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DRUGS & SUPPLEMENTS
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Ditropan XL
How often in a day do you take medicine? How many times? |
Ditropan XL uses
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
- Nonclinical toxicology
- Clinical studies
- How supplied/storage and handling
- Patient counseling information
Warnings and Precautions, Central Nervous System Effects (5.5) 07/2015
1 INDICATIONS AND USAGE
Ditropan XL 3% (oxybutynin) gel 3% is a muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14) ].
Ditropan XL 3% is a muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
2 DOSAGE AND ADMINISTRATION
The recommended dosage is three pumps of Ditropan XL 3% (84 mg/day) applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs. Apply immediately after actuating the dose. Application sites may be rotated to reduce the potential for local site reactions [see Adverse Reactions (6.1) ]. Ditropan XL 3% is for topical application only and should not be ingested.
Wash hands immediately after product application. Patients should cover the application site with clothing after the gel has dried if direct skin-to-skin contact at the application site is anticipated [see Warnings and Precautions (5.3) ].
- Apply three pumps of Ditropan XL 3% (84 mg) once daily to clean and dry, intact skin on the abdomen, or upper arms/shoulders, or thighs. (2)
- Application site may be rotated if necessary. (2)
- Ditropan XL 3% is for topical application only and should not be ingested. (2)
3 DOSAGE FORMS AND STRENGTHS
Ditropan XL 3% is a homogeneous, colorless to slightly colored gel 3%.
Gel; 3% (3)
4 CONTRAINDICATIONS
The use of Ditropan XL 3% is contraindicated in patients with the following conditions:
- Urinary retention [see Warnings and Precautions (5.1) ].
- Gastric retention [see Warnings and Precautions (5.2) ].
- Uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.8) ].
- Urinary retention (4)
- Gastric retention (4)
- Uncontrolled narrow-angle glaucoma (4)
5 WARNINGS AND PRECAUTIONS
- Urinary Retention: Caution should be exercised in patients with clinically significant bladder outflow obstruction because of urinary retention risk.
- Gastrointestinal Disorders: Use with caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis and in patients with decreased intestinal motility or gastrointestinal obstructive disorders because of the risk of gastric retention. (5.2)
- Skin Transference: Advise patients to cover the application site with clothing if skin-to-skin contact at the application site is anticipated. Wash hands immediately after product application. (5.3)
- Flammable Gel: Contains alcohol-based gel. Avoid open fire or smoking until the gel has dried. (5.4)
- Central Nervous System Effects: Somnolence has been reported with drugs containing Ditropan XL. Advise patients not to drive or operate heavy machinery until they know how Ditropan XL 3% affects them. (5.5)
- Myasthenia Gravis: Administer Ditropan XL 3% with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. (5.6)
- Angioedema: Angioedema has been reported with oral Ditropan XL use. If symptoms of angioedema occur, discontinue Ditropan XL 3% and initiate appropriate therapy. (5.7)
- Controlled Narrow-Angle Glaucoma: Administer Ditropan XL 3% with caution in patients being treated for narrow-angle glaucoma. (5.8)
5.1 Urinary Retention
Use Ditropan XL 3% with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
5.2 Use in Patients with Gastrointestinal Disorders
Use Ditropan XL 3% with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
Ditropan XL 3%, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis or intestinal atony.
Ditropan XL 3% should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs that can cause or exacerbate esophagitis.
5.3 Skin Transference
Transfer of Ditropan XL to another person can occur when vigorous bare skin-to-skin contact is made with the application site. To minimize the potential transfer of Ditropan XL from treated skin to another person, patients should cover the application site with clothing after the gel has dried if direct skin-to-skin contact at the application site is anticipated [see Clinical Pharmacology (12.3) ]. Patients should wash their hands immediately after application of Ditropan XL 3%.
5.4 Flammable Gel
Ditropan XL 3% is an alcohol-based gel and is therefore flammable. Avoid open fire or smoking until gel has dried.
