Midiana®
If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using COCs, including the combination of drospirenone + ethinyl estradiol, should be carefully weighed in each individual case and discussed with the woman before starting to take the drug. If any of these conditions, diseases or risk factors worsen, intensify or appear for the first time, a woman should consult her doctor to decide whether to stop taking the drug.
Risk of developing VTE and ATE
The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as DVT, PE, myocardial infarction, cerebrovascular disorders). These diseases are rarely reported.
The increased risk of developing VTE associated with the use of COCs is due to the presence of estrogen in its composition.
Drugs containing levonorgestrel, norgestimate, or norethisterone as a progestogen component are associated with the lowest risk of VTE.
When using other COCs, such as the combination of drospirenone + ethinyl estradiol, the risk of developing VTE is twice as high. The choice of a COC with a higher risk of VTE should only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the contraceptive, the effect of the drug on her existing risk factors and that the risk of developing VTE maximum in the first year of taking such drugs. An increased risk is also observed when COC use is resumed (after a break between doses of the drug of 4 weeks or more). The increased risk of developing VTE is present primarily during the first 3 months.
VTE can be life-threatening or lead to death (in 1-2% of cases). VTE, manifested as DVT and/or PE, can occur with all COCs.
It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of DVT:
unilateral swelling of the lower limb or along the vein, pain or discomfort only in an upright position or when walking, local increase in temperature, redness or discoloration of the skin in the affected lower limb.
Symptoms of pulmonary embolism:
difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions (eg, respiratory tract infection).
ATE can lead to stroke, vascular occlusion, or myocardial infarction.
Symptoms of a stroke:
sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, severe or prolonged headache for no apparent reason, unilateral or bilateral loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure.
Other signs of vascular occlusion:
sudden pain, swelling and slight cyanosis of the extremities, “acute” abdomen.
Symptoms of myocardial infarction:
pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. ATE can be life-threatening and lead to death.
In women with a combination of several risk factors or high severity of one of the factors, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, the combination of drospirenone + ethinyl estradiol is contraindicated.
The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:
-with age;
- in women who smoke (with an increase in the number of cigarettes or an increase in age, the risk increases, especially over the age of 35);
- if there is a family history (for example, VTE or ATE in close relatives or parents aged less than 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;
- for obesity (with a BMI more than 30 kg/m2);
- with dyslipoproteinemia;
- for arterial hypertension;
- for migraine;
- for diseases of the heart valves;
- with atrial fibrillation;
- in case of prolonged immobilization, serious surgery, any operation on the lower extremities, in the pelvic area or extensive trauma. In these cases, the use of COCs should be stopped (in the case of planned surgery, at least four weeks before it) and not resumed for two weeks after the woman has fully regained mobility.
Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors.
The possible role of varicose veins and thrombophlebitis of superficial veins in the development of VTE remains controversial.
The increased risk of thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine (which may precede cerebrovascular events) during the use of COCs is grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to the development of venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteipemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition/disease may reduce the associated risk of thrombosis.
Tumors
The most significant risk factor for the development of cervical cancer (CC) is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing CC with long-term use of COCs. However, the connection with taking COCs has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior patterns (less use of barrier methods of contraception, greater number of sexual partners).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently taking COCs or have recently taken it is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in risk may also be a consequence of earlier diagnosis of breast cancer in women using COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effects of COCs, or a combination of both of these factors.
In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Other states
Depressed mood and depression are known adverse reactions when using hormonal contraceptives. Depression can be a serious disorder and is a known risk factor for suicidal behavior and suicide. Women should be advised to contact their doctor if mood changes or depressive symptoms occur, including soon after starting treatment.
