Ethinyl estradiol and norelgestromin (transdermal)

Ethinyl estradiol and norelgestromin (transdermal)

Ethinyl estradiol and norelgestromin (Transdermal) Transdermal route (patch, extended release)

Cardiovascular risk associated with smoking, risk of venous thromboembolism and pharmacokinetic profile of ethinyl estradiol

Women over 35 years of age who smoke should not use norelgestromin-ethinyl estradiol transdermal system.

Cigarette smoking increases the risk of serious cardiovascular events due to the use of combined hormonal contraceptives (CHCs).

Women using the norelgestromin and ethinyl estradiol transdermal system may be at increased risk of venous thromboembolism (VTE) compared to women using certain oral contraceptives.

The pharmacokinetic (PK) profile of ethinyl estradiol (EE) for the norelgestromin and ethinyl estradiol transdermal system differs from the PK profile for oral contraceptives in that it has higher areas under the time-concentration curve, steady-state concentrations, and lower peak concentrations.

Used for ethinyl estradiol and norelgestromin

This patch allows more estrogen to enter the blood than oral contraceptives that contain the same amount of estrogen.

No method of contraception is 100 percent effective. Contraceptive methods such as infertility surgery or abstaining from sex are more effective. Discuss your contraceptive options with your doctor.

The combination of norelgestromin and ethinyl estradiol does not prevent AIDS or other sexually transmitted diseases. It does not prevent hepatitis B. It does not help as emergency contraception, for example after unprotected sexual contact.

This medicine is only available with a doctor's prescription.

Before using ethinyl estradiol and norelgestromin

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Appropriate studies on the association of age with the effects of the transdermal combination of norelgestromin and ethinyl estradiol have not been conducted in children and adolescents. However, child-specific problems that would limit the use of this medication in adolescents are not expected. This medicine can be used for contraception in teenage women, but should not be used before menstruation begins.

geriatrics

Adequate studies examining the association of age with the effects of a transdermal combination of norelgestromin and ethinyl estradiol have not been conducted in the geriatric population. This medicine is not suitable for use in older women.

Breastfeeding

Studies of breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed or you should stop breast-feeding while using this medication.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamsäure

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Amifampridin
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelid
• Apalutamid
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethason
• Bexaroten
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepin
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixim
• Cefpodoxim
• Cefprozil
• Ceftazidim
• Ceftibuten
• Cefuroxim
• Cenobamat
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporin
• Dabrafenib
• Darunavir
• Dexamethason
• Dicloxacillin
• Dipyron
• Donepezil
• Doxycyclin
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamid
• Eslicarbazepinacetat
• Etravirin
• Felbamat
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guarkernmehl
• Indinavir
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatid
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocyclin
• Mitapivat
• Mitotan
• Mobocertinib
• Modafinil
• Mycophenolatmofetil
• Mycophenolsäure
• Nafcillin
• Nelfinavir
• Nevirapin
• Nirmatrelvir
• Octreotid
• Oxacillin
• Oxcarbazepin
• Oxytetracyclin
• Paclitaxel
• Proteingebundenes Paclitaxel
• Penicillin G
• Penicillin G Procain
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazon
• Phenytoin
• Pibrentasvir
• Piperaquin
• Pitolisant
• Prednisolon
• Prednison
• Primidon
• Rotklee
• Rifabutin
• Rifampin
• Rifapentin
• Rilpivirin
• Ritonavir
• Rufinamid
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• Johanniskraut
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracyclin
• Theophyllin
• Thiopental
• Thioridazin
• Ticarcillin
• Tigecyclin
• Tirzepatid
• Tizanidin
• Topiramat
• Troglitazon
• Ulipristal
• Valproinsäure
• Voxilaprevir

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Amitriptylin
• Atazanavir
• Atorvastatin
• Clomipramin
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramin
• Lamotrigin
• Levothyroxin
• Lakritze
• Liothyronin
• Lorazepam
• Parecoxib
• Roflumilast
• Selegilin
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazol
• Warfarin

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Koffein

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Abnormale oder ungewöhnliche Vaginalblutungen oder
• Blutgerinnsel (z. B. tiefe Venenthrombose, Lungenembolie) oder Vorgeschichte von oder
• Brustkrebs oder Vorgeschichte von oder
• Gebärmutterhalskrebs oder Vorgeschichte von oder
• Diabetes mit Nieren-, Augen-, Nerven- oder Blutgefäßschäden oder
• Herzinfarkt, Geschichte von oder
• Erkrankungen des Herzens oder der Blutgefäße (z. B. koronare Herzkrankheit, Herzklappenprobleme), jetzt oder in der Vergangenheit oder
• Hypertonie (Bluthochdruck), unkontrollierte oder
• Lebererkrankungen, einschließlich Tumoren oder Krebs oder
• Größere Operation mit längerer Inaktivität oder
• Migränekopfschmerz oder
• Schlaganfall, Geschichte von oder
• Bekannte oder vermutete Tumoren (östrogenabhängig): Sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

