Ditropan Side effects

• Side effects of Ditropan in details
• Ditropan contraindications
• Ditropan reviews

What are the possible side effects of Ditropan?

Get emergency medical help if you have any of these signs of an allergic reaction to Ditropan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Ditropan and call your doctor at once if you have:

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• severe stomach pain or constipation;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• pain or burning when you urinate; or

• little or no urinating.

Common Ditropan side effects may include:

• dry mouth;

• dry eyes, blurred vision;

• mild constipation; or

• dizziness, drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Ditropan in details

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).

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

• Ditropan gel may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you use it with alcohol or certain medicines. Use Ditropan gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Ditropan gel.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ditropan gel; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Ditropan gel may cause decreased sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur. Contact your doctor if you have been exposed to high temperatures and you develop fever; flushing; hot, dry skin; severe or persistent headache; dizziness; sudden fatigue; fast heartbeat; seizures; or fainting.
• Ditropan gel may cause dry mouth. To help relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. Ask your doctor or pharmacist if you have any questions.
• A serious side effect called angioedema has been reported with the use of oral dosage forms of Ditropan gel (eg, tablets). Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
• Ditropan gel is flammable. Do not smoke while using Ditropan gel. Do not store or use near an open flame.
• If another person comes into contact with Ditropan gel, that person should wash it off right away with mild soap and water.
• Ditropan gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Use Ditropan gel with caution in the ELDERLY; they may be more sensitive to its effects.
• Ditropan gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Ditropan gel can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ditropan gel while you are pregnant. It is not known if Ditropan gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Ditropan gel, check with your doctor. Discuss any possible risks to your baby.

Ditropan contraindications

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.

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. European Chemicals Agency - ECHA. "Benzeneacetic acid, a-cyclohexyl-a-hydroxy-,4-(diethylamino)-2-butyn-1-yl ester: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "OXYBUTYNIN". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Ditropan 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. 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