Drospirenone is an aldosterone antagonist with potassium-sparing properties. In most cases, there should be no increase in plasma potassium concentration. In clinical studies in some patients with mild to moderate renal impairment and concomitant use of potassium-sparing drugs, plasma potassium concentrations were slightly increased while taking drospirenone. Therefore, it is necessary to monitor the concentration of potassium in the blood plasma during the first cycle of taking the drug in patients with renal failure and when the initial potassium concentration is at the upper limit of normal, especially when taking potassium-sparing drugs concomitantly.
In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while taking COCs. Although slight increases in blood pressure (BP) have been described in many women taking COCs, clinically significant increases have rarely been reported. However, if a persistent clinically significant increase in blood pressure develops while using a COC, the COC should be discontinued and treatment of arterial hypertension should be initiated. COC use can be continued if normal blood pressure values are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: cholestatic jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of COC use.
Although COCs may have an effect on insulin resistance and glucose tolerance, in patients with diabetes mellitus using low-dose COCs, as a rule, no dose adjustment of hypoglycemic drugs is required. However, women with diabetes mellitus should be carefully monitored while taking COCs.
Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.
Effect on liver function tests
In clinical studies involving patients receiving hepatitis C viral therapy (a combination of drugs containing ombitasvir, paritaprevir, ritonavir, dasabuvir, with or without ribavirin), increases in ALT activity more than 5 times the upper limit of normal were recorded more often in patients using ethynyl-containing COCs.
If a course of therapy with this combination of drugs is necessary, a patient using the combination of drospirenone + ethinyl estradiol should be switched to alternative methods of contraception (non-hormonal or progestogen-only contraceptives) before starting treatment. You can resume taking the combination of drospirenone + ethinyl estradiol no earlier than 2 weeks after the end of the course of therapy with antiviral drugs.
Laboratory tests
The use of drugs such as drospirenone + ethinyl estradiol may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in the blood plasma (for example, transcortin, lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis). These changes usually remain within normal physiological values.
Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.
Reduced efficiency
The effectiveness of COCs may be reduced in the following cases: in case of missed pills, gastrointestinal disorders or as a result of drug interactions.
Effect on bleeding pattern
While taking COCs, irregular bleeding may occur (“spotting” and/or “breakthrough” bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three drug cycles.
If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.
Some women may not develop withdrawal bleeding during a break from taking the pills; pregnancy should be ruled out before continuing to take it.
Medical examinations
Before starting or resuming taking the drug drospirenone + ethinyl estradiol, it is necessary to familiarize yourself with the woman’s life history and family history, conduct a thorough general medical examination (including measuring blood pressure, determining BMI) and gynecological examination (with mandatory examination of the mammary glands and cytological examination of the cervical epithelium), and exclude pregnancy. The scope of additional studies and the frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once every 6 months.
It must be remembered that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases!
You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.
How to use
Before starting to take the medication, it is recommended to consult a specialist and undergo a comprehensive diagnostic examination.
Start
It is necessary to start taking the drug from the first day of the menstrual cycle. Women who have previously used other hormonal agents are allowed to start the course on days 2-5 of the cycle.
The daily dose is 1 tablet, which should be taken at the same time with a sufficient amount of water. Duration of use: 3 weeks. After taking the last pill, there is a seven-day break and menstrual bleeding begins.
After a week, you should resume taking it, even if your period has not ended. You should check with your doctor about the duration of use of the product. Some recommend taking a break when using Midiana for more than 6 months in a row.
After childbirth, it is allowed to start the course after 3 weeks, after artificial termination of pregnancy in the early stages - on the day of surgery, in late stages - after 21 days.
Delay of menstruation
If it is necessary to delay the onset of the next menstruation, it is allowed not to take a seven-day break between plates and immediately start using the next one. This will allow you to delay your period for the required period.
If taken without a break, spotting or minor bleeding may occur in the middle of the cycle.
Missing one or more tablets
If you are less than 12 hours late in taking your next pill, you should take it immediately. There is usually no need to use additional contraception using barrier methods.
