Anturol

Name: Anturol

Patient information

ANTUROL
[an'-ter-all]
(oxybutynin) gel 3% Topical

Important: For use on the skin only (topical). Do not get ANTUROL in or near your eyes, nose, or mouth.

Read this Patient Information carefully before you start taking ANTUROL and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is ANTUROL?

ANTUROL is a prescription medicine used to treat the symptoms of overactive bladder including:

  • a strong need to urinate with leaking or wetting accidents (urge urinary incontinence)
  • a strong need to urinate right away (urgency)
  • urinating often (frequency)

It is not known if ANTUROL is safe or effective in children.

Who should not use ANTUROL?

Do not use ANTUROL if:

  • Your bladder does not empty or does not empty completely when you urinate (urinary retention).
  • Your stomach empties slowly or incompletely after a meal (gastric retention).
  • You have high pressure in your eye (uncontrolled narrow-angle glaucoma).
  • You have an allergy to oxybutynin or any of the ingredients in ANTUROL. See the end of this leaflet for a complete list of ingredients in ANTUROL.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What should I tell my doctor before using ANTUROL?

Before you take ANTUROL, tell your doctor if you:

  • have problems emptying your bladder completely
  • have stomach problems including:
    • constipation or difficulty in emptying your bowels
    • inflamed bowels (ulcerative colitis)
    • inflammation of the tube between your mouth and stomach (gastric reflux disease or esophagitis)
  • have generalized muscle weakness (Myasthenia Gravis)
  • are pregnant or are planning to become pregnant. It is not known if ANTUROL will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ANTUROL passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use ANTUROL.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

ANTUROL may affect the way other medicines work, and other medicines may affect how ANTUROL works. Especially tell your doctor if you take:

  • medicines used to treat osteoporosis (Bisphosphonates)
  • other medicines used to treat overactive bladder (Anticholinergic)

Ask your doctor if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I use ANTUROL?

ANTUROL is for skin use only.

  • Use ANTUROL exactly as your doctor tells you to use it.
  • ANTUROL should only be applied to dry intact skin on your stomach (abdomen), upper arms, or thighs.
  • Do not put ANTUROL on recently shaved skin, open sores, scars, tattoos, or skin with rashes.
  • Do not put ANTUROL on your breasts or genital area.
  • ANTUROL contains alcohol and is flammable. Avoid fire, flames, or smoking until the ANTUROL has dried.
  • Cover the application site with clothing after the gel has dried, if skin-to-skin contact between another person and the application site is expected.
  • After applying ANTUROL, wash your hands with soap and water right away.
  • ANTUROL may be used with sunscreen.
  • If you get ANTUROL in your eyes: Rinse your eyes well right away with clean and warm water. Seek medical attention if needed.

How to use the ANTUROL pump:

You must prime the ANTUROL pump before you use it for the first time.

To prime the pump:

  • To prime the Anturol pump, hold the pump upright and fully press down (depress) the pump 4 times. Now Anturol is ready to use.
  • Do not use any Anturol that came out while priming.

Applying ANTUROL:

1. Selecting your application site:

Apply ANTUROL only to 1 of the shaded areas shown in the figure below: (See (Figure A)).

  • stomach area (abdomen)
  • upper arms
  • shoulders
  • thighs

(Figure A)

  • Wash the area where ANTUROL will be applied with mild soap and water. Allow the area to dry completely.
  • Wash your hands with soap and water.
  • Application sites may be rotated to reduce the potential for local site reactions.

2. Dispensing your dose of ANTUROL:

  • Place your hand under the ANTUROL pump.
  • Press the pump all the way down 3 times (See (Figure B). You can also place the pump right over the application site then press the pump all the way down 3 times to dispense your dose (See (Figure C).
  • You should apply ANTUROL right after you dispense your dose.
  • Wash your hands with soap and water right away.

(Figure B)

What should I avoid while using ANTUROL?

  • Do not take a bath, swim, shower, exercise, or get the application site wet for 1 hour after you apply your dose.
  • ANTUROL can cause dizziness or blurred vision. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ANTUROL affects you.
  • You should not drink alcohol while using ANTUROL. It can increase your chances of getting serious side effects.

(Figure C)

What are the possible side effects of ANTUROL?

The most common side effects of ANTUROL include:

  • dry mouth
  • urinary tract infections
  • dry eyes
  • blurry vision
  • redness, rash, itching, pain at the application site

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ANTUROL. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store ANTUROL?

  • Store ANTUROL at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ANTUROL and all medicines out of the reach of children.

General information about the safe and effective use of ANTUROL.

