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SEASONALE 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: Seasonale® (levonorgestrel and ethinyl estradiol, USP) tablets are 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 an indication for pediatric use. Use of this product before…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 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 Seasonale is one pink (active) tablet taken daily for 84 consecutive days followed by 7 days of white (inert) tablets.
To achieve maximum contraceptive effectiveness, Seasonale 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 Seasonale on the first Sunday after the onset of menstruation.
If menstruation begins on a Sunday, the first tablet (pink) is taken that day. One pink tablet should be taken daily for 84 consecutive days, followed by 7 days on which a white (inert) tablet is taken. Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets.
Product Monograph SEASONALE (levonorgestrel and ethinyl estradiol) Page 6 of 45 During the first cycle, contraceptive reliance should not be placed on Seasonale until a pink (active) tablet has 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. The patient begins her next and all subsequent 91-day course of tablets without interruption on the same day of the week (Sunday) on which she began her first course, following the same schedule: 84 days on which pink tablets are taken followed by 7 days on which white tablets are taken.
, retinal thrombosis) · myocardial infarction · cerebral thrombosis · cerebral hemorrhage · hypertension · benign hepatic tumours · gallbladder disease · congenital anomalies 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), retinal thrombosis, intolerance to contact lenses.
Gastrointestinal disorders: gastrointestinal symptoms (such as abdominal cramps and bloating), pancreatitis. General disorders and administrative site conditions: edema. Hepatobiliary disorders: cholestatic jaundice. Infections and infestations: rhinitis, vaginal candidiasis, vaginitis.
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.
Product Monograph SEASONALE (levonorgestrel and ethinyl estradiol) Page 15 of 45 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: breakthrough bleeding, spotting, change in menstrual flow, dysmenorrhea, amenorrhea during and after treatment, temporary infertility after discontinuation of treatment, breast changes (tenderness, enlargement, secretion), endocervical hyperplasia, possible diminution in lactation when given immediately postpartum, premenstrual like syndrome.
, Cardiovascular sections). Birth control pills DO NOT PROTECT against sexually transmitted infections including HIV/AIDS. For protection against STIs, it is advisable to use latex condoms IN COMBINATION WITH birth control pills. Use of Seasonale 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 hormonal exposure per year).
While this added exposure may pose an additional risk of thrombotic and thromboembolic diseases, studies to date with Seasonale have not suggested, nor can exclude, this additional risk. 1 Dosing Considerations 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 Seasonale is one pink (active) tablet taken daily for 84 consecutive days followed by 7 days of white (inert) tablets.
To achieve maximum contraceptive effectiveness, Seasonale 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 Seasonale on the first Sunday after the onset of menstruation.
Oral contraceptives should not be used in women who have the following conditions: • 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, 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. • 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). -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 neurological symptoms.
Product Monograph SEASONALE (levonorgestrel and ethinyl estradiol) Page 5 of 45 • 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 a pink tablet daily for 7 consecutive days.
Health Canada has not authorized an indication for pediatric use. 4 Administration If spotting or breakthrough bleeding occurs: Breakthrough bleeding or spotting may occur in women taking combination oral contraceptives (COC). 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 provider.
If withdrawal bleeding does not occur:
Correct use of contraceptives can result in lower failure rates. If withdrawal bleeding does not occur while taking white (inactive) tablets, the possibility of pregnancy must be considered. Appropriate diagnostic measures to rule out pregnancy should be taken at the time of any missed menstrual period.
Seasonale should be discontinued if pregnancy is confirmed.
Use after pregnancy or abortion:
In the non-lactating mother, Seasonale may be initiated no earlier than Day 28 of postpartum for contraception 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 also 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
Seasonale may be initiated immediately after a first-trimester abortion; if the patient starts Seasonale immediately, additional contraceptive measures are not needed. 5 Missed Dose Detailed patient instructions regarding missed pills are presented in the Missed Dose section of Part III in the product monograph.
If a patient misses one pink tablet, she should take it as soon as possible, meaning she can take two tablets in one day. If a patient misses two pink tablets, she should take 2 tablets on the day she remembers and 2 tablets on the following day.
Should three or more tablets be missed, the regular dosing schedule should be resumed, that is one pink tablet per day. Any time the patient misses two or more pink tablets, she should also use another method of non-hormonal back-up contraception until she has taken a pink tablet daily for seven consecutive days.
If the patient misses one or more white tablets, she is still protected against pregnancy provided she begins taking pink tablets again on the appropriate day. The Product Monograph SEASONALE (levonorgestrel and ethinyl estradiol) Page 7 of 45 possibility of ovulation increases with each successive day that scheduled pink tablets are missed.
The risk of pregnancy increases with each active (pink) tablet missed.
