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SEASONIQUE is a brand name for Levonorgestrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Seasonique® (levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg combination tablets and ethinyl estradiol 0.01 mg tablets) is indicated for the prevention of pregnancy. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available in women under the age of 18 years; therefore, Health Canada has not authorized…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Consideration This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis.
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.
The tablets should not be removed from the protective blister packaging to avoid damage to the product. The plastic dispenser should be kept in the foil pouch until dispensed to the patient. 2 Recommended Dose and Dosage Adjustment The dosage of Seasonique consists of the daily administration of one light blue-green (levonorgestrel/ethinyl estradiol) tablet taken for 84 consecutive days followed by 7 days of yellow (ethinyl estradiol) tablets; Product Monograph SEASONIQUE levonorgestrel and ethinyl estradiol tablets ethinyl estradiol tablets Page 6 of 51 therefore patients should expect to have 4 menstrual periods per year.
To achieve maximum contraceptive effectiveness, Seasonique must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day of active treatment. During the first cycle of medication, the patient is instructed to begin taking Seasonique on the first Sunday after the onset of menstruation.
If menstruation begins on a Sunday, the first light blue-green (levonorgestrel/ethinyl estradiol) tablet is taken that day. One light blue-green (levonorgestrel/ethinyl estradiol) tablet should be taken daily for 84 consecutive days, followed by a 7- day period during which a yellow (ethinyl estradiol) tablet is taken daily.
Withdrawal bleeding should occur during the 7-day period following discontinuation of light blue-green active tablets. During the first cycle, contraceptive reliance should not be placed on Seasonique until light blue-green tablets have been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days.
The possibility of ovulation and conception prior to initiation of medication should be considered. , Sunday. The same administration schedule is followed: daily administration of one light blue-green (levonorgestrel/ethinyl estradiol) tablet taken for 84 consecutive days followed by 7 days of yellow (ethinyl estradiol) tablets.
, 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. Eye disorders: cataracts, change in corneal curvature (steepening), intolerance to contact lenses, retinal thrombosis.
Product Monograph SEASONIQUE levonorgestrel and ethinyl estradiol tablets ethinyl estradiol tablets Page 17 of 51 Gastrointestinal disorders: abdominal pain, diarrhea, gastrointestinal symptoms (such as abdominal cramps and bloating), pancreatitis.
General disorders and administrative site conditions: edema. Hepatobiliary disorders: cholestatic jaundice. Immune system disorders: hypersensitivity. Infections and infestations: rhinitis, vaginitis, vaginal candidiasis. Investigations: change in weight (increase or decrease), reduced tolerance to carbohydrates.
Metabolism and nutritional disorders: changes in appetite, porphyria. Neoplasm benign, malignant and unspecified (including cysts and polyps): increase in size of uterine leiomyomata. Nervous system disorders: chorea, dizziness, headache, migraine, optic neuritis.
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 (tenderness, enlargement, secretion), change in menstrual flow, dysmenorrhea, endocervical hyperplasia, premenstrual like syndrome, possible diminution in lactation when given immediately postpartum, spotting, temporary infertility after discontinuation of treatment, vaginal discharge.
, Cardiovascular sections). 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.
Use of Seasonique provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing similar strength synthetic estrogens and progestins (9 additional weeks of combined estrogen/progestin and 4 additional weeks of unopposed estrogen per year).
While this added exposure may pose an additional risk of thrombotic and thromboembolic diseases, studies to date with Seasonique have not suggested, nor can exclude, this additional risk. 1 Dosing Consideration This product (like all oral contraceptives) is intended to prevent pregnancy.
Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. 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. The tablets should not be removed from the protective blister packaging to avoid damage to the product.
The plastic dispenser should be kept in the foil pouch until dispensed to the patient. 2 Recommended Dose and Dosage Adjustment The dosage of Seasonique consists of the daily administration of one light blue-green (levonorgestrel/ethinyl estradiol) tablet taken for 84 consecutive days followed by 7 days of yellow (ethinyl estradiol) tablets; Product Monograph SEASONIQUE levonorgestrel and ethinyl estradiol tablets ethinyl estradiol tablets Page 6 of 51 therefore patients should expect to have 4 menstrual periods per year.
