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Drospirenone, Ethinyl Estradiol

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2019-09-19
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Clinical Pharmacology

Anabella® is a low-dose monophasic combined oral contraceptive pill (COC), which includes ethinyl estradiol and drospirenone (progestogen). The contraceptive effect of Anabella® is based on the interaction of various factors, the most important of which are the suppression of ovulation and an increase in the viscosity of cervical mucus, which makes it difficult for spermatozoa to penetrate the uterus. In therapeutic doses, drospirenone has moderate anti-mineralcorticoid properties: prevents weight gain and the appearance of edema associated with estrogen-induced fluid retention. Drospirenone also has antiandrogenic activity: helps reduce the symptoms of acne (acne), oily skin and hair. This effect of drospirenone is similar to the action of natural progesterone, produced by the female body. This property should be considered when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. If used correctly, the Pearl Index (a measure reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip pills or misuse, the Pearl Index may increase. In women taking COC, the menstrual cycle becomes more regular, less frequent painful menstruation, decreases the intensity and duration of bleeding, which reduces the risk of anemia. In combination with ethinyl estradiol, drospirenone has a beneficial effect on the lipid profile, characterized by an increase in the concentration of high-density lipoproteins (HDL) in blood plasma.

Suggested use

The preparation Anabella is intended for intake daily for 28 days without breaks approximately at the same time, washing down with a small amount of water, in the order indicated on the blister pack. Taking the pills from the new packaging begins the day after taking the last tablet from the previous package. Bleeding "cancellation" usually begins 2-3 days after the start of taking inactive pills (the last row of blister packs) and may not end before taking the pills from the next pack. How to take Anabella® In the absence of taking any hormonal contraceptives in the previous month Anabella® begins on the first day of the menstrual cycle (that is, on the first day of the menstrual bleeding). It is possible to start taking on the 2-5 day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills. When switching from other combined contraceptive drugs (COC, vaginal ring or contraceptive patch) It is preferable to start taking Anabella® the next day after taking the last active pill from the previous package, but in no case no later than the next day after the end of the 7-day break (for drugs containing 21 pills per pack) or after taking the last inactive tablet ( for preparations containing 28 pills per pack). Anabella® should be taken on the day of removal of the vaginal ring or contraceptive patch, but no later than the day when a new patch is to be inserted or a new patch is glued. When switching from contraceptives containing progestogens only ("mini-pili", injection forms, implant or intrauterine therapeutic system, releasing the gestagen) A woman can switch from "mini-pili" to taking Anabella® on any day (without a break), from an implant or intrauterine therapeutic system that releases a gestagen - on the day of removal, from an injectable contraceptive - on the day when the next injection should be given.In all cases, you must additionally use a barrier method of contraception during the first 7 days of taking pills. After termination of pregnancy in the first trimester A woman can start taking Anabella® from the first day after abortion. Subject to this condition, the woman does not need additional contraceptive measures. After childbirth (in the absence of breastfeeding) or abortion in the second trimester It is recommended to start taking Anabella ® on days 21-28 after delivery (in the absence of breastfeeding) or abortion in the second trimester. If the reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. If sexual contact has already occurred before the start of Anabella®, in this case, pregnancy should be excluded or the first menstruation should be waited. Taking missed pills Skipping inactive pills can be ignored. However, they should be thrown away in order not to accidentally extend the period of inactive pills. The following recommendations apply only to skipping active pills (1-3 rows of blister packs): - if the delay in taking the pills was less than 12 hours, contraceptive protection is not reduced. A woman should take a missed pill as soon as possible, subsequent pills should be taken at the usual time; - If the delay in taking the pills was more than 12 hours, contraceptive protection may be reduced. The more pills are missed, and the closer the skip pills to the