5.5 Central Nervous System Effects
Drugs containing Ditropan XL are associated with anticholinergic central nervous system effects. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, somnolence, confusion and hallucinations . Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment. Advise patients not to drive or operate heavy machinery until they know how Ditropan XL 3% affects them. If a patient experiences anticholinergic CNS effects, drug discontinuation should be considered.
5.6 Myasthenia Gravis
Administer Ditropan XL 3% with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.
5.7 Angioedema
Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oral Ditropan XL. In the event of angioedema, Ditropan XL containing product should be discontinued and appropriate therapy promptly provided.
5.8 Controlled Narrow-Angle Glaucoma
Administer Ditropan XL 3% with caution in patients being treated for narrow-angle glaucoma.
6 ADVERSE REACTIONS
Most common adverse reactions are dry mouth, and application site reactions. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 3% was evaluated in 626 patients (210 randomized to Ditropan XL 3% 56 mg/day, 214 randomized to Ditropan XL 3% 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 3%. 364 patients received at least 12 weeks of Ditropan XL 3% treatment and 66 patients received an additional 24 weeks of Ditropan XL 3% 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 3%.
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 3% 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.
| Treatment Group | ||
| Preferred Term* | Ditropan XL 84 mg/day (N = 214) | Placebo (N = 202) |
| n (%) | n (%) | |
| Dry mouth | 26 (12.1) | 10 (5.0) |
| Application site erythema | 8 (3.7) | 2 (1.0) |
| Application site rash | 7 (3.3) | 1 (0.5) |
* 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).
6. 2 Po s t m a r k e t ing E x perie n ce
The following adverse reactions have been identified during post approval use of GELNIQUE. Because these 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.
Nervous System Disorders: dizziness, somnolence, confusion
Psychiatric Disorders: hallucinations
7 DRUG INTERACTIONS
No specific drug-drug interaction studies have been performed with Ditropan XL 3%.
- Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, and blurred vision and other anticholinergic pharmacological effects. (7.1)
7.1 Other Anticholinergics
The concomitant use of Ditropan XL 3% with other anticholinergic (antimuscarinic) agents may increase the frequency and/or severity of dry mouth, blurred vision, and other anticholinergic pharmacological effects.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category B.
There are no adequate and well-controlled studies of topical or oral Ditropan XL use in pregnant women. Reproduction studies using Ditropan XL chloride in the hamster, rabbit, rat, and mouse have shown no evidence of impaired fertility or harm to the fetus. The safety of Ditropan XL 3% administration to women who are or who may become pregnant has not been established. Therefore, Ditropan XL 3% should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.
8.2 Labor and Delivery
Ditropan XL 3% has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
8.3 Nursing Mothers
It is not known whether Ditropan XL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ditropan XL 3% is administered to a nursing woman.
8.4 Pediatric Use
The safety and effectiveness of Ditropan XL 3% have not been established in pediatric patients.
8.5 Geriatric Use
Of the 424 patients exposed to Ditropan XL 3% in the randomized, double-blind, placebo-controlled 12-week study, 182 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.
8.6 Renal Impairment
Patients with renal impairment received Ditropan XL 3% during clinical trials. These trials were not designed to determine whether there were differences in safety or effectiveness in patients with or without impaired renal function.
8.7 Hepatic Impairment
Patients with hepatic impairment received Ditropan XL 3% during clinical trials. These trials were not designed to determine whether there were differences in safety or effectiveness in patients with or without impaired hepatic function.
10 OVERDOSAGE
Overdosage with Ditropan XL has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, exhaustion, heat sensitivity, and urinary retention. Oral ingestion of 100 mg Ditropan XL chloride in association with alcohol has been reported in a 13-year-old who experienced memory loss, and in a 34-year-old who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients recovered fully with symptomatic treatment. If overexposure occurs, monitor patients until symptoms resolve.
