ASUMate 20 Leon daily contraceptive pills (1 blister x 21 tablets)

Dosage form Box of 1 blister x 21 tablets
Specifications Levonorgestrel, ethinyletradiol
Ingredient Myocardial infarction, diabetes (diabetes), psoriasis, high blood pressure

Ingredient

Composition information	Content
Levonorgestrel	0.1mg
Ethinylestradiol	0.02mg

Uses

Indications

Asumate medicine 20mg is indicated in the following case: Oral contraceptive pills.

Pharmacokic

is a combined contraceptive pills of ethinylelestradiol and levonorgestrel with anti -androgen effects. The contraceptive effect of the drug is based on the interaction of many factors, most importantly, inhibiting ovulation and changing the cervical mucus (causing difficulties for sperm when entering the uterus) and the endometrium (reducing the adhesion of eggs).

Androgen resistance is caused by a decrease in serum androgen levels. Levonorgestrel is a substance from 19-nor-testosteron. In -Vitro it is associated with Progesterone receptors 10-30 times lower than other gestogen biosynthesis. In-Vivo levonorgestrel does not show the effects of Androgen, Mineralocorticoid or Glucocorticoid.

levonorgestrel inhibits ovulation with daily dose 1mg.

pharmacokinetic

ethinylelestradiol

absorption

Using oral medication is absorbed quickly and completely. After the dose of 30μg, the peak concentration in the serum reaches 100pg/ml to reach 1-2 hours after drinking. Birth is about 45%. Taking medicine and food reduces the bioavailability of the drug.

Distribution

DISTRIBUTION 5L/KG. The drug is attached to the albumin with high ratio (98%). The distribution volume is about 2.8 - 8.6L/kg.

Metabolism

Ethylestradiol is metabolized in both the small intestine and the liver. Ethylestradiol is metabolized by hydroxylation of aromatic rings and diverse metabolites of hydroxylation and pharmaceutical methyl chemicals, these substances are in the form of free or cohesion with gluconide and sulphate stems. The metabolic clearance rate of ethylestradiol is about 5ml/min/kg.

Elimination

Ethinylestradiol eliminates in the form of metabolism. The metabolites of ethinylelestradiol are excreted into urine and bile 4: 6. Selling time is about 1 hour and 20 hours, divided into 2 phases.

Stable status: Another posteriority of the treatment cycle when the drug concentration is doubled compared to the single dose.

levoitorgestrel

absorption

After taken, the drug is absorbed quickly and completely, the peak concentration reaches 2.3ng/ml after 1.3 hours. Birth is about 100%.

Distribution

levonorgestrel attaches to plasma albumin and globulin attaching sex hormones (SHBG). Only 1.1% of the drug exists in the form of free, while 65% is attached to SHBG and 35% attached to nonspecific albumin. Ethylesiradiol increases SHBG levels, thus affecting the distribution of levonorgestrel to different proteins. Levonorgestrel's distribution volume is 129L after single dose.

Metabolism

Completely metabolized through steroid metabolism. Serum clearance is about 1.0ml/min/kg.

Elimination

Serum concentration decreases with 2 phases. The last phase has a selling time of about 25 hours. Levonorgestrel eliminates in the form of transformation.

Stable status: Levonorgestrel's pharmacokinetics is not affected by SHBG protein levels in plasma, the sale time is about 1 day.

Before taking ASUMate 20 Leon daily contraceptive pills (1 blister x 21 tablets)

How to use

Take oral use.

Dosage

The drug is taken daily at a certain hour (if necessary can be taken with water) according to the instructions printed on the drug blister. Take a tablet a day for 21 consecutive days, take the next blister after taking the medicine for 7 days.

Normally menstruation will appear during the break. In particular, menstruation will start 2-3 days after taking the last tablet and may not end before taking the next blister.

Start taking medicine

Do not use hormone contraceptives in the month before starting to take: Take the first tablet on the first day of the menstrual cycle (the first day of the menstrual cycle is counted as the first day).

Change from combined birth control pills, vaginal cycles, skin stickers: should start taking Asumate on the next day after the day off or during the placebo use of combined birth control pills or after taking the final activity pills of combined contraceptive pills. In case of using an IUD or a skin sticker, it is recommended to start taking the medication on the day of removal or stickers.

Change from products containing only progesterone (contraceptive, injection, transplant) or from the uterus system containing progesterone, the type of drug contains only progestogen, which can switch to combined contraceptive pills at any time.

Users who implant or uterine can start on the date of removing or removing uterine tools.

Women contraception by injection may start taking the drug when the next dose must be injected.

In all the above cases should be combined with a mechanical contraception within the first 7 days of medication.

After miscarriage in the first 3 months of pregnancy

Take the medication immediately, no other contraception.

after birth or after miscarriage in the middle 3 months of pregnancy

Start taking the drug on the 21st or 28th after birth or after miscarriage in the 2nd stage. However, if you have sex, you must exclude the case of pregnancy before you take the medication or wait until the start of the next menstrual cycle.