phase of inactive pills, the higher the probability of pregnancy. In this case, you can follow the following basic rules: - The drug should never be interrupted for more than 7 days; - to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous administration of active pills. Thus, if a delay in taking active pills was more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours), the following can be recommended: The first week of taking the drug A woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. Subsequent pills she continues to take at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual contact occurred within 7 days before the tablet was missed, the possibility of pregnancy should be considered. The more pills were missed, and the closer this pass to the inactive pill intake phase, the higher the risk of pregnancy. Second week of taking the drug A woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. The following pills should be taken at the usual time. Provided that the woman took the pill correctly for the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days. Third week of taking the drug The risk of reducing contraceptive reliability is unavoidable due to the approaching phase of taking inactive pills. If during the 7 days preceding the first missed pill, the woman took the drug correctly, there is no need to use additional methods of contraception. Otherwise, she needs to use the first of the following schemes and additionally use a barrier method of contraception (for example, a condom) within 7 days. 1 option: A woman should take the last missed pill as soon as possible, as soon as she remembers, even if it means taking two pills at the same time. The following pills are taken at the usual time until the active pills in the package run out. Seven inactive pills should be thrown away and immediately start taking the pills from the next package. Most likely, there will be no "withdrawal" bleeding until the active pills in the second pack have run out, but there may be "spotting" discharge and "breakthrough" bleeding while taking the pills. Option 2: A woman can also stop taking the pills from the pack. Then she should take a break of no more than 7 days (or take inactive pills from the bottom row of the blister pack), including the days of missing the pills, and start taking the drug from the new pack. If a woman missed active pills, and subsequently during a break in taking or taking inactive pills, there was no “withdrawal” bleeding, it is necessary to exclude pregnancy. Recommendations for gastrointestinal disorders In severe gastrointestinal disorders (for example, vomiting, diarrhea), the absorption of the drug may be incomplete, therefore additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the active pill, it is necessary to take a new active (replacement) pill as soon as possible. If possible, the next pill should be taken no later than 12 hours after the usual pill intake. If more than 12 hours have passed, it is recommended to act in accordance with the recommendations for taking the missed pills. If a woman does not want to change her usual regimen and transfer the onset of menstrual-like bleeding to another day of the week, an additional active pill should be taken from another package. Postponement of the day of the onset of "withdrawal" bleeding In order to postpone the onset of menstrual bleeding, it is necessary to continue taking the pills from the new Anabella® package without taking inactive pills. The delay can be prolonged until the pills from the second package run out. While taking the drug from the second package, "spotting" bleeding from the vagina or "breakthrough" bleeding is possible. To resume taking the drug Anabella® from the next package should be after the usual intake of inactive pills. In order to postpone the day of the onset of menstrual bleeding to another day of the week, a woman should reduce intake of inactive pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have "withdrawal" bleeding, and in the future there will be "spotting" discharge and "breakthrough" bleeding during the reception of subsequent packaging (just as in the case when she would like to delay the onset of menstrual bleeding). Special categories of patients Kids and teens Use of the drug Anabella® is indicated only after the onset of menarche. Available data do not suggest dose adjustment for this age group. Elderly patients Anabella® is not indicated after menopause. Patients with impaired liver function Anabella® is contraindicated in women with severe liver disease until liver function levels return to normal (see the "Contraindications" and "Pharmacological Properties" sections). Patients with impaired renal function Anabella® is contraindicated in women with severe renal insufficiency or acute renal failure (see the sections "Contraindications" and "Pharmacological properties").

