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Ditropan XL


Udocheals.orgDitropan xl
8.16.2017 | Jessica MacAdam
Ditropan xl
Ditropan XL

Ditropan XL also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, hypromellose, lactose, magnesium stearate, polyethylene glycol, polyethylene oxide, polysorbate 80, propylene glycol, sodium chloride, synthetic iron oxides and titanium dioxide.

Ditropan XL may be administered with or without food.

10 mg: Pink, round, tablet with "10 XL" printed on one side with black ink.

The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.

The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7%). The discontinuation rate due to adverse reactions was 4.4% with Ditropan XL compared to 0% with Ditropan IR.

CSA Schedule N Not a controlled drug.

Figure 1: Mean R-oxybutynin plasma concentrations following a single dose of Ditropan XL 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment).

Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). Mean oxybutynin chloride plasma concentrations were approximay 2 fold higher when Ditropan XL was administered with ketoconazole, a potent CYP3A4 inhibitor. Caution should be used when such drugs are co-administered. The clinical relevance of such potential interactions is not known.

Data sources include Micromedex (updated June 2nd, 2017), Cerner Multum (updated June 5th, 2017), Wolters Kluwer (updated June 6th, 2017) and others. To view content sources and attributions, please refer to our editorial policy. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.

A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies. Antimuscarinic activity resides predominantly in the R-isomer.

All three studies included patients known to be responsive to oxybutynin or other anticholinergic medications, and these patients were maintained on a final dose for up to 2 weeks. Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge) as evidenced by ≥ 6 urge incontinence episodes per week and ≥ 10 micturitions per day. Study 1 was a fixed-dose escalation design, whereas the other two studies used a dose-adjustment design in which each patient's final dose was adjusted to a balance between improvement of incontinence symptoms and tolerability of side effects. The majority of patients were Caucasian (89.0%) and female (91.9%) with a mean age of 59 years (range, 18 to 98 years). Ditropan XL was evaluated for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in three controlled efficacy studies.

Availability Rx Prescription only.

For more information call or visit www.DITROPANXL.com Product of France.

Titusville, NJ 08560. Manufactured for: Janssen Pharmaceuticals, Inc.

System Components and Performance.

There were no studies conducted with Ditropan XL in patients with hepatic impairment.

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

Ditropan XL should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

Ditropan XL is not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6.

Ditropan XL (oxybutynin chloride) Extended-release tablets 10 mg Rx only.

A 24-month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity. These doses are approximay 6, 25, and 50 times the maximum human exposure, based on a human equivalent dose taking into account normalization of body surface area.

The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of Ditropan XL were similar in all patients studied (up to 78 years of age).

Ditropan XL should be used with caution in patients with myasthenia gravis due to the risk of aggravation of symptoms.

Ditropan XL (oxybutynin chloride) Extended-release tablets 15 mg Rx only.

When all available data are normalized to an equivalent of 5 mg per day of Ditropan XL, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 3. The children were on Ditropan XL total daily dose ranging from 5 to 20 mg (0.10 to 0.77 mg/kg). Sparse sampling technique was used to obtain serum samples. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg per day. Ditropan XL steady state pharmacokinetics were studied in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida).

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.

Ditropan XL should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.

Ditropan XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.

Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus.

NDC 100 tablets.

If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Advise patients not to drive or operate heavy machinery until they know how Ditropan XL affects them.

Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.

Absorption. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void.

Ditropan XL should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.

Ditropan XL should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

Ditropan XL should be used with caution in patients with Parkinson's disease due to the risk of aggravation of symptoms.

Approval History Calendar Drug history at FDA.

In some cases, angioedema occurred after the first dose. Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Angioedema associated with upper airway swelling may be life-threatening.

Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin. Dose Proportionality.

Urodynamic results were consistent with clinical results. Administration of Ditropan XL resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 60% to 28%.

Adverse reactions reported by ≥ 1% of subjects are shown in Table 1. In four of the five studies, Ditropan IR (5 to 20 mg/day in 199 subjects) was an active comparator. The safety and efficacy of Ditropan XL (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials.

Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems.

Overactive Bladder oxybutynin, Myrbetriq, VESIcare, tolterodine, Detrol, Ditropan, Toviaz, trospium, More.

There were no studies conducted with Ditropan XL in patients with renal impairment.

The following additional adverse reactions have been reported from worldwide postmarketing experience with Ditropan XL. Because postmarketing reactions 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.

Its structural formula is:

Ditropan XL is 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).

Pharmacokinetic parameters of oxybutynin and desethyloxybutynin (C max and AUC) following administration of 5–20 mg of Ditropan XL are dose proportional.

Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and suppression of lactation.

There are no significant differences in the pharmacokinetics of oxybutynin in healthy male and female volunteers following administration of Ditropan XL. Race.

Ditropan XL extended-release tablets are available as 5, 10 and 15 mg tablets for oral use:

Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl.

Generic Name: oxybutynin chloride Dosage Form: tablet, extended release.

Ditropan XL is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.

