Rosepire medicine 3mg/0.03mg Expeltis green for contraception (1 blister x 28 tablets)

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

Ingredient

Thành phần cho 1 viên

Composition informationContent
Drospirenone3mg
Ethinylestradiol0.03mg

Uses

indicated

Oral contraceptive contraception.

Pharmacokology

Pharmacological group: combining progestogen and estrogen.

ATC code: G03AA12.

The contraceptive effect of the drug is based on the interaction of many factors, the most important is to inhibit ovulation and change in endometrium.

Rosepine is an oral contraceptive that combines ethinylelestradiol and drospirenone (a progestogen). At the treatment dose, Drospirenone has both anti -Androgen and mineralocorticoid resistance; No estrogen, glucocorticoid and glucocorticoid resistance. Therefore Drospirenone has a pharmacological effect similar to natural progesterone. Clinical studies show that the lightweight mineralocorticoid activity of Drospirenone/ EthinyleLestradiol.

Dynamic pharmacokinetics

Drospirenone

absorption

The drug is absorbed quickly and almost completely. The peak concentration of serum is about 38 ng/ml achieved after 1-2 hours. Birth: 76 - 85% and not affected by food.

Distribution

Drospirenone is linked to serum albumin, not attached to globulin -mounted global hormones (SHBG) and globulin with corticosteroids (CBG). 3 - 5% of the total serum concentration of the active ingredient is free. The distribution volume is 3.7 ± 1.2 I/kg.

Metabolism

Drospirenone is metabolized after oral, forming acid form through the Lacton and 4.5-Dihydro Drospirenone 3-Sulfate. Drospirenone is less transformed through CYP 3A4 and has the ability to inhibit enzyme and CYP 1A1, CYP 2C9.

Elimination

Drospirenone is excreted a very small amount of constant form. The metabolic substance of Drospirenone is excreted in feces and urine with the ratio of 1.2 - 1.4. The disposal time of metabolites is about 40 hours. The maximum stable concentration of drosperinone in serum is about 70 mg/ml, achieved after 7 days of medication.

ethinylestradiol

absorption

The drug is absorbed quickly and completely. Peak concentration in serum: 100 PG/mL achieved 1-2 hours after drinking. Birth is about 45% and affected by food.

Distribution

DISTRIBUTION 5 L/ kg.

Metabolism

Ethinylellestradiol is metabolized in the small intestine and liver by hydroxylation of aromatic ring. The metabolites in the form of free or linked to glucuronid and sulfate. The metabolic clearance rate of ethinylelestradiol is about 5 ml/min/kg.

Elimination

Ethinylelestradiol metabolites are excreted into urine and bile fluid 4: 6. The excretion time is about 24 hours. The sale time is about 20 hours. Stable state achieved in the second half of the treatment cycle.

Before taking Rosepire medicine 3mg/0.03mg Expeltis green for contraception (1 blister x 28 tablets)

How to use

Take oral use. Users must take medicine daily for 28 consecutive days and at a certain hour.

Start the next medication after the last day of the blister. The menstrual cycle usually starts on the 2nd - 3rd day after taking a placebo pill (white pill).

Start taking the drug:

Do not use contraception with hormones (last month):

  • Start taking medicine on the first day of the menstrual cycle.
  • Start taking the drug on the day after the place of placebo or after stopping the usual medication of the previous contraceptive blister.
  • It is possible to start any day when using progesterone (if transplanting or using an IUD, taking the medication on the day of removal; After changing should use an additional method of mechanical contraception in the first 7 days of medication.
  • After miscarriage in the first 3 months of pregnancy:

  • Take the medication immediately, no other contraception is needed.
  • Start taking the drug on the 21st - 28th or after miscarriage in 3 months between pregnancy. If you start later, you should use a mechanical contraception in the first 7 days. If you have sex, you must eliminate the possibility of pregnancy before taking COCs or waiting for the first menstrual period.
  • remove 7 placebo tablets and continue drinking later. The time without menstruation may last until the last tablet of the second blister blister.
  • Shorten the time to use fake as you like. At that time, the risk of not developing menstruation is higher and may see abnormal bleeding while taking the next blister.

    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 to do when overdose?

    In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

    There is no specific antidote, symptomatic treatment when needed.

    What to do when forgetting a dose?

    If you forget the placebo:

    does not affect the effectiveness of the drug. Should remove the placebo pills that have forgotten, do not extend the place of place of placebo.

    If you forget to take pills containing active ingredients:

    If you forget 12 hours compared to daily medication, the contraceptive effect is not reduced. Should take medicine as soon as you remember and take the next tablet as usual.

