Ditropan

Ditropan (discontinued brand in the US); Ditropan XL; Oxytrol; Anturol; Gelnique

Ditropan is part of the drug class:

• Drugs for urinary frequency and incontinence

• Urinary Incontinence
• Urinary Incontinence in Children
• Urinary Incontinence in Women

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 section provides information on the proper use of a number of products that contain oxybutynin. It may not be specific to Ditropan. Please read with care.

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.

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.

Ditropan® (oxybutynin chloride) is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.

Ditropan is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

The safety and efficacy of Ditropan® (oxybutynin chloride) was evaluated in a total of 199 patients in three clinical trials. These participants were treated with Ditropan 5–20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients.

The most common adverse events reported by patients receiving Ditropan 5–20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.

In addition, the following adverse events were reported by 1 to <5% of patients using Ditropan (5–20 mg/day) in all studies. Infections and Infestations: nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders: fluid retention; Psychiatric Disorders: confusional state; Nervous System Disorders: dysgeusia, sinus headache; Eye Disorders: keratoconjunctivitis sicca, eye irritation; Cardiac Disorders: palpitations, sinus arrhythmia; Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion; Gastrointestinal Disorders: diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders: dry skin, pruritis; Musculoskeletal and Connective Tissue Disorders: back pain, arthralgia, pain in extremity, flank pain; Renal and Urinary Disorders: dysuria, pollakiuria; General Disorders and Administration Site Conditions: fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations: blood pressure increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural Complications: fall.

Postmarketing Surveillance

Because postmarketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse events have been reported from worldwide postmarketing experience with Ditropan: Psychiatric Disorders: psychotic disorder, agitation, hallucination, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: cycloplegia, mydriasis, glaucoma; Cardiac Disorders: tachycardia, QT interval prolongation; Gastrointestinal Disorders: decreased gastrointestinal motility; Skin and Subcutaneous Tissue Disorders: rash, decreased sweating; Renal and Urinary Disorders: impotence; Reproductive System and Breast Disorders: Suppression of lactation; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment.

Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered.

Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Other symptoms may include hypotension or hypertension, respiratory failure, paralysis, and coma.

Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.

You should not use Ditropan XL if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using Ditropan XL, tell your doctor if you have glaucoma, liver or kidney disease, an enlarged prostate, myasthenia gravis, ulcerative colitis, a blockage in your stomach or intestines, or a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Ditropan XL can decrease perspiration and you may be more prone to heat stroke.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

There are many other medicines that can interact with oxybutynin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, extreme thirst, severe stomach pain or constipation, pain or burning when you urinate, or if you stop urinating.

You should not use Ditropan XL 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 are unable to urinate.

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

• glaucoma;

• liver disease;

• kidney disease;

• an enlarged prostate;

• ulcerative colitis;

• Parkinson's disease;

• a nerve disorder that affects your heart rate, blood pressure, or digestion;

• a muscle disorder such as myasthenia gravis; or

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

Ditropan XL is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether oxybutynin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Taking this medicine with other drugs that make you sleepy can worsen these effects. Ask your doctor before taking Ditropan XL with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ditropan XL, especially:

• other bladder or urinary medicines such as darifenacin, fesoterodine, tolterodine, solifenacin;

• bronchodilators such as ipratropium or tiotropium;

• cold or allergy medicine that contains an antihistamine;

• medication for Parkinson's disease; or

• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.

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

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