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use ANTUROL for a condition for which it was not prescribed. Do not give ANTUROL to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about ANTUROL. If you would like more information about ANTUROL, talk with your doctor. You can ask your pharmacist or doctor for information about ANTUROL that is written for health professionals.

For more information go to www.ANTUROLGEL.com or call 1-800-328-3077.

What are the ingredients in ANTUROL?

Active ingredient: oxybutynin

Inactive ingredients: diethylene glycol monoethyl ether, NF; alcohol, USP; hydroxypropyl cellulose, NF; propylene glycol, NF; butylated hydroxytoluene, NF; HC1 0.1 M, NF; and purified water, USP.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Anturol Drug Class

Anturol is part of the drug class:

  • Drugs for urinary frequency and incontinence

Anturol 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, or soreness at the application site
  • cracked, dry, or scaly skin
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
  • redness, pain, itching, or irritation at the application site
  • unusually warm skin
Less common
  • Abdominal or stomach pain
  • diarrhea
  • loss of appetite
  • nausea
  • weakness

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
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
Less common
  • Back pain
  • bloated
  • changes in vision
  • constipation
  • excess air or gas in the stomach or intestines
  • full feeling
  • muscle aches
  • passing gas
  • sleepiness or unusual drowsiness

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.

What do I need to tell my doctor BEFORE I take Anturol?

  • If you have an allergy to oxybutynin or any other part of Anturol (oxybutynin gel).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Bowel block, poorly controlled glaucoma, slow moving GI (gastrointestinal) tract, or trouble passing urine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Anturol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Anturol?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Anturol affects you.
  • Avoid alcohol or other drugs and natural products that slow your actions.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help with dry mouth. See a dentist often.
  • A very bad reaction called angioedema has happened with this medicine. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Talk with the doctor.
  • If you are 65 or older, use Anturol with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Side effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

The safety of ANTUROL was evaluated in 626 patients (210 randomized to ANTUROL 56 mg/day, 214 randomized to ANTUROL 84 mg/day and 202 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 626 patients (N = 77) participated in the 24-week open-label safety extension that followed the placebo-controlled study. Of the 77 patients in the safety extension, 24 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 441 patients were exposed to at least one dose of ANTUROL. 364 patients received at least 12 weeks of ANTUROL treatment and 66 patients received an additional 24 weeks of ANTUROL treatment during the open-label safety extension. The study population primarily consisted of women (87%) of Caucasian descent (87%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.

Table 1 lists adverse reactions (ARs), regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than 3% of patients treated with ANTUROL.

Overall, 672 ARs were experienced by 51.9% of patients. Majority of the ARs were mild to moderate in intensity. The AR most commonly reported was dry mouth which was experienced by a greater proportion of patients in the oxybutynin group than the placebo group (26 patients [12.1%] in the oxybutynin 84 mg group, 10 patients [5.0%] in the placebo group). Application site erythema was the next most commonly reported AR (8 patients [3.7%] in the oxybutynin 84 mg group and 2 patients [1.0%] in the placebo group). Other commonly reported ARs experienced by more patients in the oxybutynin groups compared with placebo were application site rash (7 patients [3.3%] in the oxybutynin 84 mg group and 1 patient [0.5%] in the placebo group); application site pruritus (6 patients [2.8%] in the oxybutynin 84 mg group and 1 patient [0.5%] in the placebo group). The overall rate of application site adverse reactions of any kind was 14.2% in patients receiving ANTUROL as compared to 3.7% in patients receiving placebo. Other cholinergic AEs < 2% in occurrence include dry eyes and blurred vision.

There were no deaths during the study. There were no clinically meaningful changes in vital signs, laboratory values, or ECG examinations over the course of the study.

Table 1: Commonly Reported Adverse Reactions that were reported In greater than 3% of patients treated with ANTUROL and at an incidence greater than placebo.

Preferred Term1 Treatment Group
Oxybutynin
84 mg/day
(N=214)
Placebo
(N=202)
n (%) n (%)
Dry mouth 26 (12.1) 10 (5.0)
Application site erythema 8 (3.7) 2 (1.0)
Application site rash 7 (3.3) 1 (0.5)
1 Each patient is counted only once within each treatment, body system and preferred term. All percentages are based on number of patients in the ITT population within each treatment group as denominator.

During the 24-week open-label safety extension, the most commonly reported ARs were urinary tract infection and nasopharyngitis reported in 4 patients each (5.2%), followed by conjunctivitis and application site erythema (both occurred in 3 patients [3.9%]). One patient prematurely discontinued due to the application site erythema and pruritus (both considered to be of mild severity).

Read the entire FDA prescribing information for Anturol (Oxybutynin)

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