NDC 70868-218 Urised

Methenamine, Phenyl Salicylate, Methylene Blue, Benzoic Acid, Atropine Sulfate , Hyoscyamine

NDC Product Code 70868-218

NDC Code: 70868-218

Proprietary Name: Urised Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Methenamine, Phenyl Salicylate, Methylene Blue, Benzoic Acid, Atropine Sulfate , Hyoscyamine Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
19 MM
Imprint(s):
K218
Score: 1

Code Structure
  • 70868 - Key Therapeutics
    • 70868-218 - Urised

NDC 70868-218-10

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Urised with NDC 70868-218 is a a human prescription drug product labeled by Key Therapeutics. The generic name of Urised is methenamine, phenyl salicylate, methylene blue, benzoic acid, atropine sulfate , hyoscyamine. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Key Therapeutics

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Urised Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • METHENAMINE 40.8 mg/1
  • PHENYL SALICYLATE 18.1 mg/1
  • METHYLENE BLUE 5.4 mg/1
  • BENZOIC ACID 4.5 mg/1
  • ATROPINE SULFATE .03 mg/1
  • HYOSCYAMINE .03 mg/1

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Oxidation-Reduction Activity - [MoA] (Mechanism of Action)
  • Oxidation-Reduction Agent - [EPC] (Established Pharmacologic Class)
  • Ammonium Ion Binding Activity - [MoA] (Mechanism of Action)
  • Nitrogen Binding Agent - [EPC] (Established Pharmacologic Class)
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

* Please review the disclaimer below.

Urised Product Label Images

Urised Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

U R I S E D™ is a dark blue, round, tablet for oral administration. It is a combination of antiseptics (Methenamine, Methylene Blue, Phenyl Salicylate, Benzoic Acid) and parasympatholytics (Atropine Sulfate, Hyoscyamine). Each tablet contains: Methenamine 40.8 mg, Phenyl Salicylate 18.1 mg, Methylene Blue 5.4 mg, Benzoic Acid 4.5 mg, Atropine Sulfate 0.03 mg and Hyoscyamine (as the sulfate) 0.03 mg.

Clinical Pharmacology

Methenamine itself does not have antiseptic, irritant, or toxic properties in the urine. Methenamine, in an acid urine (pH 6 or below), hydrolyzes into formaldehyde within the urinary tract providing mild antiseptic activity. When given as directed and the daily urine volume is 1000 to 1500 mL, a daily dose of 2 grams will yield a urinary concentration of 18-60 mcg/mL of free formaldehyde in the urine. This is more than the minimal inhibitory dose of formaldehyde which must be available for most urinary tract pathogens. Methenamine is readily absorbed from the gastrointestinal tract and is rapidly excreted almost entirely in the urine. Methylene Blue and Benzoic Acid are mild but effective antiseptics which contribute to the antiseptic properties of Methenamine. Phenyl Salicylate is a mild analgesic and antipyretic with weak antiseptic activity. All of these compounds are readily absorbed from the gastrointestinal tract and excreted in the urine. Through parasympatholytic actions, atropine and hyoscyamine relax smooth muscle spasms resulting from parasympathic stimulation.

Indications And Usage

U R I S E D™ is indicated for the relief of discomfort of the lower urinary tract caused by hypermotility resulting from inflammation or diagnostic procedures and in the treatment of cystitis, urethritis, and trigonitis when caused by organisms which maintain or produce an acid urine and are susceptible to formaldehyde.

Contraindications

Glaucoma, urinary bladder neck obstruction, pyloric or duodenal obstruction, or cardiospasm. Hypersensitivity to any of the ingredients.

Warnings

Do not exceed recommended dose. Methenamine may combine with sulfonamides in the urine to give mutual antagonism and should not be used with sulfonamides.

General:

Administer with caution to persons with known idiosyncrasy to atropine-like compounds and to patients suffering from cardiac disease. Bacteriological studies of the urine may be helpful in following the patient response. Methylene Blue interferes with the analysis for some urinary components such as free formaldehyde. In acid urine Methenamine breaks down into formaldehyde, which may form an insoluble precipitate with certain sulfonamides and may also increase the danger of crystalluria; concurrent use is not recommended. No known long-term animal studies have been performed to evaluate carcinogenic potential. The precautions related to drug interaction, diagnostic interference, medical problems and side effects to use of belladonna alkaloids, should be observed.