Indications

Contraception (prevention of unwanted pregnancy).

Composition

Each tablet contains: Active ingredients: drospirenone - 3 mg, ethinyl estradiol - 0.03 mg. Excipients core: lactose monohydrate — 70.17 mg, hyprolose — 1.6 mg, polacrilin potassium — 1.6 mg, sodium lauryl sulfate — 3.2 mg, magnesium stearate — 0.4 mg; film shell: Opadry II yellow 85F32771 (macrogol 3350–20.2%, titanium dioxide - 23.7%, polyvinyl alcohol - 40.0%, talc - 14.8%, iron dye yellow oxide - 1.3%) - 2.0 mg. 7 white film-coated pills (placebo) Each tablet contains: Active ingredients: does not contain. Excipients core: lactose monohydrate - 73.4 mg, potassium polacrilin - 1.6 mg, povidone-K30 - 4.00 mg, colloidal silicon dioxide - 0.2 mg, magnesium stearate - 0.80 mg; film coating: Opadry II white 85F18422 (macrogol 3350 - 40.0%. Titanium dioxide - 25.0%, polyvinyl alcohol - 20.2%, talc - 14.8%) - 2.0 mg.

Drospirenone, Ethinyl Estradiol is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Anabella pills
Delcia pills
Leia Sindea Pharma S.L Spain pills
Vidora Laboratories Leon Pharma S.A Spain pills
Model Trend Oman Pharmaceutical Products Co Oman Sultanate pills
Model Pro Oman Pharmaceutical Products Co Oman Sultanate pills
Dimia Gedeon Richter Hungary pills
Midiana Gedeon Richter Hungary pills
Jess Bayer Pharma AG Germany pills
Yarin Bayer Pharma AG Germany pills

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Drospirenone, Ethinyl Estradiol

Dosage and administration

Anabella is intended to be taken orally daily for 28 days without interruption at approximately the same time, with a small amount of water, in the order indicated on the blister pack. Taking pills from a new package begins the day after taking the last pill from the previous package. Withdrawal bleeding usually begins 2–3 days after starting the inactive pill (last row of the blister pack) and may not end before the next pill begins.
How to take Anabella®
In the absence of taking any hormonal contraceptives in the previous month
Taking Anabella® begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is permissible to start taking it on day 2-5 of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills.
When switching from other combined contraceptive drugs (COCs, vaginal ring, or contraceptive patch)
It is preferable to start taking Anabella® the next day after taking the last active tablet from the previous package, but in no case later than the next day after the end of the 7-day break (for preparations containing 21 tablets per package) or after taking the last inactive tablet ( for preparations containing 28 tablets per pack). Taking Anabella® should be started on the day the vaginal ring or contraceptive patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied. When switching from contraceptives containing only progestogens ("mini-pills", injection forms, implant or intrauterine therapeutic system that releases progestogen) A woman can switch from a "mini-pill" to taking Anabella® any day (without interruption), from an implant or intrauterine therapeutic system that releases progestogen - on the day of removal, from an injectable contraceptive - on the day when the next injection is due. In all cases, it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the pills.
After termination of pregnancy in the first trimester
A woman can start taking Anabella® from the first day after termination of pregnancy. If this condition is met, a woman does not need additional contraceptive measures. After childbirth (in the absence of breastfeeding) or termination of pregnancy in the second trimester It is recommended to start taking Anabella® on days 21-28 after childbirth (in the absence of breastfeeding) or termination of pregnancy in the second trimester. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. If sexual intercourse has already occurred before the start of taking Anabella®, in this case, pregnancy should be excluded or until the first menstruation.
Taking missed pills
Skipping inactive pills can be ignored. However, they should be thrown away so as not to accidentally extend the period of taking inactive pills. The following recommendations apply only to skipping active tablets (1-3 rows of blister pack): - if the delay in taking the pills is less than 12 hours, the contraceptive protection is not reduced. The woman should take the missed pill as soon as possible, subsequent pills should be taken at the usual time;< - if the delay in taking the pills is more than 12 hours, contraceptive protection may be reduced. The more pills are missed, and the closer the pills are skipped to the inactive pill phase, the higher the likelihood of pregnancy. In this case, you can be guided by the following basic rules - taking the drug should never be interrupted for more than 7 days; - to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous intake of active tablets are required. Thus, if the delay in taking active pills is more than 12 hours (the interval since taking the last pill is more than 36 hours), the following can be recommended:
The first week of taking the drug
A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. She continues to take subsequent pills at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be considered. The more pills were missed, and the closer this skip to the inactive pill phase, the higher the risk of pregnancy.Second week of taking the drug A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. The following tablets should be taken at the usual time. Provided that the woman took the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days. The third week of taking the drug The risk of reducing the reliability of contraception is inevitable due to the approaching phase of taking inactive pills. If, within 7 days preceding the first missed pill, the woman took the drug correctly, there is no need to use additional methods of contraception. Otherwise, she needs to use the first of the following regimens and additionally use a barrier method of contraception (for example, a condom) for 7 days. Option 1: A woman should take the last missed pill as soon as possible, as soon as she

