 CIN3 S· 3H2 0 MW =373.9

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 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% to 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.

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 rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.

Sodium Phosphate Monobasic , an acidlfier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

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.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. Risk benefits 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.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

PRECAUTIONS

General

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.

Information for Patients

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.

Laboratory Tests

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 Sulfate because of secondary antimuscarinic activities of these medications); antacids/ antidiarrheals (may reduce absorption of Hyoscyamine Sulfate, 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 Sulfate; antimyasthenics (concurrent use with Hyoscyamine Sulfate 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.

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

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