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Oxytrol for Women Overactive Bladder Transdermal Patch, 8 Count

Oxytrol for Women Overactive Bladder Transdermal Patch, 8 Count

Oxytrol for Women

Medicinal Products
  • Approved in the United States as an OTC human drug product under New Drug Application (NDA) 202211.
  • Listed in DailyMed as a HUMAN OTC DRUG with active ingredient oxybutynin 3.9 mg/day per transdermal system.
  • Manufactured and distributed under current Good Manufacturing Practice (cGMP) regulations for human medicinal products in the United States.
  • Labelled with US NDC codes 0023 9637 04 and 0023 9637 08 for 4 Patch and 32 Patch cartons respectively; 8 Count packs are compliant marketing presentations derived from the approved product.
  • Subject to US FDA OTC drug labelling requirements, including Drug Facts panel with indications, directions, warnings and ingredients.
Over-the-counter overactive bladder transdermal patch (oxybutynin)

Description

Oxytrol for Women Overactive Bladder Transdermal Patch is an over-the-counter (OTC) oxybutynin transdermal system specifically indicated for adult women with symptoms of overactive bladder. Each thin, flexible, clear patch delivers oxybutynin 3.9 mg per day through the skin for up to four days, relaxing the detrusor muscle of the bladder and helping to reduce urinary urgency, frequency and urge incontinence episodes. The patch is applied to clean, dry, intact skin on the abdomen, hips or buttocks and changed every four days. The 8-count pack provides a 32-day supply at the recommended dose of one patch twice weekly. As a transdermal formulation, Oxytrol for Women offers continuous delivery of medication with less fluctuation in plasma levels compared with immediate-release oral oxybutynin, and provides a discreet, non-invasive option for managing overactive bladder symptoms in women.

Bnefits

  • Non-prescription (OTC) oxybutynin transdermal system specifically formulated and labelled for adult women with overactive bladder.
  • Provides continuous delivery of oxybutynin 3.9 mg/day for four days and nights from a single patch, offering around-the-clock symptom control.
  • Helps reduce urinary urgency, urinary frequency and urge incontinence associated with overactive bladder.
  • Transdermal delivery may reduce some systemic anticholinergic side effects compared with certain oral oxybutynin formulations by avoiding first-pass metabolism.
  • Thin, flexible, clear patch that can be discreetly worn under clothing on the abdomen, hip or buttock.
  • Convenient dosing regimen of one patch every four days (twice weekly), eliminating the need for daily pills.
  • Drug-free intervals are avoided, as each patch maintains a relatively steady rate of medication release over 4 days.
  • Can be used alongside non-drug behavioural approaches such as bladder training, pelvic floor exercises and fluid management as part of a comprehensive management plan for overactive bladder.
  • OTC status allows appropriately selected adult women to initiate therapy without an immediate prescription, using clear labelling to identify suitable candidates and safety warnings.

Indications

  • Treatment of overactive bladder in adult women (18 years and older).
  • Relief of urinary urgency (strong, sudden need to urinate right away) associated with overactive bladder in women.
  • Reduction of urinary frequency (need to urinate more often than usual, typically more than 8 times in 24 hours) associated with overactive bladder in women.
  • Reduction of urge incontinence episodes (leakage or wetting due to inability to delay urination after a strong urge) in women.
  • Use in women with overactive bladder symptoms present for at least 3 months, where other causes such as urinary tract infection, uncontrolled diabetes, early pregnancy or other serious conditions have been excluded or appropriately evaluated by a healthcare professional.

Composition

  • Active ingredient: Oxybutynin 3.9 mg/day delivered from each transdermal system (patch).
  • Route of administration: Transdermal (patch applied to intact skin on abdomen, hips or buttocks).
  • Inactive ingredients and patch matrix components: acrylic adhesive.
  • Backing and structural layers: polyester/ethylene-vinyl acetate film.
  • Release liner / protective film: siliconized polyester film (removed prior to application).
  • Plasticiser / excipient: triacetin.

Formulation

  • Dosage form: Transdermal system (patch).
  • Strength: Oxybutynin 3.9 mg/day (approximately 0.162 mg/hour) released over 4 days from each patch.
  • Dosing regimen: One patch worn continuously for 4 consecutive days (up to 96 hours), then replaced with a new patch applied to a different skin site.
  • Route: Transdermal application to clean, dry, intact skin on abdomen, hip or buttock.
  • Product type: Human OTC drug, antimuscarinic agent for overactive bladder treatment.
  • Mechanism of action: Oxybutynin acts as an antimuscarinic/anticholinergic agent that relaxes the detrusor smooth muscle in the bladder, increasing bladder capacity and reducing involuntary contractions.
  • Pack size for this product: 8 patches per carton (32-day supply at recommended twice-weekly dosing).
  • Regulatory identifiers: US NDC 0023-9637-08 for 32-patch carton; 8-count presentations are commonly marketed retail configurations derived from the same approved product line.

Packaging

  • Each patch is sealed in an individual foil pouch to protect from moisture and environmental exposure until use.
  • Retail carton typically contains 8 individually pouched transdermal patches (32-day supply at one patch every 4 days).
  • Outer carton labelling includes brand name (Oxytrol for Women), strength (oxybutynin 3.9 mg/day), route (transdermal system), indications (overactive bladder treatment) and key usage instructions.
  • Carton and pouch labelling include lot number and expiration date, storage conditions, OTC Drug Facts panel and safety warnings.
  • Cartons are shipped in secondary containers for wholesale and pharmacy distribution in accordance with temperature and humidity recommendations.

