Midiana
Midiana: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. For violations of liver function
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Midiana
ATX code: G03AA12
Active ingredient: Drospirenone + Ethinylestradiol (Drospirenone + Ethinylestradiol)
Producer: Gedeon Richter (Hungary)
Description and photo update: 2018-26-10
Prices in pharmacies: from 400 rubles.
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Midiana is a contraceptive drug.
Release form and composition
Dosage form Midiana - film-coated tablets: round, biconvex, white, engraved with "G63" on one side (21 tablets in a blister, in a cardboard box 1 or 3 blisters).
Composition of 1 tablet:
- active substances: drospirenone - 3 mg, ethinylestradiol - 0.03 mg;
- excipients: magnesium stearate, lactose monohydrate, corn starch, pregelatinized corn starch, povidone K-25;
- film shell: white opadry Colorcon 85G18490 [polyvinyl alcohol, soy lecithin, talc, titanium dioxide (E171), macrogol 3350].
Pharmacological properties
Pharmacodynamics
Midiana is a combined drug, its contraceptive effect is primarily due to inhibition of ovulation, as well as structural and functional changes in the endometrium.
In addition to the contraceptive effect, drospirenone in therapeutic doses has antiandrogenic and weak antimineralocorticoid effects, while it does not have estrogenic, glucocorticoid, antiglucocorticoid activity, which makes it similar to natural progesterone in its pharmacological profile.
In addition, there is evidence that when taking combined oral contraceptives, the risk of developing ovarian and endometrial cancer is reduced.
Pharmacokinetics
Drospirenone
Drospirenone is not completely absorbed, its bioavailability is 76–85% and does not depend on food intake. The maximum serum concentration is 37 ng / ml and is reached within a few hours. During the first cycle, the equilibrium concentration of 60 ng / ml is reached after 7-14 hours. The decrease in serum concentration occurs in two phases by binding to serum albumin.
Drospirenone metabolites are represented by acidic forms formed during the opening of the lactone ring. The average apparent volume of distribution is 3.7 l / kg. The metabolic clearance rate is 1.5 ml / min / kg. The elimination process occurs exclusively in trace amounts in an unchanged form, the excretion of metabolic products is carried out by the kidneys and intestines. The half-life is 40 hours.
Ethinylestradiol
When taken orally, ethinyl estradiol is completely absorbed in a short time. Its absolute bioavailability is 45%. The maximum concentration after taking the first dose is 0.03 mg and is reached within a few hours. The connection with plasma proteins is 98%, the apparent volume of distribution is 5 l / kg. Ethinyl estradiol can induce the synthesis of SHBG (sex hormone binding globulin) and transcortin in the liver. The substance is completely metabolized. The metabolic clearance rate is 5 ml / min / kg. Ethinyl estradiol is excreted in the form of metabolic products by the kidneys and intestines. 0.02% of the dose taken is found in breast milk.
Indications for use
According to the instructions, Midiana is indicated for contraception.
Contraindications
Absolute:
- complicated lesions of the valve apparatus of the heart, uncontrolled arterial hypertension, atrial fibrillation;
- long-term immobilization during serious surgical operations;
- venous thrombosis, including a history (deep vein thrombosis, pulmonary embolism);
- thrombosis of the arteries or conditions preceding their appearance, including a history (for example, myocardial infarction, angina pectoris, transient ischemic attack);
- the presence of risk factors for arterial thrombosis, such as diabetes mellitus, severe dyslipoproteinemia, severe arterial hypertension;
- predisposition to arterial or venous thrombosis (eg, resistance to activated protein C, protein C deficiency, protein S deficiency, antithrombin III deficiency, hyperhomocysteinemia and the presence of antiphospholipid antibodies such as antibodies to cardiolipin, lupus anticoagulant);
- cerebrovascular diseases, including in the anamnesis;
- pancreatitis (including a history of severe hypertriglyceridemia);
- liver failure;
- liver tumors, including a history (benign or malignant);
- severe liver disease, including in the anamnesis (before the normalization of liver function tests);
- renal failure (acute or severe chronic);
- hormone-dependent malignant diseases of the reproductive system or suspicion of them;
- bleeding from the vagina of unknown origin;
- migraine with a history of focal neurological symptoms;
- smoking over the age of 35;
- pregnancy or suspicion of it, lactation period;
- glucose-galactose malabsorption, hereditary galactose intolerance, lactase deficiency;
- increased sensitivity to any component of Midiana.
