Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, and Hyoscyamine Sulfate

UROGESIC-BLUE™ is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

UROGESIC-BLUE™ is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrythmias, 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).

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.

Cross sensitivity and/or related problems patients intolerant of belladonna alkaloids may be intolerant of this medication also. Pregnancy/Reproduction (Pregnancy Category C) hyoscyamine and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether UROGESIC-BLUE™ tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UROGESIC-BLUE™ tablets should be given to a pregnant woman only if clearly needed. Breast-feeding problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk. 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 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, opoid (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.

Cardiovascular – rapid pulse, flushing Central Nervous System – blurred vision, dizziness Respiratory – shortness of breath or troubled breathing Genitourinary – difficulty micturition, acute urinary retention Gastrointestinal – dry mouth, nausea/vomiting

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, opoid (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.

/Reproduction (Pregnancy Category C) hyoscyamine and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether UROGESIC-BLUE™ tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UROGESIC-BLUE™ tablets should be given to a pregnant woman only if clearly needed.

Breast-feeding problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk.

Pediatric infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness, or confusion.