Description
Oxybutynin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control), a strong urge to urinate right away, or a frequent need to urinate.
The gel form is available only with a doctor's prescription. The Oxytrol® for Men skin patch is available only with a doctor's prescription, but the Oxytrol® for Women skin patch is available without a prescription or over-the counter (OTC).
This product is available in the following dosage forms:
- Patch, Extended Release
- Gel/Jelly
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 have not been performed on the relationship of age to the effects of oxybutynin in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxybutynin in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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:
- Esophagitis (inflamed esophagus) or
- Gastroesophageal reflux disease (GERD) or
- Intestinal atony (bowels do not move) or
- Intestinal blockage (blocked bowels) or
- Ulcerative colitis (inflamed bowels) or
- Urinary problems (eg, blockage)—Use with caution. May make side effects become worse.
- Myasthenia gravis (muscle disorder)—Use with caution. May make this condition worse.
- Narrow-angle glaucoma, poorly controlled or
- Stomach problems (eg, blocked bowels, gastric retention) or
- Urinary retention (problems with passing urine)—Should not be used in patients with these conditions.
Proper Use
Use this medicine only as directed by your doctor. 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 comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, breasts, or genital area. Do not use it on skin areas that have cuts, scrapes, burns, scars, on irritated skin, or on recently shaved skin. If it does get on these areas, rinse it off right away.
To use the gel (packet or metered-dose pump):
- Wash your hands with soap and water before and after using this medicine.
- Before applying this medicine, wash the application site (eg, stomach, upper arms, shoulders, or thighs) with mild soap and water. Rinse well and pat dry.
- Packet—Tear and squeeze the entire contents of the packet into the palm of your hand or directly on the application site. Gently rub it until the gel dries.
- Metered-dose pump—Prime the pump before use by pressing all the way down 4 times or until you see the gel come out. Do not use any medicine that came out while you were priming the pump. Fully-pressed the pump one time to get your dose. It should be about the size of a nickel. Apply it into your hand or directly on the application site. Gently rub it until the gel dries.
- Do not apply this medicine on the same application site you applied the last one.
- Do not bathe, swim, shower, or exercise for 1 hour after applying oxybutynin.
- Cover the application site with a dry cloth after the medicine has dried to avoid direct contact or transfer of oxybutynin to another person.
To use the skin patch:
- Wash your hands with soap and water before and after applying the patch. Do not touch your eyes until after you have washed your hands.
- Oxtyrol® skin patches are packaged in sealed pouches. Do not use this medicine if the patch is damaged. Do not divide not cut the patches into pieces. Do not remove the patch from the sealed pouch until you are ready to apply it. When applying the patch, be careful not to touch the adhesive (sticky) side.
- Do not put oils, lotions, or powder on the skin area where the patch will be placed.
- Apply the patch to a clean, dry, smooth skin on your stomach, hips, or buttocks. Do not put the patch over oily, cut, scraped, or irritated skin. Avoid putting the patch on areas where it could be rubbed by tight clothing.
- Open the pouch and remove the patch. The adhesive (sticky) side of the patch is covered by 2 strips of overlapping protective liner. Remove the first piece of protective liner and place the patch, adhesive face down, firmly onto the skin.
- Bend the patch in half and gently roll the remaining part onto your skin using the tips of your finger. While rolling, the second piece of the protective liner should come off. Press the patch firmly with your finger.
- If the patch falls off, press it back in place and continue to follow application schedule. If it does not stay on, throw it away and apply a new patch in a different area.
- Remove the patch after 3 or 4 days. Choose a different place on your skin to apply the next patch. If you forget to change your patch after 3 or 4 days, remove the old patch and put on a new patch in a different area. Do not use the same area for at least 7 days.
- After you remove the old patch, fold it in half with sticky sides together. Wash the application site with warm water and a mild soap or baby oil to remove any adhesive on your skin. Do not use alcohol or nail polish remover.
The gel form contains alcohol which is flammable. Do not use this medicine near heat, an open flame, or while smoking.
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 bladder problems:
- For transdermal dosage form (gel):
- Adults—
- Anturol™: 84 milligrams (mg) or 3 pumps of gel applied on dry, intact skin once a day.
- Gelnique®: Apply one packet or one pump of the gel on dry, intact skin once a day.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For transdermal dosage form (skin patch):
- Adults—Apply one patch 2 times a week (every 3 to 4 days).
- Children—Use and dose must be determined by your doctor.
- For transdermal dosage form (gel):
Missed Dose
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
If you miss a dose of this medicine, apply 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.
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.
Throw away the pump dispenser after 30 pumps.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
This medicine may cause a serious allergic reaction, including angioedema, which may be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble with breathing, or chest tightness while you are using this medicine.
This medicine 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 using this medicine, since overheating may result in heat stroke.
This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause dryness of the mouth, nose, and throat. 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.
Avoid drinking alcohol while you are using this medicine.
Do not use cosmetics or other skin care products on the treated skin areas. However, you may use this medicine with a sunscreen.
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:
More common
- Bladder pain
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- burning, skin rash, swelling, soreness, redness, pain, itching, or irritation at the application site
- cracked, dry, or scaly skin
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- unusually warm skin
Less common
- Diarrhea
- loss of appetite
- nausea
- stomach pain
- weakness
Incidence not known
- Confusion as to time, place, or person
- holding false beliefs that cannot be changed by fact
- seeing, hearing, or feeling things that are not there
- unusual excitement, nervousness, or restlessness
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
- Body aches or pain
- chills
- cough
- difficulty with breathing
- ear congestion
- headache
- loss of voice
- sneezing
- sore throat
- stuffy or runny nose
Less common
- Back pain
- bloated feeling
- changes in vision
- constipation
- excess air or gas in the stomach or intestines
- feeling of fullness
- muscle aches
- passing gas
- sleepiness or unusual drowsiness
Incidence not known
- Forgetfulness
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.
DRG-20072572