• Depression, Geschichte von oder
• Dyslipidämie (hoher Cholesterin- oder Fettgehalt im Blut) oder
• Ödeme (Flüssigkeitsansammlung oder Körperschwellung) oder
• Gallenblasenerkrankung bzw
• Hypertonie (Bluthochdruck) – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Fettleibigkeit – Die Verwendung des transdermalen Pflasters kann bei Frauen mit einem Körpergewicht von mindestens 198 Pfund (90 Kilogramm) weniger wirksam sein.

Proper use of ethinyl estradiol and norelgestromin

To make the use of hormonal contraceptives as safe and reliable as possible, you should know how and when to use them and what effects to expect.

This medicine comes with instructions for use for the patient. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This transdermal patch system is to be used for a 28 day (four week) cycle. A new patch is applied every week for three weeks (21 days), and in the fourth week the patch is plaster-free.

When you start using a combination of norelgestromin and ethinyl estradiol transdermally, your body needs at least 7 days to adjust before pregnancy can be prevented. Use a second form of contraception (e.g., condoms, spermicides, diaphragms) for the first 7 days of your first patch cycle.

How to use this patch:

• Bewahren Sie jedes Pflaster in der Verpackung auf, bis Sie es verwenden möchten.
• Waschen Sie Ihre Hände vor und nach dem Anbringen eines Pflasters mit Wasser und Seife.
• Tragen Sie das Pflaster auf die saubere, trockene und intakte Haut am Bauch oder Bauch, am Oberkörper, an der oberen Außenseite des Arms oder am Gesäß auf. Vermeiden Sie es, die klebrige Oberfläche des Pflasters zu berühren.
• Stellen Sie sicher, dass sich keine Lotion, Puder, Creme oder Make-up auf der Haut befindet.
• Bringen Sie das Pflaster an und drücken Sie es dann 10 Sekunden lang mit der Handfläche, um sicherzustellen, dass es haftet.
• Ändern Sie die Position des Patches jedes Mal, wenn Sie einen neuen anwenden. Kleben Sie das Pflaster nicht auf verletzte, gebrochene oder geschnittene Haut. Kleben Sie kein Pflaster auf Ihre Brüste. Überprüfen Sie das Pflaster jeden Tag, um sicherzustellen, dass es angebracht ist.

If the patch comes off partially or completely, try again or apply a new patch. If it loosens within 24 hours, no other form of contraception is necessary. If the patch has been peeling off for more than 24 hours, apply a new patch and start a new cycle. A second form of contraception should also be used.

If the patch is not sticky or sticks to the material or itself, remove it and apply a new patch. Do not hold the patch in place with tape or bandages.

If you are switching from a birth control pill or vaginal ring to using the patch, start using the patch on the first day of your period, the day you would normally use your next pill or vaginal ring for Xulane®. If your period does not start after one week of using Xulane®, you should see your doctor for a pregnancy test. If you use Xulane® more than a week after taking your last pill or vaginal ring, use a second method of contraception with the patch for the first 7 days.

If you have a miscarriage or abortion in the first trimester of your pregnancy, you can start taking the transdermal combination of norelgestromin and ethinyl estradiol immediately. You do not need a second form of contraception. If you start taking this medication 5 days or more after the miscarriage or abortion, you should use a second form of contraception with the patch for the first 24 hours at the start of your menstruation or for the first 7 days on the first Sunday of your menstruation. If you experience a miscarriage or abortion after the first trimester, you should wait 4 weeks before starting to take this medicine.

If you are using this patch after birth and do not want to breastfeed, you can start using it after 4 weeks to avoid the risk of blood clots.

If bleeding occurs while the patch is in place, continue to use the patch as usual. If bleeding continues for two to three cycles, contact your doctor. If you miss your period while the patch is being removed, stick to your regular schedule and call your doctor.

If the patch is uncomfortable or causes irritation, replace it with a new patch in a new location. Change the patch again on your regular schedule. Do not use more than one patch at a time.

When removing a patch, gently fold it in half so that it sticks to itself and throw it away. There are still some hormones on the patch. Do not touch the inside of the patch.

Do not eat grapefruit or drink grapefruit juice while using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed into the body.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may start using the patch on the first day of your period (First Day Start) or on a Sunday (Sunday Start). If you start on a specific day, it is important that you stick to that schedule, even if you forget to change a patch. Don't change your schedule on your own. If the schedule set is not suitable for you, talk to your doctor about changing the schedule.

