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Phosenamine (Hyoscyamine Sulfate / Methenamine / Phenyl Salicylate / Sodium Phosphate, Monobasic, Monohydrate / Methylene Blue) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Each capsule for oral administration contains:
Hyoscyamine Sulfate.12 mg
Methenamine 120 mg
Phenyl Salicylate 36 mg
Sodium Phosphate Monobasic 40.8 mg
Methylene Blue 10 mg

Inactive Ingredients: Dicalcium Phosphate, FDC Blue #1, FDC Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid, Titanium Dioxide, Shellac, Propylene Glycol, Sodium Hydroxide, Povidone.

CLINICAL PHARMACOLOGY

Hyoscyamine Sulfate:
Hyoscyamine Sulfate is parasympatholytic drug which relaxes smooth muscles. Protein binding for Hyoscyamine sulfate is moderate. Biotransformation for Hyoscyamine sulfate is hepatic. It is well absorbed from the gastrointestinal tract. The majority of Hyoscyamine sulfate is excreted unchanged.

Methenamine:
Methenamine, after oral administration, undergoes hydrolysis and generates formaldehyde, which provides bactericidal or bacteriostatic action. Methenamine is rapidly absorbed from the intestinal tract and is excreted, for the most part, unchanged in the urine at which point it is hydrolyzed if the urine is acidic. It is almost completely excreted (90%) in the urine within 24 hours; of this at a ph of 5, approximately 10-30% is converted to formaldehyde in the stomach.

Phenyl Salicylate:
Phenyl Salicylate, a form of salicylic acid, is a mild analgesic for pain relief.

Sodium Phosephate, Monobasic:
Sodium Phosephate, Monobasic increases urinary acidity helping to maintain an acid pH necessary for the degradation of methenamine.

Methylene Blue:
Methylene Blue is monoamine oxidase inhibitor with weak antiseptic properties. It is well absorbed by the intestinal tract and rapidly reduced to leukomethylene blue, which is stabilized in the urine. Approximately 70-80% is excreted unchanged in the urine.

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