Drosperin 20 Abbott daily contraceptive pills (1 blister x 28 tablets)

Dosage form Box of 1 blister x 28 tablets
Specifications Drospirenone, Ethinyl Estradiol
Ingredient Recalcine

Ingredient

Thành phần cho 1 viên

Composition information	Content
Drospirenone	3mg
Ethinyl estradiol	0.02mg

Uses

indications

Drosperin® 20 drugs are indicated in the case of: contraception.

This drug is only used as prescribed by the doctor.

Pharmacokic

The combination of Drospirenone and Ethinyl Estradiol has the effect of inhibiting Gonadotropin. Although the main mechanism of this activity is to prevent ovulation, other changes also occur, including changes in cervical mucus (making it difficult to enter the uterus) and changes in the uterus (reducing the ability to nest the egg).

Pre -clinical studies on animals and in vitro shows Drospirenone without the effects of an Androgenic, estrogenic, glucocorticoid, and glucocorticoid resistance. Pre -clinical studies on animals also show that Drospirenone has anti -androgenic effects.

Pharmacokinetics

absorption

The absorption of Drospirenone's absorption is 76%. The absorption bioavailability of Ethinyl estradiol is nearly 40%, the maximum concentration in the plasma of Drospirenone and Ethinyl Estradiol is about 1-3 hours after drinking. The pharmacokinetics of Drospirenone is proportional to the single dose after oral oral fluctuations in about 1 - 10mg. 10 days after drinking daily, Drospirenone reaches a stable concentration. With Ethinyl Estradiol, the stable concentration is achieved in the second half of the treatment cycle.

The absorption speed of Drospirenone and Ethinyl estradiol after drinking 2 capsules with food will reduce CMAX by about 40% for both types, but the absorption level of Drospirenone is maintained constant. In contrast, the absorption level of Ethinyl estradiol is reduced by about 20% depending on the food condition.

Distribution

Serum concentration of Drospirenone and Ethinyl estradiol decreased in two phases. The clear distribution of Drospirenone is about 4l/kg and Ethinyl estradiol is about 4 - 5l/kg.

Drospirenone is not associated with globulin associated with sex hormones (SHBG) or with globulin attached to corticoids (CBG), but it is associated with 97% of serum protein. Ethinyl Estradiol is known for its high cohesion rate with serum albumin (approximately 98.5%), but nonsense, and it increases the concentration of SHBG and CBG in serum.

Effects of Ethinyl estradiol on SHBG and CBG are not affected by the change of Drospirenone dose in about 2-3 mg.

Metabolism

The main form of drospirenone metabolism found in human serum is the acid form of Drospirenone born by the opening of lactone and 4.5 dihydrospirorenone-3-Sulfate. This proves that these types of metabolism have no pharmacological activity.

In vitro studies with human liver microsomes show that Drospirenone is metabolized at a lesser level, mainly with Cytochrome P4503A4 (CYP3A4). Ethinyl estradiol is known as a complex in mucus in the small intestine and liver.

The main metabolism occurs by aromatic oxidation, but many types of metabolic substances are hydrogenated and methylation have been formed. These substances are present as free metabolites and combined with glucoroid and sulfate.

CYP3A4 system in the liver is responsible for metabolism 2 - hydroxylation, which is the main oxidation reaction. Metabolic 2 - Hydroxyl is further transformed by methylation and glucuronicization before urine and feces to eliminate.

Elimination

Dropirenone concentration in serum is characterized by a semi -cancellation time of 1 phase in the late stages of about 30 hours after taking single dose or multiple dose. The excretion of drospirenone completely after 10 days mainly through feces, 1 small part through the urine.

There are at least 20 different metabolites found in urine in the form of glucuronid and sulfate. In the stool, about 17-20% of metabolic substances are excreted in the form of glucuronid and sulfate.

The half -life of the last phase of Ethinyl Estradiol is about 24 hours. Ethinyl estradiol is not completely eliminated. It is excreted in urine and stool in the form of glucuronid and combined sulfate. This substance is involved in the liver - intestinal cycle.

Before taking Drosperin 20 Abbott daily contraceptive pills (1 blister x 28 tablets)

How to use

oral, can take medicine with meals or not meals.

Dosage

To achieve optimal contraceptive effect, the drug must be taken for no more than 24 hours.

Take 1 capsule a day, at the same time, 28 consecutive tablets in the order are written on the back of the plastic box without any drugs and do not leave any tablets. The distance between 2 tablets must not be more than 24 hours.

In cases of taking pills that cause vomiting or discomfort, medication at meals.

The first red tablet must be taken on the first day of the menstrual cycle (the first day to see the menstruation). This order is very important, always taking the first red (active) tablet first and ending with white tablets (no activity).

When you use 1 blister, start immediately with a new blister. Always hold a new blister to make sure you do not forget the first tablet of the next cycle.

