What is this medication?
Contraceptive; Estrogen and Progestin Combination
Brand Name US: Alyacen 1/35, Alyacen 7/7/7, Aranelle, Aurovela 1.5/30, Aurovela 1/20, Aurovela Fe 1.5/30, Aurovela FE 1/20, Balziva, Blisovi 24 Fe, Blisovi Fe 1.5/30, Blisovi FE 1/20, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Dasetta 7/7/7, Estrostep Fe, Femhrt Low, Fyavolv, Generess FE, Hailey 1.5/30, Hailey 24 Fe, Jinteli, Junel 1.5/30, Junel 1/20, June Fe 24, Kaitlib Fe, Larin 1.5/30, Larin 1/20, Larin 24 Fe, Larin Fe 1.5/30, Larin Fe 1/20, Layolis FE, Leena, Lo Loestrin Fe, Loestrin 1.5/30, Loestrin 1/20, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Melodetta 24 Fe, Mibelas 24 Fe, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin Fe 1/20, Minastrin 24 Fe, Necon 0.5/35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Philith, Pirmella 1/35, Pirmella 7/7/7, Tarina 24 Fe, Tarina FE 1/20, Tarina FE 1/20 EQ, Taytulla, Tilia Fe, Tri-Legest Fe, Vyfemla, Wera, Wymzya Fe.
Brand Name Canada: Brevicon 0.5/35, Brevicon 1/35, Loestrin 1.5/30, Lolo, Minestrin 1/20, Select 1/35, Synphasic.
“ALERT: US Boxed Warning
Cigarette smoke and serious cardiovascular events:
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives should not be used in women who are over 35 years and smoke.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be taken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal genital bleeding.
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens 0.625 mg alone, relative to placebo. Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.
The WHI estrogen-plus-progestin substudy demonstrated an increased risk of invasive breast cancer.
Estrogen-alone therapy should not be used for the prevention of dementia. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg) alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Estrogen plus progestin therapy should not be used for the prevention of dementia. The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Risk vs benefit:
In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens (with or without medroxyprogesterone acetate) and other dosage forms of estrogens (with or without progestins). Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.”
How does this medication work?
Ethinyl Estradiol is a synthesized version of estrogen with better oral absorption. Estrogen is a female sex hormone that supports the development and function of the female reproductive system, secondary sex characteristics and urogenital structures. Estradiol is the principle female estrogen and inhibits the pituitary release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) thereby inhibiting ovulation through a negative feedback system.
Norethindrone is a progestin is a synthetic form of progesterone which is another female reproductive hormone. Progestin inhibits gonadotropin production which will prevent follicular maturation and subsequently ovulation. Progestin also reduces the risk of endometrial hyperplasia as it thins out the endometrial lining of the uterus.
How should I take this medication?
Abnormal uterine bleeding, acute (Off-Label):
Oral: Take one tablet three times daily for 7 days.
Oral: Take one tablet once daily.
Oral: Take one tablet once daily.
How Do You Take the Tablet: You can take tablets with food or after a meal to reduce nausea. Take the medication exactly as prescribed by your doctor.
If You are Taking for Birth Control: Begin taking contraceptive on the first Sunday after the onset of menstruation; if the menstrual period starts on Sunday, take the first tablet that very same day. Make sure to use a backup method of contraception for the first 7 days. Alternatively, you can start taking the contraceptive on the first day of your menstrual cycle.
Contact Your Doctor if You Ever Experience: If you experience a sudden, intense, severe headache or chest pain; sudden loss of coordination; sudden loss of vision or speech disturbances; chest or calf pain; weakness in the extremities; sudden shortness of breath of pain with breathing (may indicate thromboembolic disorder); persistent or recurrent vaginal bleeding (may indicate endometrial cancer); edema; abdominal pain or jaundice (may indicate hepatitis or gallbladder disease).
What should I watch for while using this medication?
Do not use in women with an increased risk of invasive breast cancer
Do not use in women to prevent or treat dementia
Do not use unopposed estrogen in women with a uterus
Do not use in women with endometriosis
Use with caution in women with pre-existing hypertriglyceridemia
Use with caution in women with ovarian cancer
Use with caution in women with retinal vascular thrombosis
Use with caution in asthma, carbohydrate intolerance, cardiovascular disease, fluid retention, hepatic dysfunction, hypoparathyroidism, migraines, porphyria, and system lupus erythematosus
What if I miss a dose?
Take the pill as soon as you remember. Then take the rest of the pills like you normally would. To stay on schedule, this might mean that you have to take two pills in one day.
If vomiting or diarrhea occur, a back-up method of contraception may be needed.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
The frequency of side effects is not well defined and some of the adverse reactions are dependent on the dosage form and combination therapy used:
Endocrine and Metabolic: Increased sex hormone binding globulin (22%), changes in menstrual flow and withdrawal bleeding (31% to 41%), amenorrhea (8% to 36%).
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