Combined oral contraceptives, when taken correctly, are the most reliable way contraception. In addition, such drugs incorporate female sex hormones in a strictly adjusted, small dosage. And this allows you to solve many women's health problems, improve the condition of the skin, hair and nails.
Dimia is a modern, multi-phase contraceptive that has received a lot of positive feedback. What features does the drug have, according to what scheme should the tablets be used, and who should refrain from using OK?
The contraceptive drug has the form of round, white and green tablets with the marker "G73", is available in a blister pack of 28 pieces. Released by doctor's prescription.
White tablets contain the following components:
The green pills are placebo. Contain:
Self-medication, in particular, improper use of the medication, can cause side effects or reduce the contraceptive function of the drug.
Dimia is, first of all, an effective contraceptive. He can be prescribed by a doctor as nulliparous, and artificially terminated pregnancy in the first and second trimesters. It is also recommended for women who have given birth and who are not breastfeeding.
In addition to its direct purpose (protection against unwanted pregnancy), the drug can be prescribed to girls of reproductive age for the treatment of acne, seborrhea, severe dysmenorrhea. In addition, taking COCs reduces the likelihood of developing:
Tablets are prescribed to women who have undergone or have a predisposition to ectopic pregnancy. Also suffering from infertility (increase the likelihood of fertilization after stopping the use of COCs).
It should be borne in mind that the body of each woman has its own characteristics. Therefore, before using a contraceptive, it is imperative to pass all the necessary tests for the tolerance of the components of the medication. It will be a good idea to take a complete medical history and consult with the attending gynecologist.
Taking contraceptive pills Dimia can have unpleasant consequences if the dosage of the drug is incorrectly selected, the patient regularly violates the medication regimen. The most common side effects of COC use are: dizziness, nausea, sleep disturbance, loss of consciousness, increased pressure, depression, depression, bleeding from the nasal cavity. The more severe ones are:
Cases of drug intoxication from taking Dimia were not registered. But potential syndromes of drug use in excess of the norm (based on other COCs) can be: nausea, vomiting, minor vaginal blood excretion.
Like most OKs, Dimia contraceptives should not be used during pregnancy or breastfeeding. This is due to the fact that an increased concentration of hormones can adversely affect the natural development of the fetus. Also, the active substances in the composition of the product can not only reduce its amount, but also change the composition.
Contraindications to the use of contraception is the presence of a woman:
Be sure to consult with your doctor to prescribe the most effective dosage of Dimia birth control pills in the presence of work-related diseases:
In addition, women in the postnatal period should be treated with special care and caution when using Dimia. Also, with caution, the remedy is prescribed to those who have undergone diseases provoked by pregnancy or the use of hormone-containing drugs (herpes, jaundice, porphyrin disease, etc.).
Women suffering from obesity, tobacco intoxication, and heart pathologies have an increased risk of side effects.
Reception Dimia is designed for 28 days, during which a woman should take one tablet (alternating active and placebo) every day. It is approximately necessary at the same time, drinking plenty of clean, non-carbonated water. After the package is over, you need to start taking a new one immediately, without taking breaks. The use of medicines from one blister should not be interrupted for more than one week (7 days).
The adaptation period (for primary and secondary), but after a significant break in the use of a contraceptive, averages up to three months.
If after this period the use of contraceptives is accompanied by unpleasant sensations, then you should contact your doctor to adjust the regimen or a new appointment.
Reacting with others medicines, Dimia's effectiveness can either be reduced or increased. Thus, a decrease in the main function of the contraceptive is observed with the simultaneous use of antibiotics (especially ampicillin, tetracycline).
Strengthen the process of metabolism of active substances OK can:
At the same time, the rapid metabolism of OC active substances is prevented by:
In addition, COCs can also affect the level of concentration of drugs in the blood. So, the drug is capable of:
Dimia is great contraceptive drug, but even it must be taken with the permission of the gynecologist.
In this article, you can read the instructions for using the drug Dimia. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of the hormonal contraceptive Dimia in their practice are presented. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Dimia in the presence of existing structural analogues. Use for contraception in women and the prevention of unwanted pregnancy, as well as during breastfeeding. The composition of the drug.
Dimia- is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol. According to its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by a pronounced antiandrogenic and moderate antimineralocorticoid action. The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secretion and changes in the endometrium. The Pearl Index, an indicator that reflects the frequency of pregnancy in 100 women of reproductive age during the year of using a contraceptive, is less than 1.
Compound
Ethinylestradiol + Drospirenone + excipients.
Pharmacokinetics
Drospirenone
When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability - 76-85%. Simultaneous administration with food does not affect the bioavailability of drospirenone. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (transcortin). Only 3-5% of the total serum concentration of drospirenone exists as free steroids. Drospirenone is extensively metabolized after oral administration. Drospirenone is excreted only in trace amounts unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines with an excretion ratio of about 1.2:1.4.
Ethinylestradiol
When taken orally, ethinylestradiol is absorbed rapidly and completely. Absolute bioavailability as a result of first-pass conjugation and first-pass metabolism is approximately 60%. Simultaneous food intake reduced the bioavailability of ethinylestradiol in approximately 25% of the examined patients; there were no other changes. Ethinylestradiol is a substrate for presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, producing a wide range of hydroxylated and methylated metabolites, which are present both in free form and as conjugates with glucuronic acid. Unchanged ethinylestradiol is practically not excreted from the body. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6.
Indications
Release forms
Film-coated tablets in a blister of 24 pieces white color and 4 pieces of green (total 28 tablets).
Instructions for use and regimen
The tablets should be taken daily, at about the same time, with a small amount of water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days, 1 tablet per day. Taking pills from the next pack begins after taking the last pill from the previous pack. "Withdrawal" bleeding usually begins 2-3 days after the start of placebo tablets (last row) and does not necessarily end by the start of the next pack.
How to start taking Dimia
If hormonal contraceptives have not been used in the last month, Dimia is started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). The start of the reception is also possible on the 2nd-5th day of the menstrual cycle, in this case it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.
Switching from other combined contraceptives (combined oral contraceptive pills, vaginal ring, or transdermal patch)
Dimia should be started the next day after taking the last inactive tablet (for preparations containing 28 tablets) or the day after taking the last active tablet from the previous package (possibly the next day after the end of the usual 7-day break) - for drugs containing 21 tablets per pack. In the case of a woman using a vaginal ring or transdermal patch, it is preferable to start taking Dimia on the day of their removal or, at the latest, on the day when a new ring or patch is planned to be inserted.
Switching from progestogen-only contraceptives (mini-pills, injections, implants) or from a progestogen-releasing intrauterine system (IUD)
A woman can switch from taking a mini-pill to taking Dimia on any day (from an implant or from an IUD on the day of their removal, from injectable forms of drugs on the day the next injection was due), but in all cases it is necessary to use additionally barrier method of contraception during the first 7 days of taking the pills.
