Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 0023-9637 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Oxytrol for women |
||||||
| Type | Brand | ||||||
| Pharm Class | Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
||||||
| Active Ingredients |
|
||||||
| Route | TRANSDERMAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 403799, 404448 |
||||||
| Application Number | NDA202211 | ||||||
| Labeler Name | Allergan, Inc. | ||||||
| Packages |
|
||||||
| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each patch [transdermal system]) Oxybutynin 3.9 mg/day
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions women 18 years of age and older: How to use the patch: open 1 pouch and apply patch immediately to a clean, dry and smooth area of skin on your abdomen, hips or buttocks. Do not put the patch on oily, damaged (cut or scraped), or irritated (rashes) skin. Do not put the patch on skin with oils, lotions or powders because that could keep the patch from sticking to your skin. wear patch under clothing, do not expose the patch to sunlight do not cut the patch into smaller pieces wear only 1 patch at a time for 4 days in a row after 4 days, remove the used patch and apply a new one change the patch every 4 days for as long as you use this product each time you put on a new patch, change the place where you put it (i.e., abdomen, hips or buttocks) if a patch falls off and you cannot press it back onto your skin, use a new patch How to dispose of a used patch: when you take off a used patch, fold it in half with the sticky sides together throw it away so that it cannot be worn or swallowed by another person, especially a child, or a pet
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylic adhesive, polyester/ethylene-vinyl acetate film, siliconized polyester film, and triacetin
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the package)
Purpose
Information about the drug product’s indications for use.Purpose Overactive bladder treatment
Spl product data elements
Usually a list of ingredients in a drug product.Oxytrol for Women Oxybutynin OXYBUTYNIN OXYBUTYNIN TRIACETIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 0023-9637-04 Full Prescription Strength OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day Overactive Bladder Treatment Oxytrol ® FOR WOMEN RELIEF FROM Overactive Bladder 1 Patch Treats for 4 Days/4 Nights 4 PATCHES (Transdermal Systems ) 16-Day Supply NDC 0023-9637-04 Full Prescription Strength OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day Overactive Bladder Treatment Oxytrol® FOR WOMEN RELIEF FROM Overactive Bladder 1 Patch Treats for 4 Days/4 Nights 4 PATCHES (Transdermal Systems) 16-Day Supply
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have symptoms of diabetes, such as: ○ excessive thirst ○ extreme hunger unexplained weight loss liver or kidney disease
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription medication for overactive bladder taking any drugs that may cause sleepiness, dizziness, dry mouth, constipation or blurred vision taking certain antibiotics (for example, erythromycin, clarithromycin) or prescription antifungals (for example, ketoconazole, itraconazole)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have any of these symptoms, which could be the sign of a UTI or other serious condition. See your doctor as soon as possible if you have: ○ pain or burning when urinating. These symptoms may also be accompanied by a fever or chills. ○ blood in your urine ○ unexplained lower back or side pain ○ urine that is cloudy, or foul-smelling ○ are male. Your symptoms may be due to a more serious condition. ○ are under the age of 18. It is not known if it works or is safe in children. ○ only experience accidental urine loss when you cough, sneeze or laugh, you may have stress incontinence. This product will not work for that condition. ○ have been told by a doctor you have urinary retention (are not able to empty your bladder) ○ have been told by a doctor you have gastric retention (your stomach empties slowly after a meal) ○ have glaucoma ○ are allergic to oxybutynin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information product comes in individual sealed pouches, do not use if pouch is torn or opened store between 20° to 25°C (68° to 77°F) protect from moisture and humidity do not store outside the sealed pouch
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll-free: 1-888-OXYTROL (1-888-699-8765) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday © 2024 AbbVie. All rights reserved. Made in USA Distributed by: AbbVie Inc., North Chicago, IL 60064 OXYTROL and its design are trademarks of Allergan Sales, LLC, an AbbVie company.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you are not able to empty your bladder (urinary retention) condition worsens, or if new symptoms appear condition does not improve after 2 weeks of use you have an allergic reaction to this product you have severe redness, itchiness or blistering at the site of application
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product you may have itching, rash or redness where the patch was placed drinking alcohol may increase sleepiness
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Frequent urination can also be caused by: urinary tract infections (UTI) diabetes early pregnancy other more serious conditions If you think you might have one of these conditions, it is important to see your doctor before use. Sleepiness, dizziness, confusion, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you. Do not use if you have any of these symptoms, which could be the sign of a UTI or other serious condition. See your doctor as soon as possible if you have: ○ pain or burning when urinating. These symptoms may also be accompanied by a fever or chills. ○ blood in your urine ○ unexplained lower back or side pain ○ urine that is cloudy, or foul-smelling ○ are male. Your symptoms may be due to a more serious condition. ○ are under the age of 18. It is not known if it works or is safe in children. ○ only experience accidental urine loss when you cough, sneeze or laugh, you may have stress incontinence. This product will not work for that condition. ○ have been told by a doctor you have urinary retention (are not able to empty your bladder) ○ have been told by a doctor you have gastric retention (your stomach empties slowly after a meal) ○ have glaucoma ○ are allergic to oxybutynin Ask a doctor before use if you have symptoms of diabetes, such as: ○ excessive thirst ○ extreme hunger unexplained weight loss liver or kidney disease Ask a doctor or pharmacist before use if you are taking a prescription medication for overactive bladder taking any drugs that may cause sleepiness, dizziness, dry mouth, constipation or blurred vision taking certain antibiotics (for example, erythromycin, clarithromycin) or prescription antifungals (for example, ketoconazole, itraconazole) When using this product you may have itching, rash or redness where the patch was placed drinking alcohol may increase sleepiness Stop use and ask a doctor if you are not able to empty your bladder (urinary retention) condition worsens, or if new symptoms appear condition does not improve after 2 weeks of use you have an allergic reaction to this product you have severe redness, itchiness or blistering at the site of application If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API