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? There is no need for special treatment, if necessary, symptomatic treatment.

What to do when forgetting a dose? Should take medicine as soon as possible and take the next tablet as usual.

If you forget more than 12 hours compared to daily medication, contraceptive effects can be reduced. Note the following two basic principles:

Do not stop the drug for more than 7 days.

Need to take medication continuously for 7 days to achieve a full inhibition of the hill - pituitary - ovaries.

Accordingly, follow the instructions below:

The first week

Take the pills you forgot immediately after realizing, you can take 2 capsules at the same time. Continue to take the following tablets as usual and use another method of contraception such as using condoms for the next 7 days. If you have sex last week before you forget to take the medicine, you may be pregnant. The tablet you forgot closer to the place of placebo tablets, the higher the pregnancy rate.

Week 2

Take the pills you forgot immediately after realizing, you can take 2 capsules at the same time. Then continue taking the medication as usual. If you are sure you have taken the right medicine for 7 days before you forget the drug, you do not need to use another method of contraception. However, if you forget to take more than 1 tablet, should use more contraception in 7 days.

3rd week

The risk of pregnancy decreases because it has been near the temporary break. It is not necessary to use an extra method of contraception, provided that 7 days before forgetting to take the first pills to take adequate and right birth control pills. If not, you can choose one of the following two ways and use one more method of contraception in 7 days:

Take pills you forget right after remembering, you can take 2 capsules at the same time. Continue to take the medication as usual. The next blister starts as soon as the blister is over, there is no rest (do not take 7 placebo tablets). There will be no menstruation until taking the last active ingredient in the second blister, but can flow a few drops of blood during the time of taking the medication. You should take medication for 7 days or take a placebo pill for 7 days including the day forgetting to take the medicine and continue to take the next blister.

Side Effects

When using Asumate 20mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive system: Nausea, abdominal pain.

Metabolism: weight gain. nerve: headache, depression, excitement.

Breeding system: Breast pain or soft.

Skin: itching.

Uncommon, 1/1000

Digestive: vomiting, going out.

Metabolic: reducing excretion.

nerve: migraine, decreased libido.

Reproduction system: Mammary hypertrophy.

Skin: Dermatitis.

Rare, 1/10000

Sensitivity.

Metabolism: weight gain.

Mental: Increase libido.

Skin: polymorphic rash, button.

The following side effects are reported when using oral contraceptives:

Hypertension.

Liver tumor.

Venous or arterial thrombosis.

The following conditions are reported or worsened when pregnant with coc: jaundice, itching caused by bile stasis, gallstones, porphyrin metabolism, systemic lupus erythematosus, hemolysis, Sydenham dance syndrome, genital herpes, hearing loss due to ear sclerosis.

Melasma.

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

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

ASUMATE medicine 20mg contraindicated in the following cases:

Contraindications for oral contraceptives when there is one of the risk factors or many risk factors for artery or veins.

Hypersensitivity to any ingredients of the drug.

History or venous thrombosis (pulmonary embolism, deep vein thrombosis).

History or arterial thrombosis (stroke, myocardial infarction) or signs such as angina, temporary anemia.

Cases of risk factors for arterial thrombosis: diabetes with symptoms of blood vessels, hypertension, blood lipid disorders.

Factors may show genetics or arterial or veins including: Active protein C (ARC), high bloodsteine concentration in blood, deficiency of coagulation factor III, deficiency of protein C and S, anti -phospholipid antibodies (including two main types: anticoplasmic antipectors and Input anticoplasty). Severe liver disease is progressing or having a history of liver disease if the liver function test is abnormal.

Appears or a history of liver tumors (benign or malignant).

Doubt or identify hormonal tumors (genital tumors or breast cancer).

Vaginal bleeding of unknown causes.

Pancreatitis or a history of pancreatitis, plus triglyceride.

Severe renal failure or acute renal failure.

Pregnant and lactating women.

Hypersensitivity to ethinylestradiol, levonorgestrel or with any ingredients of the drug.

Be cautious when using

If any of the following undesirable effects appear, it is necessary to consider the benefits and risks in each woman and discuss with the doctor before deciding to take COC. Immediately notice to the doctor if there are side effects or severe symptoms for them to decide whether to stop the drug or not.

vascular disorders

Epidemiological research shows that the use of any combined contraceptive pills increases the risk of venous thrombosis (VTE) compared to not taking drugs. The risk on the limit of venous thrombosis usually occurs in the first year when starting to use oral contraceptives.

Increased risk of venous thrombosis when taking oral contraceptive drugs lower than the risk of this disease during pregnancy, with an estimated rate of about 60 women in 100 pregnant women. Thrombosis can be fatal in about 1-2% of cases.

Epidemiological research shows that the use of oral contraceptive pills increases the risk of myocardial infarction, transient brain anemia.

