Yarina tabl. #21

 

Description for Yarina #21

 

Pharmacological Effects: 
Low-dose monophasic oral contraceptive with antiMKS and antiandrogenic effects. The contraceptive effect is due to several factors, most important of which is inhibition of ovulation and change the viscosity of cervical mucus. Endometrium remains unprepared for the implantation of the egg. As a result of increasing the viscosity of cervical mucus penetration of sperm cells is hampered in the uterine cavity. Drospirenone has antiMKS activity that can prevent weight gain and other symptoms associated with fluid retention (delay prevents Na +, caused by estrogen provides a very good tolerability and positive impact in premenstrual syndrome). In combination with ethinylestradiol improves the lipid profile and increases the concentration of HDL. Has anti-androgenic activity, which leads to a decrease acne formation and reduced production of the sebaceous glands, has no effect on ethinylestradiol induced increase in education globulin, sex hormone binding (inactivation of endogenous androgens). Drospirenone devoid of any androgenic, estrogenic, SCS and antiGKS activity. This, coupled with antiMKS and antiandrogenic effects, drospirenone provides biochemical and pharmacological profile similar to natural progesterone. As with all combined oral contraceptives has a positive effect Noncontraceptive: menstrual bleeding becomes lighter and shorter, which reduces the risk of anemia, pain - less pronounced or disappear completely. 


Indications: 
Contraception (prevention of unwanted pregnancy). 

Appointment of a combined contraceptive with antimineralokortikoidnymi and antiandrogenic properties (Yasmin) may be particularly useful for women with hormone-dependent fluid retention, as well as women with acne (acne) and seborrhea. 


How to use: 
Oral, 1 tablet, in order listed on the packaging, every day at about the same time with a little water, continuously for 21 days. Acceptance of each of the following package starts after a 7-day break, during which there is bleed bleeding. It usually begins 2-3 days of taking the last tablet and may not end before starting a new package. In the absence of taking any hormonal contraceptive in the previous month, the drug begins on the first day of the menstrual cycle (first day of menstrual bleeding). Allowed to start taking on the 2-5 day of menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of pills from the first package. In the transition from receiving other COCs preferably start taking the drug on the day after taking the last active tablet from the previous packaging, but not later than the day after the usual 7-day break in reception (for products containing 21 tablets), or after the last inactive tablets (for products containing 28 tablets per pack). In the transition from contraceptives containing only progestogens (mini-pill, injectable form, the implant): a mini-pill you can go to any day (no break), with the implant - the day of his removal from the injection form - from the day when must had to be done following an injection. In all cases, you must additionally use a barrier method of contraception during the first 7 days of tablet. After the abortion I trimester of pregnancy can start taking immediately. Subject to this condition, there is no need for additional contraceptive protection. After childbirth or abortion in the II trimester of pregnancy is recommended to start taking the drug for 21-28 days. If the reception is started later, it is necessary to additionally use a barrier method of contraception during the first 7 days of tablet. In the case of sexual intercourse prior to taking the drug should be ruled out pregnancy, or must wait for the first menstruation.Receiving missed pills: the delay in pill was less than 12 hours, contraceptive protection is not reduced. Need to take a pill as soon as possible, should be taken at the usual time. If the delay in the pill was more than 12 h (interval since last pill taking more than 36 h), contraceptive protection may be reduced. In case of missing 1-2 weeks of taking the drug should take the last missed tablet as soon as possible (even if it means taking 2 tablets at a time). Take the next pill at the usual time. Must additionally be used a barrier method of contraception for the next 7 days. If intercourse took place within 1 week before the missed pills, you must consider the likelihood of pregnancy. The more pills missed and the closer this pass to the 7-day break in taking the drug, the greater the risk of pregnancy. In case of missing 3 weeks of medication, you should take the last missed tablet as soon as possible (even if it means taking 2 tablets at a time). Take the next pill at the usual time. Must additionally be used a barrier method of contraception for the next 7 days. In addition, the pill from the new pack should be started once the current package, ie without interruption. Most likely, the hemorrhage "undo" will not be until the end of the second pack, but can be observed "smearing" spotting or uterine bleeding "cancel" in the days of the drug from the second pack. In case of missing a pill and a lack of the first free medication interval bleeding "undo" is necessary to exclude pregnancy. In the case of missed doses can be guided by the following two basic rules: the drug should never be interrupted by more than 7 days and 7 days of continuous tablets needed to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. If vomiting occurs within 3-4 hours after taking the pill absorption may be incomplete. In this case, you must observe the rules of the drug in case of missing pills. If the patient does not want to change the normal administration of the drug, it should adopt, if necessary additional tablet (or several tablets) from other packages. To postpone the date of onset of menstruation is necessary to continue taking pills from a new package immediately after taken all the tablets from the previous one, without a break in the reception. Tablets from a new package can take up to a maximum until packaging is completed. In patients receiving the drug from the second pack can be marked "smearing" bleeding from the vagina or uterine bleeding "breakthrough." Resume taking the drug from a new package follows the usual 7-day break. To transfer the date of onset of menstruation at the other day of the week should be shortened next break in the pill for as many days, how much you want to move the onset of menstruation. The shorter the interval, the higher the risk of bleeding "cancel" in the future, "smearing" selections and "breakthrough" bleeding during the second pack (just as in the case of delay the onset of menstruation). 


