What is Ditropan XL?
Ditropan XL is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.
Ditropan XL belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms.
Ditropan XL extended-release tablets is also used to treat children 6 years of age and older who have an overactive bladder caused by a certain nerve disorder (eg, spina bifida).
Ditropan XL is available only with your doctor's prescription.
Ditropan XL indications
Ditropan XL is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
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 should I use Ditropan XL?
Use Ditropan XL gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Ditropan XL gel. Talk to your pharmacist if you have questions about this information.
- Ditropan XL gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with warm water.
- Apply Ditropan XL gel to clean, dry, undamaged skin on the stomach, upper arms, shoulders, or thighs. If you apply Ditropan XL gel to the stomach, avoid the area around the belly button.
- Application sites may be rotated to decrease the risk of skin reactions. Do not apply Ditropan XL gel to other areas of the body.
- Do not apply Ditropan XL gel to skin with an open sore, scar, tattoo, or rash, or to an area that is irritated or has been recently shaved. Do not apply it to an area with a skin condition, such as eczema, seborrhea, or psoriasis.
- Do not apply Ditropan XL gel to your breasts or genital areas.
- Do not apply Ditropan XL gel to areas of the skin that have been treated with oils, lotions, or powders. However, you may use Ditropan XL gel with sunscreen.
- Before using Ditropan XL gel for the first time, you must prime the pump. Do this by holding the pump upright and pressing down on the pump 4 times. Do not use any of the medicine that comes out of the pump during priming.
- Wash your hands and the application site with mild soap and water before you apply Ditropan XL gel. Allow the area to dry completely.
- Place your hand under the pump and press the pump down 3 times or as directed by your doctor. You can also place the pump right over the application site to dispense your dose. Gently rub Ditropan XL gel into your skin until it dries. Do not continue to rub after it dries.
- Apply Ditropan XL gel right after you dispense your dose from the pump.
- Wash your hands immediately after using Ditropan XL gel.
- Do not bathe, swim, shower, exercise, or get the application site wet for at least 1 hour after using Ditropan XL gel.
- Be careful not to get Ditropan XL gel on another person. If another person may come into contact with the application site, cover the area with clothing after the medicine dries.
- Continue to use Ditropan XL gel even if your condition improves. Do not miss any doses.
- If you miss a dose of Ditropan XL gel, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Ditropan XL gel.
Uses of Ditropan XL in details
Use: Labeled Indications
Overactive bladder: Treatment of symptoms associated with overactive bladder (eg, urge urinary incontinence, urgency, frequency, urinary leakage, dysuria); treatment of symptoms associated with overactive bladder due to a neurological condition (eg, spina bifida) in patients ≥6 years of age (extended-release tablet only).
Off Label Uses
Primary focal hyperhidrosis
Data from randomized, placebo-controlled trials with limited numbers of patients and of short duration suggest that Ditropan XL may be beneficial for treatment of primary hyperhidrosis.
Ditropan XL description
Ditropan XL is an anticholinergic medication used to relieve urinary and bladder difficulties, including frequent urination and inability to control urination, by decreasing muscle spasms of the bladder. It competitively antagonizes the M1, M2, and M3 subtypes of the muscarinic acetylcholine receptor.
Ditropan XL dosage
Ditropan XL Dosage
Generic name: Ditropan XL 100mg in 1g
Dosage form: gel
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
The contents of one sachet of Ditropan XL should be applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated. Application of Ditropan XL should not be made to the same site on consecutive days.
Ditropan XL is for topical application only and should not be ingested.
More about Ditropan XL (Ditropan XL)
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Consumer resources
- Ditropan XL
- Ditropan XL gel
- Ditropan XL topical
- Ditropan XL (Advanced Reading)
- Other brands: Ditropan, Ditropan XL, Oxytrol, Ditropan XL, More (1) »
Professional resources
- Ditropan XL (FDA)
- Ditropan XL (AHFS Monograph)
Related treatment guides
- Dysuria
- Overactive Bladder
- Urinary Incontinence
Ditropan XL interactions
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What other drugs will affect Ditropan XL?