After an abortion in the 1st trimester of pregnancy
Dimia can be started on the day of termination of pregnancy as prescribed by the doctor. In this case, the woman does not need to take additional contraceptive measures.
After childbirth or abortion in the 2nd trimester of pregnancy
A woman is recommended to start taking the drug on the 21-28th day after childbirth (provided that she is not breastfeeding) or abortion in the 2nd trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception during the first 7 days after starting Dimia. With the resumption of sexual activity (before taking Dimia), pregnancy should be excluded.
Taking missed pills
Missing a placebo tablet from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The indications below apply only to missed tablets containing the active ingredients.
If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible (as soon as she remembers) and the next pill at the usual time.
If the delay exceeds 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:
Accordingly, women can be given the following recommendations:
Days 1-7
A woman should take the missed pill as soon as she remembers, even if it means taking two pills at the same time. Then she should take her tablets at the usual time. Also, a barrier method such as a condom should be used for the next 7 days. If sexual intercourse has occurred in the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer this pass is to the 7-day break in taking the drug, the higher the risk of pregnancy.
Days 8-14
The woman should take the missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take her tablets at the usual time. If during the 7 days preceding the first missed pill, the woman took the pills as expected, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception (barrier - for example, a condom) is needed for 7 days.
Days 15-24
The reliability of the method inevitably declines as the placebo pill phase approaches. However, correcting the pill regimen can still help prevent pregnancy. If one of the two schemes described below is followed, and if the woman has observed the drug regimen in the previous 7 days before skipping the pill, there will be no need to use additional contraceptive measures. If this is not the case, she must complete the first of the two regimens and use additional precautions for the next 7 days.
1. A woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take the tablets at the usual time until the active tablets run out. 4 placebo tablets from the last row should not be taken, you must immediately start taking the tablets from the next blister pack. Most likely, there will be no "withdrawal" bleeding until the end of the second package, but "spotting" may be observed. bloody issues or "withdrawal" bleeding on the days of taking the drug from the second pack.
2. A woman can also stop taking active tablets from the started package. Instead, she should take the placebo pills from the last row for 4 days, including the days she skipped pills, and then start taking the pills from the next pack.
If a woman misses a pill and does not subsequently experience "withdrawal" bleeding in the placebo pill phase, the possibility of pregnancy should be considered.
The use of the drug in gastrointestinal upset
In case of severe gastrointestinal disturbances (eg, vomiting or diarrhea), the absorption of the drug will be incomplete and additional contraceptive measures will be required. If vomiting occurs within 3-4 hours after taking the active tablet, a new (replacement) tablet should be taken as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual tablet-taking time. If more than 12 hours have passed, it is recommended to proceed according to the instructions for skipping tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from another pack.
Postponement of menstrual bleeding "withdrawal"
To delay bleeding, the woman should skip taking the placebo tablets from the started package and start taking the drospirenone + ethinyl estradiol tablets from the new package. The delay can be extended until the active tablets in the second pack run out. During the delay, a woman may experience acyclic profuse or spotting bleeding from the vagina. Regular intake of Dimia is resumed after the placebo phase.
To shift bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When the cycle is shortened, it is more likely that a woman will not have menstrual-like "withdrawal" bleeding, but will have acyclic profuse or spotting bleeding from the vagina when taking the next pack (same as with lengthening the cycle).
Side effect
Contraindications
Dimia, like other combined oral contraceptives, is contraindicated in any of the following conditions:
Carefully
Use during pregnancy and lactation
Dimia is contraindicated during pregnancy.
If pregnancy occurs while using Dimia, it should be discontinued immediately. Extended epidemiological studies have found neither an increased risk of birth defects in children born to women who took combined oral contraceptives (COCs) before pregnancy, nor a teratogenic effect of COCs when they are inadvertently taken during pregnancy.
According to preclinical studies, undesirable effects that affect the course of pregnancy and fetal development due to the hormonal action of the active components cannot be ruled out.
Dimia can affect lactation: reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk during COC use. These amounts may affect the child. The use of the drug Dimia during breastfeeding is contraindicated.
Use in children
The use of the drug before the establishment of menarche is not indicated.
special instructions
If there are any of the conditions/risk factors mentioned below, the benefits of taking COCs should be assessed individually for each woman and discussed with her before starting use. If an adverse event worsens or if any of these conditions or risk factors appear, the woman should contact her doctor. The doctor must decide whether to stop taking the COC.
Circulatory disorders
Reception of any combination oral contraceptive increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year of a woman's use of a combined oral contraceptive.
Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogen (< 0.05 мг этинилэстрадиола) в составе комбинированного перорального контрацептива, составляет примерно 20 случаев на 100 000 женщин-лет (для левоноргестрелсодержащих КПК "второго поколения") или 40 случаев на 100 000 женщин-лет (для дезогестрел/гестоденсодержащих КПК "третьего поколения"). У женщин, не пользующихся КПК, случается 5-10 ВТЭ и 60 беременностей на 100 000 женщин-лет. ВТЭ фатальна в 1-2% случаев.
Data from a large, prospective, 3-way study showed that the incidence of VTE in women with or without other risk factors for venous thromboembolism, who used the combination of ethinylestradiol and drospirenone, 0.03 mg + 3 mg, coincided with the frequency of VTE in women who used levonorgestrel-containing oral contraceptives and other PDAs. The degree of risk of venous thromboembolism when taking the drug Dimia is not currently established.
Epidemiological studies have also found an association between COC use and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).
Very rarely, thrombosis of other blood vessels, such as veins and arteries of the liver, mesentery, kidneys, brain or retina, has occurred in women taking oral contraceptives. There is no consensus regarding the relationship of these phenomena with the use of hormonal contraceptives.
Symptoms of venous or arterial thrombotic / thromboembolic events or acute disorders of cerebral circulation:
A woman should consult with a specialist before taking COCs.
The risk of venous thromboembolic disorders when taking COCs increases with:
The risk of arterial thromboembolic complications or acute cerebrovascular accident when taking COCs increases with:
The presence of one major risk factor for venous disease or multiple risk factors for arterial disease may also be a contraindication. Anticoagulant therapy should also be considered. Women taking COCs should be properly instructed to inform their physician if symptoms of thrombosis are suspected. If thrombosis is suspected or confirmed, COC use should be discontinued. It is necessary to start adequate alternative contraception due to the teratogenicity of anticoagulant therapy (indirect anticoagulants - coumarin derivatives).
An increased risk of thromboembolism in the postpartum period should be taken into account.
Other medical conditions associated with adverse vascular events include 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 or severity of migraine while taking COCs may be an indication for the immediate abolition of combined oral contraceptives.
Tumors
The most significant risk factor for developing cervical cancer is infection with the human papillomavirus. Some epidemiological studies have reported an increased risk of cervical cancer with long-term use of combined oral contraceptives, but conflicting opinions remain as to the extent to which these findings relate to concomitant factors, such as testing for cervical cancer or the use of barrier methods of contraception.
