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Ditropan XL (Oxybutynin Chloride Extended Release Tablets) Side


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9.17.2017 | Logan Miers
Ditropan xl
Ditropan XL (Oxybutynin Chloride Extended Release Tablets) Side

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

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. A 24-month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity.

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Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of DITROPAN XL 10 mg (n=43) Parameters (units) R-Oxybutynin S-Oxybutynin Cmax (ng/mL) 1.0 (0.6) 1.8 (1.0) T max (h) 12.7 (5.4) 11.8 (5.3) t 1/2 (h) 13.2 (6.2) 12.4 (6.1) AUC(o-48) (ng-h/mL) 18.4 (10.3) 34.2 (16.9) AUC inf (ng-h/mL) 21.3 (12.2) 39.5 (21.2).

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

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

Stop using oxybutynin and call your doctor at once if you have a serious side effect such as:

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

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.

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

The relative bioavailabilities of R- and S-oxybutynin from DITROPAN XL are 156% and 187%, respectively, compared with oxybutynin. 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.

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.

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.

Less serious side effects may.

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

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

Manufactured by: ALZA Corporation, Vacaville, CA 95688. Revised: Feb 2015.

The safety and efficacy of DITROPAN XL were studied in 60 children in a 24-week, open-label, non-randomized trial. 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. 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%.

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

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).

Get emergency medical help if you have any of these signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat.

5 mg 100 count bottle NDC 10 mg 100 count bottle NDC 15 mg 100 count bottle NDC.

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

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.

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

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

Visit the FDA MedWatch website or call 1-800-FDA-1088. You are encouraged to report negative side effects of prescription drugs to the FDA.

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

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.

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

DITROPAN XL (oxybutynin chloride) Extended-release Tablet.

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

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.

In four of the five studies, Ditropan IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by ≥ 1% of subjects are shown in Table 1. 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.

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.

Its structural formula is:

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. As with any other nondeformable material, caution should be used when administering DITROPAN XL to patients with preexisting severe gastrointestinal narrowing ( pathologic or iatrogenic ).

In some cases, angioedema occurred after the first dose. Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. Angioedema associated with upper airway swelling may be life-threatening. 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.

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

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.

Included as part of the "PRECAUTIONS" Section.

DITROPAN XL should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. 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. Risk Summary.

DITROPAN XL (oxybutynin chloride) is an antispasmodic, muscarinic antagonist. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. 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.

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

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

Both patients fully recovered with symptomatic treatment. 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.

Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma ; Cardiac Disorders: arrhythmia, tachycardia, QT interval prolongation; Vascular Disorders: flushing; 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.

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.

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

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.

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

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.

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

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

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

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 ).

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.

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 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. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. 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. DITROPAN XL uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximay 24 hours. This expansion pushes the suspended drug out through the orifice.

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.

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

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.

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

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.

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

DITROPAN XL may be administered with or without food.

Table 1: Adverse Drug Reactions Reported by ≥ 1% of DITROPAN XL - treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of DITROPAN XL System/Organ Class Preferred Term DITROPAN XL 5 to 30 mg/day n = 774 % Ditropan IR* 5 to 20 mg/day n = 199 % Psychiatric Disorders Insomnia 3.0 5.5 Nervous System Disorders Headache 7.5 8.0 Somnolence 5.6 14.1 Dizziness 5.0 16.6 Dysgeusia 1.6 1.5 Eye Disorders Vision blurred 4.3 9.6 Dry eye 3.1 2.5 Respiratory, Thoracic and Mediastinal Disorders Cough 1.9 3.0 Oropharyngeal pain 1.9 1.5 Dry throat 1.7 2.5 Nasal dryness 1.7 4.5 Gastrointestinal Disorders Dry mouth 34.9 72.4 Constipation 8.7 15.1 Diarrhea 7.9 6.5 Dyspepsia 4.5 6.0 Nausea 4.5 11.6 Abdominal pain 1.6 2.0 Vomiting 1.3 1.5 Flatulence 1.2 2.5 Gastro-esophageal reflux disease 1.0 0.5 Skin and Subcutaneous Tissue Disorders Dry skin 1.8 2.5 Pruritus 1.3 1.5 Renal and Urinary Disorders Dysuria 1.9 2.0 Urinary hesitation 1.9 8.5 Urinary retention 1.2 3.0 General Disorders and Administration Site Conditions Fatigue 2.6 3.0 Investigations Residual urine volume† 2.3 3.5 *IR = immediate release †The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased.

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 and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered. Mean oxybutynin chloride plasma concentrations were approximay 2 fold higher when DITROPAN XL was administered with ketoconazole, a potent CYP3A4 inhibitor.

DITROPAN XL extended-release tablets are supplied in bottles of 100 tablets. 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 should be used with caution in patients with Parkinson's disease due to the risk of aggravation of symptoms.

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 ). Sparse sampling technique was used to obtain serum samples. The children were on DITROPAN XL total daily dose ranging from 5 to 20 mg (0.10 to 0.77 mg/kg). 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 Soxybutynin and R- and S-desethyloxybutynin are summarized in Table 3.

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

Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how DITROPAN XL affects them. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. 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.

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

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

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 O to 33 cm H O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H O) from 60% to 28%. Urodynamic results were consistent with clinical results.

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

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.

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