Oxybutynin

What is Oxybutynin?

• Oxybutynin (Ditropan; Ditropan XL) is a muscarinic antagonist used to treat overactive bladder.
• Oxybutynin (Ditropan XL) is also used as an extended-release tablet to control bladder muscles in adults and children 6 years of age and older with spina bifida.
• Oxybutynin Topical (Gelnique) is used to treat the symptoms of overactive bladder.
• Oxybutynin transdermal system (Oxytrol) is used for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.

Oxybutynin

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What are the uses of this medicine?

• Oxybutynin (Ditropan) is used for 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).
• Oxybutynin (Ditropan XL) is used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
• Oxybutynin (Ditropan XL) extended-release tablets are also indicated 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).

How does this medicine work?

• The chloride salt form of oxybutynin, a tertiary amine and anticholinergic agent with antispasmodic activity.
• Oxybutynin chloride exerts its antimuscarinic effect on bladder smooth muscle by blocking muscarinic receptors in smooth muscle, thereby inhibiting acetylcholine binding.
• It has specificity for the M1, M2 and M3 subtypes of the muscarinic acetylcholine receptor which are commonly found in bladder smooth muscle.
• This results in a relaxation of bladder smooth muscle, a reduction of involuntary muscle contractions and delays the initial desire to void.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.
• who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angioedema.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• amiodarone (Cordarone, Pacerone)
• certain antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Erythrocin), and tetracycline (Bristamycin, Sumycin, Tetrex)
• certain antifungals such as itraconazole (Sporanox),miconazole (Monistat), and ketoconazole (Nizoral)
• antihistamines
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• cimetidine (Tagamet)
• diltiazem (Cardizem, Dilacor, Tiazac)
• fluvoxamine
• ipratropium (Atrovent)
• iron supplements
• certain medications for human immunodeficiency virus (HIV) such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra) medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems
• medications for osteoporosis (a condition in which bones are weak, fragile, and can break easily) such as alendronate (Fosamax), ibandronate (Boniva), and risedronate (Actonel)
• nefazodone
• potassium supplements
• quinidine
• verapamil (Calan, Covera, Isoptin, Verelan)

Is this medicine FDA approved?

• Oxybutynin was approved for use in the United States in 1975 and is still widely used.
• It is available in regular and extended release tablets as well as oral solutions, syrups, and transdermal creams in various generic forms and under the trade name Ditropan.
• A transdermal patch formulation is available under the brand name Oxytrol.

How should this medicine be used?

Recommended dosage:

Oxybutynin chloride extended-release tablets:

• In Adults: Start with 5 mg or 10 mg, once daily at approximately the same time every day. Dose should not exceed 30 mg per day. (2.1)
• Inn Pediatric patients (6 years of age or older): Start with 5 mg, once daily at approximately the same time every day. Dose should not exceed 20 mg per day.

Oxybutynin chloride tablets: In Adults:

• The usual dose is one 5-mg tablet two to three times a day.
• The maximum recommended dose is one 5-mg tablet four times a day.
• A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly.

In Pediatric patients over 5 years of age:

• The usual dose is one 5-mg tablet two times a day.
• The maximum recommended dose is one 5-mg tablet three times a day.

Administration:

• Oxybutynin comes as a tablet, a syrup, and an extended-release tablet to take by mouth.
• The tablets and syrup are usually taken two to four times a day.
• The extended-release tablet is usually taken once a day with or without food.
• Take oxybutynin at around the same times every day.
• Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.
• Use a dose-measuring spoon or cup to measure the correct amount of liquid for each dose, not a household spoon.
• Your doctor may start you on a low dose of oxybutynin and gradually increase your dose, not more than once every week.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet, a syrup, and an extended-release tablet

This medicine is available in fallowing brand namesː

• Ditropan
• Ditropan XL

What side effects can this medication cause?