Menstrual period can occur within 3 days after the last (red) drug stopped. If a mild blood occurs between cycles (drip) or abnormal bleeding during medication, continue taking the medication as instructed. This sign is usually not important, but if the persistent blood needs to see a doctor immediately.

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 using overdose? If you think overdose, go to the medical facility immediately.

Clinical signs of overdose include: abnormal bleeding, vomiting and nausea.

In case of overdose, treatment as recommended below:

Do everything to cause vomiting.

If you forget an activity (red), take it as soon as you remember, even if you take 2 capsules in the same day, and then take the next tablets next to normal schedule.

Use an extra method of non -hormonal contraception or mechanical contraception (condoms, vaginal barriers) for the next 7 days, in addition to continuing to use Drosperin® 20 tablets as normal schedules.

If you forget to take 2 consecutive activity in the first week or the 2nd week, then take 2 capsules a day for the next 2 consecutive days, at the normal time. Then take the next tablets as normal schedule 1 tablet.

In this case, the risk of ovulation increases, so you should use another method of contraception without hormonal or mechanical contraception (condoms, vaginal barriers) in the next 7 days, in addition to using the remaining Drosperin® 20 tablets as usual.

If you forget to take 2 consecutive activities in the third week or the fourth week, or if you forget to take over 3 consecutive activity within 24 tablets with the activity: remove the remaining tablets of the blister and start with the first tablet of a new blister blister right on the next day.

You should use additional methods of other non -hormonal contraception or mechanical contraception (condoms, vaginal barriers) within 7 days after forgetting to take pills. It is likely that you will not have a period in that month, but if you don't have menstruation for 2 consecutive months, see a doctor to determine if you are pregnant.

Forgetting to drink white tablets without activity in the 4th week can be ignored, but the red -active tablet of the next blister must be taken on the plan as planned.

Side Effects

When using Drosperin® 20, you may experience unwanted effects (ADR).

The drug can increase the risk of thrombosis in women. So, if you see the following symptoms, you must see a doctor immediately:

cerebral infarction or stroke (fever, suddenly lost knowledge); Skill, headache, fingers, back pain, pelvis or stomach, ears with bells); Venous blockage caused by thrombosis (pale skin, changing skin color, sensitive, swelling of the legs and feet).

Symptoms without medical intervention include:

Common, ADR> 1/100

Reproduction: Changing menstrual cycle or abnormal bleeding such as menstruation (all without menstruation for a few months), abnormal bleeding (vaginal bleeding between menstrual cycles), low bleeding (indicating a little blood into the menstrual cycle), dripping (bleeding between normal menstrual cycles), cervical changes in fluid; Infertility after stopping the drug.

Systemic: Cramps in the abdomen or abdominal bulging; mild fish eggs after 3 months of treatment; Swelling, pain, increased pain when touching the breast; The cornea changes; jaundice bile; The lens is not tolerated, holding salt and water (ankles and feet swollen).

Uncommon, 1/1000

Systemic: headache or migraine (more pain or increased pain regularly); Hypertension (making the disease worse), falling or increasing body hair or face; The skin has brown dots when exposed to the sun; Increase or weight loss.

Reproduction: Vaginitis or vaginitis caused by Candida fungus recurring (vagina released white, thick fluid, itching, burning vagina), sexual changes (increase or decrease in sexual needs).

Rare, 1/10000

Reproduction: Breast tumors, mainly in patients with the disease before.

Metabolism: Small cell hyperplasia in central TM, hepatitis or liver cell carcinoma (stomach pain, pain next to or abdominal area; jaundice, yellow eye).

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

Drosperin® 20 drugs are contraindicated in the following cases:

pathology of liver, kidney, adrenal gland; jaundice in pregnant women or jaundice in women with a history of oral contraceptives; Liver tumor (healthy or malignant); Jaundice progresses; Abnormal in urine as blood without the cause.

Cardiovascular disease , fainting, coronary artery disease, blood circulation problems, coagulation disorders, thrombosis (blood clots), stroke.

diagnosed or suspected breast cancer, uterine mucosal cancer, or cancer dependent on estrogen.

Diagnosis or suspicion of pregnancy.

Hypersensitivity to Drospirenone, Ethinyl Estradiol or other hormones.

Diabetes with vascular damage.

Migraine's history of migraine (Migraine) has concentrated symptoms.

Suspected pregnancy or being diagnosed with pregnancy.

Be cautious when using

If there are the following signs, stop the drug immediately:

There is migraine (migraine) or severe intensity, with increasing intensity. Epigastric pain or liver area increases.

Increased seizures.

Before using oral contraceptives, body examination and gynecological examination to make sure you are not sick and have risk factors.

During the time of taking birth control pills, you have to have a health check every 6 months to 1 year to re -evaluate the contraindications (for example, a transient chest pain) and risk factors (for example, a family history of arterial thrombosis, veins), because these diseases may appear early during treatment.