Adverse reactions

This section presents the different types of adverse reactions according to the classification of the lesions of organs and organ systems of the medical dictionary for MedDRA regulatory activities. The frequency of side effects was determined according to the classification of the World Health Organization (WHO): very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1/100), rarely (≥ 1/10000 and <1/1000) and very rarely (<1/10000), including individual messages. Within each frequency group, undesirable reactions are presented in descending order of their severity. Immune system disorders Seldom: hypersensitivity reactions, bronchial asthma. Mental Disorders Often: low mood. Infrequently: increase in a libido, decrease in a libido. Nervous system disorders Often: headache. Disturbances from an organ of hearing and labyrinth disturbances Seldom: hypoacusia. Vascular disorders Often: migraine. Infrequently: increase in the arterial pressure (BP), decrease in arterial pressure. Rarely: venous thromboembolism (VTE), arterial thromboembolism (ATE). Disorders of the gastrointestinal tract Often: nausea. Infrequently: vomiting, diarrhea. Violations of the skin and subcutaneous tissue Infrequently: acne, eczema, pruritus, alopecia. Rarely: erythema nodosum, erythema multiforme. Disorders of the genitals and breast Often: violation of the menstrual cycle, acyclic bleeding, pain in the mammary glands, engorgement of the mammary glands, vaginal discharge, vulvovaginal candidiasis. Infrequently: increase in mammary glands, vaginitis. Rarely: discharge from the mammary glands. General disorders and disorders at the site of administration Infrequently: fluid retention, change in body weight. Post-registration application data In women taking COCs, the following serious adverse events were noted: VTE, ATE, increased blood pressure, liver tumors, chloasma. The connection with taking COC is not proven when the following diseases appear or worsen: Crohn's disease, ulcerative colitis, epilepsy, uterine myoma, porphyria. systemic lupus erythematosus, herpes in pregnant women, Sydengham chorea, hemolytic-uremic syndrome, cholestatic jaundice. Acute and chronic abnormal liver function can cause the withdrawal of the drug Anabella® as long as the indicators of liver function do not return to normal. COCs may affect peripheral insulin resistance and glucose tolerance. In women with hereditary angioedema, exogenous estrogens can cause the manifestation of the disease or its exacerbation. The frequency of breast cancer diagnostics among women taking COCs is slightly higher compared to women not taking these drugs. Because breast cancer is rare in women younger than 40, this increase is only marginally small in relation to the overall risk of breast cancer in the population. Currently, the causal relationship of breast cancer with the use of COC is not proven.

Anabella® is contraindicated in the presence of any condition indicated below. If any of these conditions / diseases first occur while taking the drug, you should immediately stop taking: - thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, stroke), cerebrovascular disorders (including anamnesis) ; - conditions preceding thrombosis (including transient ischemic attacks, angina) at present or in history; - hereditary or acquired susceptibility to the development of venous or arterial thrombosis, such as resistance to activated protein C; antithrombin III deficiency; protein C deficiency; deficiency of protein S; hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant); - migraine with focal neurological symptoms at present or in history; - Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the cardiac valve apparatus, atrial fibrillation; obesity (body mass index (BMI) of more than 30 kg / m2); diseases of cerebral vessels or coronary arteries; uncontrolled arterial hypertension; severe dyslipoproteinemia; diabetes with vascular complications; serious surgical intervention with prolonged immobilization; extensive injury; air flight lasting more than 4 hours; smoking over the age of 35; - pancreatitis with severe hypertriglyceridemia now or in history; - liver failure, severe liver disease (until normalization of liver test results); - liver tumors (benign or malignant), incl. in the anamnesis; - renal failure severe, acute renal failure; - hormone-dependent malignant neoplasms of the genital or mammary glands at the present time and in history or suspicion of them; - Bleeding from the vagina of unknown origin; - pregnancy or suspicion of it; - breastfeeding period; - Hypersensitivity to any of the components of the drug; - lactose intolerance, lactase deficiency or glucose-galactose malabsorption. Carefully: If a patient has any of the conditions / diseases / risk factors listed below, carefully consider the possible risk and the expected benefits of using Anabella®: - risk factors for thrombosis and thromboembolism: smoking; hereditary predisposition to thrombosis (thrombosis, myocardial infarction, or cerebral circulation at a young age in one of the closest relatives); overweight (BMI not less than 25 and not more than 30 kg / m2); dyslipoproteinemia, controlled arterial hypertension; migraine without focal neurological symptoms; uncomplicated valvular heart disease; other diseases in which disorders of the peripheral circulation can be noted: diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, as well as phlebitis of superficial veins; - hereditary angioedema; - hypertriglyceridemia; - liver disease; - Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice, cholestasis, cholelithiasis, otosclerosis with impairment of hearing, porphyria, herpes of pregnant women, Sydengam's chorea); - postpartum period.