The concomitant use of Ditropan XL 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 Ditropan XL 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 Ditropan XL 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.
Ditropan XL side effects
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What are the possible side effects of Ditropan XL?
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The safety of Ditropan XL was evaluated in 626 patients (210 randomized to Ditropan XL 56 mg/day, 214 randomized to Ditropan XL 84 mg/day and 202 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 626 patients (N = 77) participated in the 24-week open-label safety extension that followed the placebo-controlled study. Of the 77 patients in the safety extension, 24 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 441 patients were exposed to at least one dose of Ditropan XL. 364 patients received at least 12 weeks of Ditropan XL treatment and 66 patients received an additional 24 weeks of Ditropan XL treatment during the open-label safety extension. The study population primarily consisted of women (87%) of Caucasian descent (87%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.
Table 1 lists adverse reactions (ARs), regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than 3% of patients treated with Ditropan XL.
Overall, 672 ARs were experienced by 51.9% of patients. Majority of the ARs were mild to moderate in intensity. The AR most commonly reported was dry mouth which was experienced by a greater proportion of patients in the Ditropan XL group than the placebo group (26 patients [12.1%] in the Ditropan XL 84 mg group, 10 patients [5.0%] in the placebo group). Application site erythema was the next most commonly reported AR (8 patients [3.7%] in the Ditropan XL 84 mg group and 2 patients [1.0%] in the placebo group). Other commonly reported ARs experienced by more patients in the Ditropan XL groups compared with placebo were application site rash (7 patients [3.3%] in the Ditropan XL 84 mg group and 1 patient [0.5%] in the placebo group); application site pruritus (6 patients [2.8%] in the Ditropan XL 84 mg group and 1 patient [0.5%] in the placebo group). The overall rate of application site adverse reactions of any kind was 14.2% in patients receiving Ditropan XL as compared to 3.7% in patients receiving placebo. Other cholinergic AEs < 2% in occurrence include dry eyes and blurred vision.
There were no deaths during the study. There were no clinically meaningful changes in vital signs, laboratory values, or ECG examinations over the course of the study.
Table 1: Commonly Reported Adverse Reactions that were reported In greater than 3% of patients treated with Ditropan XL and at an incidence greater than placebo.
| Preferred Term Each patient is counted only once within each treatment, body system and preferred term. All percentages are based on number of patients in the ITT population within each treatment group as denominator. |
During the 24-week open-label safety extension, the most commonly reported ARs were urinary tract infection and nasopharyngitis reported in 4 patients each (5.2%), followed by conjunctivitis and application site erythema (both occurred in 3 patients [3.9%]). One patient prematurely discontinued due to the application site erythema and pruritus (both considered to be of mild severity).
Ditropan XL contraindications
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What is the most important information I should know about Ditropan XL?
You should not use this medication if you are allergic to Ditropan XL, or if you have uncontrolled narrow-angle glaucoma, a blockage in your digestive tract, if you have decreased urination, or if you are unable to urinate.
Before using Ditropan XL topical, tell your doctor if you have urination problems, glaucoma, liver or kidney disease, myasthenia gravis, severe constipation, ulcerative colitis or other intestinal disorder, gastroesophageal reflux disease (GERD), or slow digestion.
Do not bathe, shower, swim, use a hot tub, or exercise vigorously for at least 1 hour after applying this medication.
It is best to cover treated skin areas with clothing after the gel has dried completely. This will help prevent getting this medicine on your other skin or on other people.
Ditropan XL gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
Drinking alcohol can increase certain side effects of Ditropan XL topical.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids to keep yourself hydrated while you are using Ditropan XL topical.
