Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate

Description

DESCRIPTION MB CAPS for oral administration. Each capsule contains: Methenamine 120 mg Sodium Phosphate Monobasic 40.8 mg Phenyl Salicylate 36.2 mg Methylene Blue 10.8 mg Hyoscyamine Sulfate 0.12 mg Inactive ingredients: lactose monohydrate, polyethylene glycol, crospovidone, magnesium stearate, silicified microcrystalline cellulose, FD&C Blue #1, FD&C Red #3, titanium dioxide, gelatin.

What Is Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate Used For?

INDICATIONS AND USAGE MB CAPS is 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

DOSAGE AND ADMINISTRATION Adults: One capsule orally 4 times per day followed by liberal fluid intake. Pediatric: Dosage must be individualized by physician for older children. Not recommended for use in children six years of age or younger.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Cardiovascular - rapid pulse, flushing Central Nervous System - blurred vision, dizziness, drowsiness Respiratory - shortness of breath or troubled breathing Genitourinary - difficult micturition, acute urinary retention Gastrointestinal - dry mouth, nausea and vomiting Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped. Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033, or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug Interactions

DRUG INTERACTIONS Drug Interactions Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A— an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever. Additional Information for Healthcare Professionals Methylene blue can interact with serotonergic psychiatric medications and cause serious CNS toxicity. In emergency situations requiring life-threatening or urgent treatment with methylene blue (as described above), the availability of alternative interventions should be considered and the benefit of methylene blue treatment should be weighed against the risk of serotonin toxicity. If methylene blue must be administered to a patient receiving a serotonergic drug, the serotonergic drug must be immediately stopped, and the patient should be closely monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if fluoxetine [Prozac] was taken), or until 24 hours after the last dose of methylene blue, whichever comes first. In non-emergency situations when non-urgent treatment with methylene blue is contemplated and planned, the serotonergic psychiatric medication should be stopped to allow its activity in the brain to dissipate. Most serotonergic psychiatric drugs should be stopped at least 2 weeks in advance of methylene blue treatment. Fluoxetine (Prozac), which has a longer half-life compared to similar drugs, should be stopped at least 5 weeks in advance. Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of methylene blue. Serotonergic psychiatric medications should not be started in a patient receiving methylene blue. Wait until 24 hours after the last dose of methylene blue before starting the antidepressant. Educate your patients to recognize the symptoms of serotonin toxicity or CNS toxicity and advise them to contact a healthcare professional immediately if they experience any symptoms while taking serotonergic psychiatric medications or methylene blue. 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....

Contraindications

CONTRAINDICATIONS MB CAPS is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Pregnancy and Breastfeeding

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 MB CAPS can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MB CAPS 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 MB CAPS are administered to a nursing mother.

Overdosage

OVERDOSAGE 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. If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately.

How Supplied

HOW SUPPLIED MB CAPS are light blue capsules imprinted with 299, available in bottles of 60 capsules, (NDC: 28595-299-60). STORAGE Store in a cool, dry place at controlled room temperature 15° to 30°C (59° to 86°F). Keep container tightly closed. Protect from moisture and direct sunlight. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. WARNING: Keep this and all drugs out of reach of children. Rx Only