Drug interactions

The interaction of COCs with other drugs can lead to "breakthrough" uterine bleeding and / or a decrease in the reliability of contraception. Women taking these drugs should additionally use barrier methods of contraception or choose another method of contraception during treatment with other drugs. The literature describes the following types of interaction. Impact on hepatic metabolism Taking drugs that induce the activity of cytochrome P450 isoenzymes can lead to a decrease in the concentration of sex hormones in the blood plasma, which in turn can lead to "breakthrough" bleeding or a decrease in contraceptive reliability. These drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, bosentan, and HIV medications (for example, ritonavir, nevirapine), possibly also oxcarbazepine, topiramate, felbamate, zulfofulvin, and Zyrophazepine preparations, and Zyrophaumine, preparations containing Zyrophaemone, Zireptocinum, Zireptocinum, Zireptocinum, Zyroxiamine, Zirconia, Nevirapine, Nevirapine, Zyroxiamine, Zirconia, Zirconia, Zirconia, Zirconia, Nevirapine, Zircon, Zircon, Zircon, Zircon, Zircon. As a rule, the maximum stimulation of the activity of isoenzymes is observed during the first 10 days after the start of the drug intake, but it can last for at least 4 weeks after cessation of drug therapy. When used together with Anabella®, many inhibitors of HIV protease or hepatitis C virus and non-nucleoside reverse transcriptase inhibitors can either increase or decrease the concentration of estrogens or progestins in the blood plasma. In some cases, this effect may be clinically significant. Strong and mild inhibitors of CYP3A4 isoenzyme, such as azole antimycotics (for example, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase plasma concentrations of estrogen or systhistamine. It was shown that etoricoxib in doses of 60 and 120 mg per day when taken together with KOK containing 0.035 mg of ethinyl estradiol, increases the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively. Influence on the enterohepatic regulation According to separate studies, some antibiotics (for example, penicillins and tetracyclines) can decrease the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol in the blood plasma. During administration of drugs that affect the microsomal isoenzymes of the cytochrome P450 system, and within 28 days after their withdrawal, an additional method of contraception should be used. During the reception of antibiotics (such as penicillins and tetracyclines) and within 7 days after their cancellation, you should additionally use a barrier method of contraception. If during these 7 days of the barrier method of contraception the active tablets in the current packaging are finished, then you should start taking the tablets from the next package of the Anabella® preparation without taking the inactive tablets. The major metabolites of drospirenone are formed in the blood plasma without the participation of cytochrome P450 isoenzymes. Therefore, the effect of cytochrome P450 isoenzyme inhibitors on the metabolism of drospirenone is unlikely. COCs can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) of their concentration in blood plasma and tissues. In vitro, drospirenone can weakly or moderately inhibit cytochrome P450 CYP1 Al, CYP2C9, CYP2C19 and CYP3A4 isoenzymes. Based on in vitro drug interaction studies, as well as an in vivo study of female volunteers taking omeprazole, simvastatin, and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other drugs is unlikely. In vitro, ethinylestradiol is a reversible inhibitor of isoenzymes CYP2C19, CYP1A1 and CYP1A2, as well as an irreversible inhibitor of isoenzymes CYP3A4 / 5, CYP2C8 and CYP2J2. In clinical studies, the administration of a hormonal contraceptive containing ethinyl estradiol did not lead to any increase or only led to a slight increase in plasma concentrations of CYP3A4 isoenzyme (eg, midazolam), while plasma concentrations of CYP1A2 isoenzyme may increase slightly (for example, , theophylline) or moderately (for example, melatonin and tizanidine). There is a theoretical possibility of increasing the concentration of potassium in the blood plasma of women receiving the Anabella® drug at the same time as other drugs that may increase the plasma concentration of potassium. These drugs include angiotensin II receptor antagonists, some nonsteroidal anti-inflammatory drugs, potassium-saving diuretics, and aldosterone antagonists. In this case, during the first cycle of administration, it is necessary to control the concentration of potassium in the blood plasma. In studies of the interaction of drospirenone with ACE inhibitors or indomethacin, no significant difference was found between the plasma concentration of potassium compared to placebo. Go