• Für die transdermale Darreichungsform (Hautpflaster):
  • Zur Empfängnisverhütung (um eine Schwangerschaft zu verhindern):
    • Erwachsene: Tragen Sie ein Pflaster auf die Haut auf und lassen Sie es eine Woche lang dort. Kleben Sie zu Beginn der zweiten Woche und erneut in der dritten Woche ein neues Pflaster auf. Wechseln Sie das Pflaster immer am selben Wochentag. Verwenden Sie in Woche 4 kein Pflaster. Dann kommt Ihre Periode. Beginnen Sie 7 Tage nach der Entfernung des letzten Patches mit einem neuen Patch.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

Missed dose

Call your doctor or pharmacist for instructions.

Follow your doctor's instructions or the instructions on the label if you forget to change your patch. This covers just some of the ways to handle this medicine. Your doctor may want you to stop using this medicine and use other contraceptive methods for the rest of the month until your period begins. Your doctor can then tell you how to start using your medicine again.

If you forget to use your patch in the first week, apply it as soon as possible and start a new cycle. Use a second form of birth control during the first week of the new cycle. You now have a new patch start day.

If you forget to change your patch for a day or two in the 2nd or 3rd week, change it as soon as you remember. No other form of contraception is necessary. If you forget to change your patch for more than two days in the 2nd or 3rd week, switch to a new patch and start a new cycle. Use a second form of birth control during the first week of the new cycle. If you forget to remove your patch at the end of Week 3, remove it as soon as possible and then start a new patch on your regular start day. You should never stop using the patch for more than 7 days in a row.

storage

Store the patches at room temperature in a closed container, away from heat, moisture and direct light.

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

After removing a used patch, fold it in half with the adhesive sides together. Place it in a childproof container or sealed bag. Make sure you dispose of it out of the reach of children and pets.

Precautions when using ethinyl estradiol and norelgestromin

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly and is not causing any unwanted effects. These visits typically occur every 6 to 12 months, but some doctors require them more frequently. Your doctor may also want to check your blood pressure while you are using this medicine.

Although you are using this medicine to prevent pregnancy, you should be aware that using this medicine during pregnancy may harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor immediately. Make sure your doctor knows whether you have had a child within the last 4 weeks before you start using this medicine.

Before having any surgery (including dental surgery) or emergency treatment, tell your doctor or dentist that you are using this medicine. Your doctor will decide whether you should continue using this medicine.

Norelgestromin and ethinyl estradiol transdermal may not work as well for you if you weigh more than 198 pounds (98 kilograms). Talk to your doctor about the type of birth control that is best for you.

During the first three months of use, you may experience varying degrees of vaginal bleeding between your regular menstrual periods. This is sometimes called spotting if it is mild or breakthrough bleeding if it is severe. If this were to happen:

• Sollte dies der Fall sein, fahren Sie mit Ihrem regulären Dosierungsplan fort.
• Die Blutung hört normalerweise innerhalb einer Woche auf. Fragen Sie Ihren Arzt, wenn die Blutung länger als eine Woche anhält.
• Wenn die Blutung anhält, nachdem Sie hormonelle Verhütungsmittel länger als 3 Monate regelmäßig angewendet haben, wenden Sie sich an Ihren Arzt.

Do not use this medicine with medicines used to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

This medicine does not protect you against HIV/AIDS, herpes or other sexually transmitted diseases. Tell your doctor if you or your partner start having sexual intercourse with other people or if you or your partner test positive for a sexually transmitted disease. If this is a problem for you, talk to your doctor.

If you stop menstruating, contact your doctor to determine the cause. Missed periods may occur if you have not used the patch exactly as planned or the medicine is not the right strength or type for your needs. You may need a pregnancy test.

If you think you may have become pregnant, stop using this medicine immediately and consult your doctor.

Do not use this medicine if you smoke cigarettes or are over 35 years old. If you smoke while using this birth control, your risk of a blood clot, heart attack, or stroke increases. Your risk is even higher if you are over 35, have diabetes, high blood pressure or high cholesterol, or are overweight. Talk to your doctor about ways to quit smoking. Keep your diabetes under control. Ask your doctor about the type of diet and exercise to control your weight and blood cholesterol levels.

When you take this medicine, you are exposed to a higher level of estrogen than when you take a typical birth control pill. Increased estrogen exposure may increase the risk of side effects. Talk to your doctor about this risk.

Using this medicine may increase your risk of blood clotting problems. Contact your doctor immediately if you have chest, groin, or leg pain, especially in your calves, difficulty breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision problems while using this medication.