A meta-analysis of 54 epidemiological studies found a slight increase in the relative risk (RR = 1.24) of breast cancer in women who currently take COCs. The risk gradually decreases over 10 years after stopping COCs. Since breast cancer rarely develops in women under 40 years of age, an increase in the number of diagnosed cases of breast cancer in COC users has little effect on the overall likelihood of developing breast cancer. These studies did not find sufficient evidence of a causal relationship. The increased risk may be due to earlier diagnosis of breast cancer in COC users, the biological effects of COCs, or a combination of both. Diagnosed breast cancer in women who have ever taken COCs was clinically less severe, due to the early diagnosis of the disease.
Rarely, benign liver tumors and, even more rarely, malignant liver tumors have occurred in women taking COCs. In some cases, these tumors were life-threatening due to intra-abdominal bleeding. This should be taken into account when making a differential diagnosis in case of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.
Other states
The progestogen component of Dimia is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in potassium content is not expected. However, in a clinical study in some patients with mild to moderate kidney disease who were taking potassium-sparing drugs, serum potassium increased slightly while taking drospirenone. Therefore, it is recommended to monitor serum potassium levels during the first cycle of treatment in patients with renal insufficiency in whom serum potassium levels were at the upper limit of normal before treatment and, especially, while taking potassium-sparing drugs.
In women with hypertriglyceridemia or a hereditary predisposition to it, the risk of pancreatitis may be increased when taking COCs.
Although a slight increase in blood pressure has been observed in many women taking COCs, a clinically significant increase was rare. Only in these rare cases is immediate discontinuation of COCs warranted. If, when taking COCs in patients with concomitant arterial hypertension, blood pressure constantly increases or significantly elevated blood pressure cannot be corrected with antihypertensive drugs, COCs should be discontinued. After normalization of blood pressure with antihypertensive drugs, COCs can be resumed.
The following diseases appeared or worsened both during pregnancy and when taking COCs, but the evidence for their relationship with taking COCs is inconclusive: jaundice and / or itching associated with cholestasis, gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; rheumatic chorea (Sydenham's chorea); herpes during pregnancy; otosclerosis with hearing loss.
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of edema.
Acute or chronic liver disease may be an indication to discontinue COC use until liver function tests return to normal. Recurrence of cholestatic jaundice and/or cholestasis-associated pruritus, which developed during a previous pregnancy or with earlier use of sex hormones, is an indication for discontinuation of COCs.
Although COCs may affect peripheral insulin resistance and glucose tolerance, changing the treatment regimen in patients with diabetes mellitus while taking low-hormone COCs (containing< 0.05 мг этинилэстрадиола) не показано. Однако следует внимательно наблюдать женщин с сахарным диабетом, особенно на ранних стадиях приема КПК.
Exacerbation of endogenous depression, epilepsy, Crohn's disease, and ulcerative colitis has been observed during COC use.
Chloasma may occur from time to time, especially in women who have a history of chloasma of pregnancy. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet light while taking COCs.
Drospirenone + ethinyl estradiol coated tablets contain 48.53 mg lactose monohydrate, placebo tablets contain 37.26 mg anhydrous lactose per tablet. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should not take this medicine.
Women who are allergic to soy lecithin may experience allergic reactions.
The efficacy and safety of Dimia as a contraceptive have been studied in women of reproductive age. It is assumed that in the post-pubertal period up to 18 years, the efficacy and safety of the drug are similar to those in women after 18 years. The use of the drug before the establishment of menarche is not indicated.
Medical examinations
Before starting or re-using Dimia, a complete medical history (including family history) should be taken and pregnancy should be ruled out. It is necessary to measure blood pressure, conduct a medical examination, guided by contraindications and precautions. A woman needs to be reminded of the need to carefully read the instructions for use and adhere to the recommendations indicated in it. The frequency and content of the survey should be based on existing practice guidelines. The frequency of medical examinations is individual for each woman, but should be carried out at least once every 6 months.
Women need to be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of the COC may decrease, for example, if you skip taking drospirenone + ethinylestradiol tablets, gastrointestinal disorders during the period of taking drospirenone + ethinylestradiol tablets, or while taking other drugs.
Insufficient cycle control
As with other COCs, a woman may experience acyclic bleeding (spotting or "withdrawal" bleeding), especially in the first months of taking it. Therefore, any irregular bleeding should be assessed after a three-month adjustment period.
If acyclic bleeding recurs or begins after several regular cycles, the possibility of developing non-hormonal disorders should be considered and measures should be taken to exclude pregnancy or cancer, including therapeutic and diagnostic curettage of the uterine cavity.
Some women do not experience "withdrawal" bleeding during the placebo phase. If the COC was taken in accordance with the instructions for use, then it is unlikely that the woman is pregnant. However, if the rules of admission were violated before the first missed menstrual-like "withdrawal" bleeding, or if two bleedings are missed, pregnancy should be excluded before continuing to take COCs.
Influence on the ability to drive vehicles and control mechanisms
Not found.
drug interaction
Influence of others medicines for Dimia
Interactions between oral contraceptives and other medicinal products may result in acyclic bleeding and/or contraceptive failure. The interactions described below are reflected in the scientific literature.
The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations of St. John's wort (Hypericum perforatum) is based on the ability of these active substances to induce microsomal liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy.
Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is not clear.
Women with short-term treatment (up to one week) with any of the above groups of drugs or single drugs should temporarily use (during the period of simultaneous use of other drugs and for another 7 days after its completion), in addition to PDA, barrier methods of contraception.
Women receiving rifampicin therapy, in addition to taking COCs, should use a barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medications last longer than the expiration date of the active tablets in the package, the inactive tablets should be discontinued and the drospirenone + ethinyl estradiol tablets from the next package should be started immediately.
If a woman is constantly taking drugs - inducers of microsomal liver enzymes, she should use other reliable non-hormonal methods of contraception.
The main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system. Cytochrome P450 inhibitors are therefore unlikely to interfere with the metabolism of drospirenone.
Effect of Dimia on other medicinal products
Oral contraceptives may affect the metabolism of some other active substances. Accordingly, plasma or tissue concentrations of these substances may either increase (eg, cyclosporine) or decrease (eg, lamotrigine).
Other interactions
In patients without kidney failure the simultaneous use of drospirenone and ACE inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) does not significantly affect the content of potassium in the blood serum. Nevertheless, the simultaneous use of Dimia with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, during the first cycle of treatment, it is necessary to control the concentration of serum potassium.
Laboratory tests
Taking contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein (transporter) concentrations, such as corticosteroid-binding proteins and lipid / lipoprotein fractions, parameters of carbohydrate metabolism and parameters of blood clotting and fibrinolysis. In general, the changes remain within the range of normal values. Drospirenone is the cause of an increase in plasma renin activity and - due to a small amineralocorticoid activity - reduces the concentration of aldosterone in plasma.
Dimia's analogues
Structural analogues for the active substance:
Analogues by pharmacological group (estrogens and gestagens in combinations):
In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.
white or almost white, round, biconvex, marked "G73" on one side of the tablet, applied by embossing; on a cross section, the core is white or almost white (24 pieces in a blister).