Side effects: 
The following undesirable effects have been described in women taking Yasmin, and their relationship with the drug was neither confirmed nor refuted: breast tenderness, discharge from the breasts, headache, migraine, changes in libido, depressed mood, poor tolerance of contact lenses, nausea , vomiting, changes in vaginal secretion, various skin disorders, fluid retention, weight change, hypersensitivity reactions. 

Sometimes it can develop chloasma, especially in women with a history of chloasma during pregnancy. 


Contraindications: 
Yasmin should not be used if any of the states listed below. If any of these conditions develop for the first time while taking the drug should be immediately repealed. 

The presence of thrombosis (venous and arterial) present or in history (eg deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders). 
The presence of current or a history of states prior to thrombosis (eg transient ischemic attack, angina). 
Diabetes mellitus with vascular complications. 
The presence of severe or multiple risk factors for venous or arterial thrombosis may also be regarded as a contraindication. 
The presence of current or a history of severe liver disease (as long as liver tests do not come back to normal). 
Severe renal insufficiency or acute renal failure. 
The presence of current or a history of liver tumors (benign or malignant). 
Identified hormone-malignant diseases of genital organs or breasts or suspicion on them. 
Vaginal bleeding of unknown origin. 
Pregnancy or suspicion of it. 
Breastfeeding. 
Hypersensitivity to any component of Yasmin. 


Pregnancy: 
The drug is prohibited during pregnancy and lactation! 


Interaction with other drugs: 
Drug interactions that result in increased clearance of sex hormones, may lead to breakthrough bleeding or a reduction of contraceptive reliability. It has been established in respect of hydantoin, barbiturates, primidone, carbamazepine and rifampicin; also have assumptions regarding oxcarbazepine, topiramate, felbamate and griseofulvin. The mechanism of this interaction is based on changes of liver enzymes. Maximum enzyme induction is not usually seen within 2-3 weeks, but may then be stored for at least 4 weeks after cessation of drug therapy. 

Contraceptive protection is reduced when antibiotics such as ampicillin and tetracyclines. The mechanism of this action is not clear. 

Women receiving any of the above classes of drugs a short course in addition to Yarin should temporarily use a barrier method of contraception during concomitant medication, and within 7 days after their cancellation. During the reception, rifampin, and within 28 days after its cancellation, in addition to Yarin should use a barrier method of contraception (eg condoms). If concomitant use of the drug started at the end of reception packages Yasmin, Yasmin next pack should be started without the usual break in reception. 

In women, a long time receiving drugs affecting liver enzymes, it is necessary to consider other methods of contraception. 

Other interactions 

There is a theoretical possibility of increasing serum potassium levels in women receiving Yasmin simultaneously with other drugs that may increase serum potassium levels. These medications include ACE inhibitors (angiotensin-converting enzyme) receptor antagonists, angiotensin-II, some anti-inflammatory drugs (eg indomethacin), potassium-sparing diuretics and aldosterone antagonists. However, studies evaluating the interaction of an ACE inhibitor with a combination of drospirenone / estradiol in women with mild hypertension, found no significant difference between serum potassium concentration in women treated with enalapril compared with placebo. 

Effect on lab tests 

Acceptance of sex steroids may affect the biochemical parameters of liver function, thyroid gland, adrenal glands and kidneys, as well as levels of transport of plasma proteins, such as kortikosteroidsvyazyvayuschy globulin and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis. Changes usually occur within laboratory norms. Because of its activity antimineralokortikoidnoy drospirenone increases the activity of renin and aldosterone plasma. 


Overdose: 
On the serious side effects of overdose were reported. Symptoms that may occur in this case: nausea, vomiting and slight vaginal bleeding. There is no specific antidote, should be treated symptomatically. 


Product: 
Film-coated tablets for oral administration. 
Cycle pack containing 21 tablets. 


Storage Conditions: 
Shelf life - 3 years. 
You can not use after expiry date! 
Keep out of reach of children! 
Available on prescription. 


Ingredients: 
Each tablet, film coated contains. 
Active ingredients: 3 mg of drospirenone, ethinyl estradiol 0.03 mg. 
Excipients: lactose monohydrate, corn starch, modified starch (pregelatinized starch), polyvidone 25000, magnesium stearate, hydroxypropyl methylcellulose, macrogol 6000, talc, titanium dioxide, yellow iron oxide. 


Extras: 
If any of the conditions / risk factors listed below are currently available, it should carefully weigh the potential risks and expected benefits of the treatment Yasmin in each individual case and discuss it with the woman before she decides to start taking the drug. In the case of aggravation, amplification, or the first manifestation of any of these conditions or risk factors, the woman should consult with their physician, who may decide to repeal the drug. 


Diseases of the cardiovascular system 
Several epidemiological studies showed a slight increase in the incidence of venous and arterial thrombosis and thromboembolism in COC. 

Venous thromboembolism (VTE), manifested in the form of deep vein thrombosis and / or pulmonary thromboembolism may develop during use of combined oral contraceptives. The approximate incidence of VTE in women taking oral contraceptives with low-dose estrogen (<50 mcg ethinyl estradiol) is up to 4 per 10 000 women per year compared with 0,5-3 per 10000 women per year to women not using OK. However, the incidence of VTE developing in COC is less than the frequency associated with pregnancy (6 per 10,000 pregnant women per year). 
In women taking combined oral contraceptives, are described extremely rare cases, thrombosis of other blood vessels, such as hepatic, mesenteric, renal arteries and veins, central retinal vein and its branches. Communication with COC has not been proved.

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