Special instructions

If there are any diseases / conditions / risk factors listed below, you should carefully weigh the possible risks and the expected benefits of using COCs in each individual case and discuss this with the patient before you start taking Anabella®. In the event of the first exacerbation or the occurrence of any of these diseases / conditions / risk factors, the woman should consult with a physician, who may decide to discontinue the drug Diseases of the cardiovascular system The results of epidemiological studies indicate a relationship between the use of COCs and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as DVT, PEH, myocardial infarction, cerebrovascular disorders). These diseases are rare. The risk of VTE is maximum in the first year of taking COC. Increased risk is present after the initial use of drugs or the resumption of use of the same or different COCs (after a break between taking the drug in 4 weeks or more), mainly during the first 3 months. The overall risk of VTE in patients taking low-dose COCs (<50 g="" of="" ethinyl="" estradiol="" is="" two="" to="" three="" times="" higher="" than="" in="" non-pregnant="" patients="" who="" do="" not="" take="" cocs="" however="" this="" risk="" remains="" lower="" compared="" the="" vte="" during="" pregnancy="" and="" childbirth="" can="" be="" life="" threatening="" or="" fatal="" 1-2="" cases="" according="" some="" reports="" drugs="" containing="" drospirenone="" have="" a="" thromboembolic="" complications="" with="" levonorgestrel="" norgestimate="" norethindrone="" manifested="" as="" dvt="" pulmonary="" embolism="" occur="" when="" using="" any="" coc="" thrombosis="" other="" blood="" vessels="" such="" hepatic="" mesenteric="" renal="" cerebral="" veins="" retinal="" arteries="" extremely="" rare="" there="" no="" consensus="" regarding="" relationship="" between="" occurrence="" these="" events="" use="" koc="" symptoms="" include="" one-sided="" swelling="" limb="" along="" vein="" pain="" discomfort="" only="" an="" upright="" position="" walking="" local="" temperature="" increase="" affected="" redness="" discoloration="" skin="" difficulty="" breathing="" rapid="" sudden="" cough="" including="" hemoptysis="" acute="" chest="" which="" may="" worsen="" deep="" breath="" anxiety="" severe="" dizziness="" irregular="" heartbeat="" for="" example="" shortness="" are="" nonspecific="" misinterpreted="" signs="" more="" less="" conditions="" respiratory="" tract="" infections="" ate="" lead="" stroke="" vascular="" occlusion="" myocardial="" infarction="" weakness="" loss="" sensitivity="" face="" upper="" extremities="" especially="" on="" one="" side="" body="" confusion="" speech="" disorders="" aphasia="" two-sided="" vision="" diplopia="" gait="" disturbance="" balance="" coordination="" movements="" prolonged="" headache="" apparent="" reason="" consciousness="" fainting="" without="" epileptic="" seizure="" weak="" blue="" limbs="" abdomen="" pressure="" heaviness="" feeling="" constriction="" distention="" behind="" sternum="" radiating="" back="" jaw="" larynx="" arm="" stomach="" cold="" sweat="" nausea="" vomiting="" women="" combination="" several="" factors="" high="" severity="" them="" possibility="" their="" mutual="" reinforcement="" should="" considered="" total="" value="" existing="" increases="" case="" drug="" anabella="" contraindicated="" see="" section="" contraindications="" venous="" arterial="" thromboembolism="" increases:="" -="" increasing="" age="" smoke="" number="" cigarettes="" over="" 35="" years="" old="" it="" presence="" of:="" obesity="" mass="" index="" 30="" kg="" m2="" dyslipoproteinemia="" hypertension="" migraine="" damage="" valves="" heart="" atrial="" fibrillation="" family="" history="" ever="" close="" relatives="" parents="" at="" relatively="" young="" hereditary="" acquired="" predisposition="" woman="" examined="" by="" appropriate="" specialist="" decide="" immobilization="" serious="" surgery="" operation="" extensive="" trauma="" reception="" stopped="" planned="" least="" 4="" weeks="" before="" does="" resume="" even="" 