Rivelsa is 91-days course birth control preparation. It contains ethinyl estradiol and levonorgestrel devoted to preventing an unwanted pregnancy.
Indications for use
Mechanism of action
Rivelsa is a combined oral contraceptive containing progestin and estrogen for a regular long-lasting use for 91 days. This birth control effect is achieved by the suppression of ovulation, the viscosity of the cervical secretion increase. As a result, it becomes to enter the uterine cavity for spermatozoa. One more effect provided is the endometrial changes that prevent the fertilized egg implantation.
Mode of application and dosage
Rivelsa is taken orally regularly for 91 days. The dosage is comprised in 1 table per day at the same time in the order indicated on the package (blister). To achieve the greatest contraceptive effect, the drug should be taken in accordance with the recommendations and at intervals not exceeding 24 hours. The menstruation will come when taking the latest 7 pills containing the lowest hormone dosage.
- Oversensitivity to any of the medication constituents;
- Diagnosed or Suspected venous and arterial thromboses and thromboembolism;
- Diagnosed or Suspected conditions preceding thrombosis inclusively of transient ischemic attacks, angina pectoris;
- Multiple or pronounced risk factors for venous or arterial thrombosis;
- Diagnosed or Suggested migraine accompanied by focal neurologic symptoms;
- Arterial hypertension of uncontrolled character;
- Diabetes mellitus with angiopathy;
- Diagnosed or Suggested pancreatitis with severe hypertriglyceridemia;
- Hepatic insufficiency and severe hepatic disorder;
- Present or prior benign or malignant hepatic tumors;
- Severe dyslipoproteinemia;
- Defined hormone-dependent malignant diseases;
- Vaginal bleeding of unknown etiology;
- Simultaneous intake with remedies containing St. John’s wort;
- Intolerance to galactose, insufficiency of lactase or glucose-galactose malabsorption;
- Postmenopausal period;
- Diagnosed or Suggested pregnancy;
- Age under 18 years;
- Smoking at the age over 35.
- Infections: often – fungal infections, nasopharyngitis;
- Mental health: often – depression;
- Nervous system: very often – headache; often – migraine;
- Digestive tract: often – nausea, pain in the abdomen;
- Skin, subcutaneous and soft tissues: often – acne;
- Musculoskeletal system and connective tissues: often – pain in the back;
- Reproductive system and breast health: very often – painful menstrual-like bleeding/bleeding; often – metrorrhagia, the sensitivity of mammary glands.
Together with other birth control pills, Rivelsa may cause the following side effects:
- venous thrombosis;
- arterial thrombosis;
- cerebrovascular disorders;
- increased blood pressure;
- hepatic tumor;
- disordered liver function;
- impaired glucose tolerance or influence on peripheral insulin resistance;
- the emergence or deterioration of conditions, whose appearance after oral contraceptive use is not proved: 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 related to cholestasis;
- acute pancreatitis;
- impaired vision;
Acute or chronic hepatic dysfunction can be caused by the discontinuation of combined oral contraceptives prior to the normalization of functional hepatic tests. In women with hereditary angioedema, estrogens can provoke or intensify the disease’s symptoms.
The interaction of oral contraceptives with other drugs can lead to breakthrough bleeding and/or a decrease in contraceptive reliability. They are:
- 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 NNRTI (eg, nevirapine) and combinations thereof;
- some antibiotics (for example, penicillin and tetracycline).
Women who undergo short-term treatment with any of the above drugs, except rifampicin, should temporarily use the barrier method of contraception in addition to the oral contraceptive, i.e. during the application of concomitant therapy and within 7 days after its discontinuation.
What if I miss a dose?
The responsibility of Rivelsa may be reduced if a woman has missed an orange tablet (containing levonorgestrel + ethinyl estradiol). The most effect reduction is manifested when a woman misses the first pill from the blister.
If the missing time is less than 12 hours, the contraceptive effect is not leveled down. A woman should apply the pill as soon as possible, the next pill is taken at the common time period.
If the missing time of one or more orange pills is more than 12 hours, a contraceptive effect can be decreased which may influence the drug reliability.
The following pieces of advice may be offered if the missing time doesn’t exceed 12 hours
Missing orange pills = levonorgestrel + ethinyl estradiol
Week 1 (1-7 days). In the case of missing one or more tablets during the first week, the risk of becoming pregnant magnifies. The reason for this is the request to take birth control pills within 7 days without any breaks to inhibit successfully hypothalamic-pituitary-ovarian system.
In the case of the missing one orange pill, you must apply the missed tablet as soon as possible, immediately after the moment a woman realizes this fact. The next pill is taken at the common time.
In the case, if 2 orange tablets are skipped, a woman should apply 2 pills at once and continue the common regimen of the application. For 7 days, additional barrier methods of contraception (for example, a condom) should be utilized.
In the case the application of 3 orange tablets is skipped, they should not be taken, and the coming pills should be taken at the common time in accordance given on the package. Within the next week after skipping the pills, the menstruation may come. In this case, an additional barrier method (eg, a condom) should be applied for the next 7 days.
Week 2-12 (8 – 84 days). One skipped orange pill should be applied as fast as possible, even if it is implied to take 2 pills at once. The following pills are taken at the common time. The use of additional contraceptive methods is not demanded.
If the application of 2 orange pills is skipped, the woman should take 2 tablets on the day in which she understood it, and 2 more the next day. These pills are applied at the common time. Additional barrier methods of contraception should be used within the next 7 days.
If the intake of 3 orange pills is skipped, they are not applied at all. The next pills are taken at the common time in accordance with to the recommendations given on the package. The menstruation may come within the next 7 days. If it doesn’t happen it is better to exclude the pregnancy.
If the application of white pills = ethinyl estradiol (week 13) is skipped the application should be missed. Follow-up tablets should be taken at the common time, until the end of the package. Additional methods of contraception are not required.
Rivelsa and pregnancy
The drug is contraindicated during pregnancy and breastfeeding.