Description
Oxybutynin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.
Oxybutynin 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 extended-release tablets is also used to treat children 6 years of age and older who have an overactive bladder caused by a certain nerve disorder (eg, spina bifida).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
- Syrup
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of oxybutyninextended-release tablet in children 6 years of age and older. However, oxybutynin extended-release tablet is not recommended in children who cannot swallow it whole without breaking, chewing, or crushing; or in children younger than 6 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxybutynin in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Potassium Chloride
- Potassium Citrate
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amantadine
- Benzhydrocodone
- Buprenorphine
- Bupropion
- Carbamazepine
- Clozapine
- Codeine
- Dihydrocodeine
- Donepezil
- Fentanyl
- Glucagon
- Glycopyrrolate
- Glycopyrronium Tosylate
- Hydrocodone
- Hydromorphone
- Hydroxychloroquine
- Itraconazole
- LetibotulinumtoxinA-wlbg
- Meperidine
- Methacholine
- Methadone
- Morphine
- Morphine Sulfate Liposome
- Olanzapine
- Oliceridine
- Oxycodone
- Oxymorphone
- Promethazine
- Quetiapine
- Revefenacin
- Scopolamine
- Secretin Human
- Sofpironium
- Sufentanil
- Tapentadol
- Tiotropium
- Tramadol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Galantamine
- Ketoconazole
- Rivastigmine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding, severe or
- Overactive thyroid—Oxybutynin may increase heart rate, which may make these conditions worse.
- Dementia (mental problem) or
- Dryness of the mouth (severe and continuing) or
- Enlarged prostate or
- Glaucoma or
- Heart disease or
- Hiatal hernia or
- Hypertension (high blood pressure) or
- Intestinal or stomach problems (eg, blockage, constipation, intestinal atony, ulcerative colitis, or gastroesophageal reflux disease [GERD]) or
- Myasthenia gravis (severe muscle weakness) or
- Neuropathy (nerve problems) or
- Parkinson's disease or
- Toxemia of pregnancy or
- Urinary bladder blockage—Use with caution. May make these conditions worse.
- Narrow-angle glaucoma, uncontrolled or
- Stomach problems (eg, gastric retention) or
- Urinary retention (hard to pass urine)—Should not be used in patients with these conditions.
Proper Use
It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
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.
For patients taking the extended-release tablets:
- Swallow the tablet whole with water or any liquids. Do not break, crush, or chew it.
- You may take this medicine with or without food.
- Take it at the same time each day.
- While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
Dosing
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For treatment of bladder problems:
- For oral dosage form (extended-release tablets):
- Adults—At first, 5 or 10 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
- Children 6 years of age and older—At first, 5 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
- Children younger than 6 years of age—Use is not recommended.
- For oral dosage forms (syrup or tablets):
- Adults and children 12 years of age and older—5 milligrams (mg) two or three times a day.
- Children 5 to 12 years of age—5 mg two or three times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 15 mg per day.
- Children younger than 5 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
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
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it.
This medicine may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest tightness while you are using this medicine.
Oxybutynin may cause anxiety, confusion, irritability, sleepiness or unusual drowsiness, or hallucinations (seeing, hearing, or feeling things that are not there). These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. If you or your child have these symptoms, tell your doctor right away.
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, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child 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 dizzy, 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 dizzy, not alert, or not 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 or your child 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 or your child are taking this medicine.
Your mouth, nose, and throat may feel very dry while you or your child 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 immediately if any of the following side effects occur:
Rare
- Eye pain
- skin rash or hives
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Clumsiness or unsteadiness
- confusion
- convulsions
- dizziness
- drowsiness (severe)
- fainting
- fast, slow, or irregular heartbeat
- fever
- flushing or redness of the face
- hallucinations (seeing, hearing, or feeling things that are not there)
- troubled breathing
- unusual excitement, nervousness, restlessness, or irritability
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- belching
- decreased sweating
- diarrhea
- difficulty having a bowel movement (stool)
- drowsiness
- dryness of the eyes, mouth, nose, or throat
- heartburn
- indigestion
- runny nose
- stomach discomfort, upset, or pain
Less common or rare
- Blurred vision
- decreased flow of breast milk
- decreased sexual ability
- difficulty in swallowing
- feeling of warmth or heat
- headache
- increased sensitivity of the eyes to light
- nausea or vomiting
- trouble with sleeping
- unusual tiredness or weakness
Incidence not known
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