Seasonique should not be used in women who have the following conditions: • Hypersensitivity 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, STRENGTHS, COMPOSITION AND PACKAGING.
• History of or actual thrombophlebitis or thromboembolic disorders. • History of or actual cerebrovascular disorders. • History of or actual myocardial infarction or coronary artery disease. • Valvular heart disease with complications.
, transient ischemic attack, angina pectoris) • Active liver disease or history of or actual benign or malignant liver tumours. • Steroid-dependent jaundice, cholestatic jaundice, history of jaundice in pregnancy • Known or suspected carcinoma of the breast.
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia. • Undiagnosed abnormal vaginal bleeding. • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields.
• Known or suspected pregnancy. , due to MTHFR C677 T, A1298 mutations), prothrombin mutation G20210A and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant). Product Monograph SEASONIQUE levonorgestrel and ethinyl estradiol tablets ethinyl estradiol tablets Page 5 of 51 -major surgery associated with an increased risk of post-operative thromboembolism -prolonged immobilization -heavy smoking (>15 cigarettes per day) and over age 35 • Current or history of migraine with focal aura.
• History of/or actual pancreatitis if associated with severe hypertriglyceridemia. • Use of Hepatitis C drug combinations containing, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir due to the potential for ALT elevations.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If in any cycle the patient starts the 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 light blue-green tablets daily for 7 consecutive days.
Health Canada has not authorized an indication for pediatric use. 4 Administration No hormonal contraceptive use in the preceding cycle: Tablet taking should start on the first Sunday after the onset of menstruation. See above. Switching from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch): The patient should start Seasonique on the day she would normally start her next pack of combined oral contraceptive.
In case a vaginal ring or transdermal patch has been used, the woman should start using Seasonique preferably on the day of removal, but at the latest when the next application would have been due.
Switching from a progestogen-only method (mini-pill, injection):
The patient may switch from the mini-pill to Seasonique on any day of her cycle. Patients using a progestogen injection should start Seasonique on the day the next injection is due. In all cases, the patient should be advised to use an additional (barrier) method for the first 7 days of Seasonique use.
Following first trimester abortion:
The patient may start using Seasonique immediately. When doing so, she need not take additional contraceptive measures. Product Monograph SEASONIQUE levonorgestrel and ethinyl estradiol tablets ethinyl estradiol tablets Page 7 of 51 Following delivery or abortion: Seasonique may be initiated immediately after a first-trimester abortion; if the patient starts Seasonique immediately, additional contraceptive measures are not needed.
Patients should be advised to start Seasonique on day 21 to 28 after delivery or second trimester abortion, after consulting with their healthcare professional. When starting later, the patient should be advised to use an additional (barrier) method for the first seven days of Seasonique use.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of use, or the woman should be advised to wait for her next menstrual period prior to starting Seasonique. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.
In the non-lactating mother, Seasonique may be initiated no earlier than Day 28 of postpartum for contraception due to the increased risk of 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 also 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
Spotting / Breakthrough bleeding:
If spotting or breakthrough bleeding occurs while taking Seasonique, the patient should be instructed to continue taking Seasonique as instructed and by the regimen described above. She should be instructed that this type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient should be advised to consult her […]
Skin and subcutaneous tissue disorders: chloasma or melasma which may persist, erythema multiforme, erythema nodosum, hemorrhagic eruption, hirsutism, loss of scalp hair, rash (including allergic rash), urticaria.
Vascular disorder:
Raynaud’s phenomenon. 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 reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety data set [intention-to-treat (ITT) cohort] for Seasonique includes 4035 91-day cycles (13,293 28- day cycles) from studies PSE-301, PSE-302 and PSE-304 combined.
The ITT cohort includes patients with at least one complete cycle on treatment. Pivotal study PSE-301 was a Phase III, randomized, multicenter clinical trial conducted to evaluate the efficacy and safety of Seasonique and another 91-day oral contraceptive regimen for one year (4 91-day cycles).
