Yaz Bayer used contraceptive, acne treatment (1 blister x 28 tablets)

Dosage form Box of 1 blister x 28 tablets
Specifications Ethinylestradiol, Drospirenone

Ingredient

Thành phần cho 1 viên

Composition information	Content
Ethinylestradiol	0.02mg
Drospirenone	3mg

Uses

Indications

Oral contraception.

Hormone -related acne treatments in women who choose to use oral contraceptive.

Treatment of symptoms of PMDD syndrome (premenstrual dysphoric disorder: Pre -psychological disorders) in women who choose to use oral contraceptive.

Pharmacokological

The contraceptive effect of combined contraceptives (COCS) is based on the interaction of many factors, the most important factor is to inhibit ovulation and change cervical mucus.

Increased risk of venous thrombosis when using COCS drug is considered to be related to estrogen composition. There is still scientific debate related to any effect on the risk of venous thrombosis of progestin components in COCs.

In addition to contraception, COCs have some other beneficial and disadvantages, which can help in choosing contraception, making it even more steadily, less menstrual periods and less menstrual bleeding can help reduce iron deficiency.

Drospirenone has additional benefits besides contraception. Drospirenone has anti -mineralocorticoid activity that can prevent weight gain and other symptoms due to water retention. It against salts related to estrogen helps the drug have a good tolerance and has positive effects on the premium syndrome (PMS). Yaz has a shortened hormone resting space that has been studied on PMDD syndrome. PMDD is a heavy form of PMS. Yaz shows the outstanding effect in reducing the symptoms of PMDD.

The combination of ethinylelestradiol, Drospirenone has been shown to increase HDL.

Drospirenone has anti -androgen effects that produce positive effects on the skin and reduce acne damage and produce sebum. In addition, Drospirenone does not resist the increase in SHBG related to ethinylestradiol, which is helpful for the combination and inactiveness of endogenous androgen hormones. Yaz is used as an acne treatment regimen in women with average acne. Yaz has clinical and acne effects with clinical significance and statistics on all factors in the main criteria of effectiveness (inflammatory lesions, non -inflammatory lesions, the number of general damage, the number and the proportion of women with "clean" or "clean" acne in the global assessment of Investigatoris Stated Global Assessment (ISGA) and in the majority of the elements of sub -criteria.

Drospirenone does not have any effects of Androgen, estrogen, glucocorticoid and glucocorticoid resistance. This, combined with mineralocorticoid and Androgen resistant activity, helps Drospirenone have biochemical and pharmacological parameters similar to natural progesterone. In addition, there are evidence of reducing the risk of endometrial cancer and ovarian cancer. Moreover, higher doses of COCs (0.05 mg of ethinylepradiol) reduces the incidence of ovarian cysts, pelvic inflammatory disease, benign breast disease and ectopic pregnancy.

pharmacokinetic

absorption:

Drospirenone absorbs almost completely and quickly through oral. The maximum concentration of the drug in serum is about 35 ng/ml, achieved after drinking for 1-2 hours. Birth is about 76% to 85%. Food does not affect the bioavailability of Drospirenone.

Ethinylellestradiol is absorbed quickly and completely. The peak concentration in the serum is about 33 PG/mL achieved within 1-2 hours after taking the drug. Absolute bioavailability is the result of the combination before entering the whole body and the first metabolism is about 60%. Simultaneous use with food reduces the bioavailability of ethinylelestradiol by about 25% on research subjects, while no change can be observed on others.

Distribution:

Drospirenone is connected to serum albumin and is not linked to SHBG and CBF. Only 3 - 5% of the serum total drug concentration exists in the form of free steroids. SHBG increases due to EthinyleLestradiol does not affect serum protein with Drospirenone. The distribution volume of Drospirenone is 3.7 ± 1.2 l/kg.

Ethinylestradiol is highly united but not specific to serum albumin (about 98.5%) and increases SHBG levels in serum. The distribution integral is determined to be about 5 l/kg.

