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Ditropan Xl (OXYBUTYNIN)
Oxybutynin works by blocking the action of a chemical called acetylcholine on the bladder muscle, reducing spasms and urgency.
Ditropan XL (Oxybutynin) is a cholinergic muscarinic antagonist developed by Hisamitsu Pharmaceutical Co., Inc. and currently owned by Allergan. It targets the muscarinic acetylcholine receptor M3 to treat various bladder and urinary disorders. Originally approved by the FDA in 1975, it is now off-patent and available as a generic medication. Ditropan XL is used to treat conditions such as overactive bladder, hyperhidrosis, and urge incontinence. It has a half-life of 7.2 hours and bioavailability of 6%.
At a glance
| Generic name | OXYBUTYNIN |
|---|---|
| Sponsor | Hisamitsu Pharmaceutical Co., Inc. |
| Drug class | Cholinergic Muscarinic Antagonist |
| Target | Muscarinic acetylcholine receptor M3 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1975 |
Mechanism of action
The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. Oxybutynin acts as competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In patients with conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction. Oxybutynin is racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in in vitro studies.
Approved indications
- Bladder muscle dysfunction - overactive
- Hyperhidrosis of palms
- Increased Urinary Frequency
- Neurogenic bladder
- Urge incontinence of urine
- Urgent desire to urinate
Common side effects
- dry mouth
- nasopharyngitis
- upper respiratory tract infection
- bronchitis
- cystitis
- fluid retention
- confusional state
- dysgeusia
- sinus headache
- kerato conjunctivitis sicca
- eye irritation
- palpitations
Key clinical trials
- Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial (NA)
- A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective. (PHASE1)
- Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder. (PHASE2)
- Oxybutynin for Post-surgical Bladder Pain and Urgency (PHASE3)
- Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial (NA)
- Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ditropan Xl CI brief — competitive landscape report
- Ditropan Xl updates RSS · CI watch RSS
- Hisamitsu Pharmaceutical Co., Inc. portfolio CI