Xulane (Ethinyl estradiol and norelgestromin) Patch - Dosage, Directions

Xulane (Ethinyl estradiol and norelgestromin) is available as a medicated patch used to prevent pregnancy.

Xulane (Ethinyl estradiol and norelgestromin) Uses:

  • Contraception:

    • Used for the prevention of pregnancy
    • Limitations of use: The topical patch may be less effective in patients weighing 90 kg or more than 90 kg.

  • Off Label Use of Ethinyl estradiol and norelgestromin in Adults:

    • Polycystic ovary syndrome (PCOS) in women with menstrual irregularities and hirsutism/acne

Xulane (Ethinyl estradiol and norelgestromin) Dose in Adults

Xulane (Ethinyl estradiol and norelgestromin) use in females for contraception:

Topical:

  • Apply one patch each week for 3 weeks (21 total days); followed by one week that is patch-free.
  • Each patch should be applied on the same day each week (“patch change day”) and only one patch should be worn at a time.
  • No more than a weak should pass during the patch-free interval.

  • Schedule 1 (Sunday starter):

    • Dose begins on the first Sunday after the onset of menstruation; if the menstrual period starts on Sunday, apply one patch that very same day.
    • With a Sunday start, an additional method of contraception (nonhormonal) must be used until after the first weak of consecutive administration unless the menstrual period starts on Sunday.
    • Each patch change will then occur on Sunday.

  • Schedule 2 (Day 1 starter):

    • Dose starts on the first day of the menstrual cycle, applying one patch during the first 24 hours of the menstrual cycle.
    • Each patch change will then occur on that same day of the week.

  • Additional Xulane dosing considerations:

    • Switching from oral contraceptives or vaginal ring:
      • Complete the current cycle and apply the first patch on the day the next pill cycle would be started or ring would be inserted.
      • If there is no menstrual bleeding within the weak of taking the last active tablet or removing the last vaginal ring, the patient can initiate the first patch application; however, assess pregnancy status.
      • If the patch is applied later than 7 days after the last active pill or removal of the vaginal ring, an additional method of contraception (nonhormonal) should be used until after the first weak  of consecutive administration
    • Xulane Use after childbirth:
      • Therapy should not be started less than 4 weeks after childbirth.
      • Pregnancy should be ruled out prior to treatment if menstrual periods have not restarted.
      • An additional method of contraception (nonhormonal) should be used until after the first weak of consecutive administration.
    • Xulane Use after abortion or miscarriage:
      • Therapy may be started immediately if abortion/miscarriage occurs within the first trimester.
      • If therapy is not started within 5 days, follow instructions for first-time use; an additional method of contraception (nonhormonal) should be used until after the first weak of consecutive administration.
      • If abortion or a miscarriage occurs during the second trimester, therapy should not be started for at least 4 weeks.
      • Follow directions for use after childbirth.

Xulane use in Adolescents:

Refer to adult dosing.

Xulane (Ethinyl estradiol and norelgestromin) Pregnancy Risk Category: X

  • It is contraindicated in pregnant women.
  • To prevent pregnancy, combination hormonal contraceptives can be used. If pregnancy does occur, treatment should be stopped.
  • Combination hormonal contraceptives used inadvertently early in pregnancy have not been shown to cause adverse effects for either the fetus or mother.
  • According to the manufacturer, combination hormonal contraceptives should be stopped 4 weeks after birth in women who have chosen not to breastfeed.
  • It should also not be used more than 4 weeks after an abortion or miscarriage.
  • Combination hormonal contraceptives should be stopped for less than 21 days after delivery due to increased risk of venous embolism (VTE).
  • Postpartum day 42 sees a decrease in the risk to baseline.
  • Combination hormonal contraceptives should be used in women 21 to 42 days after delivery.
  • Women must consider their risk factors for VTE such as age, gender, pregnancies, birth complications, and smoking.

Use of Xulane (Ethinyl estradiol, norelgestromin), during breastfeeding

  • Breast milk may contain contraceptive steroids.
  • The manufacturer suggests that contraceptives containing estrogen be used until the child is weaned. This will reduce milk production.
  • Breastfeeding mothers who use combination hormonal contraceptives have not reported any adverse health effects or persistent effects on infant growth and illness.
  • Breastfeeding women should not start combination hormonal contraceptives less than 21 days after delivery due to an increased risk of venous embolism (VTE).
  • Postpartum day 42 sees a decrease in the risk to baseline.
  • Combination hormonal contraceptives should be used in women 21 to 42 days after delivery.
  • Women must consider their risk factors for VTE (eg., age 35 or more than 35, previous VTEs, thrombophilia and transfusion at delivery, cesarean birth, immobility, preeclampsia and peripartum cardiomyopathy), BMI >=30kg/m2, postpartum bleeding, smoking, and other health issues.
  • When starting treatment for breastfeeding women, it is important to consider the risks and benefits of combination hormonal contraception.

Xulane (Ethinyl estradiol and norelgestromin) Dose in Kidney Disease:

Manufacturers labeling doesn't provide any dosage adjustments (has not been studied); use with caution and monitor blood pressure closely.

Xulane (Ethinyl estradiol and norelgestromin) Dose in Liver disease:

It is contraindicated in patients with hepatic impairment.

The following reactions have been reported with the contraceptive patch. Adverse reactions associated with oral combination hormonal contraceptive agents are also likely to appear with the topical contraceptive patch (frequency difficult to anticipate).

Common Side Effects of Xulane (Ethinyl estradiol and norelgestromin):

  • Central Nervous System:

    • Headache

  • Endocrine & Metabolic:

    • Breast Changes Including
      • Discomfort
      • Mastalgia
      • Breast Engorgement

  • Gastrointestinal:

    • Nausea

  • Local:

    • Application Site Reaction

Less Common Side Effects Of Xulane (Ethinyl estradiol and norelgestromin):

  • Cardiovascular:

    • Increased Blood Pressure
    • Pulmonary Embolism

  • Central Nervous System:

    • Anxiety
    • Mood Disorder
    • Malaise
    • Dizziness
    • Fatigue
    • Migraine
    • Insomnia

  • Dermatologic:

    • Acne Vulgaris
    • Chloasma
    • Contact Dermatitis
    • Erythema
    • Skin Irritation
    • Pruritus

  • Endocrine & Metabolic:

    • Menstrual Disease
    • Weight Gain
    • Premenstrual Syndrome
    • Change In Libido
    • Dyslipidemia
    • Fluid Retention
    • Galactorrhea

  • Gastrointestinal:

    • Abdominal Pain
    • Diarrhea
    • Abdominal Distention
    • Cholecystitis
    • Vomiting

  • Genitourinary:

    • Dysmenorrhea
    • Vulvar Dryness
    • Vaginal Hemorrhage
    • Vulvovaginal Candidiasis
    • Genital Discharge
    • Uterine Spasm
    • Vaginal Dryness

  • Neuromuscular & Skeletal:

    • Muscle Spasm

Contraindications to Xulane (Ethinyl estradiol and norelgestromin):

  • Breast cancer and other estrogen-, progestin-dependent Neoplasms (currently or in the past).
  • Hepatic tumors (benign and malignant) or hepatic diseases.
  • pregnancy,
  • Undiagnosed abnormal uterine bleeding
  • use of hepatitis C drug combinations containing ombitasvir/paritaprevir /ritonavir with or without dasabuvir.