Metabolism:

Drospirenone is widely metabolized after drinking. The main metabolites in plasma include the acid form of Drospirenone is created by opening lacton and 4.5-dihydro-drospirenone-3sulfate, formed through the process of descending and followed by sulfate. Drospirenone is also metabolized by the catalytic oxidation process by CYP3A4.

Ethinylestradiol is first transformed through the liver and intestines significantly. Ethinylestradiol and metabolites by oxidation are connected to glucuronides or sulfate. Metabolic clearance speed is about 5 ml/min/kg.

Era:

Drospirenone metabolic liquid ratio in serum is 1.5 ± 0.2 ml/min/kg. The unprocessed Drospirenone is excreted only in the form of traces. The metabolites of Drospirenone are excreted in feces and urine with an excretion ratio of about 1.2 to 1.4. T1/2 of metabolites in feces and urine is about 40 hours. The serum drops decreased in 2 stages, with T1/2 respectively 1.6 ± 0.7 hours and 27 ± 7.5 hours.

Ethinylestradiol formal does not change, the metabolites of ethinylestradiol are excreted in urine and bile with a score of 4: 6. T1/2 of the metabolic excretion is about 1 day. Ethinylelestradiol concentration decreases in 2 phases, the last phase is characterized by T1/2 about 24 hours.

Before taking Yaz Bayer used contraceptive, acne treatment (1 blister x 28 tablets)

How to use

Oral contraceptives combined, when used correctly, the failure rate is about 1%/year. The rate of failure may increase when forgetting to take medicine or inaccurate use.

The drug must be taken in the correct order on the packaging at the same time, can use more water if necessary.

Dosage

The drug is taken on the first day of the menstrual cycle in the woman (ie the first day of bleeding).

The drug needs to be taken continuously, one tablet every day for 28 consecutive days. The next blister is started the next day after the last blister.

In case of digestive disorders

When severe digestive disorders will reduce the ability to absorb the drug, therefore, another contraceptive method should be applied during this period.

If vomiting is from 3 to 4 hours after taking pale pink pills, the measures should be taken in the instructions in the "Do what to do when forgetting the dose".

Special subject group

Pediatric patient: Yaz is only indicated after menstruation. No data shows the need to adjust the dose.

Elderly patients: Yaz is not appropriate. Yaz is not indicated after menopause.

Patients with hepatic impairment: Yaz contraindicated for women with severe liver failure.

Patients with renal failure: Yaz contraindicated in women with severe renal failure or acute renal failure.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? Based on the overall experience of combined oral contraceptives, the symptoms may occur in the case of an overdose of hormones containing hormones: nausea, vomiting, menstruation due to stopping drugs. The menstruation can occur even on girls without menstruation. There is no antidote and should treat more symptoms.

What to do when you forget the dose? However, they need to remove these tablets to avoid accidentally extending the tablet time without hormones.

The following advice is only applied when you forget to take pale pink pills containing hormones:

If you forget to take a tablet containing hormones not more than 24 hours compared to the daily medication: the contraceptive effect of the drug will not change. However, patients should take the tablet to forget when remembering and taking the next tablet as usual.

If you forget to take a tablet containing hormones more than 24 hours compared to daily medication: contraceptive effects may be reduced. Trading of the drug is forgotten based on the following two basic principles:

Never stop taking medicine for more than 7 days (note the recommended time for tablets does not contain hormones is 4 days).

It is necessary to take pills that contain continuous hormones for 7 days to achieve appropriate inhibition of the hill - pituitary - ovaries.

daily follow the following instructions:

Day 1 - 7

Patients should take the tablet to forget immediately after remembering, even when taking 2 pills at the same time. Then continue taking other tablets as usual. More protection should be used such as using condoms for the next 7 days.

