Phenyl salicylate

PROSED EC (Enteric Coated) is a delayed release, dark blue tablet for oral administration. Each tablet contains: Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, and Hyoscyamine Sulfate 0.06 mg.

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.

PHENYL SALICYLATE (2-hydroxybenzoic acid phenyl ester) exists as white crystals with a melting point of 40-43°C. It is very slightly soluble in water and freely soluble in alcohol.

METHYLENE BLUE (methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

BENZOIC ACID (benzenecarboxylic acid) exists as white crystals, scales or needles. It has a slight odor and is slightly soluble in water; freely soluble in alcohol, in chloroform and in ether.

ATROPINE SULFATE (d/tropyl tropate) is an alkaloid of belladonna. It exists as an odorless, white crystalline powder that is slowly affected by light. It is very soluble in water and freely soluble in alcohol.

HYOSCYAMINE SULFATE (l-tropyl tropate) is an alkaloid of belladonna. It exists as a white crystalline powder. Its solutions are alkaline to litmus and affected by light. It is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.

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

As a result of atropine's and 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 atropine and hyoscyamine because of secondary antimuscarinic activities of these medications.

Antacids/antidiarrheals:  Concurrent use may reduce absorption of atropine and 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 atropine and hyoscyamine.

Antimyasthenics:  Concurrent use with atropine and hyoscyaminemay further reduce intestinal motility, therefore, caution is recommended.

Ketoconazole-atropine and hyoscyamine may cause increased gastrointestinal pH.

Concurrent administration with atropine and 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 atropine and 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.

Cardiovascular rapid pulse, flushing

Central Nervous System blurred vision, dizziness

Respiratory shortness of breath or troubled breathing

Genitourinary difficult micturition, acute urinary retention

Gastrointestinal dry mouth, nausea/vomiting

DRUG ABUSE AND DEPENDENCE

A dependence on the use of PROSED EC has not been reported and due to the nature of its ingredients, abuse of PROSED EC is not expected.

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 up to 12 years of age.