Oxybutynin (Systemic)

Oxybutynin (Systemic)

US Brand Names

• Ditropan

Canadian Brand Names

• Ditropan

Description

Oxybutynin (ox-i-BYOO-ti-nin) belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms.

Oxybutynin is available only with your doctor's prescription, in the following dosage forms:

Oral

• Syrup (U.S. and Canada)

• Tablets (U.S. and Canada)

Special Considerations

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For oxybutynin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxybutynin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy

Oxybutynin has not been studied in pregnant women. However, it has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding

Oxybutynin has not been reported to cause problems in nursing babies. However, since this medicine tends to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients.

Children

There is no specific information about the use of oxybutynin in children under 5 years of age. In older children, oxybutynin is not expected to cause different side effects or problems than it does in adults.

Older adults

Elderly people are especially sensitive to the effects of oxybutynin. This may increase the chance of side effects during treatment.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking oxybutynin, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or

• Anticholinergics (medicine for abdominal or stomach spasms or cramps) or

• Antidepressants (medicine for depression) or

• Antidyskinetics (medicine for Parkinson's disease or other conditions affecting control of muscles) or

• Antihistamines or

• Antipsychotics (medicine for mental illness) or

• Buclizine (e.g., Bucladin) or

• Carbamazepine (e.g., Tegretol) or

• Cyclizine (e.g., Marezine) or

• Cyclobenzaprine (e.g., Flexeril) or

• Disopyramide (e.g., Norpace) or

• Flavoxate (e.g., Urispas) or

• Ipratropium (e.g., Atrovent) or

• Meclizine (e.g., Antivert) or

• Methylphenidate (e.g., Ritalin) or

• Orphenadrine (e.g., Norflex) or

• Procainamide (e.g., Pronestyl) or

• Promethazine (e.g., Phenergan) or

• Quinidine (e.g., Quinidex) or

• Trimeprazine (e.g., Temaril)-Taking oxybutynin with these medicines may increase the effects of either medicine

Other medical problems

The presence of other medical problems may affect the use of oxybutynin. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding (severe)-Oxybutynin may increase heart rate, which may make this condition worse

• Colitis (severe) or

• Dryness of mouth (severe and continuing) or

• Enlarged prostate or

• Glaucoma or

• Heart disease or

• Hiatal hernia or

• High blood pressure (hypertension) or

• Intestinal blockage or other intestinal or stomach problems or

• Myasthenia gravis or

• Toxemia of pregnancy or

• Urinary tract blockage or problems with urination-Oxybutynin may make these conditions worse

• Kidney disease or

• Liver disease-Higher blood levels of oxybutynin may occur, which increases the chance of side effects

• Overactive thyroid-Oxybutynin may further increase heart rate

Administration

This medicine is usually taken with water on an empty stomach. However, your doctor may want you to take it with food or milk to lessen stomach upset.

Take this medicine only as directed . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of oxybutynin will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of oxybutynin. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage forms (syrup or tablets):

o For treatment of bladder problems:

§ Adults and children 12 years of age and over-5 milligrams (mg) two or three times a day.

§ Children up to 5 years of age-Use and dose have not been determined.

§ Children 5 to 12 years of age-5 mg two or three times a day. The dose is usually not more than 15 mg a day.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

To store this medicine:

• Keep out of the reach of children.

• Store away from heat and direct light.

• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.

• Keep the syrup form of this medicine from freezing.

• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

This medicine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well .

Oxybutynin may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Your mouth, nose, and throat may feel very dry while you are taking this medicine. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Eye pain; skin rash or hives.

Symptoms of overdose

Clumsiness or unsteadiness; confusion; dizziness; drowsiness (severe); fast heartbeat; fever; flushing or redness of face; hallucinations (seeing, hearing, or feeling things that are not there); shortness of breath or troubled breathing; unusual excitement, nervousness, restlessness, or irritability.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Constipation; decreased sweating; drowsiness; dryness of mouth, nose, and throat.

Less common or rare

Blurred vision; decreased flow of breast milk; decreased sexual ability; difficult urination; difficulty in swallowing; headache; increased sensitivity of eyes to light; nausea or vomiting; trouble in sleeping; unusual tiredness or weakness.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

April 30, 1998