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Oxybutynin (Oxytrol)

Trade Name : OXYTROL

Allergan, Inc.

PATCH

Strength 3.9 mg/d

OXYBUTYNIN 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 (Oxytrol) which is also known as OXYTROL and Manufactured by Allergan, Inc.. It is available in strength of 3.9 mg/d per ml. Read more

Oxybutynin (Oxytrol) 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
  • OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.
  • OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. ()
  • OXYTROL 3.9 mg/day should be applied to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 or 4 days). A new application site should be selected with each new system to avoid re-application to the same site within 7 days.
  • Apply OXYTROL transdermal system twice weekly (every 3 to 4 days) tou00a0dry, intact skin on the abdomen, hip, or buttocks. ()n
  • Select au00a0new application site with each new system to avoid re-application to the same site within 7 days. ()
  • Transdermal System: 3.9 mg/day
  • Transdermal system: 3.9 mg/day ()
  • The use of OXYTROL is contraindicated in the following conditions:
  • Urinary retention ()n
  • Gastric retention ()n
  • Uncontrolled narrow-angle glaucoma ()n
  • Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL ()
  • 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
  • Central Nervous System Effects: Somnolence has been reported with products containing oxybutynin. Advise patients not to drive or operate heavy machinery until they know how OXYTROL affects them. ()u00a0n
  • Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue OXYTROL and initiate appropriate therapy. ()n
  • Skin Hypersensitivity: Discontinue OXYTROL in patients with skin hypersensitivity. ()n
  • Myasthenia gravis: Avoid use in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. ()
  • The most common adverse reactions (incidence > 5% and > placebo) are application site reactionsu00a0and dry mouth. ()
  • No specific drug-drug interaction studies have been performed with OXYTROL.
  • Other Anticholinergics (muscarinic antagonists):
  • 7.1
  • No data
  • The plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s). Patients should be monitored until symptoms resolve. Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oral 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 treatment directed at their symptoms.
  • OXYTROL (oxybutynin transdermal system) is designed to deliver oxybutynin over a 3- to 4-day interval after application to intact skin. OXYTROL is available as a 39 cm system containing 36 mg of oxybutynin. OXYTROL has a nominal delivery rate of 3.9 mg oxybutynin per day through skin of average permeability (inter-individual variation in skin permeability is approximately 20%).
  • Oxybutynin is an antispasmodic, anticholinergic agent. Oxybutynin is administered as a racemate of R- and S-isomers. Chemically, oxybutynin is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate. The empirical formula of oxybutynin is CHNO. Its structural formula is:
  • Oxybutynin is a white powder with a molecular weight of 357. It is soluble in alcohol, but relatively insoluble in water.
  • OXYTROL is a matrix-type transdermal system composed of three layers as illustrated in Figure 1. Layer 1 (Backing Film) is a thin flexible polyester/ethylene-vinyl acetate film that provides the matrix system with occlusivity and physical integrity and protects the adhesive/drug layer. Layer 2 (Adhesive/Drug Layer) is a cast film of acrylic adhesive containing oxybutynin and triacetin, USP. Layer 3 (Release Liner) is two overlapped siliconized polyester strips that are peeled off and discarded by the patient prior to applying the matrix system.
  • 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 , 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 OXYTROL were evaluated in patients with urge urinary incontinence in twou00a0controlled studies and one open-label extension. Study 1 was au00a0placebo controlled study, comparing the safety and efficacy of OXYTROL at dose levels of 1.3, 2.6, and 3.9 mg/day to placebo in 520 patients. Open-label treatment was available for patients completing the study. Study 2 was a study comparing the safety and efficacy of OXYTROL 3.9 mg/day versus active and placebo controls in 361 patients.
  • Study 1
  • Study 2
  • Adhesion
  • Adhesion was periodically evaluated during the pivotal studies. Of the 4,746 OXYTROL evaluations in the trials, 20 (0.4%) were observed at clinic visits to have become completely detached and 35 (0.7%) became partially detached during routine clinic use. Similar to the pharmacokinetic studies, > 98% of the systems evaluated in the pivotal studies were assessed as being u2265 75% attached and thus would be expected to perform as anticipated.u00a0