Relative:
- risk factors for thrombosis and thromboembolism;
- smoking under the age of 35;
- dyslipoproteinemia;
- controlled arterial hypertension;
- migraine without focal neurological symptoms;
- valvular heart disease (uncomplicated);
- hereditary predisposition to thrombosis;
- diseases that can lead to violations of peripheral circulation (diabetes mellitus, Crohn's disease, systemic lupus erythematosus, hemolytic uremic syndrome, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins);
- hypertriglyceridemia;
- hereditary angioedema;
- liver disease;
- diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (porphyria, herpes, jaundice, pruritus, cholelithiasis, otosclerosis with hearing impairment, chloasma, chorea minor);
- postpartum period.
Instructions for use of Midiana: method and dosage
Midian tablets should be taken for 21 days, every day at the same time, in the sequence indicated on the blister pack. This should be followed by a break in taking the drug (7 days), during which, as a rule, menstrual bleeding occurs (usually 2-3 days after stopping the intake), sometimes continuing until the next package is taken.
If hormonal contraceptives have not been used during the previous month, the first pill should be taken on the first day of the menstrual cycle (that is, on the first day of menstrual bleeding).
To replace another oral combination contraceptive, transdermal patch or vaginal ring, Midiana should be taken the day after taking the last active pill or on the day of removing any of the previously used drugs.
The transition from the mini-pill can be carried out on any day, from the injection form - on the day when the next injection was planned, from the implant or intrauterine contraceptive - on the day of its removal. In all these cases, an additional method of contraception is recommended in the first 7 days after the transition.
After termination of pregnancy in the first trimester, pills can be taken immediately, without the need for additional methods of contraception.
If pregnancy is interrupted in the second trimester or after childbirth, Midiana should be taken on days 21-28. At a later start of taking pills, an additional method of contraception is recommended in the first 7 days of using the drug. If you had sexual intercourse before taking Midiana, you should exclude pregnancy or wait until your period begins.
Taking missed pills
With a delay in taking Midiana for no more than 12 hours, a decrease in the contraceptive effect does not occur. In this case, you need to take the pill as soon as possible and then take them at the usual time.
If you are more than 12 hours late in taking a pill, you should remember 2 rules:
- you can not interrupt the drug intake for more than 7 days;
- it is necessary to take the drug continuously for 7 days to adequately suppress the hypothalamic-pituitary system of ovarian function.
In this regard, the following recommendations are relevant:
- first week: the missed dose should be taken as soon as possible, up to the simultaneous intake of 2 tablets. Then the drug is taken at the usual time, and additional barrier methods of contraception are used for 7 days. The likelihood of pregnancy depends on the number of tablets missed and the proximity to the 7-day break;
- second week: the missed dose should be taken as soon as possible, up to the simultaneous administration of 2 tablets. Then the drug is taken at the usual time. If in the previous 7 days there was no missed pill, there is no need for additional methods of contraception. If you miss at least 1 pill, an additional method of contraception is needed not for the next 7 days;
- third week: if in the previous 7 days there was no missed pills, there is no need for additional methods of contraception; otherwise, it is necessary, or you should take the drug as soon as possible and continue taking it as usual, and then start a new package without interruption, or stop taking the pills for 7 days (including the missed days) and then continue taking from the new package.
To delay withdrawal bleeding, you should not take a break from taking Midiana, but start taking the next package immediately after the previous one. The delay can last until the end of taking the tablets from 2 packs. In this case, spotting is possible, as well as the risk of breakthrough uterine bleeding. After a 7-day break, the drug is continued from a new package. To delay the onset of withdrawal bleeding, you should shorten the next break in taking the drug for the required number of days. However, the shorter this break, the higher the risk of no withdrawal bleeding and the appearance of spotting discharge and breakthrough uterine bleeding while taking the tablets from the second package.