Consult your doctor immediately if you wear contact lenses or if blurred vision, difficulty reading, or other vision problems occur during or after treatment. Your doctor may want you to have your eyes examined by an ophthalmologist.

Using this medicine may increase your risk of breast cancer or cervical cancer. Talk to your doctor about this risk. Contact your doctor immediately if you experience unusual vaginal bleeding.

Contact your doctor immediately if you have pain or tenderness in your upper abdomen, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of serious liver disease.

Using this medicine may increase your risk of gallbladder disease. Talk to your doctor about this risk.

Consult your doctor before refilling an old prescription, especially after pregnancy. You will need another physical exam and your doctor may change your prescription.

Use with caution around small children. The contraceptive patch can pose a choking hazard if swallowed by a child.

Make sure any doctor who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests. You may also need to stop using this medicine for at least 4 weeks before and 2 weeks after major surgery.

This medicine may make your skin more sensitive to sunlight. Use sunscreen when you are outdoors. Avoid sun lamps and tanning beds.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and non-prescription (over-the-counter [OTC]) medicines and herbal (e.g. St. John's wort) or vitamin supplements.

Side effects of ethinyl estradiol and norelgestromin

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

More common

• Körperschmerzen oder Schmerzen
• Schüttelfrost
• Husten
• Schwierigkeiten beim Atmen
• verstopfte Ohren
• Fieber
• Kopfschmerzen
• Verlust der Stimme
• verstopfte Nase
• laufende Nase
• niesen
• Halsentzündung
• ungewöhnliche Müdigkeit oder Schwäche

Incident not known

• Angst
• Veränderungen der Hautfarbe
• Brustschmerzen oder Unwohlsein
• Verwirrung
• dunkler Urin
• Durchfall
• Schwindel
• Augenschmerzen
• Ohnmacht
• Unfähigkeit zu sprechen
• Juckreiz
• Mangel oder Verlust des Appetits
• heller Stuhlgang
• Benommenheit
• Brechreiz
• Taubheitsgefühl in den Händen
• Schmerzen im Magen
• Schmerzen in der Brust, Leistengegend oder den Beinen, insbesondere in den Waden
• Schmerzen oder Beschwerden in Armen, Kiefer, Rücken oder Nacken
• Schmerzen, Empfindlichkeit oder Schwellung des Fußes oder Beins
• in den Ohren hämmern
• Ausschlag
• Anfälle
• langsamer oder schneller Herzschlag
• undeutliches Sprechen
• plötzliche Kopfschmerzen
• Plötzlicher Verlust der Koordination
• Plötzliche, starke Schwäche oder Taubheitsgefühl im Arm oder Bein auf einer Körperseite
• Schwitzen
• Schwellung, Schmerzen oder Druckempfindlichkeit im oberen Bauch- oder Magenbereich
• vorübergehende Blindheit
• unangenehmer Atemgeruch
• Sehstörungen
• Erbrechen von Blut
• gelbe Augen oder Haut

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Ungewöhnliche Vaginalblutungen bei Frauen
• Erbrechen

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Brennen, Jucken oder Rötung der Haut
• Menstruationsbeschwerden
• Schmerzen, Schmerzen, Schwellungen oder Ausfluss aus der Brust oder den Brüsten
• Schwellung oder Schmerzen an der Pflasterstelle

Incident not known

• Ausbleibende, versäumte oder unregelmäßige Menstruationsperioden
• blutiger Ausfluss aus der Scheide
• braune, fleckige Flecken auf freiliegender Haut
• Veränderung der Menge des Vaginalausflusses
• Veränderung des Menstruationsflusses
• verringerte Menge an Muttermilch
• Entmutigung
• trockener Mund
• sich traurig oder leer fühlen
• Gewichtszunahme oder -abnahme
• erhöhter Hunger oder Durst
• vermehrtes Wasserlassen
• Reizbarkeit
• Juckreiz in der Vagina oder außerhalb der Genitalien
• leichte Vaginalblutungen zwischen der Periode und nach dem Geschlechtsverkehr
• Verlust von Interesse oder Vergnügen
• Schmerzen beim Geschlechtsverkehr
• Magenkrämpfe oder Blähungen
• Stoppen der Menstruationsblutung
• Schwellung
• dicker, weißer, quarkartiger Vaginalausfluss ohne oder mit mildem Geruch
• Konzentrationsschwierigkeiten
• Schlafstörungen

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Ortho Evra
• Xulane

Available dosage forms:

• Patch, erweiterte Version

Therapeutic class: Monophasic contraceptive combination

Pharmacological class: Progestin

More information