Information For Patients:

You should avoid using drugs and/or foods that produce alkaline urine while taking this medicine. If you are taking any anti-infective medications containing a sulfonamide, check with your doctor before using U R I S E D™. While taking this medicine, your urine may become blue to blue-green and the feces may be discolored as a result of excretion of Methylene Blue, so care should be taken to avoid staining clothing or other items. To avoid Methylene Blue stains on skin, mouth or teeth, make sure your hands are dry and that the tablets are swallowed quickly with liberal fluid intake.

Pregnancy Category C:

Animal reproduction studies have not been conducted with U R I S E D™ tablets. It is also not known whether U R I S E D™ tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. U R I S E D™ tablets should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when U R I S E D™ tablets are administered to a nursing woman.

Prolonged Use:

There have been no studies to establish the safety of prolonged use in humans.

Adverse Reactions

Prolonged use may result in a generalized skin rash, pronounced dryness of the mouth, flushing, difficulty in initiating micturition, rapid pulse, dizziness or blurring of vision. If any of these reactions occurs, discontinue use immediately. Acute urinary retention may be precipitated in prostatic hypertrophy. See “OVERDOSE”.

Drug Abuse And Dependence

A dependence on the use of U R I S E D™ has not been reported and due to the nature of its ingredients, abuse of U R I S E D™ is not expected.

Overdose

By exceeding the recommended dosage of U R I S E D™, symptomology related to the overdose of its individual active ingredients may be expected as follows:Atropine Sulfate, Hyoscyamine:
     
Symptoms associated with an overdosage of U R I S E D™ will most probably be manifested in the symptoms related to overdosage of the alkaloids Atropine Sulfate and Hyoscyamine. Such symptoms as dryness of mucous membranes; dilation of pupils; hot, dry, flushed skin; hyperpyrexia; tachycardia; palpitations; elevated blood pressure; coma; circulatory collapse and death from respiratory failure can occur due to overdosage of these alkaloids. Methenamine:  
     
If large amounts of the drug (2-8 gm daily) are used over extended periods (3-4 weeks), bladder and gastrointestinal irritation, painful and frequent micturition, albuminuria and gross hematuria may be expected. Methylene Blue:
     
Symptoms of Methylene Blue overdosage associated with the overdosage of U R I S E D™ are not expected to be discernible from those associated with the other active ingredients in U R I S E D™. Benzoic Acid:
     
Symptoms of Benzoic Acid overdosage associated with the overdosage of U R I S E D™ are not expected to be discernable from those associated with the other active ingredients in U R I S E D™. Phenyl Salicylate:
     
Symptoms of Phenyl Salicylate overdosage include burning pain in throat and mouth, white necrotic lesions in the mouth, abdominal pain, vomiting, bloody diarrhea, pallor, sweating, weakness, headache, dizziness and tinnitus. The symptoms, however, are not expected to be discernable from those associated with the other active ingredients in U R I S E D™. *These statements have not been evaluated by the Food and Drug Administration. This product is not included in the Orange Book.

Dosage And Administration

Adults:
     
Two tablets four times daily. See “PRECAUTIONS.” Usual pediatric dosage:
     
Children up to 6 years of age—Use is not recommended. Children 6 years of age and older—Dosage must be individualized by physician.

How Supplied

Bottles of 100 blue tablets imprinted “K218”. National Drug Code 70868-218-10.

Storage:

Store at controlled room temperature 15°-25°C (59°-77°F). Protect from moisture. Dispense in well-closed, light-resistant container. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.MANUFACTURED FOR:KEY THERAPEUTICS, LLC.FLOWOOD, MS 39232www.keytx.net MADE IN USA© Rev. 11/18U R I S E D™ is a trademark licensed to Key Therapeutics.

* Please review the disclaimer below.

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