Ditropan Uses

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What is Ditropan?

Ditropan is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.

Ditropan 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 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 is available only with your doctor's prescription.

Ditropan indications

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Ditropan Chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Ditropan Chloride 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?

Use Ditropan gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Ditropan gel.

Uses of Ditropan in details

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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 may be beneficial for treatment of primary hyperhidrosis.

Ditropan description

Ditropan 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 dosage

Ditropan Dosage

Generic name: Ditropan CHLORIDE 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 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 should not be made to the same site on consecutive days.

Ditropan is for topical application only and should not be ingested.

More about Ditropan (Ditropan)

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Ditropan interactions

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What other drugs will affect Ditropan?

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The concomitant use of Ditropan 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 chloride plasma concentrations were approximately 2 fold higher when Ditropan 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 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 side effects

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What are the possible side effects of Ditropan?

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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 was evaluated in 626 patients (210 randomized to Ditropan 56 mg/day, 214 randomized to Ditropan 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. 364 patients received at least 12 weeks of Ditropan treatment and 66 patients received an additional 24 weeks of Ditropan 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.

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 group than the placebo group (26 patients [12.1%] in the Ditropan 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 84 mg group and 2 patients [1.0%] in the placebo group). Other commonly reported ARs experienced by more patients in the Ditropan groups compared with placebo were application site rash (7 patients [3.3%] in the Ditropan 84 mg group and 1 patient [0.5%] in the placebo group); application site pruritus (6 patients [2.8%] in the Ditropan 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 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 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 contraindications

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What is the most important information I should know about Ditropan?

You should not use this medication if you are allergic to Ditropan, 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 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 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 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 topical.



Active ingredient matches for Ditropan:

Oxybutynin in Argentina, Australia, Austria, Belgium, Canada, Czech Republic, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Kingdom, United States.

Oxybutynin Cl in Singapore.

Oxybutynin hydrochloride in United States.

Oxybutynin chloride

Oxybutynin chloride 5mg


Unit description / dosage (Manufacturer)Price, USD
Syrup; Oral; Oxybutynin Chloride 2.5 mg / 5 ml
Syrup; Oral; Oxybutynin Chloride 5 mg / 5 ml
Tablet; Oral; Oxybutynin Chloride 2.5 mg
Tablet; Oral; Oxybutynin Chloride 5 mg
Ditropan 5 mg x 100's$ 56.40
Ditropan 2.5 mg x 500's
Ditropan 5 mg x 300's
473 milliliter in 1 bottle
100 tablet in 1 bottle
Tablets; Oral; Oxybutynin Chloride 2.5 mg
Tablets; Oral; Oxybutynin Chloride 5 mg

List of Ditropan substitutes (brand and generic names):

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))
Diutropan 5 mg x 10 x 10's (NuPharma & HealthCare)
Diutropan tab 5 mg 10 x 10's (NuPharma & HealthCare)
Tablet; Oral; Oxybutynin Chloride 5 mg
Tablets; Oral; Oxybutynin Chloride 5 mg
Tablet; Oral; Oxybutynin Hydrochloride 5 mg (Altana)
Tablets; Oral; Oxybutynin Hydrochloride 5 mg (Altana)
Driptan 5mg - 30 Tablets$ 27.00
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)
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))
Tablet; Oral; Oxybutynin Chloride 5 mg
Tablets; Oral; Oxybutynin Chloride 5 mg

References

  1. 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).
  2. PubChem. "oxybutynin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "oxybutynin". http://www.drugbank.ca/drugs/DB01062 (accessed September 17, 2018).

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