In case of severe reactions from the gastrointestinal tract, incomplete absorption of the drug is possible, and therefore, in this case, additional contraceptive measures are necessary. If vomiting occurs within 3-4 hours after taking the pill, take a new pill as soon as possible.
In the case when you plan to continue the usual Midiana regimen, the additional tablet (s) should be taken from another package.
Side effects
- nervous system: depression, emotional lability, headache, decreased or increased libido;
- endocrine system: failure of the menstrual cycle, pain in the mammary glands, intermenstrual bleeding, discharge from the mammary glands;
- sensory organs: hearing loss, poor tolerance of contact lenses;
- digestive system: abdominal pain, nausea, diarrhea, vomiting;
- skin and subcutaneous tissue: eczema, acne, skin rash, urticaria, erythema nodosum and multiforme, pruritus, chloasma;
- vascular system: migraine, increase or decrease in blood pressure, thrombosis (arterial and venous), thromboembolism;
- systemic and local reactions: weight gain, fluid retention, weight loss;
- immune system: bronchospasm;
- reproductive system and mammary gland: vaginal candidiasis, acyclic vaginal bleeding (spotting or breakthrough uterine bleeding), pain, engorgement, breast enlargement, vaginitis, breast discharge, increased vaginal discharge.
Overdose
There is no data on overdose of drospirenone and ethinyl estradiol. However, the occurrence of nausea, vomiting and spotting or bleeding from the vagina is possible. In such cases, symptomatic therapy is recommended.
special instructions
It is necessary to weigh the benefit / risk ratio if the patient has the risk factors described below. When one of these conditions intensifies or appears for the first time, a doctor's consultation is recommended:
- violation of the circulatory system: the risk of venous thromboembolism (VTE) in patients taking Midiana is slightly higher than in women who do not use hormonal contraceptives, but lower than in pregnant women. The risk of VTE is especially increased during the first year of Midiana's use. VTE is fatal in 1–2% of cases. There is also a small risk of thromboembolism in the arteries and other blood vessels. However, a causal relationship between the occurrence of these side effects with the use of combined oral contraceptives has not been proven. Symptoms of thrombosis or thromboembolism of veins and arteries: one-sided pain or swelling of the limb, sudden severe chest pain, shortness of breath, coughing fit, unusually prolonged headache, sudden loss of vision (partial or complete), diplopia, aphasia, slurred speech, dizziness,loss of consciousness with or without a seizure, weakness, loss of sensation in one part of the body (very significant), movement disorders, signs of an acute abdomen. The risk of thrombosis and thromboembolism is increased in the presence of the following risk factors: age, presence of thromboembolism in relatives, prolonged immobilization, obesity, smoking (especially over the age of 35), dyslipoproteinemia, arterial hypertension, migraine, heart valve disease, atrial fibrillation. The presence of one or more of these factors may be a contraindication to taking Midiana;the presence of thromboembolism in relatives, prolonged immobilization, obesity, smoking (especially over the age of 35), dyslipoproteinemia, arterial hypertension, migraine, heart valve disease, atrial fibrillation. The presence of one or more of these factors may be a contraindication to taking Midiana;the presence of thromboembolism in relatives, prolonged immobilization, obesity, smoking (especially over the age of 35), dyslipoproteinemia, arterial hypertension, migraine, heart valve disease, atrial fibrillation. The presence of one or more of these factors may be a contraindication to taking Midiana;
- tumors: some studies indicate an increased risk of cervical cancer with long-term use of combined oral contraceptives. A meta-analysis of 54 epidemiological studies showed that they slightly increased the relative risk of developing breast cancer. This risk decreases for 10 years after their withdrawal. The clinical manifestations of breast cancer in patients who have ever taken combined oral contraceptives were less pronounced than in women who have never taken them. Rarely, against the background of their intake, the development of benign liver tumors was noted, even more rarely - malignant ones. Sometimes this resulted in life-threatening intra-abdominal bleeding. Symptoms of this complication: severe pain in the upper abdomen,enlarged liver or signs of intra-abdominal bleeding;
- other conditions: Midiana is able to slightly retain potassium due to the progesterone component, which is an aldosterone antagonist, especially in patients with mild or moderate renal failure and the simultaneous administration of potassium-inhibiting drugs. In this group of patients in the first cycle of taking the drug, it is recommended to keep the level of potassium in the blood serum under control. Women with hypertriglyceridemia (including family history) are at risk of developing pancreatitis while taking Midiana. In rare cases, a significant, long-term increase in blood pressure that does not respond to antihypertensive therapy, requiring discontinuation of the drug, is possible. In the presence of hereditary angioedema, there is a risk of increased symptoms. With diabetes mellitus, patients need close medical supervision,especially at the beginning of the Midiana intake. There are reports of an increase in endogenous depression, epilepsy, ulcerative colitis and Crohn's disease while taking combined oral contraceptives.
