Aurovela 1.5/30 is a combination of 2 female hormones that are used for birth control. The drug contains ethinyl estradiol and norethisterone.
Contents:
Indications for use
- Hormonal contraception;
- Menstrual disorders.
Mechanism of action
The drug suppresses ovulation and changes the nature of cervical secretions, as a result of which the cervix becomes less permeable to spermatozoa.
Dosage and mode of application
Each pack contains 28 pills (21 active pills each containing ethinyl estradiol and norethisterone and 7 ferrous fumarate pills). The dose of hormones in each active tablet (regardless of the day of the menstrual cycle) is constant.
You can start taking birth control pills on the first day of the period (the day the menstruation begins) or next Sunday (remember that if you do not start the use on the first day of the period, you should use additional methods of contraception until you have the next period).
It is necessary to take pills at the same time (it is more convenient to take pills before bedtime).
The tablets are taken for 28 days, without breaks (menstruation occurs on the 2-3rd day of taking inert tablets). Start a new pack as soon as you finish the previous one.
Overdose
Nausea, vomiting, vaginal bleeding. Symptomatic treatment.
Side effects
- endocrine system: breast engorgement, uterine bleeding, weight gain;
- nervous system: fatigue, paresthesia;
- digestive system: vomiting, nausea;
- metabolism: peripheral edema;
- others: itching, rash, melasma, chloasma.
Contraindications
Aurovela 1.5/30 is contraindicated for use in the following conditions/diseases:
- cirrhosis of the liver;
- cholestatic jaundice during pregnancy in history;
- a tendency to thrombosis;
- benign hyperbilirubinemia;
- neoplasms of the mammary glands and genitals;
- acute liver diseases (including benign and malignant neoplasms);
- impaired liver and kidney function;
- pregnancy (including suspected);
- puberty;
- acute thrombophlebitis or thromboembolism;
- bleeding from the urinary tract of unknown origin;
- bleeding from the genital tract of unknown origin;
- hypersensitivity to ethinyl estradiol or norethisterone;
- obesity;
- herpes.
With caution: bronchial asthma, chronic heart failure, epilepsy, arterial hypertension, migraine, renal failure, convulsions or other dysfunctions of the CNS (including a history), diabetes, liver disease (including a history), hyperlipidemia, thrombophlebitis and thromboembolism (including a history).
Interactions
- Use Aurovela 1.5/30 with caution at the joint administration with inducers of microsomal liver enzymes since they can enhance the metabolism of the drug.
When used simultaneously with inducers of microsomal liver enzymes, such as phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine and rifabutin, the clearance of sex hormones increases, which can lead to a decrease in their therapeutic efficacy; - Griseofulvin can also interact with norethisterone, leading to menstrual irregularities;
- Herbal preparations containing St. John’s wort can increase the metabolism of gestagens;
- Progestogens, in turn, can affect the metabolism of other drugs, changing their plasma and tissue concentrations. For example, norethisterone can inhibit the metabolism of cyclosporine;
- The use of ethinyl estradiol and norethisterone may affect the results of some laboratory tests (for example, liver function tests, thyroid hormone tests, and coagulation tests).
Pregnancy and breastfeeding
Do not use Aurovela 1.5/30 during pregnancy. The active substances may penetrate into breast milk. Depending on the type and dose, it may increase, decrease or not change the quality and quantity of milk. It is not recommended to use this drug during breastfeeding.
What if I miss a pill?
If you forget to take 1 or more pills, the following is suggested:
You missed 1 pill:
- take the missed pill as soon as you remember;
- take the next pill at your usual time.
You missed 2 consecutive pills (week 1 or week 2):
- take 2 pills on the day you remember;
- take 2 pills the next day;
- use another method of contraception for 7 days following the missed pills.
You missed 2 consecutive pills (week 3):
Sunday-Starters:
- take 1 pill a day until Sunday;
- On Sunday, throw out the rest of the pills;
- start a new pack immediately;
- use another birth control method for seven days following the missed tablets.
Day-1 Starters:
- discard remaining tablets;
- start a new pack of tablets that same day;
- use additional birth control methods for 7 days following the missed pills.
