May 28, 2017
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Ditropan XL

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Ditropan XL




Side Effects
Interactions

SIDE EFFECTS

Clinical Trials Experience

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.

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. 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.

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.

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

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.

Postmarketing Experience

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.

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.

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

Read the Ditropan XL (oxybutynin chloride extended release tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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.

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. Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide.

Mean oxybutynin chloride plasma concentrations were approximately 2 fold higher when DITROPAN XL was administered with ketoconazole, a potent CYP3A4 inhibitor. 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.

Read the Ditropan XL Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/12/2016

Side Effects
Interactions

Ditropan XL - User Reviews

Ditropan XL User Reviews

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Report Problems to the Food and Drug Administration

 

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


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