Urin D/S

Name: Urin D/S

What is Urin D/S (hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Methenamine and methylene blue work as mild antiseptics that fight bacteria in the urine and bladder.

Phenyl salicylate is a mild pain reliever.

Sodium biphosphate is a form of phosphorus, which is a naturally occurring substance that is important in every cell in the body.

Hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate is a combination medicine used to treat bladder irritation (pain, spasms, inflammation) caused by urinary tract infection. This medicine is also used to prevent bladder discomfort during a medical procedure.

Hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you are allergic to hyoscyamine, methenamine, methylene blue, phenyl salicylate, or sodium biphosphate.

During your treatment with this medicine, do not start or stop using any other medications unless your doctor tells you to.

To make sure this medicine is safe for you, tell your doctor if you have:

  • heart disease;

  • a heart rhythm disorder;

  • congestive heart failure;

  • coronary heart disease;

  • a heart valve disorder;

  • glaucoma;

  • an enlarged prostate or bladder obstruction;

  • myasthenia gravis;

  • an ulcer or obstruction in your stomach;

  • an allergy to belladonna (Donnatal and others); or

  • an allergy to salicylates (such as aspirin, choline magnesium trisalicylate, magnesium salicylate).

It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Urin D/S Description


Each tablet contains:  
Methenamine.............................81.6 mg
Sodium Biphosphate..................40.8 mg
Phenyl Salicylate.......................36.2 mg
Methylene Blue..........................10.8 mg
Hyoscyamine Sulfate...................0.12 mg

Inactive Ingredients: Carbopol 934P, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, dicalcium phosphate, polydextrose, hypromellose, D&C Red #27, titanium dioxide, FD&C Blue #2, triacetin, FD&C Red #40, macrogol, talc.

 METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C6H12N4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform.

SODIUM BIPHOSPHATE. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H2NaO4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5.

PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C13H10O3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol.

METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C16H18ClN3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C34H48N2O10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.

Urin D/S - Clinical 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%-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 at a pH of 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 pH greater than 6.8.

SODIUM BIPHOSPHATE 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 rapidly reduced to leukomethylene blue which is stabilizied in some combination form in the urine. 75% is excreted unchanged.

HYOSCYAMINE SULFATE is a parasympatholytic 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. Its biotransformation is hepatic. Its protein binding is moderate.

Indications and Usage for Urin D/S

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.

Older Children - Dosage must be individualized by physician. Not recommended for use in children six years of age or younger.

Storage

PHARMACIST: Preserve and dispense in tight-light resistant package as defined in the USP.

Store at controlled room temperature between 15-30 degrees C (59-86 degrees F)

Tamper evident by heat seal under cap. Do not use if there is evidence of tampering.

WARNING: Patient should be advised that urine may be colored blue while taking this medication

URIN  D/S
methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54859-701
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methenamine (Methenamine) Methenamine 81.6 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (Sodium Cation) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg
Phenyl Salicylate (Phenyl Salicylate) Phenyl Salicylate 36.2 mg
Methylene Blue (METHYLENE BLUE CATION) Methylene Blue 10.8 mg
Hyoscyamine Sulfate (Hyoscyamine) Hyoscyamine Sulfate 0.12 mg
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A CORN  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
POLYDEXTROSE  
HYPROMELLOSES  
D&C RED NO. 27  
TITANIUM DIOXIDE  
FD&C BLUE NO. 2  
TRIACETIN  
FD&C RED NO. 40  
POLYETHYLENE GLYCOLS  
TALC  
Product Characteristics
Color purple (purple) Score no score
Shape OVAL (Oval) Size 13mm
Flavor Imprint Code LLORENS
Contains     
Packaging
# Item Code Package Description
1 NDC:54859-701-10 100 TABLET (TABLET) in 1 BOTTLE
2 NDC:54859-701-04 4 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/01/1999
Labeler - Llorens Pharmaceutical International Division (037342305)
Revised: 06/2014   Llorens Pharmaceutical International Division

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Feeling sleepy.
  • Dry mouth.
  • Flushing.
  • Change in color of urine or stool to blue or green.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Urin D / S may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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