Active ingredient matches for Ditropan XL:
| Unit description / dosage (Manufacturer) | Price, USD |
| 100 tablet in 1 bottle | |
| Ditropan XL tablet, extended release 15 mg/1 (Janssen Pharmaceuticals, Inc. (US)) | |
| Ditropan XL tablet, extended release 10 mg/1 (Physicians Total Care, Inc. (US)) | |
| Ditropan XL tablet, extended release 5 mg/1 (Janssen Pharmaceuticals, Inc. (US)) | |
| Ditropan XL tablet / extended-release 15 mg (Janssen Inc (Canada)) | |
List of Ditropan XL substitutes (brand and generic names): | |
| Ditropan XL Extended-Release Tablets | |
| Diutropan (Thailand) | |
| Diutropan 5 mg x 10 x 10's (NuPharma & HealthCare) | |
| Diutropan tab 5 mg 10 x 10's (NuPharma & HealthCare) | |
| Dom-Oxybutynin | |
| Tablet; Oral; Oxybutynin Chloride 5 mg | |
| Tablets; Oral; Oxybutynin Chloride 5 mg | |
| Dresplan (Spain) | |
| Dridase (Germany, Netherlands) | |
| Tablet; Oral; Oxybutynin Hydrochloride 5 mg (Altana) | |
| Tablets; Oral; Oxybutynin Hydrochloride 5 mg (Altana) | |
| Driptan | |
| Driptan 5mg - 30 Tablets | $ 27.00 |
| Driptane (Bulgaria, Croatia (Hrvatska), Estonia, France, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Tunisia) | |
| Tablet; Oral; Oxybutynin Hydrochloride 5 mg (Fournier) | |
| Driptane 5 mg x 60 Tablet (Fournier) | |
| Driptane / scored 5 mg x 60's (Fournier) | $ 28.96 |
| Tablets; Oral; Oxybutynin Hydrochloride 5 mg (Fournier) | |
| Driptane Ipsen (Latvia) | |
| Dry Tropan MR (Egypt) | |
| Eurin (Slovakia) | |
| Fandeheede (Japan) | |
| Frenurin (Brazil) | |
| Gelnique | |
| Gel; Transdermal; Oxybutynin Chloride 10% | |
| 1 gram in 1 packet | |
| Gelnique metered-dose pump 100 mg (Watson Laboratories Inc (Canada)) | |
| Gelnique gel 28 mg/.92g (Actavis Pharma, Inc. (US)) | |
| Gelnique gel 100 mg/g (Actavis Pharma, Inc. (US)) | |
| Gelnique gel 100 mg (Allergan Pharma Co. (Canada)) | |
| Gelnique Gel | |
| Gelnique Pump | |
| Gelnique topical | |
| Gen-Oxybutynin (Canada) | |
| Tablet; Oral; Oxybutynin Chloride 5 mg | |
| Tablets; Oral; Oxybutynin Chloride 5 mg | |
| Golaksin (Georgia) | |
| Gradual (Uruguay) | |
| Halarase (Japan) | |
| Incontin (Uruguay) | |
| Incontinol (Brazil) | |
| Inobase (Japan) | |
| Inprax (Mexico) | |
| Tablet; Oral; Oxybutynin Hydrochloride 5 mg (Degorts) | |
| Tablets; Oral; Oxybutynin Hydrochloride 5 mg (Degorts) | |
| Jie Sai (China) | |
| Kentera (Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Slovenia, Sweden, Switzerland, United Kingdom) | |
| Patch; Topical; Oxybutynin 3.9 mg / 24 h (Nicobrand) | |
| Kentera Gel 90.7 mg/g (Nicobrand) | |
| Kentera Transdermal patch 3.9 mg/24h (Nicobrand) | |
| Kentera 3.9mg/24h (Austria, Switzerland) | |
See 483 substitutes for Ditropan XL | |
References
- DailyMed. "OXYBUTYNIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "oxybutynin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "oxybutynin". http://www.drugbank.ca/drugs/DB01062 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Ditropan XL are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ditropan XL. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