Women at high risk for arterial or vein thrombotic disease, such as women with:

  • Cerebrovascular Disease
  • Coronary artery disease
  • Diabetes mellitus and vascular disease
  • DVT or PE (current and/or historical of),
  • Hypercoagulopathies (inherited and acquired)
  • hypertension (uncontrolled),
  • Headaches with focal neurological symptoms
  • Migraine headaches with aura and migraine headaches in those over 35 years
  • Thrombogenic valvular and rhythm diseases of heart (eg subacute bacteria endocarditis or atrial fibrillation)
  • Women who smoke are older than 35 years old.

Canadian-labeling: Additional contraindications not in US labeling

  • Hypersensitivity to Ethinylestradiol or norelgestromin or any other component of the formulation
  • Myocardial Infarction (current and/or history of);
  • Steroid-dependent jaundice
  • Known as cholestatic jaundice or history of jaundice during pregnancy
  • Any ocular lesions caused by ophthalmic vessels disease, including partial or total loss of vision and defects in the visual fields.
  • Persistent blood pressure >=160mm Hg systolic, or >=100mm Hg diastolic
  • severe dyslipoproteinemia;
  • women with a hereditary or acquired predisposition for venous or arterial thrombosis (eg, Factor V Leiden mutation and activated protein C [APC-] resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia [eg, due to MTHFR C677T, A1298 mutations], prothrombin mutation G20210A, and antiphospholipid-antibodies [anticardiolipin antibodies, lupus anticoagulant]);
  • Major surgery is associated with a higher risk of post-operative bleeding.
  • Long-term immobilization
  • coadministration with paritaprevir, ritonavir, ombitasvir (with or without dasabuvir).

Warnings and precautions

  • Breast cancer

    • Combination hormonal contraceptives have not been proven to reduce breast cancer risk in women who are at high risk due to their family history or susceptibility genes (BRCA2, BRCA1).
    • Women with breast cancer history or who have had it are advised to not use this product.
    • Breast cancer is a hormone sensitive tumor. Women with a history of breast cancer or a recent diagnosis may have a worse prognosis if they use combination hormonal contraceptives.

  • Cervical cancer:

    • Theoretically, it may influence the prognosis for an existing disease.
    • Combination hormonal contraceptives may be used by women who are awaiting treatment for cervical carcinoma.
    • Combination hormonal contraceptives have been linked to a slight increase in cervical cancer risk. However, the evidence is inconsistent and could be due to other risk factors.

  • Chloasma

    • Treatment should be avoided for women who are susceptible to chloasma and other risk factors.
    • Combination hormonal contraceptives as well as sun exposure, pregnancy and sun exposure are all triggers for chloasma.

  • Cholestasis:

    • Cholesteasis risk may increase if there has been a history of cholestasis in pregnancy, or with prior oral contraceptive use.

  • The Lipid Effects

    • Combination hormonal contraceptives can increase the risk of pancreatitis in women with hypertriglyceridemia and a family history.
    • Combination hormonal contraceptives can adversely affect lipid levels, especially serum triglycerides.
    • Women with uncontrolled dyslipidemia should consider alternative contraception.

  • Retinal vascular embolism:

    • If you experience an undiagnosed loss of vision, papilledema or proptosis, discontinue use immediately and have your retinal veins examined for thrombosis.

  • Thromboembolic conditions: [US Boxed Warn]

    • The patch has a different pharmacokinetic profile than oral contraceptives.
    • Stable-state concentrations are approximately 60% higher after using the patch than oral tablets containing 35 mg ethinylestradiol.
    • Peak concentrations are lower in the patch.
    • Due to the increased estrogen exposure, the risk of venous embolism (VTE), may be increased by the contraceptive pill.
    • Increased estrogen exposure can increase the likelihood of adverse events such as venous embolism.
    • If you experience an arterial or vein thrombotic event, discontinue using combination hormonal contraceptives.
    • Women who have inherited thrombophilias, such as protein C or S deficiency and factor V Leiden mutation, antithrombin deficiencies, or prothrombin mutation, may be at greater risk for venous thromboembolism.
    • The risk of venous embolism may be increased by oral contraceptives (risk is highest in the first year and lowest during pregnancy). Some studies have suggested that the risk may be greater for preparations containing third- or fourth-generation progestins, and/or high doses of ethinylestradiol.
    • Women who use combination hormonal contraceptives for longer periods of time, such as those over 35, are more likely to experience thrombotic events than those who smoke or have hypertension.
    • Combination hormonal contraceptives can also increase the risk for arterial thrombosis (eg MI, stroke). Women with a history or ischemic heart disease should not use them.
    • Combination hormonal contraceptives are not recommended for women at high risk of venous or arterial thrombotic diseases.

  • Vaginal bleeding

    • In the initial 3 months of therapy, it is possible to experience intra-cyclic bleeding or breakthrough.
    • Combination hormonal contraceptives may cause amenorrhea and oligomenorrhea, particularly if the condition was not present previously.
    • There may be occasional missed periods.
    • Unresolved vaginal bleeding is a sign of malignancy and pregnancy.

  • Cardiovascular disease

    • Patients with high risk factors for cardiovascular disease such as hypertension, high blood pressure, diabetes, older age, smoking, and low HDL/high LDL levels should be cautious. Combination hormonal contraceptives can increase your risk of developing the disease.
    • Women at high risk for arterial or vein thrombotic disease are not advised to use this medication.

  • Depression

    • Patients with a history or depression should be cautious; discontinue use if severe depression recurs.

  • Diabetes:

    • Combination oral contraceptives have a limited effect on insulin requirements and are not effective for long-term diabetes control in women who do not have nonvascular diseases.
    • This may impair glucose tolerance. Women with diabetes and prediabetes should be cautious.
    • Contraceptive use should not be used in women who have concomitant neuropathy, nephropathy, retinopathy or other vascular conditions.
    • Women with diabetes mellitus or vascular disease should not use this medication.