Excipients: lactose monohydrate - 48.53 mg, corn starch - 16.6 mg, pregelatinized corn starch - 9.6 mg, copolymer of macrogol and polyvinyl alcohol - 1.45 mg, magnesium stearate - 0.8 mg.
The composition of the film shell: Opadry II white 85G18490 - 2 mg (polyvinyl alcohol - 0.88 mg, titanium dioxide - 0.403 mg, macrogol 3350 - 0.247 mg, talc - 0.4 mg, soy lecithin - 0.07 mg).
placebo pills
Film-coated tablets green, round, biconvex; on a cross section, the core is white or almost white (4 pieces in a blister).
Excipients: microcrystalline cellulose - 42.39 mg, lactose - 37.26 mg, pregelatinized corn starch - 9 mg, magnesium stearate - 0.9 mg, colloidal silicon dioxide - 0.45 mg.
The composition of the film shell: Opadry II green 85F21389 - 3 mg (polyvinyl alcohol - 1.2 mg, titanium dioxide - 0.7086 mg, macrogol 3350 - 0.606 mg, talc - 0.444 mg, indigo carmine - 0.0177 mg, quinoline yellow dye - 0.0177 mg, iron dye black oxide - 0.003 mg , dye sunset yellow - 0.003 mg).
28 pcs. - blisters (1) - packs of cardboard.
28 pcs. - blisters (3) - packs of cardboard.
Dimia ® is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol. According to its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by a pronounced antiandrogenic and moderate antimineralocorticoid action. The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secretion and changes in the endometrium. The Pearl Index, an indicator that reflects the frequency of pregnancy in 100 women of reproductive age during the year of using a contraceptive, is less than 1.
Drospirenone
Suction
When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. C max drospirenone in serum is about 38 ng / ml and is reached approximately 1-2 hours after a single dose.
Bioavailability - 76-85%. Simultaneous administration with food does not affect the bioavailability of drospirenone.
Distribution
After oral administration, plasma concentrations of drospirenone decreased with a final half-life of 31 hours. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (transcortin). Only 3-5% of the total serum concentration of drospirenone exists as free steroids. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The average apparent V d of drospirenone is 3.7 ± 1.2 l / kg.
During the cycle of treatment C ss max drospirenone in plasma is about 70 ng / ml, it is achieved after 8 days of treatment. Serum concentrations of drospirenone increase approximately 3-fold due to the ratio of the final T 1/2 and dosing interval.
Metabolism
Drospirenone is extensively metabolized after oral administration. The main metabolites in blood plasma are the acidic forms of drospirenone, formed during the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both are formed without the participation of the P450 system. Drospirenone is metabolized to a small extent by CYP3A4 and is able to inhibit this enzyme, as well as CYP1A1, CYP2C9 and CYP2C19 in vitro.
breeding
Renal clearance of drospirenone metabolites in serum is 1.5±0.2 ml/min/kg. Drospirenone is excreted only in trace amounts unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines with an excretion ratio of about 1.2:1.4. T1 / 2 metabolites by the kidneys and through the intestines is about 40 hours.
Ethinylestradiol
Suction
When taken orally, ethinylestradiol is absorbed rapidly and completely. C max in serum is about 33 pg / ml and is achieved within 1-2 hours after a single oral administration. Absolute bioavailability as a result of first-pass conjugation and first-pass metabolism is approximately 60%. Simultaneous food intake reduced the bioavailability of ethinylestradiol in approximately 25% of the examined patients; there were no other changes.
Distribution
Serum concentrations of ethinylestradiol decreased biphasically, in the final distribution phase T 1/2 is approximately 24 hours. Ethinylestradiol binds well, but nonspecifically, to serum albumin (approximately 98.5%) and induces an increase in SHBG serum concentrations. The apparent V d is about 5 l / kg.
C ss is achieved in the second half of the treatment cycle, and the serum concentration of ethinyl estradiol increases by 2-2.3 times.
Metabolism
Ethinylestradiol is a substrate for presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, producing a wide range of hydroxylated and methylated metabolites, which are present both in free form and as conjugates with glucuronic acid. The renal clearance of ethinylestradiol metabolites is approximately 5 ml/min/kg.
breeding
Unchanged ethinylestradiol is practically not excreted from the body. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. T 1/2 metabolites is about 24 hours.
Pharmacokinetics in special clinical situations
In case of impaired renal function
C ss drospirenone in plasma in women with mild renal insufficiency (CC 50-80 ml / min) was comparable to the corresponding indicators in women with normal renal function (CC > 80 ml / min). In women with moderate renal insufficiency (CC from 30 ml / min to 50 ml / min), the plasma concentration of drospirenone was on average 37% higher than in women with normal renal function. Drospirenone was well tolerated in all groups. Drospirenone did not have a clinically significant effect on the content of potassium in the blood serum. Pharmacokinetics in severe renal failure has not been studied.
In violation of liver function
Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment has not been studied.
Oral contraception.
The tablets should be taken daily, at about the same time, with a small amount of water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days, 1 tablet per day. Taking pills from the next pack begins after taking the last pill from the previous pack. "Withdrawal" bleeding usually begins 2-3 days after the start of placebo tablets (last row) and does not necessarily end by the start of the next pack.
How to start taking Dimia ®
If a hormonal contraceptives have not been used in the last month, Dimia ® is started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). The start of the reception is also possible on the 2nd-5th day of the menstrual cycle, in this case it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.
Switching from other combined contraceptives (combined oral contraceptive pills, vaginal ring, or transdermal patch)
Dimia ® should be started the next day after taking the last inactive tablet (for preparations containing 28 tablets) or the day after taking the last active tablet from the previous package (possibly the next day after the end of the usual 7-day break) - for preparations containing 21 tablets per package. In the case of a woman using a vaginal ring or transdermal patch, it is preferable to start taking Dimia ® on the day of their removal or, at the latest, on the day when a new ring or patch is planned to be inserted.
Switching from progestogen-only contraceptives (mini-pills, injections, implants) or from an intrauterine system (IUD) that releases progestogens.
A woman can switch from taking a mini-pill to taking Dimia ® on any day (from an implant or from an IUD on the day they are removed, from injectable forms of drugs on the day the next injection was due), but in all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.
After an abortion in the first trimester of pregnancy
Taking the drug Dimia ® can be started on the doctor's prescription on the day of termination of pregnancy. In this case, the woman does not need to take additional contraceptive measures.
After childbirth or abortion in the second trimester of pregnancy.
A woman is recommended to start taking the drug on the 21-28th day after childbirth (provided that she is not breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception during the first 7 days after starting Dimia ®. With the resumption of sexual activity (before the start of taking the drug Dimia ®), pregnancy should be excluded.
Taking missed pills
Missing a placebo tablet from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The indications below apply only to missed tablets containing the active ingredients.
If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible (as soon as she remembers) and the next pill at the usual time.
