Uro-MP

INDICATIONS AND USAGE Uro-MP Capsules are 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 Adults: One tablet orally 4 times per day followed by liberal fluid intake. Pediatric: Dosage must be individualized by physician for older children. Not recommended for use in children six years of age or younger.

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. WARNING: Keep this and all drugs out of reach of children. Rx Only Manufactured for: Method Pharmaceuticals, LLC Southlake, TX 76092 www.methodpharm.com Rev. 02/23

CONTRAINDICATIONS Uro-MP Capsules are 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 arrhythmias, congestive heart failure, coronary heart disease, and 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).

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. 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 the 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 ketoconazole. 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 and/or stools may become blue to blue-green as a result of the excretion of methylene blue. Drug Abuse And Dependence A dependence on the use of Uro-MP Capsules has not been reported and due to the nature of its ingredients, abuse of Uro-MP Capsules is not expected.

Pregnancy/Reproduction (FDA Pregnancy Category C): Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether Uro-MP Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Uro-MP Capsules should be given to a pregnant woman only if clearly needed.

Nursing mothers: Methenamine and traces of hyoscyamine are excreted in breast milk. Caution should be exercised when Uro-MP Capsules are administered to a nursing mother. 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.

ADVERSE REACTIONS Cardiovascular - rapid pulse, flushing Central Nervous System - blurred vision, dizziness, drowsiness Respiratory - shortness of breath or troubled breathing Genitourinary - difficult micturition, acute urinary retention Gastrointestinal -dry mouth, nausea and vomiting 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 Method Pharmaceuticals, LLC at (877) 250-3427.