Hormonal contraceptives are associated with the risk of increased venous thrombosis, artery embolism, myocardial infarction, stroke. However, these complications have been determined to be lower than during the period of oral contraceptives compared to pregnancy.

Before taking birth control pills, you should carefully consider risk factors - benefits and contraindications related to venous and artery thrombosis. Artery and venous embolism due to increased risk in the following cases:

Women over 35 years old, smoking (higher risk, especially artery complications); heart;

atrial fibrillation; Glucose, slightly increased insulin release in patients with diabetes 2 or slightly increased the side effects of cholesterol - lipoprotein.

In some cases, the dose of hypoglycemic groups may be changed or increased the evaluation of glucose or lipid levels in serum. If the metabolic effect is not controlled, the treatment must be stopped.

Gallbladder pathology or a history of disease, especially gallbladder stones: Estrogen can change the composition of bile salts and increase cholesterol's concentration to make gallstones progress in the first 2 years of medication, which depends on the location of each individual. In general, this risk is low, but it is still necessary to be cautious when taking birth control pills with these patients.

Liver pathology: Estrogen metabolism can be affected in patients with liver pathology so it is recommended to use hormonal contraception for this patient. Hormone contraceptives can be reused when testing for normal liver function.

High blood pressure: Low doses of oral contraceptive pills are taken to increase blood pressure in some normal blood pressure women with risk factors, low doses of multi -phase contraceptives can be suitable for these patients.

Hemorrhage: Drospirenone has anti -mineral and corticosteroid effects, which can increase blood potassium in risky patients.

Oral contraceptives can cause symptoms of bleeding (gums), hyperpigmentation (gums) or alveolar bone (dry toothpole). Please inform the dentist. Regular brushing can reduce this symptom.

Please inform the doctor without menstruation in 2 consecutive cycles.

You must notify the doctor about the contraceptive pills before doing tests because the contraceptive pills can cause the pregnancy to change the results of some blood tests.

Use one more contraceptive method for at least 7 days of the first cycle to use the drug. Use another method of contraception during the time to forget to take 1 or several doses or are taking another drug that works to reduce the ability to prevent pregnancy. Please consult a doctor.

In case of vomiting or diarrhea, another method of contraception should be used without hormones, as soon as it is stopping or a short time after use.

The ability to drive and operate machinery

Effects on drivers and operating machinery have not been reported.

pregnancy

It is not recommended to use this drug during the exam because the hormone through the placenta affects the fetus. In case of diagnosis or suspicion of pregnancy you have to stop the medicine immediately and see a doctor.

Demonstrate period

Do not take medicine for women who are breastfeeding because hormones secreted in breast milk can affect the development of the baby.

Interactive drug

Notice the doctor about the drugs you are taking, including non -prescription drugs. Drug interaction may occur in the following case:

antagonistic aldosterone, angiotensin (ACE) conversion inhibitors, Angiotensin II receptor antagonist, nonsteroidal anti -inflammatory (NSAIDs), potassium or heparin diuretic: Sharing these drugs can increase the level of potassium in serum because of the anti -corticoid and mineral effect of Drospirenone.

If you use the drug for a long time, you should check the serum potassium concentration in the first cycle.

paracetamol: This drug can be combined with paracetamol causing reduction in serum paracetamol levels and increasing the concentration of some synthetic estrogen.

Ascorbic acid: simultaneously using the concentration of some synthetic estrogen.

Atorvastatin: Used with ethinyl estradiol increases the AUC of Ethinyl Estradiol to 20%.

Ampicillin, Griseofulvin, Tetracycline: Rarely cases of effective reports of decreasing birth control pills in women using ampicillin, griseofulvin, tetracycline. Although the evidence of interactions is very limited, when taking birth control pills with any antibiotic.

Clofibrate, Morphine, Salicylic Acid and Temazepam: Used with birth control pills can increase the clearance of these drugs.

Cyclosporin, Prednisolone or Theophyllline: Used with unmodel contraceptive pills Ethinyl Estradiol can inhibit the metabolism of these drugs, thus increasing their concentration in serum.

Carbamazepine, phenobarbital , phenylbutazone, phenytoin, rifampin or hypericum Perforatum (commonly called measles venom): Sharing these drugs with oral contraceptives can increase the metabolism of Ethinyl estradiol and some Progestogen, reducing the effect of contraceptive and increased the effect of contraceptives Usually.

Tobacco: It is not recommended to use oral contraceptive pills in women who smoke because of the increased risk of cardiovascular complications including stroke, angina, inflammation of thrombosis, pulmonary clogging. This risk is higher in women over 35 years old have a habit of smoking.

Storage

Keep the drug in a dry place, avoid light, not more than 30 degrees C, away from reach of children.

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