If late exceeds 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:
1. Taking pills should never be interrupted for more than 7 days;
2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.
Accordingly, women can be given the following recommendations:
Days 1-7
A woman should take the missed pill as soon as she remembers, even if it means taking two pills at the same time. Then she should take her tablets at the usual time. Also, a barrier method such as a condom should be used for the next 7 days. If sexual intercourse has occurred in the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer this pass is to the 7-day break in taking the drug, the higher the risk of pregnancy.
Days 8-14
The woman should take the missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take her tablets at the usual time. If during the 7 days preceding the first missed pill, the woman took the pills as expected, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception (barrier - for example, a condom) is needed for 7 days.
Days 15-24
The reliability of the method inevitably declines as the placebo pill phase approaches. However, correcting the pill regimen can still help prevent pregnancy. If one of the two schemes described below is followed, and if the woman has observed the drug regimen in the previous 7 days before skipping the pill, there will be no need to use additional contraceptive measures. If this is not the case, she must complete the first of the two regimens and use additional precautions for the next 7 days.
1. A woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take the tablets at the usual time until the active tablets run out. 4 placebo tablets from the last row should not be taken, you must immediately start taking the tablets from the next blister pack. Most likely, there will be no "withdrawal" bleeding until the end of the second pack, but there may be spotting or "withdrawal" bleeding on the days of taking the drug from the second pack.
2. A woman can also stop taking active tablets from the started package. Instead, she should take the placebo pills from the last row for 4 days, including the days she skipped pills, and then start taking the pills from the next pack.
If a woman misses a pill and does not subsequently experience "withdrawal" bleeding in the placebo pill phase, the possibility of pregnancy should be considered.
The use of the drug in gastrointestinal upset
In case of severe gastrointestinal disturbances (eg, vomiting or diarrhea), the absorption of the drug will be incomplete and additional contraceptive measures will be required. If vomiting occurs within 3-4 hours after taking the active tablet, a new (replacement) tablet should be taken as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual tablet-taking time. If more than 12 hours have passed, it is recommended to proceed according to the instructions for skipping tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from another pack.
Postponement of menstrual bleeding "withdrawal"
To delay bleeding, the woman should skip taking the placebo tablets from the started package and start taking the drospirenone + ethinyl estradiol tablets from the new package. The delay can be extended until the active tablets in the second pack run out. During the delay, a woman may experience acyclic profuse or spotting bleeding from the vagina. Regular intake of Dimia ® is resumed after the placebo phase.
To shift bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When the cycle is shortened, it is more likely that a woman will not have menstrual-like "withdrawal" bleeding, but will have acyclic profuse or spotting bleeding from the vagina when taking the next pack (same as with lengthening the cycle).
The following adverse events have been reported while taking Dimia ®:
| Organ system class | Frequent (≥1/100 to | Less frequent (≥1/1000 to | Rare (≥ 1/10,000 to |
| Infections and infestations | candidiasis, incl. oral cavity | ||
| From the blood and lymphatic system | anemia, thrombocytopenia | ||
| From the side of the immune system | allergic reactions | ||
| From the side of metabolism and nutrition | weight gain | increased appetite, anorexia, hyperkalemia, hyponatremia, weight loss | |
| From the side of the psyche | emotional lability | depression, decreased libido, nervousness, drowsiness | anorgasmia, insomnia |
| From the side of the nervous system | headache | dizziness, paresthesia | vertigo, tremor |
| From the organ of vision | conjunctivitis, dryness of the mucous membrane of the eye, visual impairment | ||
| From the side of cardio-vascular system | migraine, phlebeurysm, increase in blood pressure | tachycardia, phlebitis, vascular damage, nose bleed, fainting | |
| From the digestive system | nausea, abdominal pain | vomit, diarrhea | |
| From the side of the liver and biliary tract | pain in the gallbladder cholecystitis | ||
| From the skin and subcutaneous tissue | rash (including acne), itching | chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, skin lesions, skin striae, contact dermatitis, photodermatitis, skin nodules | |
| From the musculoskeletal system | backache, limb pain, muscle cramps | ||
| From the reproductive system and mammary glands | chest pain, no withdrawal bleeding | vaginal candidiasis, pelvic pain, breast enlargement, fibrocystic breast, vaginal discharge, flushes of blood vaginitis, acyclic spotting, painful menstrual bleeding profuse bleeding "withdrawal", scanty menstrual bleeding, dryness of the vaginal mucosa, change in the cytological picture in a Pap smear | painful intercourse, vulvovaginitis, postcoital bleeding, breast cyst, breast hyperplasia, mammary cancer, cervical polyps, endometrial atrophy, ovarian cyst, uterine enlargement |
| General disorders | asthenia, increased sweating, edema (generalized edema, peripheral edema, facial edema) | feeling of discomfort |
Venous thromboembolic diseases;
Arterial thromboembolic diseases;
Tumors of the liver;
Occurrence or exacerbation of conditions for which the association with COC use has not been proven: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine fibroids, porphyria, systemic lupus erythematosus, herpes during a previous pregnancy, rheumatic chorea, hemolytic uremic syndrome, cholestatic jaundice;
Chloasma;
Acute or chronic liver disease may necessitate discontinuation of COCs until liver function tests return to normal;
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate the symptoms of angioedema.
Dimia ® , like other combined oral contraceptives, is contraindicated in any of the following conditions:
Thrombosis (arterial and venous) and thromboembolism at present or in history (including thrombosis, deep vein thrombophlebitis; pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders);
Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;
Multiple or pronounced risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35, obesity with a BMI >30 kg/m 2 ;
Hereditary or acquired predisposition to venous or arterial thrombosis, for example, resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antibodies against phospholipids (presence of antibodies to phospholipids - antibodies to cardiolipin, lupus anticoagulant);
Pancreatitis with severe hypertriglyceridemia at present or in history;
Severe chronic or acute renal failure;
Liver tumor (benign or malignant) at present or in history;
Hormone-dependent malignant neoplasms of the genital organs or breast at present or in history;
Bleeding from the vagina of unknown origin;
Migraine with a history of focal neurological symptoms;
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption, lapp lactase deficiency (lactase deficiency in some peoples of the North);
Pregnancy and suspicion of it;
lactation period;
Hypersensitivity to the drug or any of the components of the drug.
With caution
Risk factors for thrombosis and thromboembolism: smoking before the age of 35, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin);
Diseases in which peripheral circulatory disorders can occur: diabetes mellitus without vascular complications, systemic lupus erythematosus (SLE), hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
Hereditary angioedema;
Hypertriglyceridemia;
Severe liver disease (before normalization of liver function tests);
Diseases that first appeared or worsened during pregnancy or against the background of a previous intake of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy in history, minor chorea (illness Sydenham), chloasma);
postpartum period.
The drug Dimia ® is contraindicated in pregnancy.
