Anturol topical

You should not use oxybutynin topical if you have uncontrolled narrow-angle glaucoma, a blockage in your stomach or intestines, or if you are unable to urinate.

Using this medicine with other drugs that make you sleepy can worsen these effects. Ask your doctor before using oxybutynin topical with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• cold or allergy medicine that contains an antihistamine;

• medicine for Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• bronchodilators--aclidinium, ipratropium, or tiotropium;

• medicine to treat osteoporosis or Paget's disease of bone--alendronate, etidronate, ibandronate, pamidronate, risedronate, tiludronate, zoledronic acid; or

• other bladder or urinary medicines--darifenacin, fesoterodine, oral oxybutynin, tolterodine, solifenacin.

This list is not complete. Other drugs may interact with oxybutynin topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

You should not use Anturol if you are allergic to oxybutynin, or if you have:

• untreated or uncontrolled narrow-angle glaucoma;

• a blockage in your digestive tract (stomach or intestines); or

• if you have decreased urination or are unable to urinate.

To make sure Anturol is safe for you, tell your doctor if you have:

• glaucoma;

• liver or kidney disease;

• myasthenia gravis;

• severe constipation;

• an enlarged prostate;

• an intestinal disorder, such as ulcerative colitis;

• a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion; or

• if you have trouble emptying your bladder.

Anturol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether oxybutynin topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• transdermal gel/jelly, transdermal patch extended release

Along with its needed effects, oxybutynin (the active ingredient contained in Anturol) 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 while taking oxybutynin:

• Eye pain
• skin rash or hives

Get emergency help immediately if any of the following symptoms of overdose occur while taking oxybutynin:

• 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 of oxybutynin 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:

• 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

• 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

• 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

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release, transdermal film extended release, transdermal gel

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Anaphylactic reaction[Ref]

Cardiovascular

Common (1% to 10%): Palpitations
Uncommon (0.1% to 1%): Cardiac arrhythmia tachycardia, vasodilation, hypertension, flushing
Frequency not reported: Heat stroke[Ref]

Dermatologic

Very common (10% or more): Dry skin, pruritus
Common (1% to 10%): Flushing, rash
Frequency not reported: Angioedema, hypohidrosis[Ref]

Endocrine

Postmarketing reports: Decreased lactation[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 72%), constipation (up to 15%), nausea
Common (1% to 10%): Diarrhea, dyspepsia, abdominal pain, vomiting, flatulence, gastroesophageal reflux disease
Uncommon (0.1% to 1%): Abdominal discomfort
Frequency not reported: Pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility), decreased GI motility[Ref]

General

The most common (incidence 5% or greater) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, urinary hesitation, urinary retention, dysuria, increased post void retention
Frequency not reported: Impotence, suppression of lactation, cystitis, aggravation of prostatic hypertrophy[Ref]

Immunologic

Uncommon (0.1% to 1%): Fungal infection[Ref]

Local

Very common (10% or more): Application site pruritus (16.8%)
Common (1% to 10%): Application site erythema, application site vesicles, application site rash, application site macules[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, fluid retention[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 17%), somnolence (up to 14%), headache, drowsiness, confusion
Common (1% to 10%): Dysgeusia
Uncommon (0.1% to 1%): Dysphagia, convulsions
Frequency not reported: Cognitive disorders in elderly, convulsions, agitation, nightmares, anxiety, paranoia, symptoms of depression, hallucinations, asthenia, insomnia, restlessness, dependence to this drug (in patients with history of drug or substance abuse)[Ref]

Ocular

Common (1% to 10%): Blurred vision, dry eye, abnormal vision
Uncommon (0.1% to 1%): Angle closure glaucoma
Frequency not reported: Onset of narrow-angle glaucoma, mydriasis, intraocular hypertension, amblyopia, cycloplegia, decreased lacrimation[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Dysphonia, thirst
Frequency not reported: Falls, accidental injury[Ref]

Psychiatric

Common (1% to 10%): Insomnia, nervousness
Uncommon (0.1% to 1%): Hallucinations, confusional state, agitation, memory impairment
Frequency not reported: Psychotic disorder, anxiety, nightmares, paranoia[Ref]

Respiratory

Common (1% to 10%): Cough, oropharyngeal pain, dry throat, nasal dryness
Uncommon (0.1% to 1%): Upper respiratory tract infection, rhinitis, chest discomfort, hoarseness
Rare (0.01% to 0.1%): Nasal congestion, throat irritation[Ref]

Some side effects of Anturol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Immediate Release Tablets/Syrup/Solution:
Pediatric patients over 5 years of age:
-Usual dose: 5 mg orally 2 times a day
-Maximum dose: 5 mg orally 3 times a day

Extended Release Tablets:
Pediatric patients over 6 years of age:
-Initial dose: 5 mg orally once a day at approximately the same time each day; the dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability
-Maximum dose: 15 mg orally per day

Comments:
-Tablets should be swallowed whole, with water.
-In case of a missed dose, the patient should wait and take the next dose at the regular time.

Uses:
-Immediate Release Tablets/Syrup/Solution: For the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria) in patients 5 years of age and older.
-Extended Release Tablets: For the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

Immediate Release Tablets/Syrup/Solution:
Pediatric patients over 5 years of age:
-Usual dose: 5 mg orally 2 times a day
-Maximum dose: 5 mg orally 3 times a day

Extended Release Tablets:
Pediatric patients over 6 years of age:
-Initial dose: 5 mg orally once a day at approximately the same time each day; the dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability
-Maximum dose: 15 mg orally per day

Comments:
-Tablets should be swallowed whole, with water.
-In case of a missed dose, the patient should wait and take the next dose at the regular time.

Uses:
-Immediate Release Tablets/Syrup/Solution: For the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria) in patients 5 years of age and older.
-Extended Release Tablets: For the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

Immediate Release Tablets/Syrup/Solution:
Pediatric patients over 5 years of age:
-Usual dose: 5 mg orally 2 times a day
-Maximum dose: 5 mg orally 3 times a day

Extended Release Tablets:
Pediatric patients over 6 years of age:
-Initial dose: 5 mg orally once a day at approximately the same time each day; the dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability
-Maximum dose: 15 mg orally per day

Comments:
-Tablets should be swallowed whole, with water.
-In case of a missed dose, the patient should wait and take the next dose at the regular time.

Uses:
-Immediate Release Tablets/Syrup/Solution: For the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria) in patients 5 years of age and older.
-Extended Release Tablets: For the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

-Tablet/Syrup/Solution formulation: Safety and efficacy have not been established in patients younger than 5 years.
-Extended-release formulation: Safety and efficacy have not been established in patients younger than 6 years.
-Patch or gel formulation: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.