You missed 3 or more consecutive pills (week 1, 2, 3):
Sunday-Starters:
- take 1 pill per day until Sunday;
- on Sunday, throw out the rest of the pills;
- start a new pack immediately;
- use an additional method of preventing pregnancy for 7 days following the missed pills.
Day-1 Starters:
- throw out the rest of the pills;
- start a new pack that same day;
- use an additional method of preventing pregnancy for 7 days following the missed pills.
The possibility of pregnancy increases with each missed active pill. The possibility of spotting or bleeding is also increased. This is particularly likely to occur if 2 or more active pills in a row are missed.
You missed any of the 7 inert pills:
- discard the missed pills;
- keep taking 1 pill until the pack is finished;
- additional birth control methods are not required.
Precautions
Before using Aurovela 1.5/30, it is necessary to undergo a medical examination, including measuring blood pressure, assessing the condition of the mammary glands, abdominal organs and small pelvis, as well as a cytological examination of the cervix.
The therapy should be immediately discontinued in the following cases:
- first-time appeared migraine-type headaches, unusually severe headaches;
- sudden disorders of perception (for example, impaired vision or hearing);
- first signs of thrombophlebitis or symptoms of thromboembolism, feeling of pain and chest tightness;
- 6 weeks before the planned surgery, as well as in the case of prolonged immobilization;
- jaundice or deterioration of liver function, the development of anicteric forms of hepatitis, pruritus;
- a significant increase in blood pressure;
- pregnancy.
If any of the risk factors listed below are present or occur during the use of birth control pills, an individual assessment of the risk/benefit ratio should be carried out before starting treatment or continuing to take the drug.
Vascular disorders
According to the results of epidemiological studies, the use of oral estrogen/gestagens is associated with an increase in the number of thromboembolic complications. Thus, one should bear in mind the possibility of their development, especially if there is an indication of thromboembolic diseases in a history.
If you have symptoms that indicate the development of thromboembolic complications, you should immediately stop taking the contraceptive and consult a doctor.
The generally accepted risk factors for venous thromboembolism (VTE) include:
- episodes of VTE or aggravated family history;
- age;
- obesity;
- SLE;
- prolonged immobilization;
- extensive surgical intervention;
- severe injuries.
Patients with a history of VTE or with the presence of thrombophilic disorders have an increased risk of developing VTE. Use of combination oral contraceptives (COCs) may increase this risk.
The indication of episodes of thromboembolism or habitual spontaneous abortion in a personal or family history should be carefully studied to exclude susceptibility to thromboembolism.
If a thorough assessment of thrombophilic factors has not been performed or treatment with an anticoagulant has begun, the use of the drug in these patients is contraindicated. In patients taking anticoagulants, the risk and benefit of COCs should be carefully weighed.
The risk of VTE may temporarily increase with prolonged immobilization, severe injury or extensive surgical intervention. If long-term immobilization is planned, especially in abdominal surgery or orthopedic surgery on the lower extremities, it is necessary to stop the hormonal contraception 4-6 weeks before surgery. Treatment should not be resumed until the patient has fully recovered motor activity.
Hyperlipidemia
Women with hypertriglyceridemia or an indication of hypertriglyceridemia in the family history may have an increased risk of developing pancreatitis when taking combined oral contraceptives.
Women with hypertriglyceridemia have an increased risk of developing arterial lesions. At the same time, there is no need for routine screening of all women taking birth control pills.
Neoplasm
In rare cases, women reported benign tumors and malignant liver tumors. In some cases, these tumors led to life threatening intra-abdominal bleeding. If you have pain in the upper abdomen, enlarged liver, or if there are signs of intra-abdominal bleeding, a liver tumor should be excluded, and the drug should be canceled.
Other warnings
Norethisterone may affect carbohydrate metabolism. The parameters of carbohydrate metabolism must be carefully controlled in all patients with diabetes mellitus before and during treatment.
Chloasma can sometimes develop, especially in women with a history of chloasma in pregnant women. Women with a tendency to chloasma should minimize their exposure to the sun and exposure to ultraviolet radiation during treatment with Aurovela 1.5/30.