If pregnancy occurs during the use of the drug Dimia ® , it should be stopped immediately. Extended epidemiological studies have found neither an increased risk of birth defects in children born to women who took COCs before pregnancy, nor a teratogenic effect of COCs when they were inadvertently taken during pregnancy.
According to preclinical studies, undesirable effects that affect the course of pregnancy and fetal development due to the hormonal action of the active components cannot be excluded.
The drug Dimia ® can affect lactation: reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk during COC use. These amounts may affect the child. The use of the drug Dimia ® during breastfeeding is contraindicated.
Contraindicated:
Existing (or history of) severe liver disease, provided that liver function is not currently normal;
Liver tumor (benign or malignant) at present or in history.
Contraindicated:
Severe chronic or acute renal failure
The use of the drug before the establishment of menarche is not indicated.
If there are any of the conditions/risk factors mentioned below, the benefits of taking COCs should be assessed individually for each woman and discussed with her before starting use. If an adverse event worsens or if any of these conditions or risk factors appear, the woman should contact her doctor. The doctor must decide whether to stop taking the COC.
Circulatory disorders
Taking any combined oral contraceptive increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year of a woman's use of a combined oral contraceptive.
Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogen (
Data from a large, prospective, 3-arm study showed that the incidence of VTE in women with or without other risk factors for venous thromboembolism who used the combination of ethinylestradiol and drospirenone, 0.03 mg + 3 mg, coincided with the frequency of VTE in women who used levonorgestrel-containing oral contraceptives and other handhelds. The degree of risk of venous thromboembolism when taking Dimia ® has not yet been established.
Epidemiological studies have also found an association between COC use and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).
Very rarely, thrombosis of other blood vessels, such as veins and arteries of the liver, mesentery, kidneys, brain or retina, has occurred in women taking oral contraceptives. There is no consensus regarding the relationship of these phenomena with the use of hormonal contraceptives.
Symptoms of venous or arterial thrombotic / thromboembolic events or acute disorders of cerebral circulation:
Unusual unilateral pain and / or swelling of the lower extremities;
Sudden severe chest pain, whether it radiates to the left arm or not;
sudden shortness of breath;
Sudden onset of cough;
any unusual severe prolonged headache;
Sudden partial or complete loss of vision;
Diplopia;
Impaired speech or aphasia;
Vertigo;
Collapse with or without partial epileptic seizures;
Weakness or very noticeable numbness, suddenly affecting one side or one part of the body;
Movement disorders;
Symptom complex "acute" abdomen.
A woman should consult with a specialist before taking COCs.
Risk venous thromboembolic disorders
Increasing age;
Hereditary predisposition (venous thromboembolism ever happened to siblings or parents at a relatively early age);
Prolonged immobilization, advanced surgery, any surgical intervention on the lower extremities or major trauma. In such situations, it is recommended to stop taking the drug (in the case of a planned surgical intervention, at least four weeks in advance) and not resume until two weeks after the full restoration of mobility. If the drug has not been discontinued in advance, anticoagulant treatment should be considered;
Lack of consensus on the possible role of varicose veins and superficial thrombophlebitis in the appearance or exacerbation of venous thrombosis.
Risk arterial thromboembolic complications or acute cerebrovascular accident when taking COC increases with:
Increasing age;
Smoking (women over 35 are strongly advised to stop smoking if they want to take COCs);
Dyslipoproteinemia;
arterial hypertension;
Migraines without focal neurological symptoms;
Obesity (BMI over 30 kg/m2);
Hereditary predisposition (arterial thromboembolism ever in siblings or parents at a relatively early age). If a hereditary predisposition is possible, a woman should consult a specialist before taking COCs;
Damage to the heart valves;
Atrial fibrillation.
The presence of one major risk factor for venous disease or multiple risk factors for arterial disease may also be a contraindication. Anticoagulant therapy should also be considered. Women taking COCs should be properly instructed to inform their physician if symptoms of thrombosis are suspected. If thrombosis is suspected or confirmed, COC use should be discontinued. It is necessary to start adequate alternative contraception due to the teratogenicity of anticoagulant therapy (indirect anticoagulants - coumarin derivatives).
An increased risk of thromboembolism in the postpartum period should be taken into account.
Other medical conditions associated with adverse vascular events include 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 or severity of migraine while taking COCs may be an indication for the immediate abolition of combined oral contraceptives.
Tumors
The most significant risk factor for developing cervical cancer is infection with the human papillomavirus. Some epidemiological studies have reported an increased risk of cervical cancer with long-term use of combined oral contraceptives, but conflicting opinions remain as to the extent to which these findings relate to concomitant factors, such as testing for cervical cancer or the use of barrier methods of contraception.
A meta-analysis of 54 epidemiological studies found a slight increase in the relative risk (RR = 1.24) of breast cancer in women who currently take COCs. The risk gradually decreases over 10 years after stopping COCs. Because breast cancer rarely develops in women under 40 years of age, an increase in the number of diagnosed cases of breast cancer in COC users has little effect on the overall likelihood of breast cancer. These studies did not find sufficient evidence of a causal relationship. The increased risk may be due to earlier diagnosis of breast cancer in COC users, the biological effects of COCs, or a combination of both. Diagnosed breast cancer in women who have ever taken COCs was clinically less severe, due to the early diagnosis of the disease.
Rarely, benign liver tumors and, even more rarely, malignant liver tumors have occurred in women taking COCs. In some cases, these tumors were life-threatening due to intra-abdominal bleeding. This should be taken into account when making a differential diagnosis in case of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.
Other states
The progestogen component of Dimia ® is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in potassium content is not expected. However, in a clinical study in some patients with mild to moderate kidney disease who were taking potassium-sparing drugs, serum potassium increased slightly while taking drospirenone. Therefore, it is recommended to monitor serum potassium levels during the first cycle of treatment in patients with renal insufficiency in whom serum potassium levels were at the upper limit of normal before treatment and, especially, while taking potassium-sparing drugs.
In women with hypertriglyceridemia or a hereditary predisposition to it, the risk of pancreatitis may be increased when taking COCs.
Although a slight increase in blood pressure has been observed in many women taking COCs, a clinically significant increase was rare. Only in these rare cases is immediate discontinuation of COCs warranted. If, when taking COCs in patients with concomitant arterial hypertension, blood pressure constantly increases or
There have been no cases of overdose of Dimia ® yet. Based on the general experience with the use of combined oral contraceptives, potential symptoms overdose can be: nausea, vomiting, slightly pronounced bleeding from the vagina.
Treatment: there are no antidotes. Treatment should be symptomatic.
Effect of other medicinal products on Dimia ®
Interactions between oral contraceptives and other medicinal products may result in acyclic bleeding and/or contraceptive failure. The interactions described below are reflected in the scientific literature.
The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations of St. John's wort (Hypericum perforatum) is based on the ability of these active substances to induce microsomal liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy.
Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is not clear.
Women with short-term treatment (up to one week) with any of the above groups of drugs or single drugs should temporarily use (during the period of simultaneous use of other drugs and for another 7 days after its completion), in addition to PDA, barrier methods of contraception.
