Drospirenone and Ethinylestradiol Tablets for Contraception

• Transport Package: Box
• Specification: 3mg*100tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC080
• Production Capacity: 10000PCS/

Product Description

Item Name:Drospirenone and Ethinylestradiol Tablets
Molecular formula:

Item Description

Item nanme:Drospirenone and Ethinylestradiol Tablets
Item character:The product is yellow

Indication:
Female contraception

Item specifications: 3mg*100tab/box

Usage and dosage:Route of administration
Oral administration
Administration method
How to take this product
If taken correctly, the contraceptive failure rate of compound oral contraceptive is about 1% per year. If you have missed medication or you don't take the right way, the rate of contraceptive failure will increase.
The clothing must be delivered in a small amount of liquid at the same time every day in the order indicated in the packaging. Take one tablet a day for 21 days. Take the next box seven days after stopping, and usually retreat bleeding occurs. Bleeding usually begins 2-3 days after the last drug in the cycle is taken, and may not be over at the beginning of the next drug box.
How to start taking this product
·Women who did not use hormone contraceptives before taking the drug (last month)
The drug should be taken on the first day of the woman's natural menstrual cycle (i.e. the first day of menstrual bleeding). It can also start on day 2-5, in which case, it is recommended that barrier contraception be added within the first 7 days of the first medication cycle.
·Women who take from another compound hormone contraceptive (compound oral contraceptive /coc), vaginal ring or skin patch
It is better to take the last hormone containing drug of COC used before, and start taking the product on the second day. At the latest, it should be taken immediately at the end of the period of suspension of COC or the end of the period of use of hormone free tablets. For women who have used a ring or transdermal patch, it is better to start taking the product on the day of removal, but should start taking it at the latest on the next use.
·Women who were changed from the simple progesterone method (micropills, injections, implants) or from the IUS, which released progesterone
This product may be changed from pellets (from implants or IU to IU on the date of withdrawal and injection on the next injection day) at any time, but for all of these cases, it is recommended that barrier contraception be added within the first 7 days of taking the drug.
·Women after early pregnancy abortion
You can start taking medicine immediately. In this case, no additional contraceptive methods are required.
·After delivery or after miscarriage in the middle of pregnancy
For the methods of taking lactation women, see [pregnant women and lactation women's medication]
It should be suggested that women should start taking them after childbirth or the 21st-28th day after miscarriage of the mid pregnancy. If it starts later, it should be recommended that women use barrier contraception within the first seven days of taking the drug. However, if sexual behavior has occurred, the possibility of pregnancy should be excluded before taking this product or taking it again after the first menstrual tide.
Treatment of missed medication
If the user forgets to take the medicine for less than 12 hours, the contraceptive protection effect will not be reduced. Once women think about it, they must take it immediately, and the next drug should be taken at regular times.
If you forget to take more than 12 hours, contraceptive protection may be reduced. The treatment of missed medication can follow the following two basic principles:
1. stop taking medicine in any case for no more than 7 days
2. it is necessary to take 7 days continuously to keep the hypothalamus pituitary ovarian axis fully inhibited, so the following suggestions can be given in daily medication:
·Week 1
Users should take missed pills as soon as they think about it, even if this means taking two pills at the same time. Then continue taking the medicine at regular times. In addition, in the next 7 days, we should add barrier contraceptive methods such as condoms. If sexual behavior has occurred within 7 days before, the possibility of pregnancy should be considered. The more missed pills and the closer to the regular stop period, the higher the risk of pregnancy.
·Week 2
Users should take missed pills as soon as they think about it, even if this means taking two pills at the same time. Then continue taking the medicine at regular times. If the user takes the drug correctly within 7 days before the first missed pill, no additional contraceptive measures are required. However, if this is not the case, or if she missed more than one pill, she should be advised to add additional contraceptive measures for 7 days.
·Week 3
Because of the near stopping period, the risk of contraceptive reliability reduction is increased. However, the reduction of contraceptive protection can still be prevented by adjusting the medication plan. If women take the first pill correctly within 7 days before the first pill, then follow either of the following two recommendations, and the user does not need to take additional contraceptive measures. If not, it is recommended that women follow the first of the two recommendations and add additional contraceptives within the next seven days.
1. users should take missed pills as soon as they think of it, even if this means taking two pills at the same time. Then continue taking the medicine at regular times. The next box of drugs was taken immediately after the drug was taken, i.e. there was no stopping period between the two boxes. It is unlikely that the user has retreating bleeding until the second box of medicine is taken, but it may have a drip or breakthrough bleeding during the medication.
2. it is also advisable that women no longer continue to take the drug cycle. The woman should go through a seven day period of discontinuation, including days of missed medication, before continuing to take the next cycle of medication. If women have missed medication and no withdrawal bleeding occurs during the first normal interval after the drug stop, the possibility of pregnancy should be considered.
[u] Suggestions for gastrointestinal disorders [/u]
If severe gastrointestinal disorders occur, absorption may not be complete, additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the drug, the recommendations in "treatment of missed medication" can be used. If a woman does not want to change her normal medication plan, she must take the drug supplement from another box.
[u] How to change menstrual period or delay menstrual period [/u]
To delay menstruation, women can continue to take the next box of drugs after taking a box of drugs without stopping the interval. Menstruation can be postponed to any time before the second box of drugs is taken. Breakthrough bleeding or drip bleeding may occur during the extended period of administration. The regular administration of the product can be resumed after the usual 7-day stop period.
To change the current menstrual period to another day of the week, it is recommended that she shorten the interval between the stops to the time she wants. The shorter the interval between the drugs, the greater the risk of no withdrawal bleeding and breakthrough bleeding and drip bleeding (as described in postponing menstruation) during the next drug administration.
Special people use drugs
Patients with liver function impairment
Women with severe liver disease are prohibited: see [taboos] and [pharmacokinetics].
Renal function impairment
Women with severe renal dysfunction or acute renal failure are prohibited from this product. See [taboo] and [pharmacokinetics].