If intercourse in 7 days earlier, may consider the possibility of pregnancy. The more uneven medication is taken, the shorter the break between cycles and the risk of pregnancy will increase.

day 8 -14

Patients should take the tablet for forgotten immediately after remembering, even if you have to take 2 capsules at the same time.

Then continue taking other pills as usual. In the school meeting, the patient took the medication in accordance with the instructions for 7 consecutive days before forgetting, it was not necessary to use any other contraceptive measures. However, if you do not take the drug continuously on time as above or forget to take more than 1 pill, you should use other contraception in 7 days.

Day 15 - 24

The contraceptive effect of the drug may be reduced due to nearly taken time to take medication. However, it is possible to prevent the risk of reducing contraception by adjusting the medication schedule.

Doing true one of the two options below is not necessary to use any other contraceptive methods in case the patient has taken the medication in accordance with the instructions during 7 days before forgetting.

In case of not taking medicine on time 7 days before forgetting to drink, the patient should follow one of the two options below and apply other contraceptive methods in the next 7 days:

Take the tablet to forget immediately after remembering, even if you have to take both capsules at the same time. Then continue taking other tablets as usual until you take all pale pink tablets. 4 white tablets must be removed without hormones. Start taking a new blister short after. The patient will not have menstrual bleeding until the end of the pale pink pills containing the hormone of the second blister, but the phenomenon of abnormal bleeding or mid -term bleeding may appear during the time of taking the drug.

Patients may also stop taking the light pink pills of the current blister. Take a 4 -day -day break, forget to take medicine all day, then continue to drink new blisters.

If the patient forgets to take the medicine and then there is no menstruation during the first time to stop taking the first medication, it is necessary to consider the risk of being pregnant.

Side Effects

Common, ADR> 1/100

Nervous system: headache, migraine.

Mental system: emotional disorders, depression.

Digestive system: Nausea.

Reproductive organs: Breast pain, genital/uterine bleeding is uncertain, haemorrhage, amenorrhea.

Uncommon, 1/1000

Nervous system: dizziness, paresthesia.

Mental system: Reduce or lose desire, worry, sleep.

blood vessels: varicose veins, hypertension.

Digestive system: abdominal pain, vomiting, indigestion, flatulence, gastritis, diarrhea.

Skin and subcutaneous tissue: Acne, itching, rash.

Bone muscle and connective tissue: back pain, headache, cramps.

Reproductive organs: Vaginal candidiasis, pelvic pain, breast size, mammary cystic fibrosis, genital secretion, fire, vaginitis menstrual disorders, menstrual pain, menstruation, menorrhagia, vaginal dryness, PAP Smear results suspected of being immortal.

Common disorders: weakness, increased sweat, edema (edema, edema, face edema), weight gain.

Rare, ADR

Infections and parasites: Candidas infection.

Blood and lymphatic system: Anemia, platelet increase.

The immune system: allergic reactions.

Endocrine system: endocrine disorders.

Metabolism and nutrition: Increase appetite, anorexia, increase potassium, decrease sodium.

Nervous system: dizziness, tremor.

Mental system: Inability to achieve orgasm, insomnia.

eyes: Eye inflammation, dry eyes, eye disorders.

Cardiovascular system: tachycardia. blood vessels: intravenous inflammation, vascular disorders, venous thrombosis and artery, nosebleeds, fainting.

Digestive system: Big abdomen, digestive disorders, bloating, hernia, mouth and mouth, constipation, dry mouth.

Bile liver system: Biliary pain, cholecystitis.

Skin and subcutaneous tissue: Dark skin, eczema, hair loss, skin folliculitis, dry skin, pink button, hyperpigmentation, skin disorders, stretch marks, contact dermatitis, sensitive skin sensitive to light, skin on the skin.

Reproduction and mammary glands: Pain during intercourse, vulva - vaginal inflammation, anal bleeding, menstrual bleeding when stopping birth control pills, breast cysts, breast hyperplasia, breast tumors, cervical polyps, uterine endometriosis, uterine cysts, uterine size.

