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ELFY is a brand name for Ethinyl Estradiol (also known as Ethinylestradiol), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ELFY (ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets) is indicated for: • the prevention of pregnancy. In a one year (thirteen 28-day cycles) multicenter open-label clinical trial 1,582 women were studied to assess the safety and efficacy of ethinyl estradiol tablets / norethindrone…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations To achieve maximum contraceptive effectiveness, ELFY should be taken exactly as directed and at intervals not exceeding 24 hours. • ELFY tablets may be administered without regard to meals. • ELFY provides a regimen consisting of 24 blue estrogen-progestin tablets, 2 white ELFY (ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets) Page 6 of 59 Unclassified / Non classifié estrogen-only tablets, and 2 lilac placebo tablets.
2 Recommended Dose and Dosage Adjustment During the first cycle of use: • The possibility of ovulation and conception prior to initiation of medication should be considered. The patient is instructed to begin taking ELFY on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start).
If menstruation begins on a Sunday, the first tablet (blue) is taken that day. One blue tablet should be taken daily for 24 consecutive days followed by one white tablet for 2 consecutive days, followed by one lilac tablet daily for 2 consecutive days.
During the first cycle with a Sunday Start, contraceptive reliance should not be placed on ELFY until a blue tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as latex or polyurethane condoms or spermicide) should be used during those 7 days.
ELFY is effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle. • The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 24 days on blue tablets – 2 days on white tablets - 2 days on lilac tablets.
If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a blue tablet daily for 7 consecutive days.
Health Canada has not authorized an indication for pediatric use. See 1 INDICATIONS. 4 Administration Switching from another hormonal method of contraception: When the patient is switching to ELFY after completing a 21-day regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring, she should wait 7 days after her last tablet, patch, or ring before she starts ELFY.
, retinal thrombosis) • pulmonary embolism • thrombophlebitis The following adverse reactions also have been reported in patients receiving oral contraceptives: Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or fewer of patients during the first cycle.
The following other reactions, as a general rule, are seen less frequently or only occasionally: Blood and lymphatic system disorders: hemolytic uremic syndrome Ear and labyrinth disorders: auditory disturbances, otosclerosis-related hearing loss1 Eye disorders: cataracts, change in corneal curvature (steepening), intolerance to contact lenses, retinal thrombosis Gastrointestinal disorders: abdominal pain, Crohn’s disease1, diarrhea, gastrointestinal symptoms (such as abdominal cramps and bloating), pancreatitis, ulcerative colitis1 General disorders and administration site conditions: edema Hepatobiliary disorders: cholestatic jaundice, gallstone formation1, liver function disturbances1 Immune system disorders: hypersensitivity Infections and infestations: rhinitis, vaginal candidiasis, vaginitis Investigations: change in weight (increase or decrease), reduced tolerance to carbohydrates Metabolism and nutrition disorders: changes in appetite, hypertriglyceridemia (increased risk of pancreatitis when using COCs)1, porphyria Musculoskeletal and connective tissue disorders: systemic lupus erythematosus1 Neoplasms benign, malignant and unspecified (including cysts and polyps): increase in size of uterine leiomyomata Nervous system disorders: chorea, dizziness, headache, migraine, optic neuritis, Sydenham’s chorea1 Psychiatric disorders: changes in libido, mental depression, nervousness Renal and urinary disorders: cystitis-like syndrome, impaired renal function Reproductive system and breast disorders: amenorrhea during and after treatment, breakthrough bleeding, breast changes including tenderness, enlargement, and secretion, change in menstrual flow, dysmenorrhea, endocervical hyperplasia, possible diminution in lactation when given immediately post- partum, premenstrual-like syndrome, spotting, temporary infertility after discontinuance of treatment, vaginal discharge Skin and subcutaneous tissue disorders: chloasma or melasma which may persist, loss of scalp hair, hirsutism, erythema multiforme, erythema nodosum, hemorrhagic eruption, herpes gestationis1, pruritis related to cholestasis1, rash (allergic), urticaria Vascular disorders: hypertension1, Raynaud's phenomenon ELFY (ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets) Page 19 of 59 Unclassified / Non classifié 1.
• ELFY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING.
, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) - severe dyslipoproteinemia - over age 35 and smoke - diabetes mellitus with vascular involvement - major surgery associated with an increased risk of postoperative thromboembolism - prolonged immobilization 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Cigarette smoking increases the risk of serious cardiovascular events associated with the use of hormonal contraceptives.
This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, ELFY should not be used by women who are over 35 years of age and smoke. See Cardiovascular. • Patients should be counselled that birth control pills DO NOT PROTECT against sexually transmitted infections (STIs) including HIV/AIDS.
For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH birth control pills. 1 Dosing Considerations To achieve maximum contraceptive effectiveness, ELFY should be taken exactly as directed and at intervals not exceeding 24 hours.
