FDA label 0ac16477-ab3a-61e7-e063-6394a90a7f06

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

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. Methylene blue inhibits a range of CYP isozymes in vitro, including 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5. This interaction could be more pronounced with narrow therapeutic index drugs that are metabolized by one of these enzymes (e.g., digoxin, warfarin, phenytoin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus). However, the clinical relevance of these in vitro interactions is unknown. 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.