Ethinyl Estradiol/Norelgestromin (Transdermal Patch)

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[edit] BRAND NAMES

[edit] STRUCTURE

[edit] MECHANISM OF ACTION

Ethinyl Estradiol/Norelgestromin patch act by suppression of gonadotropins (FSH and LH). Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Using a weekly patch instead of a daily pill may help the patient to stick to using her contraception appropriately.

[edit] INDICATIONS

Ethinyl Estradiol/Norelgestromin patch is indicated for use by women to prevent pregnancy

[edit] DOSAGE

Ethinyl Estradiol/Norelgestromin is used as one patch per week for three weeks, followed by a fourth week, which is patch-free. Patches must always be applied regularly, on the same day of the week. The first patch is applied on day 1, and then changed on day 8. The second patch is then changed on day 15. The patch-free interval starts on day 22 and lasts for seven days. The patch-free interval must not be longer than seven days; otherwise, additional non-hormonal contraceptive methods must be used, such as condoms.

The effectiveness of Ethinyl Estradiol/Norelgestromin patch may be lower in women weighing over 90 kg.

The patch must be firmly applied to the buttock, abdomen (tummy), upper arm or upper back, but not on the breast, or on skin that is red, irritated or cut. The same area of skin should not be used for two consecutive patches.

[edit] CONTRAINDICATIONS

  • Do not use Ethinyl Estradiol/Norelgestromin patch, if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from hormonal contraceptives, including death from heart attack, blood clots, or stroke. The risk increases with age and the number of cigarettes you smoke.
  • Known or suspected pregnancy
  • A history of heart attack or stroke
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
  • A history of blood clots in the deep veins of your legs
  • An inherited problem that makes your blood clot more than normal
  • Chest pain (angina pectoris)
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
  • Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
  • Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives
  • Liver tumor (benign or cancerous)
  • Severe high blood pressure
  • Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
  • Headaches with neurological symptoms
  • Use of oral contraceptives (birth control pills)
  • Disease of heart valves with complications
  • Major surgery with prolonged immobilization

[edit] WARNINGS AND PRECAUTIONS

  • Ethinyl Estradiol/Norelgestromin patch does not protect against HIV infection (AIDS) and other sexually transmitted diseases
  • Vascular risks: Stop applying the patches if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
  • Liver disease: Discontinue if jaundice occurs.
  • High blood pressure: Do not prescribe Ethinyl Estradiol/Norelgestromin patch for women with uncontrolled hypertension or hypertension with vascular disease.
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women applying the patches. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache: Evaluate significant change in headaches and discontinue Ethinyl Estradiol/Norelgestromin patch if indicated.
  • Uterine bleeding: Unscheduled (breakthrough) bleeding and spotting sometimes occur in women using Ethinyl Estradiol/Norelgestromin patch. Consider non-hormonal causes and take adequate diagnostic measures to rule out malignancy, other pathology, or pregnancy in the event of unscheduled bleeding, as in the case of any abnormal vaginal bleeding. If pathology and pregnancy have been excluded, time or a change to another contraceptive product may resolve the bleeding.

[edit] INTERACTIONS

  • Anti-infective agents and anticonvulsants: Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampicin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.
  • Anti-HIV Protease inhibitors: significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of combination oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
  • Herbal products: St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
  • CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

[edit] PREGNANCY AND LACTATION

  • Pregnancy: There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy.
  • Nursing mothers: Not recommended; can decrease milk production

[edit] SIDE EFFECTS

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.

[edit] RELATED LINKS

[edit] BIBLIOGRAPHY

[edit] REFERENCES