• ELFY tablets may be administered without regard to meals. • ELFY provides a regimen consisting of 24 blue estrogen-progestin tablets, 2 white ELFY (ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets) Page 6 of 59 Unclassified / Non classifié estrogen-only tablets, and 2 lilac placebo tablets.
2 Recommended Dose and Dosage Adjustment During the first cycle of use: • The possibility of ovulation and conception prior to initiation of medication should be considered. The patient is instructed to begin taking ELFY on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start).
• Use with the hepatitis C virus (HCV) combination drug regimen ombitasvir, paritaprevir, ritonavir with or without dasabuvir. See 7 WARNINGS AND PRECAUTIONS. • ELFY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING. , due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) - severe dyslipoproteinemia - over age 35 and smoke - diabetes mellitus with vascular involvement - major surgery associated with an increased risk of postoperative thromboembolism - prolonged immobilization
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ethinyl Estradiol in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching to ELFY after completing a 28-day regimen of oral contraceptive tablets, she should start her first pack of ELFY on the day after her last tablet.
She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin ELFY the next day. If switching from an implant or injection, the patient should start ELFY on the day of implant removal or, if using an injection, the day the next injection would be due.
If switching from an intrauterine device (IUD), depending on the timing of removal, back-up contraception may be needed.
If spotting or breakthrough bleeding occurs:
Breakthrough bleeding or spotting may occur in women taking combination oral contraceptives (COC), especially during the first 3 months of use. The patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare ELFY (ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets) Page 7 of 59 Unclassified / Non classifié provider.
If withdrawal bleeding does not occur:
Although pregnancy is unlikely if ELFY is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.
Use after pregnancy, abortion or miscarriage:
ELFY should be initiated no earlier than 28 days postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see 2 CONTRAINDICATIONS, and 7 WARNINGS AND PRECAUTIONS concerning thromboembolic disease).
The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered.
ELFY may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts ELFY immediately, additional contraceptive measures are not needed. 5 Missed Dose The possibility of follicular growth, ovulation, and risk of pregnancy increases with each successive day that scheduled blue or white tablets are missed.
If the patient misses one or more lilac tablets, she is still protected against pregnancy provided she begins taking the active blue tablets again on the proper day. Delayed restarting of active pills may result in reduction of contraceptive reliability.
Missing pills can cause spotting or light bleeding, even if the missed pills are made up. If breakthrough bleeding occurs following missed blue or white tablets, it will usually be transient and of no consequence. Nausea may also occur on the days two pills are taken to make up for missed pills.
The patient should be instructed to use the following chart if she […]
Occurrence or deterioration of conditions for which association with COC use is not conclusive. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and approximate rates of adverse drug reactions in real-world use. A multicenter phase 3 clinical trial evaluated the safety and efficacy of ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets for pregnancy prevention.
The study was a one year, open-label, single-arm, uncontrolled study. A total of 1,660 women aged 18 to 45 were enrolled and took at least one dose of ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets. A list of adverse reactions experienced by ≥ 1% of the subjects is listed in Table 2.
8 lb). Serious Adverse Events leading to discontinuation included: deep vein thrombosis, ovarian vein thrombosis and cholecystitis. 7% of the women discontinued from the clinical trial due to an adverse event. Adverse events occurring in ≥ 1% of subjects leading to discontinuation of treatment were, in decreasing order: menstrual irregularities (including metrorrhagia, irregular menstruation, menorrhagia and vaginal hemorrhage) (4%), headache/migraine (1%), mood disorder (including mood swings, depression, anxiety) (1%), and weight fluctuation (1%).
Less than 1% of subjects discontinued because of amenorrhea. 1 Clinical Trial Adverse Reactions – Pediatrics The safety and efficacy of ethinyl estradiol tablets / norethindrone acetate and ethinyl estradiol tablets have not been established in women under the age of 18 years.
3 Less Common Clinical Trial Adverse Reactions Rare […]
If menstruation begins on a Sunday, the first tablet (blue) is taken that day. One blue tablet should be taken daily for 24 consecutive days followed by one white tablet for 2 consecutive days, followed by one lilac tablet daily for 2 consecutive days.
During the first cycle with a Sunday Start, contraceptive reliance should not be placed on ELFY until a blue tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as latex or polyurethane condoms or spermicide) should be used during those 7 days.
ELFY is effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle. • The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 24 days on blue tablets – 2 days on white tablets - 2 days on lilac tablets.
If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a blue tablet daily for 7 consecutive days.
Health Canada has not authorized an indication for pediatric use. See 1 INDICATIONS. 4 Administration Switching from another hormonal method of contraception: When the patient is switching to ELFY after completing a 21-day regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring, she should wait 7 days after her last tablet, patch, or ring before she starts ELFY.
She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching to ELFY after completing a 28-day regimen of oral contraceptive tablets, she should start her first pack of ELFY on the day after her last tablet.
She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin ELFY the next day. If switching from an implant or injection, the patient should start ELFY on the day of implant removal or, if using an injection, the day the next injection would be due.
If switching from an intrauterine […]