UR N-C Urinary Antiseptic

UR N-C URINARY ANTISEPTIC- hyoscyamine sulfate, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methenamine and methylene blue tablet
Libertas Pharma, Inc.

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.

Each tablet for oral administration contains:
Hyoscyamine sulfate 0.12 mg
Methenamine 81.6 mg
Methylene blue 10.8 mg
Phenyl salicylate 36.2 mg
Sodium phosphate, monobasic 40.8 mg

Inactive ingredients: calcium sulfate, carbopol 934P, D &C #27, FD &C Blue #2, FD& C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, purified water, starch 1500, talc and titanium dioxide.

Hyoscyamine sulfate. [620-61-1] [3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5α H-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C34 H48 N2 O10 S. 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. [100-97-0] 1,3,5,7- Tetraazatricyclo [3.3.1.137 ] decane; hexamethylenetetramine; 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 4.71%, O 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 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol.

Sodium phosphate, monobasic. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; [H2 NaO4 P:] mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100°C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25°C: 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. C16 H18 CIN3 S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

INDICATIONS AND USAGE:

UR N-C is 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.

DOSAGE AND ADMINISTRATION:

FOR ORAL USE ONLY
Adults: One tablet 4 times per day by mouth, followed by liberal fluid intake. Older Children: Dosage must be individualized by physician. Not recommended for use in children younger than six years.

CONTRAINDICATIONS:

UR N-C is contraindicated in patients hypersensitive to any of its ingredients. Risk benefits should be carefully considered when the following medical problems exist: achalasia of esophagus, atony of colon, diseases of cardiovascular system, gastrointestinal hemorrhage; glaucoma; hemolytic anemia from pyruvate kinase and G6PD deficiencies, infected urolithiasis, myasthenia gravis, paralytic ileus, severe ulcerative colitis, toxic megacolon; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

WARNINGS AND PRECAUTIONS:

Do not exceed recommended dosage. This drug may make you dizzy or drowsy or cause blurred vision; use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. Limit alcohol consumption. 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. There have been no studies to establish the safety of prolonged use of this product in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pregnancy: Teratogenic Effects. Pregnancy Category C:

Hyoscyamine sulfate and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether UR N-C tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UR N-C tablets should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Problems in humans have not been documented; however, methenamine and traces of hyoscyamine sulfate are excreted in breast milk. Accordingly, UR N-C tablets should be given to a lactating woman only if clearly needed. Discuss the risks and benefits with your doctor.

Pediatric Use:

Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids (hyoscyamine sulfate). This product contains salicylate, which is related to aspirin. Children and teenagers should not take aspirin, aspirin-containing or aspirin-related medications if they have chickenpox, influenza, or any undiagnosed illness without first consulting a doctor. A rare but serious illness known as Reye’s syndrome may occur. This medication is not recommended for children younger than 6 years.

Geriatric Use:

Kidney function becomes impaired with age. This medication is removed by the kidneys. Therefore, use with caution in elderly patients as they may respond to usual doses of hyoscyamine sulfate with excitement, agitation, drowsiness or confusion.

ADVERSE REACTIONS:

Cardiovascular: rapid heartbeat, flushing Central Nervous System: blurred vision, dizziness, drowsiness Genitourinary: difficulty 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-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. The following number does not provide medical advice, but in the U.S. you may report suspected side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

This drug should not be used with the following medications because very serious interactions may occur: live influenza virus vaccine, pramlintide. 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). This is not a complete list of all drug interactions. Tell your doctor or pharmacist of all prescription medications prior to use.

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