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• Lenditro indications
• Uses of Lenditro in details
• Lenditro description
• Lenditro dosage
• Lenditro interactions
• Lenditro side effects
• Lenditro contraindications

What is Lenditro?

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

Lenditro 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.

Lenditro 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).

Lenditro is available only with your doctor's prescription.

Lenditro indications

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

Lenditro 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 Lenditro?

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

• An extra patient leaflet is available with Lenditro gel. Talk to your pharmacist if you have questions about this information.
• Lenditro 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 Lenditro gel to clean, dry, undamaged skin on the stomach, upper arms, shoulders, or thighs. If you apply Lenditro 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 Lenditro gel to other areas of the body.
• Do not apply Lenditro 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 Lenditro gel to your breasts or genital areas.
• Do not apply Lenditro gel to areas of the skin that have been treated with oils, lotions, or powders. However, you may use Lenditro gel with sunscreen.
• Before using Lenditro 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 Lenditro 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 Lenditro gel into your skin until it dries. Do not continue to rub after it dries.
• Apply Lenditro gel right after you dispense your dose from the pump.
• Wash your hands immediately after using Lenditro gel.
• Do not bathe, swim, shower, exercise, or get the application site wet for at least 1 hour after using Lenditro gel.
• Be careful not to get Lenditro 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 Lenditro gel even if your condition improves. Do not miss any doses.
• If you miss a dose of Lenditro 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 Lenditro gel.

Uses of Lenditro 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 Lenditro may be beneficial for treatment of primary hyperhidrosis.

Lenditro description

Lenditro 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.

Lenditro dosage

Lenditro Dosage

Generic name: Lenditro 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 Lenditro should be applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated. Application of Lenditro should not be made to the same site on consecutive days.

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

More about Lenditro (Lenditro)

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Consumer resources

• Lenditro
• Lenditro gel
• Lenditro topical
• Lenditro (Advanced Reading)

• Other brands: Ditropan, Lenditro, Oxytrol, Lenditro, More (1) »

Professional resources

• Lenditro (FDA)
• Lenditro Chloride (AHFS Monograph)

Related treatment guides

• Dysuria
• Overactive Bladder
• Urinary Incontinence

Lenditro interactions

See also:
What other drugs will affect Lenditro?

The concomitant use of Lenditro 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 Lenditro chloride plasma concentrations were approximately 2 fold higher when Lenditro 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 Lenditro 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.

Lenditro side effects

See also:
What are the possible side effects of Lenditro?

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

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

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).

Lenditro contraindications

See also:
What is the most important information I should know about Lenditro?

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

Lenditro 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 Lenditro topical.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids to keep yourself hydrated while you are using Lenditro topical.

Active ingredient matches for Lenditro:

Oxybutynin in South Africa.

Oxybutynin hydrochloride in South Africa.

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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Information checked by Dr. Sachin Kumar, MD Pharmacology