  • Endometrial and ovarian cancers:

    • Combination hormonal contraceptives may be used by women awaiting treatment for ovarian or endometrial cancer.
    • Women who use combination oral contraceptives have a lower risk of developing ovarian or endometrial cancer. It is not known if using the contraceptive patch can also reduce this risk.

  • Gallbladder disease

    • Combining hormonal contraceptives can increase the risk of gallbladder diseases or worsen existing gallbladder diseases.

  • Hepatic adenomas and carcinomas

    • A higher risk of developing hepatocellular carcinoma in the long term (rare).
    • Combination hormonal contraceptives can cause hepatic tumors (rare); rupture could lead to fatal intra-abdominal bleeding.
    • Preexisting hepatic cancers are not recommended.

  • Hepatic impairment

    • If jaundice occurs during treatment or if the liver function is abnormal, discontinue use.
    • Women with hepatic diseases should not use this product.
    • Women with impaired liver function may not be able to process hormonal contraceptives in combination.
    • Combination hormonal contraceptives can be used for women with mild (compensated), but not severe (decompensated), cirrhosis.

  • Hepatitis

    • Women with chronic hepatitis have not been shown to experience an increase in the severity or rate of cirrhotic fibrisis.
    • It has been proven that continued use of a drug by women who are carriers does not cause liver disease or severe hepatic dysfunction.
    • Combination hormonal contraceptives are not recommended for women suffering from acute viral hepatitis, flares, or other severe conditions.

  • Hereditary angioedema:

    • Women with hereditary angioedema may be affected by estrogens.

  • Hypertension:

    • Hypertension risk may increase with age, dosage, and length of use.
    • Women with mild hypertension (140-159 mmHg systolic, 90-99 mmHg diastolic) and women with moderate hypertension (140-159 mmHg systolic; or hypertension controlled to an acceptable level) may not be at risk.
    • Women with hypertension or vascular disease or persistent blood pressure levels >=160mm Hg Systolic or >=100mm Hg Diastolic should not use combination hormonal contraceptives.
    • The manufacturer warns against use in women with uncontrolled hypertension. They recommend monitoring women with well-controlled hypertension. Stop taking the medication if your blood pressure increases significantly.
    • When prescribing contraceptives, it is important to consider other risk factors such as older age, smoking, and diabetes.

  • Migraine

    • Women with migraines without aura, including menstrual migraines, may consider using combination hormonal contraceptives.
    • Assess new, persistent, severe or recurring headaches.
    • If you are over 35 years old, it is not recommended to be used in women suffering from migraine headaches or focal neurological symptoms.

  • Transplantation of solid-organs:

    • Although limited data are available, serious medical complications have been reported in patients with complex organ transplants.

  • Systemic lupus erythematosus (SLE):

    • Women with SLE should not use combination hormonal contraceptives if they have antiphospholipid antibodies. This is because there is a greater risk of arterial or venous embolism.
    • SLE women are more at risk for heart disease, stroke and VTE.

Ethinyl estradiol and norelgestromin: Drug Interaction

Risk Factor C (Monitor therapy)

Ajmaline

Estrogen derivatives may intensify ajmaline's harmful or hazardous effects. In particular, there may be an elevated risk for cholestasis.

Anthrax Immune Globulin (Human)

Anthrax Immune Globulin's thrombogenic action may be enhanced by oestrogen derivatives (Human).

Antidiabetic Agents

The therapeutic benefit of anti-diabetic agents may be reduced by hyperglycemia-associated agents.

Ascorbic Acid

May raise the level of oestrogen derivatives in the serum.

C1 inhibitors

The thrombogenic impact of C1 inhibitors may be enhanced by oestrogen derivatives.

C1 inhibitors

The thrombogenic action of C1 inhibitors may be enhanced by progestins.

Chenodiol

Estrogen derivatives may lessen Chenodiol's therapeutic efficacy. When administered with any oestrogen derivative, chenodiol's clinical reaction should be continuously monitored.

CloZAPine

CYP1A2 Inhibitors (Weak) may raise the level of CloZAPine in the serum. Management: Separate drug interaction monographs go into further detail about the medications indicated as exceptions to this book.

Corticosteroids (Systemic)

Estrogen derivatives may raise the level of corticosteroids in the blood (Systemic).

CYP3A4 Inducers (Moderate)

May lower the serum level of CYP3A4 substrates (High risk with Inducers).

CYP3A4 Inhibitors (Moderate)

May raise the level of oestrogen derivatives in the serum.

CYP3A4 Inhibitors (Strong)

May raise the level of oestrogen derivatives in the serum.

Dantrolene

Dantrolene's hepatotoxic action may be enhanced by oestrogen derivatives.

Deferasirox

May lower the serum level of CYP3A4 substrates (High risk with Inducers).

Erdafitinib

May lower the serum level of CYP3A4 substrates (High risk with Inducers).

Flibanserin

The serum levels of flibanserin may rise in response to oestrogen derivatives (contraceptive).

Flibanserin

Flibanserin's serum levels may rise in response to progestins (contraceptive).

Guanethidine

Guanethidine's therapeutic impact may be diminished by oestrogen derivatives (contraceptive).

Herbs (Estrogenic Properties)

Estrogen derivatives' harmful or toxic effects might be amplified.

Herbs (Progestogenic Properties) (eg, Bloodroot, Yucca)

Could make progestins' harmful or hazardous effects worse.

Immune Globulin

Estrogen derivatives may intensify Immune Globulin's thrombogenic action.

Lenalidomide

Lenalidomide's ability to induce thrombosis may be enhanced by oestrogen derivatives.

Metreleptin

Might lower the serum level of oestrogen derivatives (Contraceptive). The serum levels of oestrogen derivatives may rise in response to metreleptin (Contraceptive).

Metreleptin

May lower the level of progestins in the serum (Contraceptive). The serum concentration of progestins may rise in response to metreleptin (Contraceptive).

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective)

Could make oestrogen derivatives' thrombogenic impact stronger. The serum concentration of oestrogen derivatives may rise in response to non-steroidal anti-inflammatory drugs (COX-2 selective).

Proguanil

 It's possible that ethinyl estradiol will lessen proguanil's therapeutic effects.

ROPINIRole

The serum concentration of ROPINIRole may rise in response to oestrogen derivatives.

Sarilumab

May lower the serum level of CYP3A4 substrates (High risk with Inducers).