Ditropan XL extended-release tablets are available in three dosage strengths, 5 mg (pale yellow), 10 mg (pink), and 15 mg (gray) and are imprinted on one side with "5 XL", "10 XL", or "15 XL" with black ink. Ditropan XL extended-release tablets are supplied in bottles of 100 tablets.

Ditropan XL uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximay 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. The function of Ditropan XL depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the gastrointestinal tract. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the push layer to expand. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer side of the tablet. This expansion pushes the suspended drug out through the orifice.

The safety and efficacy of Ditropan XL were studied in 60 children in a 24-week, open-label, non-randomized trial. Study results demonstrated that administration of Ditropan XL 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%. Patients were aged 6–15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride.

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The following adverse reactions were reported by <1% of Ditropan XL -treated patients and at a higher incidence than placebo in clinical trials: Metabolism and Nutrition Disorders: anorexia, fluid retention; Vascular disorders: hot flush; Respiratory, thoracic and mediastinal disorders: dysphonia; Gastrointestinal Disorders: dysphagia, frequent bowel movements; General disorders and administration site conditions: chest discomfort, thirst.

Distribution Metabolism. The rate and extent of absorption and metabolism of oxybutynin are similar under fed and fasted conditions.

Gender. The pharmacokinetics of Ditropan XL in these pediatric patients were consistent with those reported for adults (see Tables 2 and 3, and Figures 1 and 2 above). The pharmacokinetics of Ditropan XL were evaluated in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida).

Activated charcoal as well as a cathartic may be administered. Patients should be monitored for at least 24 hours. The continuous release of oxybutynin from Ditropan XL should be considered in the treatment of overdosage. Treatment should be symptomatic and supportive.

Infections and Infestations: Urinary tract infection; Psychiatric Disorders: psychotic disorder, agitation, confusional state, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Respiratory, Thoracic and Mediastinal Disorders: nasal congestion; Cardiac Disorders: arrhythmia, tachycardia, palpitations QT interval prolongation; Vascular Disorders: flushing, hypertension; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; anaphylactic reactions requiring hospitalization for emergency treatment; Injury, poisoning and procedural complications: fall.

Urinary Incontinence oxybutynin, VESIcare, tolterodine, Detrol, Ditropan, Toviaz, trospium, Enablex, More.

Food Effects. Plot represents all available data normalized to an equivalent of Ditropan XL 5 mg once daily. Figure 2: Mean steady state (± SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Ditropan XL once daily in children aged 5–15.

Ditropan XL, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony.

NDC 100 tablets.

15 mg: Gray, round, tablet with "15 XL" printed on one side with black ink.

Excretion. Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4 found mostly in the liver and gut wall. Following Ditropan XL administration, plasma concentrations of R- and S-desethyloxybutynin are 73% and 92%, respectively, of concentrations observed with oxybutynin. Its metabolic products include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active.

The efficacy results for the three controlled trials are presented in the following tables and figures.

Other brands: Oxytrol, Gelnique.

Ditropan XL is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angiodema.

The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 2. The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from Ditropan XL are 156% and 187%, respectively, compared with oxybutynin.

As with any other nondeformable material, caution should be used when administering Ditropan XL to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.

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

Pregnancy Category B No proven risk in humans.

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Ditropan XL should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

Following the first dose of Ditropan XL, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin.

5 mg: Pale yellow, round, tablet with "5 XL" printed on one side with black ink.

Pregnancy Category B. Ditropan XL should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Risk Summary. There are no adequate and well-controlled studies using Ditropan XL in pregnant women. Women who become pregnant during Ditropan XL treatment are encouraged to contact their physician.

Based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk. Animal Data.

Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide. This may be of concern for drugs with a narrow therapeutic index. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.

Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day). The recommended starting dose of Ditropan XL is 5 mg once daily at approximay the same time each day.

The pharmacokinetics of Ditropan XL in these patients were consistent with those reported for adults.

Use in Specific Populations Pediatric.

Because many drugs are excreted in human milk, caution should be exercised when Ditropan XL is administered to a nursing woman. It is not known whether oxybutynin is excreted in human milk.

Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis.

Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). The recommended starting dose of Ditropan XL is 5 or 10 mg once daily at approximay the same time each day. In general, dosage adjustment may proceed at approximay weekly intervals.

Ditropan XL and OROS are registered trademarks of ALZA Corporation.

Ditropan XL (oxybutynin chloride) is an antispasmodic, muscarinic antagonist. Each Ditropan XL extended-release tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers.

NDC 100 tablets.

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Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility.

Manufactured by: ALZA Corporation, Vacaville, CA 95688 An ALZA OROS Technology Product.

Ditropan XL (oxybutynin chloride) Extended-release tablets 5 mg Rx only.

urinary antispasmodics oxybutynin, Myrbetriq, VESIcare, tolterodine, Detrol, Ditropan.

More FDA updates. Dysuria oxybutynin, Pyridium, phenazopyridine, Ditropan, Oxytrol, flavoxate, Azo-Standard, Urispas, More.

Ditropan XL (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Available data suggest that there are no significant differences in the pharmacokinetics of oxybutynin based on race in healthy volunteers following administration of Ditropan XL.

Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated Ditropan XL dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters.

No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects). Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle.

Ditropan xl