Lenditro

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Lenditro uses



Warnings and Precautions, Central Nervous System Effects (5.5) 07/2015

1 INDICATIONS AND USAGE

Lenditro 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) ].

Lenditro 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 Lenditro 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) ]. Lenditro 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 Lenditro 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)

  • Lenditro 3% is for topical application only and should not be ingested. (2)
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3 DOSAGE FORMS AND STRENGTHS

Lenditro 3% is a homogeneous, colorless to slightly colored gel 3%.

Gel; 3% (3)

4 CONTRAINDICATIONS

The use of Lenditro 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 Lenditro. Advise patients not to drive or operate heavy machinery until they know how Lenditro 3% affects them. (5.5)

  • Myasthenia Gravis: Administer Lenditro 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 Lenditro use. If symptoms of angioedema occur, discontinue Lenditro 3% and initiate appropriate therapy. (5.7)

  • Controlled Narrow-Angle Glaucoma: Administer Lenditro 3% with caution in patients being treated for narrow-angle glaucoma. (5.8)

5.1 Urinary Retention

Use Lenditro 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 Lenditro 3% with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.

Lenditro 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.

Lenditro 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 Lenditro to another person can occur when vigorous bare skin-to-skin contact is made with the application site. To minimize the potential transfer of Lenditro 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 Lenditro 3%.

5.4 Flammable Gel

Lenditro 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 Lenditro 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 Lenditro 3% affects them. If a patient experiences anticholinergic CNS effects, drug discontinuation should be considered.

5.6 Myasthenia Gravis

Administer Lenditro 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 Lenditro. In the event of angioedema, Lenditro containing product should be discontinued and appropriate therapy promptly provided.

5.8 Controlled Narrow-Angle Glaucoma

Administer Lenditro 3% with caution in patients being treated for narrow-angle glaucoma.

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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 Lenditro 3% was evaluated in 626 patients (210 randomized to Lenditro 3% 56 mg/day, 214 randomized to Lenditro 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 Lenditro 3%. 364 patients received at least 12 weeks of Lenditro 3% treatment and 66 patients received an additional 24 weeks of Lenditro 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 Lenditro 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 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 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* Lenditro

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

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7 DRUG INTERACTIONS

No specific drug-drug interaction studies have been performed with Lenditro 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 Lenditro 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 Lenditro use in pregnant women. Reproduction studies using Lenditro chloride in the hamster, rabbit, rat, and mouse have shown no evidence of impaired fertility or harm to the fetus. The safety of Lenditro 3% administration to women who are or who may become pregnant has not been established. Therefore, Lenditro 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

Lenditro 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 Lenditro is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lenditro 3% is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of Lenditro 3% have not been established in pediatric patients.

8.5 Geriatric Use

Of the 424 patients exposed to Lenditro 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 Lenditro 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 Lenditro 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.

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10 OVERDOSAGE

Overdosage with Lenditro 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 Lenditro 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

Lenditro is an antispasmodic, antimuscarinic agent. Lenditro 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 Lenditro per gram of gel. Lenditro 3% is available in a 0.92 gram (1 mL) unit dose that contains 28 mg Lenditro. Lenditro is delivered as a racemate of R- and S-isomers. Chemically, Lenditro base is d, l (racemic) 4-(Diethylamino)-2-butynyl (±)-α-phenylcyclohexaneglycolate.

The empirical formula of Lenditro base is C22H31NO3. Its structural formula is:

Distribution

Lenditro 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 Lenditro chloride.

Metabolism

Lenditro 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 Lenditro 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 Lenditro 3%. The apparent half-life was approximately 30 hours.

Excretion

Lenditro 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 Lenditro from a treated person to an untreated person was evaluated in a single-dose study where subjects dosed with Lenditro 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 Lenditro (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 Lenditro plasma concentrations (Cmax = 0.06 ng/mL) during the 24 hours following contact with treated subjects; Lenditro 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 Lenditro when applied 30 minutes before or 30 minutes after Lenditro 3% application was evaluated in a single-dose randomized crossover study (N = 20). Concomitant application of sunscreen, either before or after Lenditro 3% application, had no effect on the systemic exposure of Lenditro.

Showering

The effect of showering on the absorption of Lenditro was evaluated in a randomized, steady-state crossover study under conditions of no shower, or showering 1, 2 or 6 hours after Lenditro 3% application (N = 22). The results of the study indicate that showering one hour after administration does not affect the overall systemic exposure to Lenditro.

Race

The effect of race on the pharmacokinetics of Lenditro 3% has not been studied.

Geriatric Patients

Available data suggest that there are no significant differences in the pharmacokinetics of Lenditro based on geriatric status in patients following administration of Lenditro 3% [see Use in Specific Populations (8.5) ].

Pediatric Patients

The pharmacokinetics of Lenditro and N-desethyloxybutynin following application of Lenditro 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 Lenditro based on gender in healthy volunteers following administration of Lenditro 3%.

Renal Impairment

There is limited experience with the use of Lenditro 3% in patients with renal insufficiency [see Use in Specific Populations (8.6) ].

Hepatic Impairment

There is limited experience with the use of Lenditro 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 Lenditro 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. Lenditro chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems. Reproduction studies with Lenditro chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility.