The most common side effects of this medicine include: Psychiatric Disorders:

• Insomnia

Nervous System Disorders:

• Headache
• Somnolence
• Dizziness
• Dysgeusia

Eye Disorders:

• Vision blurred
• Dry eye

Respiratory, Thoracic and Mediastinal Disorders:

• Cough
• Oropharyngeal pain
• Dry throat
• Nasal dryness

Gastrointestinal Disorders:

• Dry mouth
• Constipation
• Diarrhea
• Dyspepsia
• Nausea
• Abdominal pain
• Vomiting
• Flatulence
• Gastro-esophageal reflux disease

Skin and Subcutaneous Tissue Disorders:

• Dry skin
• Pruritus

Renal and Urinary Disorders:

• Dysuria
• Urinary hesitation
• Urinary retention

General Disorders and Administration Site Conditions:

• Fatigue
• Residual urine volume

• Anticholinergic agents can precipitate acute narrow angle glaucoma and acute urinary retention.

What special precautions should I follow?

• Angioedema has been reported with oxybutynin. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience swelling of the tongue, edema of the laryngopharynx, or difficulty breathing.
• CNS effects have been reported with oxybutynin.

Use with caution due to aggravation of symptoms:

• Pre-existing dementia in patients treated with cholinesterase inhibitors,
• Parkinson's disease,
• Myasthenia gravis, and
• Decreased gastrointestinal motility in patients with autonomic neuropathy.
• Oxybutynin chloride may produce drowsiness (somnolence), dizziness or blurred vision. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until Oxybutynin chloride extended-release tablets effects have been determined.
• Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as Oxybutynin chloride.
• Patients should be informed that Oxybutynin chloride extended-release tablets should be swallowed whole with the aid of liquids. Patients should not chew, divide, or crush tablets. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
• Oxybutynin chloride extended-release tablets should be taken at approximately the same time each day.
• Use with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
• Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention. Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis.
• Oxybutynin Chloride should be used with caution in the frail elderly, in patients with hepatic or renal impairment, and in patients with myasthenia gravis.
• Oxybutynin Chloride may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, myasthenia gravis, and prostatic hypertrophy.
• Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxybutynin chloride is administered to a nursing woman.
• Oxybutynin has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include: 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.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment should be symptomatic and supportive.
• Activated charcoal as well as a cathartic may be administered.
• The continuous release of oxybutynin from Oxybutynin chloride extended-release tablets should be considered in the treatment of overdosage. Patients should be monitored for at least 24 hours.
• Treatment should be symptomatic and supportive.
• A cathartic may be administered.

Can this medicine be used in pregnancy?

• Category B.
• The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established.
• Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazard.

Can this medicine be used in children?

• The safety and efficacy of oxybutynin chloride administration have been demonstrated for pediatric patients 5 years of age and older.
• Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• OXYBUTYNIN CHLORIDE

Inactive ingredients:

• FERROSOFERRIC OXIDE
• CELLULOSE ACETATE
• SILICON DIOXIDE
• ANHYDROUS DEXTROSE
• HYPROMELLOSES
• ANHYDROUS LACTOSE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MANNITOL
• POLYETHYLENE GLYCOL 400
• PROPYLENE GLYCOL
• TARTARIC ACID
• TITANIUM DIOXIDE
• TRIACETIN

Who manufactures and distributes this medicine?

Oxybutynin chloride extended-release tablets: Distributed by:

• Lannett Company, Inc.,
• Philadelphia, PA

Oxybutynin chloride tablets: Manufactured By:

• Appco Pharma LLC
• Piscataway, New Jersey

Distributed By:

• Rising Pharmaceuticals, Inc.
• Saddle Brook, NJ

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted within 15° C to 30° C (59° F to 86° F)
• Protect from moisture and humidity.

Urologic agents

• Overactive bladder syndrome agents - darifenacin, fesoterodine, flavoxate, hyoscyamine, mirabegron, oxybutynin, solifenacin, tolterodine, trospium

• Dailymed label info on Oxybutynin
• FDA Oxybutynin

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