11 DESCRIPTION
Ditropan XL is an antispasmodic, antimuscarinic agent. Ditropan XL 3% is a topical, homogeneous, very lightly to moderately opalescent, translucent colorless to slightly colored gel, without particles. The product is a hydroalcoholic gel containing 30 mg Ditropan XL per gram of gel. Ditropan XL 3% is available in a 0.92 gram (1 mL) unit dose that contains 28 mg Ditropan XL. Ditropan XL is delivered as a racemate of R- and S-isomers. Chemically, Ditropan XL base is d, l (racemic) 4-(Diethylamino)-2-butynyl (±)-α-phenylcyclohexaneglycolate.
The empirical formula of Ditropan XL base is C22H31NO3. Its structural formula is:
Distribution
Ditropan XL is widely distributed in body tissues following systemic absorption. The volume of distribution was estimated to be 193 L after intravenous administration of 5 mg Ditropan XL chloride.
Metabolism
Ditropan XL is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4, found mostly in the liver and gut wall. Metabolites include N-desethyloxybutynin (DEO), which is pharmacologically active and phenylcyclohexylglycolic acid, which is pharmacologically inactive.
Transdermal administration of Ditropan XL bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyloxybutynin metabolite. Only small amounts of CYP3A4 are found in skin, limiting pre-systemic metabolism during transdermal absorption. The AUC ratio of N-desethyloxybutynin metabolite to parent compound following multiple transdermal applications is approximately 1:1 for Ditropan XL 3%. The apparent half-life was approximately 30 hours.
Excretion
Ditropan XL undergoes extensive hepatic metabolism, with less than 0.1% of the administered dose excreted unchanged in the urine. Less than 0.1% of the administered dose is excreted as the metabolite N-desethyloxybutynin.
Person-to-Person Transference
The potential for dermal transfer of Ditropan XL from a treated person to an untreated person was evaluated in a single-dose study where subjects dosed with Ditropan XL 3% engaged in vigorous contact with an untreated partner for 15 minutes, either with (N = 14 couples) or without (N = 14 couples) clothing covering the application area. The untreated partners not protected by clothing demonstrated low detectable plasma concentrations of Ditropan XL (mean Cmax = 0.65 ng/mL). Only one of the 14 untreated subjects participating in the clothing-to-skin contact regimen had very low measurable Ditropan XL plasma concentrations (Cmax = 0.06 ng/mL) during the 24 hours following contact with treated subjects; Ditropan XL was not detectable with the remaining 13 untreated subjects. Regardless of the low exposure observed in this study, patients should avoid skin-to-skin contact with partners after applying the gel.
Use of Sunscreen
The effect of sunscreen on the absorption of Ditropan XL when applied 30 minutes before or 30 minutes after Ditropan XL 3% application was evaluated in a single-dose randomized crossover study (N = 20). Concomitant application of sunscreen, either before or after Ditropan XL 3% application, had no effect on the systemic exposure of Ditropan XL.
Showering
The effect of showering on the absorption of Ditropan XL was evaluated in a randomized, steady-state crossover study under conditions of no shower, or showering 1, 2 or 6 hours after Ditropan XL 3% application (N = 22). The results of the study indicate that showering one hour after administration does not affect the overall systemic exposure to Ditropan XL.
Race
The effect of race on the pharmacokinetics of Ditropan XL 3% has not been studied.
Geriatric Patients
Available data suggest that there are no significant differences in the pharmacokinetics of Ditropan XL based on geriatric status in patients following administration of Ditropan XL 3% [see Use in Specific Populations (8.5) ].
Pediatric Patients
The pharmacokinetics of Ditropan XL and N-desethyloxybutynin following application of Ditropan XL 3% has not been evaluated in individuals younger than 18 years of age [see Use in Specific Populations (8.4) ].
Gender
Available data suggest that there are no significant differences in the pharmacokinetics of Ditropan XL based on gender in healthy volunteers following administration of Ditropan XL 3%.
Renal Impairment
There is limited experience with the use of Ditropan XL 3% in patients with renal insufficiency [see Use in Specific Populations (8.6) ].
