Seasonique is an extended-cycle combination estrogen-progestogen contraceptive which prevents pregnancy and suppresses menstruation for 91 days.
Contents:
Indications for use
- Long-term hormonal contraception
Mechanism of action
The drug suppresses ovulation, increases the viscosity of the secretion of the cervix, which makes it difficult for spermatozoa to penetrate into the uterine cavity, and prevents the implantation of a fertilized egg.
When using Seasonique, the number of menstrual bleeding decreases to four per year.
Dosage and mode of application
Seasonique with an extended dosing regimen is used for an extended period of 91 days.
Each of the 84 green tablets contains a small amount of two female hormones, levonorgestrel and ethinyl estradiol. 7 yellow tablets contain a small amount of the female hormone ethinyl estradiol.
The preparation is taken continuously for 91 days, 1 tablet a day at the same time in the order indicated on the package.
To achieve the best contraceptive effect, the drug should be taken in accordance with the recommendations and at intervals not exceeding 24 hours.
Drug-use initiation:
Tablets should be taken every day with a small amount of liquid. One green tablet containing levonorgestrel and ethinylestradiol is taken daily for 84 days, then you need to take a yellow pill containing ethinylestradiol for 7 days, during which there is a menstrual bleeding “cancellation”.
Each subsequent cycle of using Seasonique with the duration of 91 days begins without interruption the next day after the last tablet from the previous package is taken, adhering to the same order of reception.
In the absence of taking any hormonal contraceptive drugs in the previous month:
Pills should be taken on the first day of the menstrual period (on the first day of menstrual bleeding). It is allowed to start taking the menstrual period on the 2nd-5th day, but in this case, it is recommended to use the barrier method of contraception during the first 7 days of taking the birth control pills.
When switching from using other hormonal combined contraceptive drugs (COC, vaginal ring or transdermal patch):
A woman should start taking Seasonique on the day after taking the last active tablet (the last pill containing the active substances) of her previously used oral contraceptive. If a vaginal ring or transdermal patch is used, a woman should start taking the drug at a time when a new ring is to be inserted or a new patch is stuck.
When switching from using gestagen-only contraceptives (“mini-pills”, implants):
You can switch from a mini-pill to Seasonique on any day (without interruption) after an implant or an intrauterine contraceptive with gestagen is removed. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
After an abortion in the first trimester of pregnancy:
You can start taking Seasonique immediately – on the day of abortion. In this case, a woman does not need additional contraception.
After childbirth or abortion in the second trimester of pregnancy:
You should start taking the drug no earlier than 21-28 days after giving birth (if there is no breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. Before taking tablets for the first time, pregnancy should be excluded or it is necessary to wait for the first menstruation.
Overdose
No serious side effects were reported with an overdose of Seasonique. Overdose symptoms may include nausea, vomiting, spotting from the vagina, metrorrhagia.
Treatment: symptomatic therapy. There is no specific antidote.
Contraindications
- 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);
- multiple or expressed risk factors for venous or arterial thrombosis;
- hereditary or acquired predisposition to venous or arterial thrombosis: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein deficiency C, protein S deficiency, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
- a migraine with focal neurologic symptoms;
- uncontrolled arterial hypertension;
- diabetes mellitus with diabetic angiopathy;
- pancreatitis with severe hypertriglyceridemia;
- liver failure and severe liver disease;
- liver tumors (benign or malignant);
- identified hormone-dependent malignant diseases (including genitals or mammary glands);
- bleeding from the vagina of unknown origin;
- pregnancy;
- the period of breastfeeding;
- the age under 18 years (due to the lack of data on the efficacy and safety of the drug in adolescents under the age of 18);
- simultaneous use with preparations of St. John’s wort perfumed;
- hypersensitivity to any of the components of the drug (ethinylestradiol or levonorgestrel);
- intolerance to galactose, insufficiency of lactase or glucose-galactose malabsorption; intolerance to lactose;
- postmenopausal period.
If any of the above diseases or conditions develop against the background of taking Seasonique, the contraceptive should be immediately canceled.
Side effects
The most common side effects associated with the use of Seasonique are a headache, acyclic or copious uterine bleeding, painful menstrual bleeding, nausea, vomiting and back pain.
Other possible side effects include:
- venous thrombosis;
- arterial thrombosis;
- cerebrovascular disorders;
- increased blood pressure;
- hypertriglyceridemia;
- liver tumor;
- impaired liver function;
- impaired glucose tolerance or influence on peripheral insulin resistance;
- Crohn’s disease, ulcerative colitis, epilepsy, migraine, uterine myoma, cervical cancer, gallbladder stones, porphyria, SLE, herpes during pregnancy, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice, hearing loss associated with otosclerosis, jaundice and / or itching associated with cholestasis;
- dizziness;
- cholecystitis;
- acute pancreatitis;
- impaired vision;
- Chloasma.