The second 91-day regimen is identical to Seasonique, except that higher dose of ethinyl estradiol-alone is administered during the last 7 days of each 91-day cycle (see CLINICAL TRIALS). This second higher dose- regimen is investigational and is not approved for use in Canada.
Product Monograph SEASONIQUE levonorgestrel and ethinyl estradiol tablets ethinyl estradiol tablets Page 18 of 51 Supportive study PSE-302 was a Phase III, randomized, multicenter, clinical trial conducted to evaluate the efficacy and safety of Seasonique, an investigational 91-day regimen.
The duration of study PSE-302 was one year (4 91-day cycles). 03 mg) but taken in a conventional monthly (21 days levonorgestrel/ethinyl estradiol followed by placebo for 7 days) regimen is also available for one year from study PSE-302.
Study PSE-304 was an extension safety study in which subjects who completed the one-year PSE-301 or PSE- 302 studies were eligible to receive either Seasonique or the investigational higher dose 91-day regimen for up to an additional three years, following their one-year exposure to any of the regimens in the PSE-301/302 studies.
Over the course of PSE-304, all patients initially assigned to receive the higher dose investigational 91-day regimen were ultimately switched over to receive Seasonique. Despite the switch, all subjects were analyzed in the group to which they were originally assigned.
Table 2 shows the adverse events reported by at least 2% or more of treated patients in pivotal study PSE- 301. 08 Investigations […]
To achieve maximum contraceptive effectiveness, Seasonique must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day of active treatment. During the first cycle of medication, the patient is instructed to begin taking Seasonique on the first Sunday after the onset of menstruation.
If menstruation begins on a Sunday, the first light blue-green (levonorgestrel/ethinyl estradiol) tablet is taken that day. One light blue-green (levonorgestrel/ethinyl estradiol) tablet should be taken daily for 84 consecutive days, followed by a 7- day period during which a yellow (ethinyl estradiol) tablet is taken daily.
Withdrawal bleeding should occur during the 7-day period following discontinuation of light blue-green active tablets. During the first cycle, contraceptive reliance should not be placed on Seasonique until light blue-green tablets have been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days.
The possibility of ovulation and conception prior to initiation of medication should be considered. , Sunday. The same administration schedule is followed: daily administration of one light blue-green (levonorgestrel/ethinyl estradiol) tablet taken for 84 consecutive days followed by 7 days of yellow (ethinyl estradiol) tablets.
If in any cycle the patient starts the 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 light blue-green tablets daily for 7 consecutive days.
Health Canada has not authorized an indication for pediatric use. 4 Administration No hormonal contraceptive use in the preceding cycle: Tablet taking should start on the first Sunday after the onset of menstruation. See above. Switching from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch): The patient should start Seasonique on the day she would normally start her next pack of combined oral contraceptive.
In case a vaginal ring or transdermal patch has been used, the woman should start using Seasonique preferably on the day of removal, but at the latest when the next application would have been due.
Switching from a progestogen-only method (mini-pill, injection):
The patient may switch from the mini-pill to Seasonique on any day of her cycle. Patients using a progestogen injection should start Seasonique on the day the next injection is due. In all cases, the patient should be advised to use an additional (barrier) method for the first 7 days of Seasonique use.
Following first trimester abortion:
The patient may start using Seasonique immediately. When doing so, she need not take additional contraceptive measures. Product Monograph SEASONIQUE levonorgestrel and ethinyl estradiol tablets ethinyl estradiol tablets Page 7 of 51 Following delivery or abortion: Seasonique may be initiated immediately after a first-trimester abortion; if the patient starts Seasonique immediately, additional contraceptive measures are not needed.
Patients should be advised to start Seasonique on day 21 to 28 after delivery or second trimester abortion, after consulting with their healthcare professional. When starting later, the patient should be advised to use an additional (barrier) method for the first seven days of Seasonique use.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of use, or the woman should be advised to wait for her next menstrual period prior to starting Seasonique. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.
In the non-lactating mother, Seasonique […]