Hepatic Impairment
There is limited experience with the use of Ditropan XL 3% in patients with hepatic insufficiency [see Use in Specific Populations (8.7) ].
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
A 24-month study in rats at dosages of Ditropan XL chloride of 20, 80, and 160 mg/kg showed no evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum exposure in humans taking an oral dose, based on body surface area. Ditropan XL chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems. Reproduction studies with Ditropan XL chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility.
14 CLINICAL STUDIES
The efficacy and safety of Ditropan XL 3% were evaluated in a single randomized, double-blind, placebo-controlled, multicenter 12-week study in patients with urinary frequency and urge and mixed urinary incontinence with a predominance of urge incontinence episodes. This was followed by an open-label safety extension. Key entry criteria included adults with overactive bladder (OAB) symptoms for at least 3 months who were either treatment-naïve or had demonstrated a beneficial response to anticholinergic treatment for OAB. Subjects were randomly assigned to receive 84 mg/day Ditropan XL, 56 mg/day Ditropan XL, or placebo. A total of 214 patients received 84 mg/day Ditropan XL, 210 patients received 56 mg/day Ditropan XL, and 202 patients received placebo gel. The majority of patients were Caucasian (87%) and female (87%), with a mean age of 59 years (range: 19 to 89 years). The primary efficacy endpoint was the change from baseline to week 12 in the number of urinary incontinence episodes (UIE) per week, as determined from a 3‑day patient daily diary.
Patients treated with Ditropan XL 3% (84 mg) experienced a statistically significant decrease in the number of urinary incontinence episodes per week from baseline to endpoint (the primary efficacy endpoint) compared with placebo (p = 0.0445) and patients treated with the 56 mg dose did not show statistically significant efficacy. Statistically significant improvements in daily urinary frequency (p = 0.0010) and urinary void volume (p < 0.0001) were also seen with Ditropan XL 3% (84 mg) relative to placebo. The mean difference from placebo for Ditropan XL 3% (84 mg) was -2.3 for urinary incontinence episodes per week in a group of patients with a mean of greater than 40 incontinence episodes per week at baseline. Mean and median change from baseline in weekly incontinence episodes (primary endpoint), daily urinary frequency, and urinary void volume (secondary endpoints) between placebo and Ditropan XL 3% are summarized in Table 3.
| Parameter | Placebo (N = 202) | GELNIQUE 3% (84 mg/day) (N = 214) | ||
| Mean (SD) | Median | Mean (SD) | Median | |
| Weekly Urinary Incontinence Episodes | ||||
| Baseline | 45.8 (31.87) | 40.9 | 43.6 (27.90) | 37.3 |
| Reduction | -18.1 (28.81) | -14.0 | -20.4 (24.39) | -16.4 |
| Mean difference [GELNIQUE 3% – placebo] (SE) | -2.3 (2.65) | |||
| P-value† vs. placebo | 0.0445‡ | |||
| Daily Urinary Frequency | ||||
| Baseline | 11.5 (3.34) | 11.0 | 11.3 (2.87) | 10.7 |
| Reduction | -1.9 (3.34) | - 1.7 | - 2.6 (2.66) | - 2.3 |
| Mean difference [GELNIQUE 3% - placebo] (SE) | - 0.7 (0.30) | |||
| P-value† vs. placebo | 0.0010§ | |||
| Urinary Void Volume (mL) | ||||
| Baseline | 184.5 (85.71) | 173.4 | 196.9 (88.11) | 189.2 |
| Increase | 9.8 (64.98) | 5.7 | 32.7 (77.25) | 26.6 |
| Mean difference [GELNIQUE 3% – placebo] (SE) | 23.0 (7.24) | |||
| P-value† vs. placebo | < 0.0001§ | |||
¶ Last-Observation-Carried-Forward imputation for missing data
† P-value is based on ANCOVA analysis on rank-transformed data
‡ Comparison is significant if p ≤ 0.05
§ Comparison is significant if p ≤ 0.0125, adjusting for multiplicity
16 HOW SUPPLIED/STORAGE AND HANDLING
Ditropan XL 3% (oxybutynin) gel 3% is supplied in a metered-dose pump dispenser composed of an inner aluminum laminated foil liner encased in a rigid plastic bottle with a plastic cap. The nozzle of the pump dispenser is sealed by a removable cap attached to the actuator by a plastic string.
