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Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
Overview
What is Uro-458?
Uro-458 Tablets for oral administration.
Each tablet contains:
Methenamine 81 mg
Sodium Phosphate Monobasic 40.8 mg
Phenyl Salicylate 32.4 mg
Methylene Blue 10.8 mg
Hyoscyamine Sulfate 0.12 mg
Inactive ingredients:
METHENAMINE
SODIUM PHOSPHATE MONOBASIC.
PHENYL SALICYLATE.
METHYLENE BLUE
HYOSCYAMINE SULFATE
What does Uro-458 look like?
What are the available doses of Uro-458?
Sorry No records found.
What should I talk to my health care provider before I take Uro-458?
Sorry No records found
How should I use Uro-458?
Uro-458 Tablets 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.
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.
What interacts with Uro-458?
Uro-458 Tablets 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 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).
What are the warnings of Uro-458?
The benefits of immediate-release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.
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.
What are the precautions of Uro-458?
Sorry No Records found
What are the side effects of Uro-458?
Sorry No records found
What should I look out for while using Uro-458?
Uro-458 Tablets 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 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).
WARNING: Keep this and all drugs out of reach of children.
Rx Only
Manufactured for:
Method Pharmaceuticals, LLC
Fort Worth, TX 76118
www.methodpharm.com
Rev. 05/2016
What might happen if I take too much Uro-458?
Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children) repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.
Administration of small doses of diazepam to control excitement and seizures.
Artificial respiration with oxygen if needed for respiratory depression.
Adequate hydration.
Symptomatic treatment as necessary.
If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately.
How should I store and handle Uro-458?
Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USADistributed by:Actavis Inc.60 Columbia Rd., Bldg. BMorristown, NJ 07960 USAMarketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USA40-9186Revised – March 2014Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USADistributed by:Actavis Inc.60 Columbia Rd., Bldg. BMorristown, NJ 07960 USAMarketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USA40-9186Revised – March 2014Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USADistributed by:Actavis Inc.60 Columbia Rd., Bldg. BMorristown, NJ 07960 USAMarketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USA40-9186Revised – March 2014Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USADistributed by:Actavis Inc.60 Columbia Rd., Bldg. BMorristown, NJ 07960 USAMarketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USA40-9186Revised – March 2014Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USADistributed by:Actavis Inc.60 Columbia Rd., Bldg. BMorristown, NJ 07960 USAMarketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USA40-9186Revised – March 2014Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USADistributed by:Actavis Inc.60 Columbia Rd., Bldg. BMorristown, NJ 07960 USAMarketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USA40-9186Revised – March 2014Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USADistributed by:Actavis Inc.60 Columbia Rd., Bldg. BMorristown, NJ 07960 USAMarketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USA40-9186Revised – March 2014Uro-458 Tablets are blue to dark blue speckled, capsule-shaped tablets debossed with 210 on one side and plain on the opposite side, available in bottles of 90 tablets, (NDC:58657-458-90).FOR THE PHARMACISTUro-458 Tablets are blue to dark blue speckled, capsule-shaped tablets debossed with 210 on one side and plain on the opposite side, available in bottles of 90 tablets, (NDC:58657-458-90).FOR THE PHARMACIST
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70 to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at a pH greater than 6.8.
SODIUM PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine.
PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.
METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.
HYOSCYAMINE SULFATE is a parasympatholytic drug which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Protein binding for hyoscyamine sulfate is moderate and biotransformation is hepatic.
Non-Clinical Toxicology
Uro-458 Tablets 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 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).WARNING: Keep this and all drugs out of reach of children.
Rx Only
Manufactured for: Method Pharmaceuticals, LLC Fort Worth, TX 76118 www.methodpharm.com
Rev. 05/2016
No drug interactions have been identified. Studies with famotidine in man, in animal models, and have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.
Cross sensitivity and/or related problems:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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