Common disorders: fatigue, weight loss.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

contraindicated

Yaz drugs contraindicated in the following cases:

are suffering from or have a history of blood thrombosis/thrombosis of arteries or veins (for example, deep veins, pulmonary embolism, myocardial infarction, stroke). Head with localized neuropathy symptoms. History or a history of liver tumors (benign or malignant).

Be cautious when using

circulatory disorders

The epidemiological studies have shown the relationship between the use of COCS and the risk of increased arterial and vein thrombosis, thrombotic embolism such as myocardial infarction, deep vein thrombosis, pulmonary obstruction, cerebrovascular damage. These complications rarely occur.

The risk of venous thrombosis (VTE) is the highest in the first year of use. This increased risk when starting to use COCS or start again (after 4 weeks or long medication breaks) of the same type or different type of COCS.

Venous thrombosis may be life-threatening or fatal (in 1-2% of cases).

Venous thrombosis (VTE), manifested as a deep vein thrombosis, pulmonary obstruction may occur during the use of all COCS.

Symptoms of deep vein thrombosis may include: swelling on one leg or along the leg veins, pain or damage can only feel when standing up or walking, increasing heat in the legs, red -legged skin or discoloration.

Symptoms of pulmonary embolism (PE) include: Suddenly breathing or breathing rapidly for unknown reasons, suddenly coughing up blood, chest pain may increase when deep breathing, anxiety, dizziness, fast or abnormal heartbeat, some symptoms such as cough, shortness of breath are unclear and misunderstand as other few serious cases such as respiratory infections.

Aortic embolism may include: cerebrovascular lesions, embolism or myocardial infarction (Mi). Symptoms of brain vascular lesions may include: Suddenly numb or weak on the face, arms, legs, especially on one side of the body. Suddenly confused, difficult to say and difficult to understand. Suddenly, partially or completely vision, but. Suddenly difficulty walking, imbalance or coordination, suddenly severe headache or unexplained cause, loss of consciousness or fainting when there is or no epilepsy. Other signs of obstruction may include: pain, swelling, mild blue changes at the head of the limb, acute abdominal pain.

Symptoms of myocardial infarction may include: pain, discomfort, severe, pressure, pressing or heavy chest, arms and under the breastbone, uncomfortable in the back, jaw, throat, arms, stomach. Flushing, indigestion, breathing feeling, sweating, nausea, vomiting, dizziness, weakness, anxiety, shortness of breath, heart beating fast or irregular.

Cases of artery embolism may threaten life or death.

This risk may increase if the risk factors are listed below. Do not prescribe a COCS if the benefits and risks are not favorable. Risk factors for cases of arterial thrombosis, veins, stroke are:

Age;

obesity (BMI> 30 kg/m2); In these cases, the drug should be stopped (if the program surgery, it is advisable to stop the drug 4 weeks) and do not use it again until 2 weeks after fully recovery; head;

valve disease;

Other cases of pathology accompanied by an adverse circulatory complications include: diabetes, systemic erythema lupus, hemolytic hyperur syndrome, chronic bowelitis (Crohn's disease or colon ulcer) and sickle cell disease.

Increase the frequency and severity of migraines during the use of COCS (maybe the symptoms of a stroke) should stop the drug.

Note that the risk of thrombosis associated with pregnancy is higher than the risk of low -dose COCS thrombosis ( tumor

The most important risk factor for cervical cancer is prolonged HPV infection. Long -term use can contribute to this risk.

The risk gradually disappears over 10 years after stopping using COCS.

In rare cases, benign liver tumors, or even more rare, malignant liver tumors have been reported in COCS users. In special gatherings, tumors have led to life -threats due to bleeding in the abdominal cavity. The liver tumor should be diagnosed distinguished when the epigastric pain is severe, the liver is enlarged or shows signs of bleeding in the abdominal cavity in people who drink COCS.