Very rare reports occur in other arteries such as liver, intestines, kidneys, brain, eyes when using oral contraceptives.

Women over 35 years old using oral contraceptives should be recommended not to smoke. If you do not quit smoking, other contraceptive measures should be applied, especially when risk factors appear. People who are taking anticoagulants should not use this drug.

Coc drug users should notify the doctor if there are symptoms of thrombosis. If suspected or certainly suffer from thrombosis, do not continue using this medication. Should choose the appropriate contraception to avoid the teratogenic effect of anticoagulant drugs (Coumarin derivatives).

Note the risk of artery occlusion increases during postpartum period. The pathological conditions accompanied by adverse circulatory complications include: diabetes, systemic erythema lupus, hemolytic hyperur syndrome, acute bowelitis (Crohn's disease or ulcerative colitis).

If the frequency or severity of migraine increases when using COC (foreshadowing of cerebral vascular disease), it is advisable to stop coc immediately.

The risk of cervical cancer increases in those who use drugs that last (over 5 years) are reported in a number of epidemiological studies, but this is still controversial due to other causes such as sexual acts or evidence of Papilloma virus infection (HPV) ... Analysis reports from 54 epidemiological studies show the risk of relative diagnosis of mild breast cancer in women. The risk of reduction gradually disappears for 10 years after stopping using COC. A number of epidemiological studies have shown the development of breast cancer in the middle -aged age related to early use and COC use time.

Hypergly hyperglyceration or family history, may increase the risk of pancreatitis when using COC. Some women mild blood pressure when taking coc drugs, but rare cases of clinical significance. If the blood pressure continues to increase significantly, COC should stop treating and treating hypertension. When blood pressure returns to normal, it is possible to consider using coc back with hypertension.

If acute or chronic hepatitis appears, stop coc until the results of liver function test return to normal. Hormonal contraceptives should be stopped if they relapse jaundice/cholestasis (first occurred during pregnancy or when using sex steroids before). Coc drugs reduce glucose tolerance and increase insulin demand in peripheral cells. Usually there is no need to change the treatment regimen in women using COC, but should closely monitor the situation when starting to take the drug.

Crohn's disease and ulcerative colitis have been reported while using COC. Using adolescents in women can affect the tip of cartilage, making the body not developing height. Oral contraceptives are not prevented with HIV infection and sexually transmitted diseases.

The evaluation to start taking the drug or the use of the drug should include the medical details of yourself and your family. Should eliminate the case of pregnancy. Need to check blood pressure and health as instructed. Should read carefully and strictly follow the user manual before use. The evaluation should be based on the relevant and appropriate instructions for each woman.

Hemorrhagic hemorrhage may not occur in all cases. If the medication is right, it is difficult to get pregnant. If hemorrhage due to hormonal decrease does not occur after the second blister use, or does not follow the instructions for the use of the drug, eliminating the possibility of pregnancy before using the next blister.

The ability to drive and operate machinery

There is no research on the effect of the drug on the ability to drive and operate machinery. However, it has not been observed that the drug affects the ability to drive and operate machinery.

Pregnancy

Not for pregnant women.

If pregnant while taking oral contraceptive pills, stop immediately.

Data related to the use of drugs during pregnancy is very limited to be able to conclude the negative effects affecting the pregnant woman, the health of the fetus and the newborn.

so far there is no related epidemiological data.

Breastfeeding period

may be affected by COC birth control pills, which can cause reduced amount and quality of milk. Do not use contraceptives until you stop breastfeeding. A small amount of steroidal contraceptives or metabolites can be excreted in breast milk while taking the drug and can affect breastfeeding.

Medicinal interaction

Interactions between oral contraceptives and other drugs: may cause bleeding between cycle or cause contraception.

Reducing absorption: Metoelopramid may reduce hormones.

contraceptive effects decreased when used with antibiotics such as ampicillin and tetracyclin. Add temporary contraception with coc while taking antibiotics and 7 days after stopping the drug.

For rifampicin, another contraceptive measure is added with coc while taking rifampicin and 28 days after stopping the drug. If the contraceptive pill is combined during the same use, the next blister can be used without a break.

Should increase the dose of steroidal contraceptives when used long -term with drugs that reduce liver enzymes and apply other mechanical contraception.

The effect of oral contraceptives on other drugs.

Increased serum and tissue concentration (cyclosporin) or decrease (lamotrigin).

Progesfin -containing drugs that can interact with enzyme inhibitors, potassium -keeping diuretics, aldosteron anti -drugs, Angiotensin II receptor anti -receptor drugs, nonsteroidal anti -inflammatory drugs.

Steroidal contraceptives can affect a number of tests: including the biochemical parameters of the liver, thyroid, adrenal and kidney function, serum protein levels, for example, globulin and lipid/lipoprotein liver corticosteroids, cabohydrate metabolic parameters, coagulation and decomposition of fibrin. Changes in general are still in normal threshold.

Storage

At temperatures below 30 ° C.

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