Skin and subcutaneous tissue disorders: chloasma or melasma which may persist, loss of scalp hair, hirsutism, erythema multiforme, erythema nodosum, hemorrhagic eruption, rash (allergic).
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. Seasonale included 15,027 28-day equivalent cycles for the safety ITT data; 609 subjects completed 1 year treatment, 123 subjects completed 18 months treatment and 108 subjects completed 2 years treatment.
Two subjects had pulmonary embolism and one subject had myocardial infarction while on Seasonale in clinical studies. The comparative safety data with a conventional monthly oral contraceptive containing similar strength synthetic estrogens and progestins on lipids profile were used as controls; liver functions and endometrial biopsies (50 subjects only) is available for one year only.
Study SEA-301 (A Phase III, Parallel, Randomized, Multicenter, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Seasonale Extended Oral Contraceptive Therapy - 84-Day Active Cycle) Table 3 shows the incidence rates for the most frequently reported adverse events for all treated patients with 1 year of treatment.
The table displays results where the 5% or greater criterion was observed within any treatment group. 75 *Control: a conventional monthly oral contraceptive containing similar strength synthetic estrogens and progestins Study SEA-301A (A Phase IIIb, Parallel, Multicenter, Open-Label Clinical Study To Evaluate The Safety Of Seasonale Extended Oral Contraceptive Therapy – 84-Day Active Cycle), is an extension study to Study SEA- 301 providing an additional 2 years of safety data (n=189) for Seasonale [levonorgestrel levonorgestrel (150 μg); ethinyl estradiol (30 μg), oral].
The adverse reactions most commonly reported in Study SEA-301A were similar to those observed in Study SEA-301. 3 Less Common Clinical Trial Adverse Reactions Less Common Clinical Trial Adverse Drug Reactions (≥1% to <5%) Study SEA-301 Infections and Infestations: Urinary Tract Infection, Bronchitis, Pharyngitis Streptococcal, Ear Infection, Vaginitis Bacterial, Vaginosis Fungal, Bladder Infection, Pharyngitis, Vaginal Candidiasis.
Gastrointestinal Disorders:
Abdominal Pain Upper, Vomiting, Dyspepsia, Toothache, Abdominal Pain, Diarrhoea, Abdominal Distension, Constipation.
Nervous System:
Migraine, Dizziness (Excl. Vertigo), Sinus […]
If menstruation begins on a Sunday, the first tablet (pink) is taken that day. One pink tablet should be taken daily for 84 consecutive days, followed by 7 days on which a white (inert) tablet is taken. Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets.
Product Monograph SEASONALE (levonorgestrel and ethinyl estradiol) Page 6 of 45 During the first cycle, contraceptive reliance should not be placed on Seasonale until a pink (active) tablet has 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. The patient begins her next and all subsequent 91-day course of tablets without interruption on the same day of the week (Sunday) on which she began her first course, following the same schedule: 84 days on which pink tablets are taken followed by 7 days on which white tablets are taken.
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 a pink tablet daily for 7 consecutive days.
Health Canada has not authorized an indication for pediatric use. 4 Administration If spotting or breakthrough bleeding occurs: Breakthrough bleeding or spotting may occur in women taking combination oral contraceptives (COC). 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 provider.
If withdrawal bleeding does not occur:
Correct use of contraceptives can result in lower failure rates. If withdrawal bleeding does not occur while taking white (inactive) tablets, the possibility of pregnancy must be considered. Appropriate diagnostic measures to rule out pregnancy should be taken at the time of any missed menstrual period.
Seasonale should be discontinued if pregnancy is confirmed.
Use after pregnancy or abortion:
In the non-lactating mother, Seasonale may be initiated no earlier than Day 28 of postpartum for contraception 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 also 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
Seasonale may be initiated immediately after a first-trimester abortion; if the patient starts Seasonale immediately, additional contraceptive measures are not needed. 5 Missed Dose Detailed patient instructions regarding missed pills are presented in the Missed Dose section of Part III in the product monograph.
If a patient misses one pink tablet, she should take it as soon as possible, meaning she can take two tablets in one day. If a patient misses two pink tablets, she should take 2 tablets on the day she remembers and 2 tablets on the following day.
Should three or more tablets be missed, the regular dosing schedule should be resumed, that is one pink tablet per day. Any time the patient misses two or more pink tablets, she should also use another method of non-hormonal back-up contraception until she has taken a pink tablet daily for seven consecutive days.
If the patient misses one or more white tablets, she is still protected against pregnancy provided she begins taking pink tablets again on the appropriate day. The Product Monograph SEASONALE (levonorgestrel and ethinyl estradiol) Page 7 of 45 possibility of ovulation increases with each successive day that scheduled pink tablets are missed.
The risk of pregnancy increases with each active (pink) tablet missed. 5 OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may […]