    If you forget more than 12 hours after taking the medication, the contraceptive effect may be reduced. Note: Do not stop taking the drug for more than 7 days, must take the drug continuously for 7 days to achieve appropriate inhibition of the hypothalamus axis - pituitary - ovaries.

    Need to follow the following instructions:

    The first week: Take the tablet forgotten as soon as you remember, you can take 2 capsules at the same time. Continue to take the following tablets as usual and add another contraceptive method such as using condoms for the next 7 days. If you have sex the week before you forget to take the medicine, you may be pregnant. The tablet forgot closer to the placebo, the higher the pregnancy.

    Week 2: Take the tablet forgotten as soon as you remember, you can take 2 capsules at the same time. Continue to take the medication as usual. If you have certainly taken the right medicine for 7 days before forgetting the medicine, there is no need to use other contraception. If you forget to take more than 1 tablet, you should use more contraception in 7 days.

    3rd week: The contraceptive ability of the drug may decrease. However, it can be prevented by adjusting the medication schedule. If you have certainly taken the right medicine for 7 days before forgetting the medicine, there is no need to use other contraception. If not, you can choose one of the following two ways and use an extra method of contraception in 7 days:

    1. Take the tablet forgotten as soon as I remember, you can take 2 capsules at the same time. Continue to take the medication as usual, remove 7 placebo tablets and start drinking new blisters. There will be no menstrual period until the end of the 2nd activity of blister 2, but may be mild bleeding while taking the medicine.

      Gastrointestinal disorders:

      In case of severe digestive disorders (vomiting, diarrhea ...): The drug is not fully absorbed, so another contraceptive method should be used. If you vomit after taking medicine for 3-4 hours, you should take a replacement immediately within 12 hours after the usual medication.

      If vomiting after 12 hours, handle as "forget the drug". If you do not want to change the medication schedule, you can use the tablet in another blister.

  • Side Effects

    Common, ADR> 1/100

  • Mental: depressed.
  • Neurological: headache 1/100
  • Mental: Increasing or decreasing sexual desire.

    Rare, ADR

  • immune: Hypersensitivity, asthma.

    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

    Rosepire drugs contraindicated in the following cases:

    There is a risk or a venous thrombosis (VTE):

  • are suffering from vte venous thrombosis using anticoagulants or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE). There is increased venous thrombosis due to many risk factors.
  • There are risk factors or arterial thrombosis (ATE):

  • is suffering from or have a history of arterial thrombosis (such as myocardial infarction) or showing signs of priority (such as angina). Cardiples resistance, anticoagulant lupus).

    The risk of increased arterial thrombosis due to many risk factors or a serious risk factor such as: blood vessel diabetes, severe hypertension, lipoprotein metabolism disorders.

  • There is or a history of severe liver disease until the liver function returns to normal. Feeling with one of the ingredients of the drug.
  • Be cautious when using

    circulatory disorders

    Oral contraceptives that increase the risk of turbulent thrombosis. The highest risk of venous thrombosis (VTE) in the first year using combined contraceptives (COCS).

    In general, the risk of VTE in COCS user with low -dose estrogen (

    Venus thrombosis (VTE) manifests itself as deep vein thrombosis, pulmonary obstruction may occur during the process of drinking all COCS.

    Very rarely occur in other blood vessels such as the liver, mesenteric, kidney, static and retinal artery or brain. There is no consistency of views although the appearance of these cases is related to the use of COCS.

    Symptoms of venous thrombosis include:

  • Pain and/or swelling on one side. Yes or not related to seizures.

    When using oral contraceptives, the risk of venous thrombosis increases when accompanied by the following factors:

  • Age. In the above cases, the drug should be stopped and medication after 2 weeks of immobility.

    When using oral contraceptives combined oral at risk of complications of artery blockage or stroke increases when accompanied by the following factors:

  • Age
  • Smoking (Women over 35 years of age should not smoke if the contraceptive pills combine).
  • Cardiac disease.

    Contraindicated use of oral contraceptives in the presence of one of the risk factors or many risk factors for artery or veins.

    Do not use COCs for those who are taking anticoagulants.

    Taking oral contraceptives combined or oral should notify the doctor in the event that there are symptoms of thrombosis.

    If suspected or certainly suffer from thrombosis, do not continue using combined birth control pills.

    The frequency or severity of migraine increases when using COCSS (may be a warning sign of cerebrovascular disease), which is the reason to stop taking the drug immediately.

    tumor

    The risk of cervical cancer increases in drug users for a long time (over 5 years) has been reported in a number of epidemiological studies, but this is still controversial due to the causes that can be seen as sexual behavior or other factors such as Papilloma virus (HPV).