Selegiline

Selegiline's serum levels may rise in response to oestrogen derivatives (contraceptive).

Selegiline

Selegiline's serum levels may rise in response to progestins (contraceptive).

Siltuximab

May lower the serum level of CYP3A4 substrates (High risk with Inducers).

Succinylcholine

The serum content of succinylcholine may rise as a result of oestrogen derivatives.

Thalidomide

Thalidomide's thrombogenic action may be enhanced by oestrogen derivatives (contraceptive).

Thalidomide

The thrombogenic action of thalidomide may be enhanced by progestins (contraceptive).

Thalidomide

The thrombogenic effect of thalidomide may be enhanced by oestrogen derivatives.

Theophylline Derivatives

Theophylline derivatives' serum levels may be raised by oestrogen derivatives. Exceptions: Dyphylline.

Thyroid Products

Estrogen derivatives may reduce a thyroid product's ability to treat you.

Tocilizumab

May lower the serum level of CYP3A4 substrates (High risk with Inducers).

Ursodiol

Ursodiol's therapeutic effects could be lessened by oestrogen derivatives.

Valproate Products

The serum content of valproate products may be reduced by oestrogen derivatives (contraceptive).

Voriconazole

Estrogen derivatives' metabolism might be slowed (Contraceptive). The serum levels of voriconazole may rise in response to oestrogen derivatives (contraceptive).

Voriconazole

May raise progesterone levels in the blood (Contraceptive). The serum levels of voriconazole may rise in response to progestins (contraceptive).

Risk Factor D (Consider therapy modification)

Acitretin

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: Progestin-only preparations shouldn't be depended upon because they may not be effective at preventing pregnancy while using acitretin. During acitretin therapy, alternative, nonhormonal methods of contraception must be used.

Anticoagulants

Estrogen derivatives might lessen an anticoagulant's ability to stop bleeding. More particular, some estrogens and progestin-estrogen combos may have prothrombotic actions that work against any anticoagulant effects. Management: Carefully balance the potential advantages of estrogens against the probable elevated risk of thromboembolism and procoagulant effects. Under some conditions, use is deemed contraindicated. For particular advice, consult the relevant policies.

Anticoagulants

Anticoagulants' therapeutic effects may be lessened by progestins. More particular, some progestins and progestin-estrogen combos may have prothrombotic actions that work against any anticoagulant effects. Management: Carefully balance the progestins' possible advantages against their potential increased risk of thromboembolism and procoagulant effects. Under some conditions, use is deemed contraindicated. For particular advice, consult the relevant policies.

Aprepitant

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: It is advised to use a contraception that is not hormone-based.

Aprepitant

May lower the level of progestins in the serum (Contraceptive). Treatment: Alternative or additional methods of contraception should be used for at least one month after the final dosage of aprepitant or fosaprepitant, as well as while using aprepitant or fosaprepitant.

Armodafinil

Might lower the serum level of oestrogen derivatives (Contraceptive). Therapy: During and for one month after treatment with armodafinil, the manufacturer advises patients to take nonhormonal contraceptives in addition to or in place of hormonal contraceptives.

Artemether

Might lower the serum level of oestrogen derivatives (Contraceptive). Management: All women of reproductive potential who are taking artemether should think about utilising an alternative method of contraception (i.e., one that is not hormonal).

Artemether

May lower the level of progestins in the serum (Contraceptive). Management: All women of reproductive potential who are taking artemether should think about utilising an alternative method of contraception (i.e., one that is not hormonal).

Asunaprevir

May lower the level of ethinyl estradiol in the serum. Management: Using a high-dose oral contraceptive during asunaprevir treatment that contains at least 30 mcg of ethinyl estradiol coupled with norethindrone acetate/norethindrone is advised for patients who use hormone-based contraception.

Asunaprevir

May lower the level of Norelgestromin in the serum. Management: Using a high-dose oral contraceptive during asunaprevir treatment that contains at least 30 mcg of ethinyl estradiol coupled with norethindrone acetate/norethindrone is advised for patients who use hormone-based contraception.

Atazanavir

May raise progesterone levels in the blood (Contraceptive). Atazanavir, however, may result in lower ethinyl estradiol levels and reduced efficiency of oral contraceptive medications. Management: When using combination estrogen/progestin medications, take into account an extra means of contraception. It is possible to utilise depot medroxyprogesterone acetate without the use of supplementary contraception.

Barbiturates:

Might reduce the therapeutic benefit of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Use of a non-hormonal contraception is advised for management.

Barbiturates

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: It is advised to use complementary, nonhormonal contraception.

Bexarotene (Systemic)

Might lower the serum level of oestrogen derivatives (Contraceptive). Management: Women who are sexually active and on bexarotene should utilise two trustworthy methods of contraception (including at least one nonhormonal form).

Bexarotene (Systemic)

May lower the level of progestins in the serum (Contraceptive). Management: Women who are sexually active and on bexarotene should utilise two trustworthy methods of contraception (including at least one nonhormonal form).

Bile Acid Sequestrants

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: Give bile acid sequestrants at least 1 to 4 hours before or 6 to 8 hours after giving estrogen-based oral contraceptives.

Bile Acid Sequestrants

May lower the level of progestins in the serum (Contraceptive). Treatment: Give oral contraceptives containing progestin at least one to four hours before or six to eight hours after taking a bile acid sequestrant.

Bosentan

Might lower the serum level of oestrogen derivatives (Contraceptive). Management: Do not solely rely on hormonal contraceptives for all women of reproductive potential who are taking bosentan; instead, use an alternative (i.e., non-hormonal) method of contraception.

Bosentan

May lower the level of progestins in the serum (Contraceptive). Management: Do not solely rely on hormonal contraceptives for all women of reproductive potential who are taking bosentan; instead, use an alternative (i.e., non-hormonal) method of contraception.

Brigatinib

Might lower the serum level of oestrogen derivatives (Contraceptive). Management: For at least 4 months following the last dosage of brigatinib, females of reproductive potential should use an alternative, non-hormonal method of contraception.

Brigatinib

May lower the level of progestins in the serum (Contraceptive). Management: For at least 4 months following the last dosage of brigatinib, females of reproductive potential should use an alternative, non-hormonal method of contraception.

CarBAMazepine

Might reduce the therapeutic benefit of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Treatment: It is advised to use a nonhormonal contraception.

CarBAMazepine

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: It is advised to use complementary, nonhormonal contraception.

Carfilzomib

Could make oestrogen derivatives' thrombogenic impact stronger (Contraceptive). In patients who need carfilzomib medication, alternate, non-hormonal methods of contraception should be taken into account.

