XULANE 35 ug/d
norelgestromin and ethinyl estradiol · PATCH · A-S Medication Solutions
XULANE is a patch containing norelgestromin and ethinyl estradiol at 35 ug/d, taken transdermal. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- XULANE
- Generic Name
- norelgestromin and ethinyl estradiol
- NDC Code (Product)
50090-1683- Manufacturer
- A-S Medication Solutions
- Strength
- 35 ug/d
- Dosage Form
- PATCH
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- ANDA200910
- Drug Class
- Estrogen [EPC]; Progestin [EPC]
- Marketing Start
- 04/16/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m 2 [see Contraindications (4) , Warnings and Precautions (5.1) and Clinical Studies (14) ] . Xulane is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. ( 1 ) Limitations of Use: Xulane may be less effective in preventing pregnancy in women at or above 198 lbs. (90 kg). ( 1 , 4 , 14 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Xulane must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling. • Xulane uses a 28-day (4-week) cycle. Apply a new patch to the upper outer arm, abdomen, buttock or back each week for 3 weeks (21 total days). Week 4 is patch-free. ( 2.1 , 2.3 ) • Apply each new patch on the same day of the week. Wear only one patch at a time. ( 2.1 ) • Do not cut or alter the patch in any way. ( 2.1 ) 2.1 How to Use Xulane The Xulane transdermal system uses a 28-day (4-week) cycle. A new patch is applied each week for 3 weeks (21 total days). Week 4 is patch-free. Withdrawal bleeding is expected during this time. Every new patch should be applied on the same day of the week. This day is known as the “Patch Change Day.” For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. Do not cut, damage or alter the Xulane patch in any way. If the Xulane patch is cut, damaged or altered in size, contraceptive efficacy may be impaired. On…
Contraindications
4 CONTRAINDICATIONS Xulane is contraindicated in females who are known to have or develop the following conditions: • At high risk of arterial or venous thromboembolic events. Examples include women who: o Smoke, if over age 35 [see Boxed Warning , and Warnings and Precautions (5.1) ] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] o Have cerebrovascular disease [see Warnings and Precautions (5.1) ] o Have coronary artery disease [see Warnings and Precautions (5.1) ] o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] o Have uncontrolled hypertension [see Warnings and Precautions (5.5) ] o Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7) ] o Have headaches with focal neurological symptoms or have migraine headaches with aura ▪ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.8) ] • Body Mass Index ≥ 30 kg/m 2 [see Warnings and…
Drug Interactions
7 DRUG INTERACTIONS Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs. ( 7.1 ) 7.1 Effects of Other Drugs on Combined Hormonal Contraceptives Substances Decreasing the Plasma Concentrations of CHCs and Potentially Diminishing the Efficacy of CHCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other dr…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions with the use of combination hormonal contraceptives, including Xulane, are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] • Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions (5.1) ] • Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by users of combination hormonal contraceptives are: • Irregular uterine bleeding • Nausea • Breast tenderness • Headache The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 …
Frequently Asked Questions
What is XULANE used for?
XULANE contains norelgestromin and ethinyl estradiol. It is a patch taken transdermal. Consult your doctor for specific uses.
Is XULANE a controlled substance?
XULANE is not classified as a controlled substance by the DEA.
What is the generic name for XULANE?
The generic name for XULANE is norelgestromin and ethinyl estradiol. There are 5 other brand versions of norelgestromin and ethinyl estradiol.
What is the NDC code for XULANE 35 ug/d?
The NDC (National Drug Code) for XULANE 35 ug/d is 50090-1683, listed by A-S Medication Solutions.