Seasonale is an extended cycle combined hormonal contraceptive containing 2 hormones: an estrogen (ethinyl estradiol) and a progestin (levonorgestrel), that are used to prevent pregnancy
Indications for use
- Oral hormonal contraception;
- Hormone-dependent functional disorders of the menstrual period (including dysmenorrhea, menorrhagia without an organic cause, premenstrual syndrome).
Mechanism of action
Seasonale prevents ovulation by suppressing the hormones of the pituitary gland and the development of follicles. Condensation of cervical mucus interferes with the penetration of spermatozoa into the uterus. The drug normalizes the menstrual period, reducing pain and bleeding.
Dosage and mode of application
The pack contains 91 pills (3 months supply): 84 pink active pills (0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol) and 7 white inert pills (without hormones).
Begin taking this contraceptive on the first Sunday following the beginning of your period. Take 1 pill daily for 91 days in a row. You should have your menstruation during when you are taking the inert pills. Begin a new pack of Seasonale the day after you take the last pill in the pack, even if you do not have your period. If the expected menstruation does not occur, consult your doctor.
- Common side effects: tenderness and tension of the mammary glands, enlargement of the mammary glands, discharge from the mammary glands, spotting and breakthrough uterine bleeding, headache, migraine, changes in libido, mood changes, poor contact lens wear, visual impairment, nausea, vomiting, abdominal pain, changes in vaginal secretion, skin rash, erythema nodosum, erythema multiforme, generalized pruritus, cholestatic jaundice, fluid retention, weight change, allergic reactions;
- Rare side effects: increased fatigue, diarrhea, chloasma, thrombosis and thromboembolism.
Seasonale should not be used in the presence of any of the conditions listed below (including in an anamnesis). If you have any of these conditions, the drug should be discontinued.
- Thrombosis (venous and arterial) and thromboembolism (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
- Migraine with focal neurologic symptoms;
- Diabetes mellitus with vascular complications;
- Multiple or expressed risk factors for venous or arterial thrombosis, including damage to the valvular apparatus of the heart, disturbance of the rhythm of the heart, disease of the vessels of the brain or coronary arteries of the heart; uncontrolled arterial hypertension;
- Pancreatitis with severe hypertriglyceridemia;
- Liver failure and severe liver disease;
- Liver tumors (benign or malignant);
- Revealed hormone-dependent malignant diseases (including genitals or mammary glands);
- Vaginal bleeding of unknown origin;
- The period of breastfeeding;
- Hypersensitivity to ethinyl estradiol or levonorgestrel;
- Long-term immobilization, serious surgical intervention, surgical operations on the legs, extensive injuries.
With caution: disorders of fat metabolism (obesity, hyperlipidemia), thrombophlebitis of superficial veins, otosclerosis with hearing impairment, idiopathic jaundice or pruritus during an earlier pregnancy, migraine, congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson and Rotor), diabetes, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn’s disease, sickle-cell anemia, arterial hypertension.
- Barbiturates, some antiepileptic medicines (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives are able to enhance the metabolism of steroid hormones included in Seasonale tablets;
- Reduction of contraceptive effectiveness can be observed with simultaneous use of some antimicrobial drugs (ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines);
- When taking gestagen-estrogenic medicines, you may need to adjust the dosage regimen for hypoglycemic agents and indirect anticoagulants.
Seasonale and pregnancy
These pills are not used during pregnancy and during a breastfeeding period. If the pregnancy is detected during the use of Seasonale, the drug is discontinued. However, epidemiological studies have not revealed any increased risk of developmental defects in children born to women who used oral hormonal contraceptives before pregnancy or during early pregnancy.
This preparation can reduce the amount of breast milk and change its composition, so Seasonale is contraindicated during breastfeeding. A small amount of sex steroids can be excreted in milk, but there is no evidence of their negative impact on the health of the newborn.
What if I miss a pill?
The reliability of Seasonale birth control pills may decrease if a woman has missed an active tablet (containing hormones), and especially if it’s the first tablet from the blister.
If the delay in taking an active tablet does not exceed 12 hours, the contraceptive effect of the preparation remains reliable. A woman should take the missed tablet as soon as possible, the next tablet is taken according to the usual schedule.
If the delay in taking active tablet exceeds 12 hours, the contraceptive effect may be reduced. Follow the recommendations given below:
Missing active tablets on Day 1 – Day 7:
Take the missed tablet as soon as possible (even if you need to take two tablets at once). Take the next pill according to the usual schedule.
If you missed two tablets during the 1st week, take two pills per day and two pills the next day. Take the following tablets according to the usual schedule. Use additional non-hormonal birth control methods for 7 days.
If you missed 3 tablets during the 1st week, discard them. Take the following tablets according to the directions listed on the package. Within 7 days after missing the tablets, you may have a bleeding. In either case, use additional non-hormonal birth control methods for the next 7 days.
Missing active tablets on Day 8 – Day 84:
Take the missed pill as soon as possible, even if you have to take two pills at once. Take the following tablets according to the usual schedule. Additional methods of contraception are not required.
If you missed two orange pills, take two pills on the day you remember it, and two more pills the next day. Take the following tablets according to the usual schedule. Use additional non-hormonal birth control methods for 7 days.
If you missed 3 pills, discard them. Take the following tablets according to the usual schedule. Within 7 days after missing the pills, you may have a bleeding. Use additional non-hormonal birth control methods for 7 days.
Missing inert tablets (Day 85 – Day 91):
Discard the missed tablets. Take the following tablets according to the usual schedule. Additional birth control methods are not required.
If you do not have a menstrual bleeding during the 13th week (when taking inert tablets), you need to exclude pregnancy before starting a new 91-day pack of Seasonale.
After discontinuation of the contraceptive, fertility is restored after 1-3 menstrual periods.
The use of the drug after childbirth or abortion is recommended after the first normal menstrual period.
Before starting contraception, a general medical and gynecological examination is recommended (including breast examination, liver function, blood pressure control and cholesterol concentration in the blood, urinalysis). A woman is also recommended to undergo a general medical and gynecological examination every 6 months.
Smoking women who take Seasonal tablets have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depends on the number of cigarettes smoked per day (especially in women over 35).
Diarrhea and vomiting may reduce the contraceptive effect of the birth control pills (in this case, it is necessary to use additional non-hormonal methods of contraception).
The drug should be discontinued immediately in the following cases:
- the development of pregnancy,
- migraine headaches,
- early signs of phlebitis or phlebotrombosis (unusual pain or bloating of the veins on the legs),
- visual impairment,
- cerebrovascular disorders,
- stitching pains of unclear etiology when breathing or coughing,
- pain and feelings of tightness in the chest,
- an increase in blood pressure,
- 3 months before the planned pregnancy and approximately 6 weeks before the planned surgery,
- prolonged immobilization.
Moderate bleeding during the use of Seasonale does not require discontinuation of the drug