Before taking Midiana, you should undergo a medical examination. Further observation and the frequency of medical examinations are established on an individual basis, but at least 1 time in 6 months. The drug does not protect against sexually transmitted diseases, including HIV infection.
Reception of Midiana can cause an irregularity of the cycle, in this regard, the assessment of the regularity of bleeding can be objective only after three cycles of taking the drug.
The absence of withdrawal bleeding twice in a row is the reason for conducting studies in order to exclude / confirm the onset of pregnancy.
Influence on the ability to drive vehicles and complex mechanisms
There have been no studies of the influence of Midiana on the ability to drive vehicles and other complex mechanisms that require the speed of psychomotor reactions.
Application during pregnancy and lactation
The use of Midian tablets during pregnancy and breastfeeding is contraindicated. When pregnancy occurs while taking the drug, you should immediately stop using it.
For violations of liver function
Acute or chronic liver dysfunctions require discontinuation of Midiana until the indicators return to normal.
Drug interactions
- phenytoin, barbiturates, carbamazepine, primidone, rifampicin, oxcarbazepine, topiramate, ritonavir, felbamate, griseofulvin, St. John's wort: an increase in the clearance of sex hormones due to the induction of microsomal enzymes is possible;
- ritonavir and other HIV protease inhibitors, non-nucleoside reverse transcriptase inhibitors (eg, nevirapine): have an effect on hepatic metabolism;
- antibiotics of the tetracycline and penicillin series: can cause a decrease in the concentration of ethinyl estradiol by reducing the intestinal-hepatic recirculation of estrogen.
When using Midiana with the above drugs, it is recommended to use an additional barrier method of contraception, or switch to using other contraceptives. When using drugs containing active substances that affect liver microsomal enzymes (and within 28 days after their cancellation), as well as antibiotics (and within 7 days after their cancellation), you should additionally use a non-hormonal method of contraception (except for griseofulvin and rifampicin) …
Taking the drug can affect the metabolism of drugs taken simultaneously:
- cyclosporine: the plasma concentration of Midiana increases;
- lamotrigine: decreases the plasma concentration of Midiana;
- renin: its activity is increased.
Analogs
The analogues of Midiana are: Yarina, Simitsia, Anabella, Vidora, Jess, Dimia, Leia, Model Trend, Yamera.
Terms and conditions of storage
Store away from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Midian
Reviews about Midian on the network are mostly positive, among the advantages of the drug they note the lack of its effect on the skin, weight and libido, a high degree of reliability. The main disadvantage is that Midiana can not be found in all pharmacies. In addition, some patients pay attention to severe addiction, complicated by headaches, gastrointestinal disorders, etc.
Price for Midiana in pharmacies
The approximate price for Midiana is 740 rubles. per pack containing 21 tablets.
Midiana: prices in online pharmacies
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Drug name Price Pharmacy |
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Midiana 3 mg + 30 mcg film-coated tablets 21 pcs. RUB 400 Buy |
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Midiana tablets p.p. 21 pcs. RUB 690 Buy |
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Midiana 3 mg + 30 mcg film-coated tablets 63 pcs. 1673 RUB Buy |
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Midiana tablets p.p. 63 pcs. 1794 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
