Rosepire medicine 3mg/0.02mg Expeltis purple for contraception (1 blister x 28 tablets)

Drospirenone has a mineralocorticoid resistance that limits weight gain and other symptoms caused by water retention. Drospirenone neutralizes the sodium holding of estrogen to create good tolerances and positive effects on the premenstrual syndrome (PSM). When combined with ethinylestradiol, Drospirenone plays a role in providing appropriate lipid sources to increase HDL. Drospirenone has antimicrobial effects that reduce the growth of acne and sebum on the skin. Drospirenone does not lose the effect of increasing the SHBG related to ethinylelestradiol brings the efficiency for the cohesion and inactivity of androgen in the body.

Drospirenone has biochemical and pharmacological properties similar to natural progesterone hormones.

In addition, the combination of Drospirenone and EthinyleLestradiol also reduces the risk of endometrial cancer, ovarian cancer, pelvic inflammation, breast tumor and ectopic pregnancy.

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. Bioions 76 - 85% and not affected by food.

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

Metabolic: Drospirenone is metabolized after drinking, forming an acid form through the lacton -opening reaction 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.

Era: 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 reaches 1-2 hours after drinking. Birth is about 45% and affected by food.

Distribution: The volume of distribution 5 l/kg.

Metabolic: Ethinylestradiol is metabolized in the small intestine and liver by hydroxylation of aromatic ring. The metabolites in the form of free or linked to glucuronide 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.

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 abandon the placebo, not extending the place of the placebo pill.

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 medicine for more than 7 days, must take medicine continuously for 7 days to achieve appropriate inhibition of the hypothalamus - 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 had sex last week before you forget to take 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. pregnancy.

   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.

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.

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:

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

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

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 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. If you are pregnant while taking the medication, you should stop immediately.

The period of breastfeeding

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

Drug interaction

Interaction between oral contraceptive pills Drospirenone and ethinylelestradiol and other drugs such as HytanToin, Barbiturate, Primidone, Carbamazepine and Rifampicin, Oxcarbamazepine, Topiramate, Felbamate, Ritonavir, Griseofulvin can make cyclical disorders Influence on contraceptive effects.

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

While taking the above drug groups, a temporary contraceptive method should be used with COCs, even in 7 days after stopping the medication.

For women who are being treated for rifampicin, an additional contraceptive is used with coc during rifampicin and 28 days after stopping the drug.

If using two types of drugs lasts until the tablet runs out of activity of the COC blister, using the next blister without a vacation time or without a placebo.

Effects of Drospirenone and Ethinylestradiol on other drugs:

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

Other interactions: Some patients impaired renal function, simultaneously using Drospirenone with ACE or NSAID inhibitors that do not affect serum potassium levels. However, simultaneous use of drugs with other anti -aldosteron or potassium -keeping pills that have 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.