2="" after="" restoration="" full="" mobility="" if="" necessary="" recommended="" barrier="" methods="" contraception="" temporary="" air="" travel="" lasting="" hours="" also="" factor="" development="" question="" possible="" role="" varicose="" superficial="" thrombophlebitis="" controversial="" peripheral="" circulatory="" diabetes="" mellitus="" systemic="" lupus="" erythematosus="" hemolytic-uremic="" syndrome="" chronic="" inflammatory="" bowel="" disease="" crohn="" s="" ulcerative="" colitis="" sickle="" cell="" anemia="" frequency="" attacks="" precede="" cerebrovascular="" grounds="" immediate="" discontinuation="" biochemical="" indices="" indicating="" susceptibility="" following:="" resistance="" activated="" c-protein="" hyperhomocysteinemia="" antithrombin="" iii="" deficiency="" s-protein="" anti-phospholipid="" antibodies="" anti-cardiolycin="" anti-phosphine="" anti-thrombin="" anti-c-protein="" deficiencies="" assessing="" benefit="" ratio="" borne="" mind="" that="" adequate="" treatment="" corresponding="" condition="" reduce="" associated="" taking="" low-dose="" 50="" tumors="" most="" significant="" cervical="" cancer="" persistent="" papillomavirus="" infection="" connection="" proven="" controversies="" persist="" extent="" findings="" related="" screening="" pathology="" sexual="" behavior="" evidence="" reduction="" endometrial="" ovarian="" meta-analysis="" 54="" epidemiological="" studies="" has="" shown="" slightly="" increased="" relative="" developing="" breast="" diagnosed="" present="" time="" 1="" 24="" gradually="" disappears="" within="" 10="" due="" fact="" rarely="" observed="" under="" 40="" diagnoses="" now="" recently="" taken="" insignificant="" overall="" earlier="" diagnosis="" biological="" effects="" both="" used="" stages="" detected="" never="" against="" background="" benign="" malignant="" liver="" led="" life-threatening="" intra-abdominal="" bleeding="" was="" carrying="" out="" differential="" event="" enlarged="" states="" results="" clinical="" effect="" plasma="" potassium="" concentration="" mild="" moderately="" failure="" theoretical="" hyperkalemia="" impaired="" function="" initial="" limit="" norm="" while="" delay="" nevertheless="" determine="" first="" cycle="" hypertriglyceridemia="" pancreatitis="" although="" small="" been="" described="" many="" clinically="" develops="" canceled="" begin="" continued="" normal="" achieved="" help="" antihypertensive="" therapy="" following="" arise="" aggravated="" but="" proven:="" jaundice="" pruritus="" cholestasis="" formation="" gallstones="" porphyria="" hemolytic="" uremic="" chorea="" herpes="" pregnant="" hearing="" otosclerosis="" forms="" angioedema="" exogenous="" estrogens="" cause="" dysfunction="" require="" until="" returns="" relapse="" cholestatic="" developed="" previous="" intake="" sex="" hormones="" requires="" influence="" insulin="" glucose="" tolerance="" dose="" adjustment="" dosing="" regimen="" hypoglycemic="" usually="" required="" supervision="" endocrinologist="" chloasma="" sometimes="" develop="" predisposed="" avoid="" exposure="" sun="" ultraviolet="" radiation="" medical="" checkup="" starting="" resuming="" familiarize="" conduct="" thorough="" measurement="" rate="" determination="" bmi="" gynecological="" examination="" cytological="" epithelium="" exclude="" amount="" additional="" research="" control="" examinations="" determined="" individually="" typically="" follow-up="" carried="" 6="" months="" warned="" protect="" hiv="" aids="" sexually="" transmitted="" diseases="" you="" tell="" about="" precautions="" laboratory="" tests="" affect="" indicators="" kidney="" thyroid="" adrenal="" glands="" transport="" proteins="" corticosteroids="" binding="" globulin="" lipid="" lipoprotein="" fractions="" carbohydrate="" metabolism="" clotting="" fibrinolysis="" changes="" go="" beyond="" range="" activity="" renin="" content="" aldosterone="" its="" antimineralocorticoid="" reduced="" efficiency="" effectiveness="" cases:="" skip="" pills="" vomit="" diarrhea="" result="" interactions="" insufficient="" menstrual="" spotting="" breakthrough="" appear="" therefore="" evaluated="" period="" adaptation="" approximately="" cycles="" recurs="" regular="" consider="" non-hormonal="" causes="" well="" rule="" diagnostic="" curettage="" break="" active="" experience="" withdrawal="" took="" directed="" unlikely="" she="" irregularly="" row="" were="" excluded="" continuing="" lactose="" tablets="" contain="" intolerance="" lactase="" glucose-galactose="" malabsorption="" impact="" ability="" drive="" trans="" wed="" fur="" :="" negative="" vehicles="" engage="" potentially="" hazardous="" activities="" identified="" p="" gt="" --50--="">