If the absence was more than a day, you are allowed to take 2 tablets; it is important to use condoms for a week
If a woman has missed several days, she must start taking it again immediately, but she should not take the missed pills, but those that fall on today. Over the next 2 weeks, the use of additional contraception is mandatory. In case of a longer absence, you should consult a specialist.
Cancel
Drug withdrawal is almost always done gradually. Gynecologists strongly recommend using all the tablets from the blister and then stopping the course.
Urgent withdrawal is indicated only in the case of pregnancy, the development of an acute allergic reaction with severe symptoms from the respiratory system and skin. The decision to terminate the course is made by a specialist.
Mechanism of action
COC Midiana is a hormonal contraceptive. The contraceptive effect is achieved due to the content of ethinyl estradiol and drospirenone. When the components enter the body, they influence the maturation processes of the egg, inhibit them, and prevent it from leaving the ovary into the fallopian tube.
In addition, the medication changes the consistency of cervical mucus. Normally, a healthy woman has liquid mucus during ovulation, which facilitates the rapid penetration of sperm into the egg. When taking an oral contraceptive, the mucus becomes viscous and closes the cervical canal, preventing fertilization.
If a meeting of male and female cells occurs, the drug acts on the endometrium and prevents the attachment of a fertilized egg. Thanks to the triple effect, the effectiveness of the drug is very high.
The product is quickly absorbed in the digestive tract, which ensures high bioavailability within 1 hour after use.
Rules for taking the drug
If you have not taken birth control pills before, you should take your first pill on the first day of your period. In this situation, you do not need to use condoms from the start of taking the drug.
You can also start taking Median during the period from the 2nd to the 5th day of your period, but in this case it is important to use condoms for another seven days after starting to take the drug. It is recommended to take the tablets at the same time every day, regardless of meals.
However, small deviations from time are not dangerous. If the delay in taking the next tablet is no more than 12 hours, the effect of the drug is not reduced.
It is recommended to take the tablets at the same time every day, regardless of meals. However, small deviations from time are not dangerous. If the delay in taking the next tablet is no more than 12 hours, the effect of the drug is not reduced.
It is recommended to take the tablets in the order indicated on the blister, but this rule is not strict. In all tablets, the Median dose of hormones is the same, so the order of administration is not important
It is important to take one tablet per day
When all the tablets in the blister are finished, you need to take a 7-day break, during which you do not need to take tablets. During these days, withdrawal bleeding may begin, which is similar to your period.
The next package should be taken on the 8th day after a 7-day break
In this case, it does not matter at all whether your period has already begun or ended by the time you start taking the next package.
Pharmacology
The action of the oral contraceptive is aimed at reducing the likelihood of ovulation and changes in the endometrium.
The medicinal properties of drospirenone are characterized by antiandrogenic and minor antimineralocorticoid properties. The substance does not produce estrogenic, glucocorticoid or antiglucocorticoid effects. This feature makes drospirenone similar to natural progesterone.
It is quickly and completely absorbed into the body. The highest concentration of the active substance, equal to 37 ng/ml, is observed 1-2 hours after taking the tablet. For a full cyclic dose (7-14 hours) of the drug, the maximum concentration reaches 60 ng/ml.
After taking the drug "Median" (reviews about this drug indicate its good contraceptive effect), there is a repeated decrease in the concentration of drospirenone in the serum with a half-life of 1.6 ± 0.7 hours and 27.0 ± 7.5 hours.
After administration, drospirenone binds to serum albumin, which is superior to globulin, which affects sex hormones.
Ethinyl estradiol, like drospirenone, is also quickly and completely absorbed in a woman’s body. The maximum concentration of the active substance is observed 1-2 hours after taking the drug and is equal to 100 pg/ml. The substance binds to blood proteins in 98%, and its volume of distribution is 5 l/kg. Affects the process of protein synthesis of sex hormones and the content of transcortin in the liver. When taking the drug daily, the concentration of the active substance reaches 350 nmol/l.
special instructions
The risk of side effects is present even if the drug is taken correctly, so it is worth considering special instructions that affect the effect.
