Prosed DS

PROSED®/DS 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.

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.

Risk-benefit should be considered when the following medical problems exist: glaucoma, urinary bladder neck obstruction, pyloric or duodenal obstruction or cardiospasm. Hypersensitivity to any of the ingredients.

WARNINGS

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

PRECAUTIONS

Cross sensitivity and/or related problems: Patients intolerant of other belladonna alkaloids or other salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

Pregnancy/Reproduction (FDA Pregnancy Category C): Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether PROSED®/DS tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PROSED®/DS tablets should be given to a pregnant woman only if clearly needed.

Nursing mothers: Methenamine and traces of hyoscyamine are excreted in breast milk. Caution should be exercised when PROSED®/DS tablets are administered to a nursing mother.

Prolonged use: There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenicpotential.

Pediatric: Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric: Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.

As a result of 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 hyoscyamine because of secondary antimuscarinic activities of these medications.

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

Antimyasthenics: Concurrent use with hyoscyamine may further reduce intestinal motility, therefore, caution is recommended.

Ketoconazole and hyoscyamine may cause increased gastrointestinal pH.

Concurrent administration with 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 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®/DS has not been reported and due to the nature of its ingredients, abuse of PROSED®/DS is not expected.

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.

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.

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.

BENZOIC ACID has a mild antibacterial and antifungal action. It also helps maintain an acid pH in the urine necessary for the degradation of methenamine.

HYOSCYAMINE SULFATE is a 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.

Round, dark blue, sugar-coated tablets imprinted with "PROSED®/DS". Bottles of 100-NDC 15456-805-03 and Samples of 2-NDC 15456-805-02.

Storage

Store in a dry place between 15° and 30°C (59° to 86°F). Keep container tightly closed.

Medical Inquiries: 1-(888)-FERRING (1-(888)-337-7464) and www.prosed.com. Distributed by: FERRING PHARMACEUTICALS INC. PARSIPPANY, NJ 07054. Manufactured by: Contract Pharmacal Corp. Hauppauge, NY 11788. www.cpchealth.com. FDA Rev date: n/a