Overdosage

Given the clinical experience with COCs, in the event of an overdose, nausea, vomiting, spotting or metrorrhagia can occur. There is no antidote, symptomatic treatment.

  • Brand name: Anabella
  • Active ingredient: Drospirenone, Ethinyl Estradiol
  • Manufacturer: Synthesis AKOMP

Studies and clinical trials of Drospirenone, Ethinyl Estradiol (Click to expand)

  1. Conventional vs. Extended-Cycle Oral Contraceptives on the Quality of Sexual Life: Comparison between Two Regimens Containing 3 mg Drospirenone and 20 µg Ethinyl Estradiol
  2. Effects of two combined oral contraceptives containing ethinyl estradiol 20 μg combined with either drospirenone or desogestrel on lipids, hemostatic parameters and carbohydrate metabolism
  3. A prospective study on the effects on hemostasis of two oral contraceptives containing drospirenone in combination with either 30 or 20 μg ethinyl estradiol and a reference containing desogestrel and 30 μg ethinyl estradiol
  4. Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 μg of ethinyl estradiol and 3 mg of drospirenone
  5. Serum potassium monitoring for users of ethinyl estradiol/drospirenone taking medications predisposing to hyperkalemia: physician compliance and survey of knowledge and attitudes
  6. The concomitant prescribing of ethinyl estradiol/drospirenone and potentially interacting drugs
  7. Novel ethinyl estradiol-beta-cyclodextrin clathrate formulation does not influence the relative bioavailability of ethinyl estradiol or coadministered drospirenone
  8. Bleeding pattern with drospirenone 3 mg+ethinyl estradiol 20 mcg 24/4 combined oral contraceptive compared with desogestrel 150 mcg+ethinyl estradiol 20 mcg 21/7 combined oral contraceptive
  9. Erratum to “Bleeding pattern with drospirenone 3 mg+ethinyl estradiol 20 mcg 24/4 combined oral contraceptive compared with desogestrel 150 mcg+ethinyl estradiol 20 mcg 21/7 combined oral contraceptive” [Contraception 2009;80:445–51]
  10. Effect of oral contraceptive containing ethinyl estradiol combined with drospirenone vs. desogestrel on clinical and biochemical parameters in patients with polycystic ovary syndrome
  11. A combined oral contraceptive containing 30 mcg ethinyl estradiol and 3.0 mg drospirenone does not impair endothelium-dependent vasodilation
  12. A prospective randomized trial comparing low-dose ethinyl estradiol and drospirenone 24/4 combined oral contraceptive vs. ethinyl estradiol and drospirenone 21/7 combined oral contraceptive in the treatment of hirsutism
  13. Efficacy of a new oral contraceptive containing drospirenone and ethinyl estradiol in the long-term treatment of hirsutism
  14. Comparison of effects of 3 mg drospirenone plus 20 μg ethinyl estradiol alone or combined with metformin or cyproterone acetate on classic metabolic cardiovascular risk factors in nonobese women with polycystic ovary syndrome
  15. Ethinyl estradiol 20 μg/drospirenone 3 mg 24/4 oral contraceptive for the treatment of functional impairment in women with premenstrual dysphoric disorder
  16. O491 Effect of oral contraceptive containing Ethinyl Estradiol combined with Drospirenone vs Desogestrel on clinical and biochemical parameters in patients of polycystic ovarian syndrome
  17. Psychological effect of the oral contraceptive formulation containing 3 mg of drospirenone plus 30 μg of ethinyl estradiol
  18. Clinical and metabolic effects of medroxyprogesterone acetate and ethinyl estradiol plus drospirenone in women with polycystic ovary syndrome
  19. The effect of ethinyl estradiol and drospirenone-containing oral contraceptives upon mucoprotein content of cervical mucus
  20. Effect of a combined oral contraceptive containing 3 mg of drospirenone and 30 μg of ethinyl estradiol on the human endometrium
  21. The effects of drospirenone-ethinyl estradiol and drospirenone-ethinyl estradiol
  22. Drospirenone and non-fatal venous thromboembolism: is there a risk difference by dosage of ethinyl-estradiol?
  23. Body composition in lean women with polycystic ovary syndrome: effect of ethinyl estradiol and drospirenone combination

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