Childhood
The medication is not prescribed to patients under 18 years of age without strict indications. Sometimes teenage girls need to take hormonal contraceptives to treat certain conditions.
The decision on the advisability of prescribing medication is made by the gynecologist after a thorough diagnostic examination.
Pregnancy and lactation
Midiana is not prescribed during breastfeeding. Active components penetrate into breast milk and negatively affect its composition, quality, and baby’s health.
During pregnancy, the medication is contraindicated. If a woman is taking the product but suspects that she is pregnant, she should stop using it immediately.
Climax
During menopause, medicine is rarely prescribed, if necessary to normalize hormonal levels.
If negative symptoms occur or the condition worsens, you should stop taking it and consult your doctor.
Kidney and liver failure
The drug can be taken only in cases of mild liver or kidney failure, in the absence of severe symptoms.
As the disease progresses, the medicine is contraindicated; it can aggravate the clinical picture and provoke complications.
Drug interactions
There are drugs that weaken the effect of the hormonal drug, causing complications if simultaneous use is necessary.
You should not combine the use of Midiana with the following medications:
- barbiturates;
- penicillins;
- tetracyclines;
- cephalosporins.
Such drugs weaken the effect of birth control pills and reduce the concentration of active components in the blood. You should also not combine the drug with antacids and enterosorbents.
When prescribing drugs at the same time, the use of additional methods of contraception is required.
Do you need breaks from taking Mediana?
There is a misconception that once every six months or a year you need to take a 1-2 month break from taking contraceptive medications. In fact, everything is not like that.
Long breaks in taking the drug Median will not give the body anything useful, because this is a very serious stress for the ovaries.
Research on this topic has proven that birth control pills can be taken for up to five years in a row, without taking long breaks. This does not at all affect the likelihood of getting pregnant in the future. You can conceive a child immediately after canceling Median.
If you still take a month-long break, the likelihood of getting pregnant during the period of stopping the pills increases.
To avoid unwanted pregnancy, it is important to use condoms. It is important to remember that interrupted sexual intercourse is not considered a reliable method of protection against pregnancy, and is therefore not recommended for use.
After a break in taking the drug, many women complain of delayed periods, menstrual cycle disorders, acne, hair loss, deterioration of health and other unpleasant symptoms. Therefore, if you take such breaks, be prepared for their side effects.
Why is Midiana not suitable for some women?
Among the reviews about this drug, you can often find posts that Midiana did not suit someone. This is the scourge not only of a specific contraceptive, but of all existing hormonal drugs in general. This is largely due to the inattention of doctors to prescribing medications.
Even women who have not given birth can have severe hormonal imbalances. Relying on data such as age, number of abortions and births is not enough. It is better to send the patient to take hormone tests and assess the state of the blood coagulation system, and then, based on the results, select suitable pills.
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Precautionary measures
When using combined oral contraceptives, you should avoid alcoholic beverages, which will avoid complications and deterioration of your general condition. Experts strongly recommend quitting smoking, especially for women over 35 years of age.
The combination of COCs with smoking increases the risk of the formation of malignant tumors several times, especially in the mammary glands. You should not independently exceed or reduce the recommended dosage, extend or shorten the course.
Any changes must be agreed with your doctor. If side effects occur, you should immediately seek qualified help; you should not take medications on your own to alleviate the condition.
Skipping several pills
If you miss two tablets in a row, you need to take two tablets a day for two days. So in two days you will catch up with the required number of tablets.
If you miss three tablets in a row, you need to take two tablets for three days until you catch up with the required number of tablets.
If 4 or more tablets were missed, you need to additionally consult with your doctor about your further actions.
If you missed several tablets in a row, you must additionally protect yourself with other means of contraception for seven days after resuming taking the drug.
1-2 days after the missed period, breakthrough bleeding similar to menstruation or spotting may appear. It's not dangerous at all. You need to continue taking the pills according to the instructions, and the discharge will stop.