Carfilzomib

Could make progestins' thrombogenic impact stronger (Contraceptive). In patients who need carfilzomib medication, alternate, non-hormonal methods of contraception should be taken into account.

Cladribine

May reduce the hormonal contraceptives' therapeutic effect. Management: During cladribine dosage and for at least 4 weeks after the final dose in each treatment period, women who are using systemically acting hormonal contraceptives should add a barrier device.

CloBAZam

Might lower the serum level of oestrogen derivatives (Contraceptive).

CloBAZam

May lower the level of progestins in the serum (Contraceptive).

Cobicistat

Might lower the serum level of oestrogen derivatives (Contraceptive). When treating patients who are using cobicistat-containing products, take into account a different, nonhormone-based method of contraception.

Cobicistat

May raise progesterone levels in the blood (Contraceptive). When treating patients who are taking cobicistat-containing medications, take into account an alternative, nonhormone-based method of contraception. Atazanavir and cobicistat are specifically contraindicated with dronabinol.

Colesevelam

May lower the level of ethinyl estradiol in the serum. Treatment: Ethinyl estradiol and norethindrone-containing oral contraceptives should be used at least 4 hours before colestipol.

Cosyntropin

Cosyntropin's diagnostic potential may be diminished by oestrogen derivatives. Treatment: Stop taking any medications that include oestrogen 4 to 6 weeks before cosyntropin (ACTH) testing.

CYP3A4 Inducers (Strong)

May speed up CYP3A4 substrate metabolism (High risk with Inducers). Management: Take into account a substitute for one of the interfering medications. Specific contraindications may apply to some combinations. the relevant manufacturer's label.

Dabrafenib

May lower the serum level of CYP3A4 substrates (High risk with Inducers). Management: When possible, look for substitutes for the CYP3A4 substrate. If concurrent therapy cannot be avoided, pay special attention to the substrate's clinical consequences (particularly therapeutic effects).

Dabrafenib

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: Women who are sexually active or who are planning a pregnancy should take contraception that is highly effective, nonhormonal, and alternative for at least 2 weeks (if taking dabrafenib alone) or 4 months (if taking dabrafenib plus trametinib).

Dabrafenib

May lower the level of progestins in the serum (Contraceptive). Treatment: Women who are sexually active or who are planning a pregnancy should take contraception that is highly effective, non-hormonal, and alternative for at least 2 weeks (if taking dabrafenib alone) or 4 months (if taking dabrafenib plus trametinib).

Darunavir

May lower the level of progestins in the serum (Contraceptive). Management: Take into account utilising a different or additional method of contraception. There is no requirement for supplemental contraception when using injected depot medroxyprogesterone acetate.

Efavirenz

May lower the level of progestins in the serum (Contraceptive). Management: In light of potentially decreased contraceptive effectiveness, use an extra or alternative method of contraception. Depot medroxyprogesterone administered intravenously does not seem to be involved in this interaction.

Elagolix

The therapeutic benefit of Elagolix may be diminished by oestrogen derivatives (contraceptive). Use a different, non-hormonal method of birth control while taking elagolix and for at least a week after stopping the medication.

Elvitegravir

Might lower the serum level of oestrogen derivatives (Contraceptive). Management: If a patient is on elvitegravir-containing medication, they should think about switching to an other, non-hormone-based method of birth control.

Enzalutamide

May lower the serum level of CYP3A4 substrates (High risk with Inducers). Treatment: Enzalutamide should not be used concurrently with CYP3A4 substrates that have a limited therapeutic index. Enzalutamide use, like with the use of any other CYP3A4 substrate, should be done cautiously and under close observation.

Eslicarbazepine

Might lower the serum level of oestrogen derivatives (Contraceptive). Management: Women who are capable of having children should think about non-hormonal birth control alternatives.

Eslicarbazepine

May lower the level of progestins in the serum (Contraceptive). Management: For women who are capable of having children, alternative, non-hormonal methods of birth control should be taken into account.

Exenatide

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: Oral contraceptives should be taken at least an hour before exenatide.

Felbamate

Might lower the serum level of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Treatment: It is advised to use a nonhormonal contraception.

Felbamate

May lower the level of progestins in the serum (Contraceptive). Management: It is possible for contraceptives to fail. It is advised to use an alternative, nonhormonal method of contraception.

Fosamprenavir

The serum concentrations of the active metabolite(s) of fosamprenavir may drop when using progestins (contraceptives). Fosamprenavir may lower the level of progestins in the serum (Contraceptive). Management: Take into account utilising a different or additional method of contraception. There is no requirement for supplemental contraception when using injected depot medroxyprogesterone acetate.

Fosaprepitant

Might lower the serum level of oestrogen derivatives (Contraceptive). Probably the active metabolite aprepitant is the cause of this effect. Therapy: Alternative or additional methods of contraception should be used for at least a month after the last dosage of fosaprepitant or aprepitant, as well as while receiving treatment with these drugs.

Fosaprepitant

May lower the level of progestins in the serum (Contraceptive). Probably the active metabolite aprepitant is the cause of this effect. Treatment: Alternative or additional methods of contraception should be used for at least one month after the final dosage of aprepitant or fosaprepitant, as well as while using aprepitant or fosaprepitant.

Fosphenytoin

Might reduce the therapeutic benefit of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Management: It is advised to use an alternative, nonhormonal method of contraception.

Fosphenytoin

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: It is possible for contraceptives to fail. It is advised to use an alternative, nonhormonal method of birth control.

Hyaluronidase

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: It is possible for contraceptives to fail. It is advised to use an alternative, nonhormonal method of birth control.

Ivosidenib

Estrogen derivatives may lessen Hyaluronidase's therapeutic impact. Treatment: Standard doses of hyaluronidase may not produce the desired clinical response in patients receiving estrogens (especially at higher doses). Hyaluronidase may be needed at higher doses.

Ivosidenib

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: If a patient is taking ivosidenib, consider non-hormonal contraception alternatives.
may lower the level of progestins in the serum (Contraceptive). Treatment: If a patient is taking ivosidenib, consider non-hormonal contraception alternatives.

LamoTRIgine

The serum content of LamoTRIgine may be decreased by oestrogen derivatives (contraceptive). After discontinuing or reducing the dosage of a hormonal contraceptive, patients should be watched for any changes in lamotrigine's serum concentrations and potential side effects (this includes during a pill-free week). Lamotrigine dosage may need to be decreased.

Lesinurad

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: Patients on lesinurad who want reliable contraception are advised to use an additional nonhormonal method of contraception.