Patients with a history of depression should be carefully monitored. Hormonal contraception should be discontinued if depression recurs in a severe form.
In each case of acute visual impairment, exophthalmos, diplopia or a migraine, it is necessary to exclude optic nerve edema or retinal damage before continuing hormonal contraception.
Progestins can cause fluid retention. Particular attention should be given to patients with the following diseases: epilepsy, migraine, asthma, heart disease, impaired renal function.
Arterial and venous thromboembolism
Epidemiological studies have shown that the incidence of venous thromboembolism (VTE) in women taking oral contraceptives is approximately 20-40 per 100,000 cases per year, but this risk estimate varies depending on the content progestogen. For comparison, in women who do not take COCss, the frequency is 5-10 per 100,000 cases per year. The use of any COC entails an increased risk of VTE compared with patients who do not use them. The degree of this risk is less than the risk of VTE associated with pregnancy, the frequency of which is estimated at 60 cases per 100,000 pregnancies. The highest risk of VTE exists during the first year of use of Aurovela 1.5/30 or after an interruption in use with a minimum period of 1 month. VTE can be life-threatening or can be fatal (1-2% of cases).
VTE in the form of deep vein thrombosis and / or pulmonary embolism can occur during the use of any COC. Extremely rarely, when using CPC, thrombosis can occur in other blood vessels, for example, in the hepatic, mesenteric, renal, cerebral, and also in the veins and arteries of the retina. There is no consensus as to whether the development of these complications is related to the use of COC.
Common symptoms of VTE include:
- severe pain in the calf muscle of one leg, swelling of the leg;
- sudden shortness of breath, chest pain.
The use of birth control pills may also increase the risk of diseases such as stroke and myocardial infarction, which are secondary arterial thromboembolic complications.
Common symptoms of arterial thromboembolism include:
- sudden severe chest pain, radiating or non-irradiating to the left arm;
- sudden cough for no apparent reason;
- any unusually strong, prolonged headache, especially for the first time.
The condition gradually worsens or any of the following symptoms occur: sudden partial or complete loss of vision or double vision; aphasia; dizziness; collapse with or without seizures of focal epilepsy; weakness or pronounced sudden numbness of one side or one part of the body.
Risk factors for thromboembolic complications:
- age;
- obesity;
- an indication in the family history of the presence of venous or arterial thromboembolism in a brother, sister or parent at a relatively young age (if the hereditary predisposition is known or suspected, a woman should consult a specialist for advice before deciding on the use of the contraceptive);
- prolonged immobilization, extensive surgical intervention, any surgery on the lower limbs or extensive trauma (in these situations it is desirable to stop using the drug);
- smoking (risk increases with smoking and with age, especially in women over the age of 35);
- dyslipoproteinemia;
- arterial hypertension;
- a migraine (an increase in the frequency and severity of migraine attacks while taking COCs may be a precursor of cerebral circulation and, therefore, the reason for the immediate cessation of taking COCs);
- valvular heart disease;
- atrial fibrillation.
Other factors that cause circulatory disorders: diabetes mellitus, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn’s disease / ulcerative colitis), sickle cell anemia.
Biochemical factors that may indicate hereditary or acquired susceptibility to venous or arterial thrombosis: resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
Cervical cancer
The most important risk factor for cervical cancer is persistent HPV infection. Some epidemiological studies have shown that prolonged use of COCs may further contribute to an increased risk, but there is still no unequivocal opinion due to the presence of additional factors (for example, sexual behavior, including the use of barrier contraceptives).
Mammary cancer
There is a slightly increased relative risk of breast cancer in women who currently use oral hormonal contraception.
Increased risk gradually disappears within 10 years after discontinuation of the pills.
Other factors
Although a small increase in blood pressure has been reported in many women taking COCs, a clinically significant increase is rare.
There are reports that Crohn’s disease and ulcerative colitis may be associated with taking birth control pills.
The preparation contains lactose monohydrate. Patients with congenital intolerance to galactose, lactase deficiency or glucose-galactose malabsorption should not use the drug.
Influence on ability to drive motor transport and control mechanisms
Aurovela 1.5/30 does not affect the ability to drive motor transport and operate machinery.