Adverse reactions
Safety summary
The most frequently reported adverse reactions were nausea and breast pain. More than 6% of the users had the above adverse reactions.
Serious adverse reactions were arterial and venous thromboembolism.
MedDRA Dictionary (version 12.1) was used for adverse events in clinical trials. Different MedDRA terms expressing the same medical phenomenon are combined into an adverse reaction to avoid weakening or masking the real effects.
*-Incidence assessment from epidemiological studies
The incidence of compound oral contraceptive group is critical to very rare
*-The "arterial and venous thromboembolism event" includes the following medical entities:
Peripheral deep vein occlusion, thrombosis and embolism / pulmonary occlusion, thrombosis, embolism and infarction / myocardial infarction / cerebral infarction and non bleeding stroke.
For arterial and venous thromboembolism events and hemicephalic pain, please refer to [taboo], [precautions].
MedDRA preferred terms are used to describe a specific reaction and its synonyms and related conditions. The term for adverse reactions is based on MedDRA version 12.1.
Description of specific adverse reactions
The list of adverse reactions with very low incidence or delayed symptoms considered to be associated with the compound oral contraceptive group is as follows (see [taboo], [precautions]):
tumour
·The diagnosis rate of breast cancer increased slightly in OC users. Since breast cancer is rarely seen in women under 40, the increase is rare relative to the overall risk of breast cancer. The relationship with COC is not clear.
·Liver tumor (benign and malignant)
Other circumstances
·Erythema nodosa
·Women with hypertriglyceridemia (increased risk of pancreatitis with COC)
·Hypertension
·The relationship between occurrence or deterioration of the following and the use of COC is uncertain:
Jaundice and / or pruritus associated with cholestasis; Gallstone formation; Porphyria; Systemic lupus erythematosus; Hemolytic uremia; Little dance; Herpes gravis; Hearing loss associated with otosclerosis.
·Exogenous estrogen can induce or aggravate the symptoms of vascular edema in women with hereditary vascular edema.
·Abnormal liver function
·Change glucose tolerance or influence peripheral insulin resistance
·Clonosis and ulcerative colitis
·Chloasma
·Hypersensitivity (including symptoms such as rash, rubella, etc.)
Drug interactions
The interaction of other drugs (enzyme inducers, some antibiotics) with oral contraceptives may lead to breakthrough bleeding and / or contraceptive failure (see [drug interaction].
The third phase clinical trial conducted in China showed that 163 (28.6%) of 570 patients in the yousiming group had drug-related adverse events, the most common three adverse events (incidence over or close to 5%) were irregular bleeding of uterus (36 cases, 6.3%), nausea (27 cases, 4.7%), and emotional fluctuation (32 cases, 5.6%). These events are known adverse reactions to compound oral contraceptives. In the trial, the serious adverse events related to the positive drug in the group of best care were 2 (0.4%) pregnancies, both of which had missed or delayed medication before the pregnancy was found. No other serious adverse reactions occurred in patients who took ulinamine.

Taboo:
Compound oral contraceptives (COCs) shall not be used in any of the following cases. If any of the following conditions first occurs during COC use, the drug must be stopped immediately.
·Occurrence of venous or arterial thrombosis / thromboembolism (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular accident, or with the above-mentioned history
·A precursor to thrombosis or a related history (e.g. transient cerebral ischemia, angina)
·Severe or multiple risk factors for venous or arterial thrombosis (see [precautions])
·Migraine history with focal nervous symptoms
·Diabetes involving blood vessels
·Pancreatitis or history associated with severe hypertriglyceridemia
·Severe liver disease, as long as the liver function index does not return to normal
·Severe renal insufficiency or acute renal failure
·Adrenal insufficiency
·The presence or history of liver tumors (benign or malignant)
·Known or suspected of having a malignant tumor (e.g., reproductive organ or breast) affected by sex steroids
·Vaginal bleeding with unknown cause
·Known or suspected pregnancy
·Allergic to active ingredients or any excipients of the product