Lesinurad

May lower the level of progestins in the serum (Contraceptive). Treatment: Patients on lesinurad who want reliable contraception are advised to use an additional nonhormonal method of contraception.

Lixisenatide

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: Give oral contraceptives 11 hours or more after giving lixisenatide, whichever comes first.

Lixisenatide

May lower the level of progestins in the serum (Contraceptive). Treatment: Give oral contraceptives 11 hours or more after giving lixisenatide, whichever comes first.

Lomitapide

The serum concentration of lomitapide may rise in response to ethinyl estradiol. Treatment: Patients taking 5 mg/day of lomitapide may continue doing so. Patients taking 10 mg or more of lomitapide per day should cut their dosage in half. The dosage of lomitapide may thereafter be increased up to a maximum daily adult dose of 40 mg.

Lopinavir

May lower the level of progestins in the serum (Contraceptive). Lopinavir may raise the level of progestins in the serum (Contraceptive). Management: Take into account utilising a different or additional method of contraception. Without the need for supplementary contraception, injectable depot medroxyprogesterone acetate and etonogestrel implants may be utilised.

Lorlatinib

May lower the serum level of CYP3A4 substrates (High risk with Inducers). Management: Avoid taking lorlatinib at the same time as any CYP3A4 substrates for which even a small drop in serum levels of the substrate could result in therapeutic failure and negative clinical outcomes.

Lumacaftor

Might lower the serum level of oestrogen derivatives (Contraceptive). Management: If lumacaftor and ivacaftor are taken together, avoid using hormone-based contraceptives; instead, choose an other, non-hormonal type of contraception.

Lumacaftor

May lower the level of progestins in the serum (Contraceptive). Management: If lumacaftor and ivacaftor are taken together, avoid using hormone-based contraceptives; instead, choose an other, non-hormonal type of contraception.

MiFEPRIStone

May reduce the progestins' therapeutic impact (Contraceptive). MiFEPRIStone may raise the level of progestins in the serum (Contraceptive). Management: During and for four weeks after mifepristone treatment, women of reproductive potential should use an efficient, nonhormonal method of contraception.

MiFEPRIStone

Might reduce the therapeutic benefit of oestrogen derivatives (Contraceptive). The blood concentration of oestrogen derivatives may rise when using MiFEPRIStone (Contraceptive). Management: During and for four weeks after mifepristone treatment, women of reproductive potential should use an efficient, nonhormonal method of contraception.

Mitotane

May lower the serum level of CYP3A4 substrates (High risk with Inducers). Treatment: When administered in individuals receiving mitotane, doses of CYP3A4 substrates may need to be significantly modified.

Modafinil

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: During and for one month after modafinil treatment, the manufacturer advises patients to use nonhormonal contraceptives in addition to or in place of hormonal contraceptives.

Mycophenolate

Might lower the serum level of oestrogen derivatives (Contraceptive). However, there was evidence of significant patient-to-patient variability in response to this combination, even if average AUC values remained unchanged. Management: Women who are sexually active and on mycophenolate mofetil should think about using an extra type of birth control.

Mycophenolate

May lower the level of progestins in the serum (Contraceptive). Management: Employing a different (nonhormonal) type of contraception should be taken into consideration.

Nafcillin

Could speed up how quickly oestrogen derivatives are metabolised (Contraceptive). Treatment: It is advised to use an alternative, nonhormonal method of contraception while using nafcillin.

Nelfinavir:

May lower the level of progestins in the serum (Contraceptive). Management: In light of potentially decreased contraceptive effectiveness, use an extra or alternative method of contraception. Depot medroxyprogesterone administered intravenously does not seem to be involved in this interaction.

Nevirapine

Might lower the serum level of oestrogen derivatives (Contraceptive).

Nevirapine

May lower the level of progestins in the serum (Contraceptive). Management: Advise nevirapine-treated individuals to utilise a different or supplemental nonhormonal method of birth control. However, depo-medroxyprogesterone acetate may be used as the exclusive means of contraception, according to the labelling on nevirapine products.

OXcarbazepine

Might lower the serum level of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Management: It is advised to use a complementary, nonhormonal method of birth control.

OXcarbazepine

May lower the level of progestins in the serum (Contraceptive). Management: It is possible for contraceptives to fail. It is advised to use a second or additional nonhormonal method of contraception.

Perampanel

May lower the level of progestins in the serum (Contraceptive). Treatment: Patients should utilise an alternative method of contraception that is not hormonally based both while taking perampanel and for one month after stopping it.

Phenytoin

Might reduce the therapeutic benefit of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Management: It is advised to use an alternative, nonhormonal method of contraception.

Phenytoin

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: It is possible for contraceptives to fail. It is advised to use an alternative, nonhormonal method of birth control.

Pitolisant

Might reduce the therapeutic benefit of oestrogen derivatives (Contraceptive). Management: An alternative method of contraception should be utilised instead of combining hormonal contraceptives with pitolisant.

Pitolisant

May reduce the progestins' therapeutic impact (Contraceptive). Management: An alternative method of contraception should be utilised instead of combining hormonal contraceptives with pitolisant.

Pitolisant

May lower the serum level of CYP3A4 substrates (High risk with Inducers). Management: Pitolisant should not be used in conjunction with a CYP3A4 substrate that has a limited therapeutic index. When administered with pitolisant, other CYP3A4 substrates need to be checked more carefully.

Pomalidomide

Could make oestrogen derivatives' thrombogenic impact stronger. Care should be taken while using hormone replacement treatment, and hormonal contraceptives are not advised, according to Canadian pomalidomide labelling. These precise guidelines are not included on the pomalidomide labelling in the US.

Pomalidomide

Pomalidomide's thrombogenic action may be strengthened by progestins. Care should be taken while using hormone replacement treatment, and hormonal contraceptives are not advised, according to Canadian pomalidomide labelling. These precise guidelines are not included on the pomalidomide labelling in the US.

Primidone

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: It is advised to use complementary, nonhormonal contraception.

Protease Inhibitors

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: For individuals using atazanavir/ritonavir, use oral contraceptives containing no more than 30mcg of ethinyl estradiol or at least 35mcg of ethinyl estradiol. It is advised to use an alternative, non-hormonal method of birth control when using other protease inhibitors. Examples include Indinavir.

Retinoic Acid Derivatives

May reduce the progestins' therapeutic impact (Contraceptive). Progesterone serum levels may be reduced by retinoic acid derivatives (Contraceptive). Treatment: Patients using retinoic acid derivatives should utilise two kinds of reliable contraception. Particularly, formulations that contain merely microdoses of progesterone may not be sufficient. Adapalene, Bexarotene (Topical), and Tretinoin are exceptions (Topical).

