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Oxybutynin Chloride (Gelnique)

Trade Name : GELNIQUE

Allergan, Inc.

GEL

Strength 100 mg/g

OXYBUTYNIN CHLORIDE Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oxybutynin Chloride (Gelnique) which is also known as GELNIQUE and Manufactured by Allergan, Inc.. It is available in strength of 100 mg/g per ml. Read more

Oxybutynin Chloride (Gelnique) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • GELNIQUE is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency [n )].
  • GELNIQUE is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ()
  • The contents of one sachet or one actuation of the metered-dose pump of GELNIQUE should be applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated. Application of GELNIQUE should not be made to the same site on consecutive days [n ].
  • GELNIQUE is for topical application only and should not be ingested.
  • Apply contents of one sachet or one actuation of the metered-dose pump of GELNIQUE once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. ()n
  • Rotate application sites, avoiding use of the same site on consecutive days. ()n
  • GELNIQUE is for topical application only and should not be ingested. ()
  • Gel: 10%
  • Gel: 10%
  • The use of GELNIQUE is contraindicated in the following conditions:
  • Urinary retention ()n
  • Gastric retention ()n
  • Uncontrolled narrow-angle glaucoma ()n
  • Known serious hypersensitivity reaction to GELNIQUE, oxybutynin, or to any of the components of GELNIQUEu00a0()
  • No data
  • Urinary Retention: Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ()n
  • Gastrointestinal Disorders: Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis. ()n
  • Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue GELNIQUE and initiate appropriate therapy. ()n
  • Skin Hypersensitivity: Discontinue GELNIQUE in patients with skin hypersensitivity. ()n
  • Central Nervous System Effects: Somnolence has been reported with GELNIQUE. Advise patients not to drive or operate heavy machinery until they know how GELNIQUE affects them. ()n
  • 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. ()n
  • Flammable Gel: Contains alcohol-based gel. Avoid open fire or smoking until the gel has dried. ()n
  • Myasthenia gravis: Avoid use in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. (5.8)
  • 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 most common adverse reactions (incidence > 5% and > placebo) were dry mouth, urinary tract infection, and application site reactions. ()
  • No specific drug-drug interaction studies have been performed with GELNIQUE.
  • Other Anticholinergics (muscarinic antagonists):
  • 7.1
  • No data
  • Overdosage with oxybutynin has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Oral ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and in a 34-year-old woman 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.
  • Plasma concentrations of oxybutynin begin to decline 24 hours after GELNIQUE application. If overexposure occurs, monitor patients until symptoms resolve.
  • Oxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a metered-dose pump that dispenses 30 metered 1 gram doses or in a 1 gram (1.14 mL) unit dose. Each doseu00a0contains 100 mg oxybutynin chloride. Oxybutynin is delivered as a racemate of R- and S- isomers. Chemically, oxybutynin chloride is d, l (racemic) 4-(Diethylamino)-2-butynyl (u00b1)-u03b1-phenylcyclohexaneglycolate hydrochloride.
  • The empirical formula of oxybutynin is CHNOn HCl. Its structural formula is:
  • Oxybutynin chloride is a white powder with a molecular weight of 393.95.
  • Inactive ingredients in GELNIQUE are alcohol, USP; glycerin, USP; hydroxypropyl cellulose, NF; sodium hydroxide, NF; and purified water, USP.
  • No data
  • A 24-month study in rats at dosages of oxybutynin 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. Oxybutynin chloride showed no increase of mutagenic activity when tested in n n n and test systems. Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no definite evidence of impaired fertility.
  • The efficacy and safety of GELNIQUE were evaluated in a single randomized, double-blind, placebo-controlled, parallel group 12-week study for the treatment of overactive bladder with symptoms of urge incontinence, urgency and frequency. Key entry criteria included adults with symptomatic overactive bladder with an average of u2265 4 incontinence episodes in a 3-day period and at least 8 micturitions per day. Patients were randomized to daily applications of GELNIQUE 1 gram or matching placebo gel. A total of 389 patients received GELNIQUE and 400 patients received placebo gel. The majority of patients were Caucasian (86.3%) and female (89.2%), with a mean age of 59.4 years (range: 18 to 88 years). The average duration of urinary incontinence was approximately 8.5 years and approximately 75% of patients had no prior pharmacological treatment for urinary incontinence.