14 CLINICAL STUDIES

The efficacy and safety of Lenditro 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 Lenditro, 56 mg/day Lenditro, or placebo. A total of 214 patients received 84 mg/day Lenditro, 210 patients received 56 mg/day Lenditro, 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 Lenditro 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 Lenditro 3% (84 mg) relative to placebo. The mean difference from placebo for Lenditro 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 Lenditro 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-valuevs. 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-valuevs. 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-valuevs. 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

Lenditro 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 Lenditro 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:

  • Lenditro 3% is for topical application only and should not be ingested. Keep out of reach of children.

  • Lenditro 3% should be applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs.

  • Do not use any Lenditro 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.

  • Lenditro 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 Lenditro 3%, may produce clinically significant adverse reactions related to anticholinergic pharmacological activity. Heat prostration (due to decreased sweating) can occur when anticholinergics such as Lenditro 3% are used in a hot environment. Because anticholinergic (antimuscarinic) agents, such as Lenditro 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 Lenditro 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

Lenditro [Gel-nēk] 3%

(oxybutynin) gel 3%

Topical

Important: For use on the skin only (topical). Do not get Lenditro 3% in or near your eyes, nose, or mouth.

Read this Patient Information carefully before you use Lenditro 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 Lenditro 3%?

Lenditro 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 Lenditro 3% is safe or effective in children.

Who should not use Lenditro 3%?

Do not use Lenditro 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 Lenditro or any of the ingredients in GELNIQUE 3%. See the end of this leaflet for a complete list of ingredients in Lenditro 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 Lenditro 3%?

Before you use Lenditro 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 Lenditro 3% will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if Lenditro 3% passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Lenditro 3%.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Lenditro 3% may affect the way other medicines work, and other medicines may affect how Lenditro 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 Lenditro 3%?

Lenditro 3% is for skin use only.

  • Use Lenditro 3% exactly as your doctor tells you to use it.

  • Lenditro 3% should only be applied to dry intact skin on your stomach (abdomen), upper arms, or thighs.

  • Do not put Lenditro 3% on recently shaved skin, open sores, scars, tattoos, or skin with rashes.

  • Do not put Lenditro 3% on your breasts or genital area.

  • Lenditro 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 Lenditro 3%, wash your hands with soap and water right away.

  • Lenditro 3% may be used with sunscreen.

  • If you get Lenditro 3% in your eyes: Rinse your eyes well right away with clean and warm water. Seek medical attention if needed.

How to use the Lenditro 3% pump:

You must prime the pump before you use it for the first time.

To prime the pump:

  • To prime the Lenditro 3% pump, hold the pump upright and fully press down (depress) the pump 4 times. Now Lenditro 3% is ready to use.

  • Do not use any product that came out while priming.

Applying Lenditro 3%:

1. Selecting your application site:

Apply Lenditro 3% only to 1 of the shaded areas shown in the figure below:.

  • stomach area (abdomen)

  • upper arms

  • shoulders

  • thighs

  • Wash the area where Lenditro 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 Lenditro 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 Lenditro 3% right after you dispense your dose.

  • Wash your hands with soap and water right away.

What should I avoid while using Lenditro 3%?

  • Do not take a bath, swim, shower, exercise, or get the application site wet for 1 hour after you apply your dose.

  • Lenditro 3% can cause dizziness or blurred vision. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Lenditro 3% affects you.

  • You should not drink alcohol while using Lenditro 3%. It can increase your chances of getting serious side effects.

What are the possible side effects of Lenditro 3%?

The most common side effects of Lenditro 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 Lenditro 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 Lenditro 3%?

  • Store Lenditro 3% at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Keep Lenditro 3% and all medicines out of the reach of children.

General information about the safe and effective use of Lenditro 3%.

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use Lenditro 3% for a condition for which it was not prescribed. Do not give Lenditro 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 Lenditro 3%. If you would like more information about Lenditro 3%, talk with your doctor. You can ask your pharmacist or doctor for information about Lenditro 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 Lenditro 3%?

Active ingredient: Lenditro

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 Lenditro 3% pump Figure A Figure B Figure C

Lenditro 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.


Lenditro available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
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.


Lenditro destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Lenditro Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Lenditro pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."GELNIQUE (OXYBUTYNIN) GEL [ACTAVIS PHARMA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. 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/dailym... (accessed August 28, 2018).
  3. "oxybutynin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lenditro?

Depending on the reaction of the Lenditro after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Lenditro not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Lenditro addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Lenditro, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Lenditro consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported useful

How is the drug Lenditro useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Not useful1
100.0%

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Lenditro drug as prescribed by the doctor?

Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Lenditro is mentioned below.
Visitors%
Twice in a day1
100.0%

Three visitors reported doses

What is the dose of Lenditro drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg2
66.7%
51-100mg1
33.3%

One visitor reported time for results

What is the time duration Lenditro drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed > 3 month to notice the result from using Lenditro drug. The time needed to show improvement in health condition after using the medicine Lenditro need not be same for all the users. It varies based on other factors.
Visitors%
> 3 month1
100.0%

Visitor reported administration

No survey data has been collected yet

Two visitors reported age

Visitors%
30-451
50.0%
> 601
50.0%

Visitor reviews


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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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