  • How Supplied
  • Each 39 cm system imprinted with u201cOXYTROL 3.9 mg/dayu201d contains 36 mg of oxybutynin for nominal delivery of 3.9 mg oxybutynin per day when dosed in a twice weekly regimen.
  • NDC n- 0023-6153-08
  • Storage
  • Keep out of reach of children.
  • u00a0See u00a0(Patient Information and Instructions for Use)
  • Instructions for Use
  • Inform patients that OXYTROL should be applied to dry, intact skin on the abdomen, hip, or buttock and not be applied to areas that have been treated with oils, lotions or powders. The patch should not be exposed to sunlight. Contact with water while bathing, swimming, showering or exercising will not change the effect of OXYTROL.
  • A new application site should be selected with each new system to avoid re-application to the same site within 7 days. Inform patients to try to change the patch on the same 2 days each week and that the package of OXYTROL has a calendar checklist printed on the back to remind patients of their schedule. Inform patients to avoid rubbing the patch area during bathing, swimming, showering or exercising. Inform patients that details on use of the system are explained in the Patient Information Leaflet.
  • Inform patients to discard used OXYTROL in household trash in a manner that prevents accidental application or ingestion by children, pets, or others. Inform patients to keep out of reach of children.
  • Important Anticholinergic Adverse Reactions
  • Patients should be informed that anticholinergic (antimuscarinic) agents, such as OXYTROL, may produce adverse reactions related to anticholinergic pharmacological activity including:
  • Distributed By:Allergan USA, Inc.
  • Irvine, CA 92612
  • u00a9 2017 Allergan. All rights reserved.
  • Oxytrolu00ae is a registered trademark of Allergan Sales, LLC
  • FDA-approved patient labeling
  • PATIENT INFORMATION
  • OXYTROL n- (OKSEE TROLE)
  • What is OXYTROL?
  • OXYTROL is a transdermal system (skin patch) for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.u00a0 It delivers the active ingredient, oxybutynin, directly into your bloodstream through your skin.
  • Overactive bladder makes it hard to urinate (passing water). Overactive bladder can make you urinate more often (increased frequency) or make you feel the need to urinate often (urgency). Overactive bladder can also lead to accidental urine loss (leaking or wetting oneself).
  • It is not known if OXYTROL is safe and effective in children.n n n
  • Do not use
  • What should I tell my doctor before using OXYTROL?n- Array
  • Tell your doctor about all the medicines you take,
  • Using OXYTROL with certain other medicines may affect each other.u00a0 Using OXYTROL with other medicines can cause serious side effects.
  • Especially tell your doctor if you take:
  • Ask your doctor or pharmacist for a list of these medicines if you are not sure if this is your medicine.n
  • Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
  • How should I use OXYTROL?
  • What should I avoid while using OXYTROL?
  • What are the possible side effects of OXYTROL?
  • OXYTROL may cause serious side effects, including:
  • The most common side effects of OXYTROL include skin reactions where the patch is placed and dry mouth.
  • Since oxybutynin treatment may decrease sweating, you may overheat or have fever or heat stroke if you are in warm or hot temperatures.n Tell your doctor if you have any side effect that bothers you or that does not go away or if you have constipation.
  • These are not all the side effects of OXYTROL. For a complete list, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects.u00a0 You may report side effects to FDA at 1-800-FDA-1088.n- Array
  • Keep OXYTROL and all medicines out of the reach of children.n- Array
  • For more information, go to www.OXYTROL.com website or call 1-800-678-1605.u00a0
  • What are the ingredients of OXYTROL?
  • Active Ingredient:
  • Inactive Ingredients:
  • Instructions for Usen- Arrayn- (OKSEE TROLE)
  • Where to apply OXYTROL:
  • u00a0
  • How to apply OXYTROL:
  • Step 1.
  • Step 2.
  • Step 3.
  • u00a0
  • How to remove OXYTROL:
  • This Patient n- Package Insertn- u00a0and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Distributed By:Allergan USA, Inc.
  • Irvine, CA 92612
  • u00a9 2017 Allergan. All rights reserved.
  • Oxytrolu00ae is a registered trademark of Allergan Sales, LLC
  • PRINCIPAn- L DISPLAY PANEL

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