  • Patients treated with GELNIQUE experienced a statistically significant decrease in the number of urinary incontinence episodes per day from baseline to endpoint compared with placebo (p < 0.0001) as well as a decrease in the average daily urinary frequency (p = 0.0017) and an increase in the average urine volume per void (p = 0.0018).
  • Mean and median change from baseline in daily incontinence episodes (primary endpoint), urinary frequency, and urinary void volume (secondary endpoints) between placebo and GELNIQUE are summarized in Table 3.
  • Metered-Dose Pump: Metered-dose pump dispenser capable of delivering 30 metered 1 gram doses.
  • Carton of 1 metered-dose Pump (NDC 0023-5812-30)
  • Unit Dose Heat-sealed sachet containing 1 gram (1.14 mL) of GELNIQUE gel for topical use.
  • Carton of 30 Sachets (NDC 0023-5861-11)
  • Storage
  • Store at 20-25u00b0C (68-77u00b0F). [See USP controlled room temperature.] Protect from moisture and humidity. Apply immediately after the sachets are opened and contents expelled or dose delivered from dispenser. Discard used sachets and empty dispensers in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.
  • Keep out of reach of children.
  • u00a0n- [See n- Arrayn- ]n- (Patient Information)
  • Instructions for Use
  • GELNIQUE is for topical application only and should not be ingested.
  • GELNIQUE should not be applied to recently shaved skin surfaces. Patients should wash hands immediately after product application. Application sites should not be subject to showering or water immersion for 1 hour after product application. Application sites should be covered with clothing if close 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.
  • Important Anticholinergic Adverse Reactions
  • Patients should be informed that anticholinergic (antimuscarinic) agents, such as GELNIQUE, may produce clinically significant adverse reactions related to anticholinergic pharmacological activity including:
  • Distributed By:Allergan USA, Inc.Madison, NJ 07940n u00a9 2019u00a0Allergan. All rights reserved.n Gelnique is a registered trademark of Allergan Sales, LLC.n
  • v1.1USPI5812
  • FDA-Approved Patient Labeling
  • PATIENT INFORMATION
  • GELNIQUE n- [n- JEL NEEKn- ]n- (oxybutynin chloride) 10% gel Topical
  • IMPORTANT: For use on the skin only (topical). Do not use GELNIQUE in or near your eyes, nose, or mouth.
  • What is GELNIQUE?
  • GELNIQUE is a prescription medicine used to treat the symptoms of overactive bladder:
  • Do not use GELNIQUE ifn- :
  • Before n- using n- GELNIQUE, tell your healthcare provider n- about all of your medical conditions, includingn- , n- if you:
  • Especially tell your doctor if you take:
  • Ask your doctor or pharmacist for a list of these medicines if you are not sure if you take any of these medicines.
  • Know the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • u00a0n
  • Applying GELNIQUE:
  • 1. Selecting your application site:n- Array
  • 2. How to use the GELNIQUE packets (sachets):
  • 3. How to use the GELNIQUEn- pump:
  • You must prime the GELNIQUE pump before you use it for the first time.
  • To prime the pump:
  • Figure Dn- :
  • Dispensing your dose of GELNIQUE:
  • Figure E:
  • What should I avoid while using GELNIQUE?
  • What are the possible side effects of GELNIQUE?n- Array
  • The most common side effects of GELNIQUE include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GELNIQUE. For more information, ask your healthcare provider 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 GELNIQUE?
  • Keep GELNIQUE and all medicines out of the reach of children.
  • General information about GELNIQUE
  • Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use GELNIQUE for a condition for which it was not prescribed. Do not give GELNIQUE to other people, even if they have the same symptoms you have. It may harm them.
  • You can ask your pharmacist or healthcare provider for information about GELNIQUE that is written for health professionals.
  • For more information about GELNIQUE call 1-800-678-1605u00a0or go to n
  • What are the ingredients of GELNIQUE?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Distributed By:Allergan USA, Inc.Madison, NJ 07940
  • u00a9 2019u00a0Allergan. All rights reserved.n Gelnique is a registered trademark of Allergan Sales, LLC.n
  • v1.1PPI5812
  • PRINCIPAL DISPLAY PANEL
  • PRINCIPAL DISn- PLAY PANEL
  • Gelnique (oxybutynin chloride) Gel, 10%Carton 30 SachetsNDC 0023-5861-11

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