Urolet MB

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.

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, and sodium biphosphate is a combination medicine used to treat bladder irritation (pain, burning, inflammation) caused by urinary tract infection. This medicine is also used to prevent bladder discomfort during a medical procedure.

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

If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and sodium biphosphate.

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

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; or
• if you are allergic to belladonna (Donnatal and others).

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.

This medicine should not be given to a child younger than 7 years old.

Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, and sodium biphosphate. Antacids or anti-diarrhea medicine can make it harder for your body to absorb hyoscyamine.

If you also take ketoconazole (Nizoral), wait at least 2 hours after taking it before you take hyoscyamine, methenamine, methylene blue, and sodium biphosphate.

Many drugs can interact with this medicine. Not all possible interactions are listed here. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all your medications and any you start or stop using, especially:

• neostigmine or pyridostigmine;
• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
• bronchodilators such as ipratropium or tiotropium;
• cold or allergy medicine that contains an antihistamine;
• a diuretic or "water pill";
• an MAO inhibitor--furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine;
• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
• medication to treat gout, kidney stones, or an electrolyte imbalance (such as low levels of potassium);
• medication to treat symptoms of Alzheimer's disease or Parkinson's disease;
• narcotic pain or cough medication--codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, propoxyphene, and others; or
• sulfa drugs.

This list is not complete and many other drugs can interact with hyoscyamine, methenamine, methylene blue, and sodium biphosphate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• Take with or without food.
• Drink lots of noncaffeine liquids every day unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A fast heartbeat.
• Blurred eyesight.
• Dizziness.
• Feeling very sleepy.
• Feeling confused.

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.

MONOBASIC SODIUM PHOSPHATE an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

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.

HYOSCYAMINE SULFATE is a parasympatholytic drug 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. Protein binding for hyoscyamine sulfate is moderate and biotransformation is hepatic.

Urolet MB™ 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).

Cross sensitivity and/or related problems

Patients intolerant of other belladonna alkaloids may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

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.

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.

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 Urolet MB™ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Urolet MB™ 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 Urolet MB™ is 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 carcinogenic potential.

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.

NDC 35573-302-100

Urolet MB™

URINARY ANTISEPTIC

ANTISPASMODIC

DESCRIPTION: Each tablet contains:

CONTENTS: 100 TABLETS

RX ONLY

Manufactured for:
Burel Pharmaceuticals, Inc
Richland, MS 39218