How Supplied
NDC 52544-041-54 100 mL (92 g) metered pump dispenser containing 90 metered 0.92 g (1 mL) pumps delivering 28 mg Ditropan XL per pump actuation.
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). See USP controlled room temperature. Protect from moisture and humidity.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
Instructions for Use
Inform patients of the following:
- Ditropan XL 3% is for topical application only and should not be ingested. Keep out of reach of children.
- Ditropan XL 3% should be applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs.
- Do not use any Ditropan XL 3% that came out while priming.
- Apply immediately after actuating the dose.
- Application sites may be rotated to reduce the potential for local site reactions.
- Ditropan XL 3% should not be applied to recently shaved skin surfaces. Avoid skin with open sores, wounds, irritation, scars, and tattoos.
- Do not apply the gel to the breasts or genital area.
- Discard used pump dispensers in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.
- Wash hands immediately after product application.
- Do not shower or immerse the application site in water for 1 hour after product application.
- Cover the application sites with clothing if skin-to-skin contact at the application site is anticipated.
- Alcohol based gels are flammable. Avoid open fire or smoking until the gel has dried.
- If you get the gel in your eyes, thoroughly rinse your eyes right away with warm, clean water to flush out any gel. Seek medical attention if needed.
Important Anticholinergic Adverse Reactions
Patients should be informed that anticholinergic (antimuscarinic) agents, such as Ditropan XL 3%, may produce clinically significant adverse reactions related to anticholinergic pharmacological activity. Heat prostration (due to decreased sweating) can occur when anticholinergics such as Ditropan XL 3% are used in a hot environment. Because anticholinergic (antimuscarinic) agents, such as Ditropan XL 3%, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until this product's effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic (antimuscarinic) agents such as Ditropan XL 3%.
For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
1-800-272-5525
Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Content Updated: July 2015
FDA-approved patient labeling
Patient Information
Ditropan XL [Gel-nēk] 3%
(oxybutynin) gel 3%
Topical
Important: For use on the skin only (topical). Do not get Ditropan XL 3% in or near your eyes, nose, or mouth.
Read this Patient Information carefully before you use Ditropan XL 3% and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is Ditropan XL 3%?
Ditropan XL 3% is a prescription medicine used to treat the symptoms of overactive bladder including:
- a strong need to urinate with leaking or wetting accidents (urge urinary incontinence)
- a strong need to urinate right away (urgency)
- urinating often (frequency)
It is not known if Ditropan XL 3% is safe or effective in children.
Who should not use Ditropan XL 3%?
Do not use Ditropan XL 3% if:
- Your bladder does not empty or does not empty completely when you urinate (urinary retention).
- Your stomach empties slowly or incompletely after a meal (gastric retention).
- You have high pressure in your eye (uncontrolled narrow-angle glaucoma).
- You have an allergy to Ditropan XL or any of the ingredients in GELNIQUE 3%. See the end of this leaflet for a complete list of ingredients in Ditropan XL 3%.
Talk to your healthcare provider before taking this medicine if you have any of these conditions.
What should I tell my doctor before using Ditropan XL 3%?
Before you use Ditropan XL 3%, tell your doctor if you:
- have problems emptying your bladder completely
- have stomach problems including:
- constipation or difficulty in emptying your bowels
- inflamed bowels (ulcerative colitis)
- inflammation of the tube between your mouth and stomach (gastric reflux disease or esophagitis)
- have generalized muscle weakness (myasthenia gravis)
- are pregnant or are planning to become pregnant. It is not known if Ditropan XL 3% will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Ditropan XL 3% passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Ditropan XL 3%.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Ditropan XL 3% may affect the way other medicines work, and other medicines may affect how Ditropan XL 3% works.