Women receiving rifampicin therapy, in addition to taking COCs, should use a barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medications last longer than the expiration date of the active tablets in the package, the inactive tablets should be discontinued and the drospirenone + ethinyl estradiol tablets from the next package should be started immediately.
If a woman is constantly taking drugs - inducers of microsomal liver enzymes, she should use other reliable non-hormonal methods of contraception.
The main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system. Cytochrome P450 inhibitors are therefore unlikely to interfere with the metabolism of drospirenone.
Effect of Dimia ® on other medicinal products
Oral contraceptives may affect the metabolism of some other active substances. Accordingly, plasma or tissue concentrations of these substances may either increase (eg, cyclosporine) or decrease (eg, lamotrigine).
Based on in vitro inhibition and in vivo interaction studies in female volunteers treated with omeprazole, simvastatin and midazolam as a substrate, an effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely.
Other interactions
In patients without renal insufficiency, the simultaneous use of drospirenone and ACE inhibitors or NSAIDs does not significantly affect the content of potassium in the blood serum. But still, the simultaneous use of the drug Dimia ® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, during the first cycle of treatment, it is necessary to control the concentration of serum potassium.
Laboratory tests
Taking contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein (transporter) concentrations, such as corticosteroid-binding proteins and lipid / lipoprotein fractions, parameters of carbohydrate metabolism and parameters of blood clotting and fibrinolysis. In general, the changes remain within the range of normal values. Drospirenone is the cause of an increase in plasma renin activity and - due to a small antimineralocorticoid activity - reduces the concentration of aldosterone in plasma.
The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C. Shelf life - 2 years.
The drug is dispensed by prescription.
Most effective method contraception, which is popular in Western Europe and Russia, is the use of hormonal pills, including estrogen and progestogen.
Currently, many different drugs have been developed with minimal side effects, one of which is Dimia. Reviews about this new drug indicate its good tolerance and the occurrence of side effects in only a small number of women.
The drug contains two types of tablets: 24 tablets containing 0.02 ethinylestradiol and 3 mg of drospirenone, and 4 tablets that are pacifiers. This is done for the convenience of women. The first 24 tablets are taken one every day at a certain time of the day. Women most often set a reminder on their mobile phone. It is the hormones included in its composition that provide a contraceptive effect.
After this, a break in taking the pills is required for the onset of menstruation. 4 placebo tablets allow you to continue taking Dimia. In order not to get confused with taking contraceptives and take pills daily, these pacifiers are used. Thus, the constant use of contraceptives is ensured.
Ethinylestradiol in the composition of the drug supports the proliferation or growth of the endometrium, thereby providing the so-called cycle control - the absence of intermenstrual bleeding when taking Dimia. Doctors' comments indicate that in the absence of a sufficient amount of estradiol in the ovaries while taking any oral contraceptive, synthetic ethinyl estradiol replaces its production.
Drospirenone is a synthetic progestogen, a derivative of spironolactone, which has a number of effects that determine the contraceptive effect of the drug. This is:
Due to the low content of hormones in the preparation, with its correct use, pronounced side effects are not observed. You can find out by reading the reviews. "Dimia" - birth control pills that cause minor unpleasant symptoms:
Each side effect depends on individual intolerance and compliance or non-compliance with the recommendations at the time when Dimia birth control pills are used. Reviews of women say that when taking these pills, general well-being is normalized, skin condition improves - seborrhea and acne disappear, swelling decreases, symptoms of premenstrual tension are eliminated. In the study of blood, a decrease in testosterone is determined and there are normal indicators of the protein and lipid composition of the blood. It was noted that while taking these pills for 3 months, women lost an average of 0.8 kg.
There are absolute and relative contraindications to taking Dimia. Instructions for use (reviews of doctors also warn about this) prohibits the use of the drug for:
It is also not recommended to take the drug if a woman has had a pulmonary embolism. There are relative contraindications in which the appointment of the drug is possible, but it should be done with care after a preliminary examination of the woman. In each case, you should start taking the drug after talking with your doctor.
A woman should be under the supervision of her gynecologist when taking Dimia tablets. Patient reviews testify to this. It is advisable to visit a gynecologist once every six months. In this case, an examination is necessary with the taking of cytological smears, colposcopy, palpation of the mammary glands, control of blood pressure, if necessary, a special examination: ultrasound, biochemical blood test, etc.
Only an obstetrician-gynecologist, taking into account indications and contraindications, establishes the rules for taking Dimia tablets. Reviews of women that the drug can be used and prescribed independently without harm to health cannot be considered true. This can lead to unwanted complications.
The initial intake of an oral contraceptive must be prescribed from the first day of the cycle. If the tablets were taken from day 5 onwards, additional use of other methods of contraception is required.
After an abortion at any time and after a septic interruption, the reception is started immediately on the same day. After childbirth, the drug is not indicated. If there is no lactation, then you can start from day 21.
There are a number of recommendations for patients who take contraceptive pills "Dimia". Reviews indicate that if you follow these tips, then the negative effect of the drug on the body will decrease. Doctors advise:
The drug is produced by the Hungarian company Gedeon Richter. "Jess", "Midiana", "Yarina" are 100% analogues of the contraceptive "Dimia". Instructions, reviews indicate that the composition of these drugs does not differ from the Hungarian drug, the contraceptive effect and side effects are the same, but the price of Dimia is much lower, which is most convenient for women who must take a contraceptive for a year.
It should be noted that the drug "Dimia" is also used to treat certain diseases. Reviews of gynecologists speak of its positive effect in the treatment of such diseases: endometriosis, fibromyoma, polycystic ovary syndrome, iron deficiency anemia in reproductive age, premenstrual syndrome and menstrual cycle dysfunction.
Also, for the prevention of endometrial hyperplastic processes, Dimia tablets are used. Reviews of doctors who prefer this particular drug are positive. After examining patients while taking the drug, they note that in women the thickness of the endometrium is significantly reduced, which reduces the risk of developing oncological lesions of the uterus, as well as the mammary glands.
It is impossible not to say about the positive impact on the reproductive function of Dimia tablets. Reviews of both doctors and patients indicate that after using this drug for three to four months (after discontinuation), a withdrawal syndrome occurs and pregnancy occurs.
In addition, as auxiliary compounds in the composition of the drug there are such substances as: corn starch (16.6 mg.), including pregelatinized (9.6 mg.), magnesium stearate (0.8 mg.) and polyvinyl alcohol copolymer (1.45 mg.).
The drug shell contains a complex of compounds Opadry II 85G18490, which in turn includes substances such as talc, titanium dioxide, as well as soy and macrogol.
As part of the second tablet (so-called placebo ), coated with a green shell contains 37.26 mg. lactose , 42.39 mg. MCC, 0.9 mg. magnesium stearate , 0.45 mg. colloidal silicon dioxide , as well as 9 mg. pregelatinized corn starch .
film sheath placebo pills contains a complex of compounds under the name Opadry II 85F21389 , whose chemical composition is macrogol ,polyvinyl alcohol , talc, quinoline yellow dye , indigo carmine , as well as the Sunset dye.