    There is a slight increase in the risk of diagnosing breast cancer in women using COCs. High risk gradually disappears over 10 years after stopping using COCS. Because breast cancer is rarely seen in women under 40 years old, the number of people diagnosed with breast cancer due to COCS is very small compared to the entire cause of breast cancer.

    Very rare benign tumor in the liver, the malignant tumor in the liver has been reported in COCS users. In some special cases, the tumor can threaten life due to gastrointestinal bleeding. The liver tumor should be considered distinguished diagnosis when pain in the upper abdomen, liver enlargement or no signs of bleeding in 6 abdomen when using combined contraceptive preparations.

    Other effects

    The progestin ingredient in the drug is anti -Aldosteron that can hold potassium. In most cases, there is no increase in the concentration of potassium in the blood. However, some patients with mild to medium mild renal impairment and simultaneously used with potassium drugs, blood potassium concentration increased slightly, negligible during the use of Drospirenone. Therefore, it is advisable to check the concentration of blood potassium during the first treatment cycle in patients with renal impairment and had prevention prophylaxis for previous serum potassium, especially when using two drugs simultaneously.

    Hypergly hyperglycerers or family history, can increase the risk of pancreatitis when using COCS.

    Although a few women with hypertension when using COCs have been reported, clinical manifestations are very rare, this case should stop taking the drug immediately. If the blood pressure continues to increase and does not respond to blood pressure loss drugs, COCS is stopped. When the value of blood pressure returns to normal, COCS can be used with hypertension.

    jaundice and/or itching due to bile stasis occur during pregnancy or when taking steroids, COCS.

    Although COCS may affect peripheral insulin resistance and glucose threshold, there is no need to replace diabetic treatments while using low -dose COCs (

    Depression, epilepsy, Corhn disease and ulcerative colitis have been reported during COCS.

    Skin melasma can occur especially in women with a history of melasma during pregnancy. Women tend to be melasma should avoid light or ultraviolet rays while using COCS.

    Rosepire 0.03 mg contains lactose. People with a history of galactose intolerance, lapp or galactose lack of galactose, who are in the lactose diet must pay attention when taking this drug.

    Before taking the drug, the medical history must be checked (including family history) and eliminates the possibility of pregnancy.

    Oral contraceptives are not prevented from HIV and sexually transmitted diseases.

    Reducing menstrual cycle control

    Use COCs may have abnormal bleeding, especially in the first month. Therefore, evaluating abnormal bleeding is meaningful after adapting about 3 cycles. If abnormal bleeding lasts after a normal cycle, it is necessary to consider the cause of non -hormone and take appropriate diagnostic measures to eliminate malignant or pregnant tumors.

    The ability to drive and operate machinery

    Side effects and ear fibers of the drug can reduce the ability to hear, affect the ability to drive and operate machinery.

    Pregnancy

    does not specify Rosepire for pregnant women.

    The period of breastfeeding

    The drug can be excreted in breast milk and reduce the quality of milk. Do not use the drug until you stop breastfeeding.

    Drug interaction

    COCS can interact with drugs that cause microsome liver enzymes: Hytantoin, Barbiturate, Primidone, Carbamazepine and Rifampicin, Oxcarbamazepine, Topiramate, Felbamate, Ritonavir, Griseofulvin can cause cycle disorders for periods and/or influence.

    contraceptive effects are reduced when used with antibiotics such as ampicillin and tetracyclin. The mechanism of this interaction has not been determined.

    Should use a temporary contraception along with COCS during the use of the above drugs and 28 days after stopping the drug. If you use two types of drugs simultaneously last until the tablet has the activity of the COC blister, use the next blister without a break or do not use a placebo.

    The effects of Drospirenone and EthinyleLestradiol on other drugs: serum and tissue concentration (cyclosporin) or decrease (lamotrigin).

    Some patients with no renal failure, simultaneous use of drospirenone with ACE or NSAID inhibitors do not affect serum potassium levels. However, simultaneous use of Drospirenone with other anti -aldosteron substances or potassium -keeping diuretics has not been studied. In this case, serum potassium concentration must be checked in the first cycle.

    Steroid contraceptives can affect a number of tests: including the biochemical parameters of the liver, thyroid, adrenal and kidney function, serum protein levels, such as globulin and lipid/ lipoprotein -mounted corticosteroids, parameters of Cabohydrate metabolism, blood clotting and decomposition of fibrin. Changes in general are still in normal threshold. Drospirenone causes the activity of aldosteron in the kidneys to keep salt.

  • Storage

    Store in a dry place, temperature below 300C, avoid light.

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