Especially tell your doctor if you take:
- medicines used to treat osteoporosis (Bisphosphonates)
- other medicines used to treat overactive bladder (Anticholinergic)
Ask your doctor if you are not sure if your medicine is one listed above.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I use Ditropan XL 3%?
Ditropan XL 3% is for skin use only.
- Use Ditropan XL 3% exactly as your doctor tells you to use it.
- Ditropan XL 3% should only be applied to dry intact skin on your stomach (abdomen), upper arms, or thighs.
- Do not put Ditropan XL 3% on recently shaved skin, open sores, scars, tattoos, or skin with rashes.
- Do not put Ditropan XL 3% on your breasts or genital area.
- Ditropan XL 3% contains alcohol and is flammable. Avoid fire, flames, or smoking until the product has dried.
- Cover the application site with clothing after the gel has dried, if skin-to-skin contact between another person and the application site is expected.
- After applying Ditropan XL 3%, wash your hands with soap and water right away.
- Ditropan XL 3% may be used with sunscreen.
- If you get Ditropan XL 3% in your eyes: Rinse your eyes well right away with clean and warm water. Seek medical attention if needed.
How to use the Ditropan XL 3% pump:
You must prime the pump before you use it for the first time.
To prime the pump:
- To prime the Ditropan XL 3% pump, hold the pump upright and fully press down (depress) the pump 4 times. Now Ditropan XL 3% is ready to use.
- Do not use any product that came out while priming.
Applying Ditropan XL 3%:
1. Selecting your application site:
Apply Ditropan XL 3% only to 1 of the shaded areas shown in the figure below:.
- stomach area (abdomen)
- upper arms
- shoulders
- thighs
- Wash the area where Ditropan XL 3% will be applied with mild soap and water. Allow the area to dry completely.
- Wash your hands with soap and water.
- Application sites may be rotated to reduce the potential for local site reactions.
2. Dispensing your dose of Ditropan XL 3%:
- Place your hand under the pump. Press the pump all the way down 3 times . You can also place the pump right over the application site then press the pump all the way down 3 times to dispense your dose .
- You should apply Ditropan XL 3% right after you dispense your dose.
- Wash your hands with soap and water right away.
What should I avoid while using Ditropan XL 3%?
- Do not take a bath, swim, shower, exercise, or get the application site wet for 1 hour after you apply your dose.
- Ditropan XL 3% can cause dizziness or blurred vision. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Ditropan XL 3% affects you.
- You should not drink alcohol while using Ditropan XL 3%. It can increase your chances of getting serious side effects.
What are the possible side effects of Ditropan XL 3%?
The most common side effects of Ditropan XL 3% include:
- dry mouth
- urinary tract infections
- dry eyes
- blurry vision
- redness, rash, itching, pain at the application site
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Ditropan XL 3%. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store Ditropan XL 3%?
- Store Ditropan XL 3% at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Keep Ditropan XL 3% and all medicines out of the reach of children.
General information about the safe and effective use of Ditropan XL 3%.
Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use Ditropan XL 3% for a condition for which it was not prescribed. Do not give Ditropan XL 3% to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Ditropan XL 3%. If you would like more information about Ditropan XL 3%, talk with your doctor. You can ask your pharmacist or doctor for information about Ditropan XL 3% that is written for health professionals.
For more information go to www.gelnique.com or call 1-800-272-5525.
What are the ingredients in Ditropan XL 3%?
Active ingredient: Ditropan XL
Inactive ingredients: diethylene glycol monoethyl ether, NF; alcohol, USP; hydroxypropyl cellulose, NF; propylene glycol, NF; butylated hydroxytoluene, NF; HCl 0.1 M, NF; and purified water, USP.
This Patient Information has been approved by the U.S. Food and Drug Administration.
For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
1-800-272-5525
Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Content Updated: January 2013
219404-01
How to use the Ditropan XL 3% pump Figure A Figure B Figure C
Ditropan XL pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Ditropan XL available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.