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  • Urogesic Blue
    (hyoscyamine sulfate/methenamine/methylene blue/monobasic sodium phosphate)

    THERAPEUTIC CLASS

    Acidifier/antibacterial/anticholinergic/antiseptic

    DEA CLASS

    RX

    INDICATIONS

    Treatment of symptoms of irritative voiding. Relief of local symptoms, such as hypermotility that accompany lower urinary tract infections, and as antispasmodic. Relief of urinary tract symptoms caused by diagnostic procedures.

    ADULT DOSAGE

    Adults: 1 tab qid, followed by liberal fluid intake.

    PEDIATRIC DOSAGE

    Pediatrics: >6 yrs: Individualize dose.

    ADMINISTRATION

    Oral route.

    HOW SUPPLIED

    Tab: (Hyoscyamine Sulfate- Methylene Blue-Methenamine-Monobasic Sodium Phosphate) 0.12mg-10.8mg-81.6mg-40.8mg

    CONTRAINDICATIONS

    Consider risk-benefit with the following: cardiac disease (especially cardiac arrhythmias, congestive heart failure [CHF], coronary heart disease [CHD], mitral stenosis), GI tract obstructive disease, glaucoma, myasthenia gravis. Acute urinary retention may be precipitated in obstructive uropathy (eg, bladder neck obstruction due to prostatic hypertrophy).

    WARNINGS/PRECAUTIONS

    Do not exceed recommended dosage. D/C immediately if rapid pulse, dizziness, or blurred vision occurs. Intolerance may occur in patients intolerant to belladonna alkaloids. Caution in elderly. Urine may become blue to blue-green and feces may be discolored due to excretion of methylene blue.

    ADVERSE REACTIONS

    Rapid pulse, flushing, blurred vision, dizziness, SOB, troubled breathing, difficulty micturition, acute urinary retention, dry mouth, N/V.

    DRUG INTERACTIONS

    May decrease absorption of other PO medications (eg, urinary alkalizers, thiazide diuretics, antimuscarinics, antacids/antidiarrheals, antimyasthenics, ketoconazole, MAOIs, opioids, sulfonamides). Concomitant use with antimyasthenics may reduce intestinal motility. Concomitant use with MAOIs may intensify antimuscarinic side effects. Thiazide diuretics may decrease effectiveness of methenamine. Antimuscarinic effects of hyoscyamine may be intensified with antimuscarinics. Antacids/antidiarrheals may reduce absorption of hyoscyamine and antacids may reduce effectiveness of methenamine. Space dosing by 1 hr with antacids/antidiarrheals. Take at least 2 hrs after ketoconazole intake. May increase the risk of severe constipation with opioids. Sulfonamides may precipitate with formaldehyde in the urine, increasing the danger of crystalluria.

    PREGNANCY AND LACTATION

    Category C, safety not known in nursing.

    MECHANISM OF ACTION

    Hyoscyamine: Parasympatholytic; relaxes smooth muscle and produces antispasmodic effect. Methenamine: Degrades in an acidic urine environment, releasing formaldehyde providing bactericidal or bacteriostatic action. Methylene Blue: Possesses weak antiseptic properties. Monobasic Sodium Phosphate: Acidifier; helps maintain an acid pH in the urine necessary for the degradation of methenamine.

    PHARMACOKINETICS

    Absorption: Hyoscyamine/Methenamine/Methylene Blue): Well absorbed. Distribution: Plasma protein binding: Moderate (hyoscyamine), some formaldehyde bound to substances in urine and surrounding tissues (methenamine). Methenamine/Hyoscyamine: Crosses placenta; found in breast milk. Metabolism: Hyoscyamine: Hepatic. Methenamine: Hydrolysis to formaldehyde. Methylene Blue: Reduced to leukomethylene blue. Elimination: Hyoscyamine: Urine (13-50% unchanged). Methenamine: Urine (70-90% unchanged, 20% formaldehyde). Methylene Blue: Urine (75% unchanged).

    ASSESSMENT

    Assess for cardiac disease, GI tract obstructive disease, glaucoma, myasthenia gravis, obstructive uropathy, intolerance to belladonna alkaloids, hypersensitivity, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for rapid pulse, dizziness, blurring of vision, and other adverse reactions.

    PATIENT COUNSELING

    Counsel about risks and benefits of therapy. Advise not to exceed recommended dose. Inform that urine and feces may be discolored.

    STORAGE

    25°C (77°F); excursions permitted to 15-30°C (59-86°F).