Rifamycin Derivatives

Might lower the serum level of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Management: It is advised to use a complementary, nonhormonal method of birth control.

Rifamycin Derivatives

May lower the level of progestins in the serum (Contraceptive). Failure with contraception is possible. Management: It is possible for contraceptives to fail. It is advised to use an alternative, nonhormonal method of birth control.

Rufinamide

May lower the level of ethinyl estradiol in the serum.

Saquinavir

May lower the level of progestins in the serum (Contraceptive). Management: In light of potentially decreased contraceptive effectiveness, use an extra or alternative method of contraception. Depot medroxyprogesterone administered intravenously does not seem to be involved in this interaction.

St John's Wort

Might reduce the therapeutic benefit of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Management: If possible, look into alternatives to St. John's wort. If this combination is taken, a different, nonhormonal form of birth control is advised.

St John's Wort

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible. Management: Take into account using something other than St. John's wort. Failure with contraception is possible. It is advised to use an alternative, nonhormonal method of birth control.

St John's Wort

May lower the serum level of CYP3A4 substrates (High risk with Inducers). Management: Take into account a substitute for one of the interfering medications. Specific contraindications may apply to some combinations. the relevant manufacturer's label.

Sugammadex

May lower the level of progestins in the serum (Contraceptive). Treatment: During and for 7 days after having sugammadex, patients receiving any hormonal contraceptive (oral or non-oral) should utilise an additional, non-hormonal method of contraception.

Sugammadex

Might lower the serum level of oestrogen derivatives (Contraceptive). Treatment: During and for 7 days after having sugammadex, patients receiving any hormonal contraceptive (oral or non-oral) should utilise an additional, non-hormonal method of contraception.

Tipranavir

Estrogen derivatives may intensify Tipranavir's unfavourable effect on the skin. A high incidence of skin rash was linked to the use of tipranavir/ritonavir and ethinyl estradiol/norethindrone together. The serum levels of oestrogen derivatives may drop when taking tipranavir. Management: Women who use hormonal contraceptives should think about non-hormonal alternatives.

Tipranavir

May raise progesterone levels in the blood (Contraceptive). Management: In light of potentially decreased contraceptive effectiveness, use an extra or alternative method of contraception. Depot medroxyprogesterone administered intravenously does not seem to be involved in this interaction.

TiZANidine

The concentration of TiZANidine in the serum may rise in response to CYP1A2 Inhibitors (Weak). Management: Whenever you can, stay away from these pairings. Tizanidine should be started at an adult dose of 2 mg and increased in 2 to 4 mg increments depending on the patient's reaction if combination use is required. Watch out for tizanidine side effects, such as increased effects.

Tobacco (Smoked)

Could intensify the negative or harmful effects of oestrogen derivatives (Contraceptive). In particular, there may be an elevated risk of major cardiovascular events such myocardial infarction, stroke, and venous thromboembolism. Management: Whenever feasible, refrain from smoking if a patient uses an estrogen-containing birth control method. 

Topiramate

Might lower the serum level of oestrogen derivatives (Contraceptive). Failure with contraception is possible. Management: Risk seems to be greatest at dosages of 200 mg or more of topiramate per day. The usefulness of utilising at least 50 mcg/day of ethinyl estradiol has been suggested, but this is debatable. Think about a nonhormonal method of birth control.

Topiramate

May lower the level of progestins in the serum (Contraceptive). Treatment: Inform patients that this combination may result in decreased contraceptive efficacy. Think about including an additional (non-hormonal) type of birth control.

Vitamin K Antagonists (eg, warfarin)

Vitamin K antagonists' ability to prevent clotting may be lessened by oestrogen derivatives (contraceptive). On the other hand, several products have also been observed to have heightened anticoagulant effects.

Vitamin K Antagonists (eg, warfarin)

Vitamin K antagonists' ability to prevent clotting may be lessened by progestins (contraceptives). On the other hand, several products have also been observed to have heightened anticoagulant effects. Management: To reduce the risk of thromboembolic diseases, concurrent hormonal contraceptives and coumarin derivatives should be avoided wherever possible. Think about switching to a hormonal-free method of birth control.

Risk Factor X (Avoid combination)

Anastrozole

Estrogen derivatives may lessen anastrozole's therapeutic efficacy.

Antihepaciviral Combination Products

Antihepaciviral Combination Products' hepatotoxic effects may be increased by ethinyl estradiol. Treatment: Ethinyl estradiol use must be stopped before using this combination; it can be begun again two weeks after stopping the antihepaciviral combo product.

Dasabuvir

Dasabuvir's hepatotoxic effects may be exacerbated by ethinyl estradiol.

Dehydroepiandrosterone

Estrogen derivatives' harmful or toxic effects might be amplified.

Encorafenib

Might lower the serum level of oestrogen derivatives (Contraceptive).

Encorafenib

May lower the level of progestins in the serum (Contraceptive).

Exemestane

Estrogen derivatives may reduce Exemestane's therapeutic efficacy.

Glecaprevir and Pibrentasvir

The harmful or hazardous effects of glecaprevir and pibrentasvir may be intensified by ethinyl estradiol. In particular, this combination may raise the risk for ALT elevation.

Griseofulvin

May reduce the progestins' therapeutic impact (Contraceptive). Failure with contraception is possible.

Hemin

Estrogen derivatives may lessen Hemin's therapeutic impact.

Indium 111 Capromab Pendetide

Indium 111 Capromab Pendetide's diagnostic effectiveness may be reduced by oestrogen derivatives.

Ixazomib

May lower the level of progestins in the serum (Contraceptive). More precisely, the serum concentrations of contraceptive progestins may be lowered when ixazomib and dexamethasone are combined. Treatment: Women of reproductive potential should use a nonhormonal barrier contraceptive for the duration of their ixazomib treatment and for 90 days after.

Ospemifene

Estrogen derivatives may intensify Ospemifene's harmful or hazardous effects. Ospemifene's therapeutic efficacy may be lessened by oestrogen derivatives.

Tranexamic Acid

Tranexamic Acid's thrombogenic impact may be enhanced by progestins (contraceptives).

Tranexamic Acid

The thrombogenic effect of tranexamic acid may be enhanced by oestrogen derivatives (contraceptive).

Ulipristal

May lessen progestins' therapeutic impact. Ulipristal's therapeutic effects may be lessened by progestins. Avoid progestins within 12 days of quitting ulipristal for uterine fibroids (Canadian indication); avoid progestins within 5 days of stopping ulipristal for emergency contraception (U.S. indication).