- acute or chronic liver dysfunction
- symptoms of angioedema (with a hereditary predisposition to angioedema).
Interactions
There are interactions that lead to a decrease in the effectiveness of Seasonique:
- drugs that induce microsomal enzymes of the liver (phenytoin, bosentan, vemurafenib, barbiturates, primidone, carbamazepine, rifampicin, rifabutin);
- oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John’s Wort;
- HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and their combinations;
- rifampicin and griseofulvin;
- some antibiotics (for example, penicillin and tetracycline);
- cyclosporine, lamotrigine
What if I miss a pill?
The reliability of Seasonique may decrease if the patient has forgotten to take a green tablet (containing levonorgestrel + ethinyl estradiol), and especially if the patient forgot to take the first pill from the blister.
If the delay in taking the drug was less than 12 hours, the contraceptive protection is not reduced. A woman should take the pill as soon as possible, the next pill is taken at the usual time. If the interval is more than 12 hours, a contraceptive effect may be reduced.
There are two basic rules:
- The drug intake should never be interrupted for more than 7 days;
- It takes 7 days of continuous intake of tablets to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.
Accordingly, the following recommendations can be given if the delay in taking the tablets exceeds 12 hours:
Missing green tablets containing levonorgestrel + ethinyl estradiol:
Week 1 (Day 1 Day 7):
If you missed 1 or more tablets during the first week, the risk of pregnancy increases.
If you missed 1 green tablet, you must take the missed green tablet as soon as possible (even if you need to take two tablets at the same time). The next tablet is taken at the usual time.
If you missed 2 green tablets, you should take 2 pills on the day you remember it, and 2 more the next day. The following tablets are taken at the usual time. You should use additional barrier methods of contraception (for example, a condom).
If you missed 3 green tablets, do not take them. The subsequent tablets are taken at the usual time according to the directions on the package. Within the next week after missing the pills, a woman may have a bleeding. An additional barrier method of contraception (eg, a condom) should be used for the next 7 days. If you had sexual intercourse within a week before passing the pill, it is necessary to exclude pregnancy.
Week 2-12 (Day 8 – Day 84)
1 missed green tablet should be taken as soon as possible, even if you have to take 2 tablets at the same time. The following tablets are taken at the usual time. The use of additional methods of contraception is not required.
If you missed taking 2 green tablets, you should take 2 pills on the day you remember it, and 2 more the next day. The following tablets are taken at the usual time. Use additional barrier methods of contraception (for example, a condom) for 7 days.
If you missed 3 green tablets, throw them away, All the subsequent tablets are taken at the usual time according to the directions on the package. Within the next week after missing the pills, a woman may have a bleeding. Use additional barrier methods of contraception for 7 days.
Missing yellow tablets containing ethinylestradiol (Week 13):
Tablets that the patient forgot to take should be omitted. Follow-up tablets should be taken at the usual time, until the end of the package. Additional methods of contraception are not required.
If a woman did not have a bleeding “withdrawal” during the 13th week (with yellow tablets containing ethinyl estradiol), pregnancy should be excluded before starting a new 91-day course of Seasonique.
Seasonique and pregnancy
Seasonique birth control pills are contraindicated in pregnancy and during breastfeeding.
If pregnancy occurred during the use of Seasonique, the drug should be immediately discontinued. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children from mothers who received COC prior to pregnancy or teratogenic effects, with the occasional use of COCs in early pregnancy.
The preparation can reduce the amount of breast milk and change its composition, so its use is contraindicated until the termination of breastfeeding. A small number of active substances, ethinylestradiol and levonorgestrel, may penetrate into breast milk and influence the child.
Precautions
Seasonique does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
The effectiveness of tablets can be reduced in the following cases: diarrhea, use of penicillins or tetracyclines. In this case, you need to use barrier contraception (eg, a condom)
The drug does not affect the ability to drive vehicles and operate mechanisms.
The potential risk and the expected benefit of using combined contraceptive oral medicines in each individual case should be carefully weighed in the presence of the following diseases/conditions or risk factors:
- risk factors for thrombosis and thromboembolism: smoking, hereditary predisposition to thrombosis (myocardial infarction or impaired cerebral circulation at a young age), overweight (body mass index;
- other diseases in which peripheral circulation disorders may occur: diabetes mellitus without diabetic angiopathy, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn’s disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
- hypertriglyceridemia;
- liver disease of mild and moderate severity with normal liver function tests;
- diseases that first occurred or worsened during the previous pregnancy or against the background of previous reception of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham’s chorea);
- women with hereditary angioedema, chloasma, depression, epilepsy.