Usage

  • For women 18 years of age and older only; not for use in men or children.
  • Before starting treatment, review the OTC Drug Facts label carefully to confirm that symptoms are consistent with overactive bladder and that no listed contraindications apply.
  • Apply exactly one patch at a time. Do not use more than one patch at once.
  • Open one foil pouch immediately before use and remove the patch. Do not use if the pouch is torn, damaged or previously opened.
  • Apply the patch to a clean, dry, smooth, intact area of skin on the abdomen, hips or buttocks. Avoid areas that are oily, cut, scraped, irritated (rashes), or where lotions, creams, powders or oils have been applied, as these can interfere with adhesion.
  • Press the patch firmly in place with the palm of the hand to ensure good contact, especially around the edges.
  • Wear the patch continuously under clothing and do not expose it directly to sunlight.
  • Do not cut the patch into smaller pieces; use it only whole as supplied.
  • Wear the patch for 4 days (up to 96 hours), then remove and discard it and immediately apply a new patch to a different skin site (rotate between abdomen, hip and buttock to reduce skin irritation).
  • If a patch falls off and cannot be re-applied securely, discard it and apply a new patch to a different site; continue the original schedule so that patches are still changed every 4 days.
  • Wash hands after applying or removing a patch.
  • If no improvement is seen after 2 weeks (after using multiple patches as directed), or if symptoms worsen or new symptoms appear, stop use and consult a healthcare professional.
  • Do not drive, operate machinery or perform tasks requiring alertness until you know how the patch affects you, as sleepiness, dizziness, confusion or blurred vision may occur.
  • Avoid excessive alcohol consumption while using the patch, as alcohol may increase drowsiness or dizziness.
  • If pregnant, planning pregnancy or breastfeeding, consult a healthcare professional before use.
  • Keep patches and all medicines out of the reach of children and pets.

Contraindications

  • Use in males (this OTC product is labelled only for women; men with urinary symptoms require medical evaluation).
  • Use in children and adolescents under 18 years of age (safety and effectiveness not established).
  • Patients who have been told by a doctor they have urinary retention (inability to empty the bladder).
  • Patients with gastric retention or severe gastrointestinal conditions that result in delayed gastric emptying.
  • Patients with narrow-angle glaucoma or those at risk for untreated narrow-angle glaucoma.
  • Known hypersensitivity or allergy to oxybutynin or any component of the patch (e.g., acrylic adhesive, triacetin, polyester/ethylene-vinyl acetate film, siliconized polyester liner).
  • Women whose primary symptom is stress incontinence only (leakage with coughing, sneezing, laughing or physical activity) without urgency or frequency, as this product is not indicated for stress incontinence.
  • Presence of symptoms suggestive of urinary tract infection or other serious conditions (e.g., painful or burning urination with fever or chills, blood in urine, unexplained lower back or flank pain, cloudy or foul-smelling urine) unless evaluated and cleared by a healthcare professional.
  • Use during pregnancy or breastfeeding without prior discussion with a healthcare professional, as safety has not been fully established.
  • Use in women with uncontrolled narrow-angle glaucoma, myasthenia gravis or severe gastrointestinal motility disorders, according to prescription oxybutynin safety information.

Adverse Effects

  • Common anticholinergic-type effects: dry mouth, constipation, blurred vision, dizziness, drowsiness, nausea and abdominal discomfort.
  • Application-site reactions: itching, redness, rash, irritation or discomfort where the patch is applied; occasionally blistering or more severe local reactions.
  • Central nervous system effects: confusion, headache, insomnia, hallucinations or agitation, especially in sensitive individuals or older adults.
  • Cardiovascular effects: palpitations, tachycardia or increased heart rate in some patients.
  • Urinary effects: urinary retention or difficulty urinating, particularly in predisposed individuals.
  • Heat-related effects: reduced sweating and possible heat prostration or fever in very hot environments due to anticholinergic activity.
  • Hypersensitivity reactions: generalized rash, pruritus, urticaria or, rarely, more serious allergic reactions; therapy should be discontinued if signs of allergy occur.
  • Worsening of narrow-angle glaucoma or increased intraocular pressure in susceptible patients.
  • If severe redness, intense itching, blistering at the application site, inability to empty the bladder, new or worsening confusion, hallucinations, chest pain, severe constipation or visual changes occur, use should be stopped and medical attention sought.

Storage Conditions

  • Store between 20°C and 25°C (68°F to 77°F); excursions permitted as described in standard controlled room temperature guidelines if stated on the label.
  • Keep patches in their individual sealed pouches until ready for use; do not store the patch outside the pouch.
  • Protect from moisture and humidity.
  • Do not use the patch if the pouch is torn, cut, damaged or previously opened.
  • Do not expose stored patches to excessive heat, open flames or direct sunlight.
  • Keep out of the reach of children and pets.
  • For disposal, after removing a used patch, immediately fold it in half with the sticky sides together and discard in a manner that prevents accidental use or ingestion by children, pets or others.

Duration

Oxytrol for Women patches are intended for ongoing, twice-weekly use in adult women with overactive bladder. The OTC label recommends reassessing if symptoms do not improve after 2 weeks of proper use; women should seek medical advice if there is no benefit, if symptoms worsen or if new symptoms develop. Long-term duration of therapy should be determined in consultation with a healthcare professional based on symptom control, tolerability and overall clinical assessment.

Onset

Symptom improvement may begin within the first few days to weeks of treatment as steady oxybutynin levels are reached with twice-weekly patch application, although individual responses vary. Full assessment of benefit is typically made after at least 2 weeks of continuous, correct use.

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