Other conditions

The risk of hyperkalemia in people with kidney failure or using potassium diuretics. Pancreatitis can occur in people with high triglycerides or a family history of this disease.

Taking COCS can cause mild hypertension.

The disease may occur or worsened for pregnant people and COCS users are jaundice, itching is related to bile obstruction, gallstones, porphyrin metabolic disorders, systemic erythema lupus, hemolytic hyperur syndrome due to hemolytic dance, Sydenham dance, herpes genital, hearing loss due to fibrous fibrosis.

Patients with genetic angioedema, external estrogen can cause or worsen angioedema symptoms.

Acute or chronic liver dysfunctions must stop using COCS until the liver function returns to normal. The jaundice occurred for the first 3 months of pregnancy or during the use of sex steroids that had to stop using COCS.

Women with diabetes should be carefully monitored when using COCS.

Crohn's disease and ulcerative colitis are related to COCS.

Melasma occasionally occurs, especially in women with a history of melasma during pregnancy, should avoid exposure to sunlight or ultraviolet radiation when using COCS.

Patients with rare genetic problems such as galactose intolerance, lactase deficiency or malposive glucose-galactose and people with lactose-free diet should consider lactose in the drug.

The ability to drive and operate machinery

does not affect.

Pregnancy

yaz is not indicated during pregnancy. If pregnant occurs during YAZ's use, stop the drug immediately.

The period of breastfeeding

breastfeeding can be affected by COCs because they reduce the number and change the composition of breast milk. It is not recommended to use drugs for breastfeeding women. A small number of contraceptive steroids and/or its metabolites can be excreted into milk.

Interactive interaction

Interactions can occur with drugs that induce microsome enzymes that can increase the clearance of sex hormones and this can lead to bleeding between cycle or contraception failure.

Women who are being treated with any of the following drugs should use additional methods with COCS or choose other contraceptives. The diaphragm method should be used during the medication period and lasted for 28 days after stopping. If during the period of using the diaphragm measure that menstrual bleeding occurs outside the end of the tablet containing hormones, you should skip the stage of taking hormone -free tablets and start new blisters.

Increases of COCS's clearance (reducing the effectiveness of COCs with enzyme induction substances): Phenytoin, Barbiturates, Primidone, Carbamazepine, Rifampicin, Oxcarbazepine, Topiramate, Felbamate, Griseofulvin and products containing St John grass).

Substances have different effects on COCS clearance: HIV/HIV/HCV Protease inhibitors and reverse copy inhibitors that are non -nucleoside can increase or decrease plasma concentrations of estrogen or progestin.

Substances that reduce the clearance of COCS (inhibitors): Strong and average CYP3A4 inhibitors such as Azole antifungal (such as Itraconazole, Voriconazole, Fluconazole), Verapamil, Diltiazem, Macrolides (such as Clarithromycin, erythromycin) and grapefruit water that can increase soybura of soybura Estrogen or progestin or both.

Etoricoxib increases the plasma concentration of ethinylelestradiol.

The effect of COCS on other drugs

Yaz can cause plasma concentrations and tissues of the drug used at the same time (such as cyclosporin) or decrease (such as lamotrigine).

On In vitro, Drospirenone has the ability to limit from weak to medium enzymes Cytochrome P450 CYP1A1, CYP2C9, CYP2C19 and CYP3A4.

Pharmacological interactions

Concomitance the drugs containing ethinylelestradiol with direct anti -virus drugs (DAA) containing ombitasvir, paritaprevir or dasabuvir and the combinations of these drugs are seen that it is related to an increase in ALT levels more than 20 times the upper limit of normal levels in healthy women and women infected with HCV.

Other types of interactions

Serum potassium

Theoretically, women using bright pink film tablets Yaz containing hormones with other drugs may increase serum potassium level.

Testing

Drospirenone is the cause of increased serum renal and plasma aldosterone caused by mild anti -salt effect.

Storage

Store under 30⁰C.

Other drugs

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