 

Monitoring parameters when using Xulane:

  • Assessment of pregnancy status (prior to therapy);
  • blood presssure (prior to therapy and yearly);
  • weight (optional;
  • BMI at baseline may be helpfull to monitor changes during therapy);
  • assess potential health status changes at routine visits.
  • If all patches have been applied on schedule and 1 menstrual period is missed, the possibility of pregnancy should be considered.
  • However, if no withdrawal bleeding occurs for 2 consecutive cycles (2 consecutive menstrual periods are missed), pregnancy status should be assessed.
  • If the patch has not been applied as directed, and 1 menstrual period is missed, pregnancy status should be assessed prior to continuing treatment.

Monitor patient for:

  • vision changes; blood pressure;
  • signs and symptoms of thromboembolic disorders;
  • signs or symptoms of depression;
  • glycemic control in patients with diabetes;
  • lipid profiles in patients being treated for hyperlipidemias.
  • Adequate diagnostic measures should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding.

How to administer Xulane (Ethinyl estradiol and norelgestromin)?

  • New patches should be applied on the same day each week.
  • Apply to clean, dry, intact, healthy skin on the buttock, abdomen, upper outer arm, or back.
  • Avoid areas that will be rubbed by tight clothing.
  • Do not apply to the breasts or to skin that is red, irritated, or cut.
  • Alternate application sites; do not apply to the same place as the previous patch.
  • Do not apply make-up, creams, lotions, powders, or other topical products to the skin where the patch will be placed.
  • Remove the patch and the plastic liner from the foil pouch, being careful not to remove the clear liner when removing the patch.
  • Apply patch by first peeling back half of the clear protective liner.
  • Avoid touching the surface of the patch.
  • Apply the patch to the skin and remove the rest of the liner.
  • Press the patch down firmly onto the skin using the palm of the hand; apply pressure for 10 seconds.
  • Run fingers over the entire surface area to smooth out any wrinkles in the patch.
  • The patch should be checked daily to ensure all edges are sticking.
  • When changing the patch each week, the new patch may be applied in the same anatomic area but should be applied to a new spot in that area.
  • Do not use supplemental adhesives or wraps to hold the patch into place.
  • Do not cut, damage, or alter the size of the patch; contraceptive efficacy may be impaired.

If a patch becomes partially or completely detached for less than 24 hours:

  • Try to reapply to the same place or replace it with a new patch immediately.
  • Do not reapply if the patch is no longer sticky, if it is sticking to itself or another surface, or if it has material sticking to it.

If a patch becomes partially or completely detached for >24 hours (or time period is unknown):

  • Apply a new patch and use this day of the week as the new “patch change day” from this point on.
  • An additional method of contraception (nonhormonal) must be used until after the first weak of consecutive administration.

Forgetting to apply the patch at the start of the cycle (week 1/day 1):

  • Apply the first patch as soon as remembering, using this day of the week as the new “patch change day” from this point on.
  • An additional method of contraception (nonhormonal) must be used until after the first weak of consecutive administration.

Forgetting to change patch in the middle of the cycle (week 2/day 8 or week 3/day 15):

  • If less than 48 hours from normal “patch change day,” apply a new patch immediately.
  • No back-up contraception is needed.
  • If longer than 48 hours from normal “patch change day,” apply a new patch and use this day of the week as the new “patch change day” from this point on.
  • An additional method of contraception (nonhormonal) must be used until after the first weak of consecutive administration.

Forgetting to remove the patch at end of cycle (week 4/day 22):

  • Take off as soon as remembered, start a new cycle on the usual “patch change day.”

Changing the “patch change day”:

  • The “patch change day” can be changed to an earlier day in the week by first completing the current cycle.
  • Then, during the “patch-free interval”, select an earlier day to start the new cycle.
  • Shortening the patch-free interval may increase the incidence of spotting or breakthrough bleeding.
  • Do not allow >7 consecutive patch-free days.

Skin irritation:

  • If the patch is in an uncomfortable location, it can be removed and a new patch applied to a different location until the next “patch change day.”

To dispose of the patch, fold the sticky sides together and dispose in the trash within a child-resistant container. Do not flush down the toilet.

Mechanism of action of Xulane (Ethinyl estradiol and norelgestromin):

  • Combination hormonal contraceptives can inhibit ovulation through a negative feedback mechanism on hypothalamus.
  • This alters the normal pattern gonadotropin production of a follicle stimulating hormone (FSH), and luteinizing hormone from the anterior pituitary.
  • Inhibition of the follicular phase FSH, and a mid-cycle surge in gonadotropins is possible.
  • Combination hormonal contraceptives can also cause alterations in the genital system, including cervical mucus changes, which makes it difficult for sperm penetration, even if there is ovulation.
  • Alterations in the endometrium can also cause unfavorable conditions for nidation.
  • Combinations of hormonal contraceptives drugs could alter tubal transport of the eggs through the fallopian tubes. 
  • The fertility of sperm may also be affected by progestational drugs.

AbsorptionTopical:

  • Equivalent when applied to abdomen, buttocks, upper outer arm, and upper trunk
  • Ethinyl estradiol, and norelgestromin
    • Rapid; plateau reached in 48 hours.
    • Heat exposure such as sauna, whirlpool or treadmill may increase the absorption of ethinylestradiol.

After the use of the patch, the AUC plasm concentrations of ethinylestradiol are 60% lower than those obtained after an oral 35 mg tablet. The patch has a 25% lower peak plasma concentration of ethinylestradiol than the tablet.

Protein binding:

  • Ethinylestradiol: Albumin
  • Norelgestromin and norgestrel: more than 97 percent ; norelgestromin to albumin and norgestrel to sexhormone-binding globulin

Metabolism:

  • Topical: The first-pass effect is avoided
  • Ethinyl estradiol: Forms metabolites
  • Norelgestromin: Hepatic to norgestrel and others

Bioavailability:

  • Ethinyl estradiol: ~60% greater using the topical patch when compared to oral tablets.

Half-life elimination: Topical:

  • Ethinyl estradiol: ~17 hours
  • Norelgestromin: ~28 hours

Excretion:

  • Metabolites of ethinylestradiol and norelgestromin: Urine and feces

International Brands of Ethinyl estradiol and norelgestromin:

  • Xulane
  • Evra
  • Ortho Evra

Ethinyl estradiol and norelgestromin Brand Names in Pakistan:

There is no brand available in Pakistan.

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