Dimia tablets containing active substances drospirenone and ethinylestradione have a round biconvex shape. On one side of the tableted medicinal product, the marking “G73” is embossed.
The same round and biconvex shape placebo pills are distinguished by the green color of the shell. One package of the drug contains 28 tablets, which can be packaged in 1 or 3 blisters.
Dimia is a combined drug, which is monophasic contraceptive .
This medicinal product contains ethinylestradiol , as well as drospirenone (substance close to natural origin). The active substances that make up this contraceptive do not have antiglucocorticoid, estrogenic, glucocorticoid abilities , as well as a pronounced moderate antimineralocorticoid and antiandrogenic action .
Its effectiveness contraceptive Dimia achieves through several factors, for example, due to inhibition of ovulation , changes endometrium and raising secretion viscosity located in cervix .
When taken orally drospirenone almost completely and fairly quickly absorbed in the stomach. The maximum concentration of the substance in the blood (Cmax) is reached a maximum of two hours after ingestion contraceptive . After the stage of distribution and metabolism drospirenone be excreted from the body kidneys , a small part of the drug is excreted with the help of intestines .
Active ingredient ethinylestradiol, included in contraceptive, as well as drospirenone is rapidly absorbed and reaches its maximum concentration in the blood after two hours. The compound is excreted from the body intestines and kidneys .
Dimia is used as a contraceptive.
This contraceptive is contraindicated in such conditions as:
Dimia contraceptives should be used with caution when , otorosclerosis, porphyria, chorea minor, thromboembolism, cholelithiasis, as well as in diseases that are accompanied by disorders blood circulation , For example, Crohn's disease , phlebitis , other.
Side effects of Dimia can be expressed in the following ailments from the side genitourinary, nervous, digestive and cardiovascular systems :
In addition, while taking the drug, there may be allergic reactions and expressed in , skin rashes, and . It should be remembered that when using contraceptive , including the drug Dimia, body weight may increase, as well as intolerance to contact lenses, develops chloasma (hyperpigmentation) .
You can read about how to take the drug correctly in the instructions for Dimia. These contraceptives should be taken every day without skipping. Doctors recommend doing this at the same time, always in the order that is usually indicated on the blister. Tocontraceptives Dimia, as well as other similar drugs, should be used continuously for 28 days.
new packaging birth control pills Dimia should be opened only after the end of the previous one. Approximately from the third day from the start of taking the last row of tablets in a blister (placebo period), mild bleeding . If the packaging contraceptive did not end by the end of the month, then they start taking the pills again on the first day menses .
During sexual intercourse during the first seven days of using the drug, additional methods must be used. contraception (barrier). When switching to the use of Dimia after other complex contraceptives , For example, transdermal patch , tablets ,vaginal rings and so on, you should start taking this drug immediately the next day after using the previous method contraception .
When switching to Dimia after using contraceptive , which contain exclusively ( injections, implants, ) or after you can take this drug on any convenient day. However, before using the tablets, you should apply barrier methods of contraception.
As prescribed by the doctor, a woman can start taking these pills on the day after the interruption. pregnancy (, vacuum) . After childbirth it is recommended to wait 28 days and only then resume taking the drug. It is important to note that a missed appointment placebo pills (from the 4th row of the blister) is an insignificant factor.
However, this rule does not apply to tablets containing active substances in their composition. ethinylestradiol and drospirenone . If 12 hours have not passed since the last pill, then the level of contraceptive protection does not decrease. The missed tablet should be taken as soon as possible and the next one at the usual time.
You should not take a break in taking pills for more than 7 days, since this is the amount of time needed to suppress hypothalamic-pituitary ovarian system . For correct use contraceptive you should adhere to the following recommendations:
To avoid unwanted pregnancy if the last of the described situations of skipping the drug occurs, the woman should take the pill as soon as possible to replace the missed one. Next, you should stick to your usual schedule of taking the drug until the active pills run out. As a result of mixing the intake schedule contraceptive , designed for 28 days, will remain in the blister placebo pills which do not need to be accepted.
Most likely, with this variant of normal withdrawal bleeding there will be no contraceptive until the end of the next package, however, I may appear spotting . If the drug is missed between 15 and 24 days of the start of its use, the woman may not return to her usual schedule of use contraceptives and take 4 days (including missed days) placebo pills and then proceed with a new package.
If with this option did not come "withdrawal" bleeding then the possibility of pregnancy should be considered. In the presence of gastrointestinal disorder the effectiveness of the drug is reduced, since the active compounds will not be completely absorbed by the stomach. If, after 4 hours after taking the contraceptive pill, the woman vomited, it is worth immediately taking the second one, i.e. replacement tablet.
If not monthly when taking Dimia, this may signal the onset of pregnancy . It is worth noting that spotting "cancellation" a woman can correct, for example, postpone it on her own by changing the schedule for taking the drug.
For this you can skip placebo pills and immediately start taking tablets containing the active compound from the new package. It is noteworthy that when postponing or shifting withdrawal bleeding may appear acyclic spotting or profuse bleeding .
At the moment, there is no information about cases of overdose of Dimia. However, based on experience with complex contraceptives similar to this drug in case of overdose, symptoms such as nausea, vaginal bleeding, as well as vomit . If these symptoms occur, stop using the drug and consult a doctor for advice.
To avoid weakening the effectiveness of contraceptives, you should not use Dimia in conjunction with drugs that affect liver enzymes , For example, , Primidone, Phenytoin, Oxcarbazepine, Felbamate, barbiturates and others, as well as medicinal products containing in their chemical composition St. John's wort.
On the hepatic metabolism drugs can have a negative effect HIV protease inhibitors and non-nucleoside , as well as their combinations. downgrade estrogen circulation , and consequently, the effectiveness of Dimia occurs while taking and .
For 28 and 7 days (respectively) after taking drugs that affect induction of liver enzymes, as well as antibiotics you should stop using this drug. Contraceptives can affect the effect of some drugs, so before using Dimia, you should carefully read the instructions.
Available by prescription only.
Contraceptives are stored out of the reach of children, at a temperature not exceeding 25 C.
Constant use contraceptives may increase the risk of development. Moreover, this risk is highest in the first year of using a contraceptive. If the following symptoms occur while taking Dimia, you should immediately stop using the drug:
During the use of Dimia, the risk of dangerous thromboembolic disorders occurs significantly when:
When using a contraceptive, be sure to take into account the risk of thromboembolism especially after childbirth , as well as the development of other adverse effects when diabetes mellitus, Crohn's disease, colitis, anemia etc. Women should not start taking the drug without the advice of a doctor, as well as a preliminary medical examination.
It is important to exclude pregnancy . During the use of the contraceptive, "withdrawal" bleeding may occur, so the assessment of the normality of such secretions can be carried out after three months (adaptation period) since the start of the use of birth control pills.