Matters needing attention:
warning
If any of the following conditions / risk factors exist, each woman should weigh the benefits of applying COC and the possible risks, and discuss it before she decides to start taking the drug. If any of the following conditions or risk factors aggravates, worsens or first occurs, contact your doctor. The doctor should decide whether COC should be stopped.
·Circulatory diseases
Epidemiological studies have shown that the use of COCs is associated with increased risk of arteriovenous thrombosis and thromboembolism diseases such as myocardial infarction, deep vein thrombosis, pulmonary embolism and cerebrovascular events. These events are rare.
VTE was the most dangerous in the first year of use. The risk increases when COC is started or the same or different COC is used again (the interval between the discontinuation lasts for 4 weeks or longer). A large prospective three group cohort study showed that increased risk was mainly in the first three months. In short, low dose estrogen (< 50 μ The risk of thromboembolism in COCs women with g-ethinylestral) was 2-3 times higher than that of women without COCs, but the risk was lower than that of pregnant and childbirth.
VTE may be life-threatening or cause death (1% - 2%).
Epidemiological studies have shown that VTE risk with trospironoids is higher than that of levonorgestrel OCS (i.e. the second generation oral contraceptive), which may be comparable to the risk of OCS containing desoxypregnene / pregnedienone OCS (i.e. the third generation oral contraceptive).
VTE is a deep vein thrombosis and / or pulmonary embolism, which may occur during all COCs use.
It is rare that thrombosis of other blood vessels, such as liver, mesentery, kidney, brain or retinal vein and artery, has been reported in COC users. There is no consensus on whether these events are related to the use of COCs.
The symptoms of DVT include: swelling of one leg or swelling along the leg vein; Leg pain or tenderness when standing or walking; The warmth of legs increased; The skin of the legs is red or discolored.
The symptoms of PE may include sudden unexplained shortness of breath or shortness of breath; Sudden cough may be accompanied by bleeding; Acute chest pain may be accompanied by increased deep breathing; Anxiety; Severe dizziness or vertigo; Fast or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are not unique and may be considered to be derived from other common or non serious events (e.g., respiratory infections).
Arterial thromboembolism events may include cerebrovascular accidents, vascular occlusion, or myocardial infarction (MI). The symptoms of cerebrovascular accidents may include: anesthesia or weakness of face, arm or leg, especially unilateral body; The sudden consciousness is vague, language or comprehension is obstructed; One side or two sides of vision disorder; Sudden walking disorder, vertigo, loss of balance or coordination ability; Long term headache with sudden, serious or unknown reasons; Loss of consciousness or fainting with or without seizure. Other signs of occlusion include sudden pain, swelling of extremity end and discoloration of pale blue; Acute abdominal pain.
The symptoms of MI include pain, discomfort, compression, heaviness, compression and swelling in the lungs, arms or sternum, and discomfort radiates to the back, jaw, throat, arm, stomach; Feeling of inflation, dyspepsia or asphyxia; Sweating, nausea, vomiting, or vertigo; Extreme weakness, anxiety, or shortness of breath; Fast or irregular heartbeat.
Arterial thromboembolism may endanger life or lead to death.
The risk of venous or arterial thrombosis / thromboembolism events or cerebrovascular accidents can increase with:
-Age increase;
-Obesity (BMI over 30kg/m2);
-Positive family history (i.e. siblings or parents had venous or arterial thromboembolism at an earlier age). If genetic susceptibility is suspected, consult the specialist before deciding to use any COC;
-Long term braking, large surgery, any leg surgery, or greater trauma. For these cases, it is recommended to stop taking COC (stop the drug at least 4 weeks before the selective operation), and take the drug after two weeks after the full recovery of activity.
-Smoking (the risk of smoking increased with the increase of smoking and age, especially for women over 35 years old);
-Abnormal lipoproteinemia;
-Hypertension;
-Migraine;
-Heart valve disease;
-Atrial fibrillation;
There is no consensus on the possible role of varicose vein and superficial thrombophlebitis in the thromboembolism.
The increased risk of thromboembolism during the puerperal period should be considered (see [medication for pregnant and lactating women].
Other clinical conditions related to circulatory adverse events include diabetes, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (clonal disease or ulcerative colitis), and sickle cell disease.
During COC use, migraine attacks frequency or pain level increased (may be a precursor symptom of cerebrovascular accident), and this may require immediate withdrawal of COC.
It is suggested that there may be biochemical factors that may be genetic or acquired venous or arterial thrombosis, including active protein C (APC) resistance, hypercysteinemia, antithrombin deficiency, protein C deficiency, protein S deficiency, anti phospholipid antibody (anti cardiolipin antibody, wolf sore anticoagulant).
When weighing the benefits and disadvantages, doctors should consider that adequate treatment of a condition may reduce the risk of associated thrombosis and that the risk of thrombosis associated with pregnancy is higher than that associated with the use of low-dose COC (ethinylestradiol < 0.05mg).
·Tumor
The most important risk factor of official neck cancer is the persistent HPV infection. Some epidemiological studies have shown that long-term use of COCs can further increase this risk. But there has been controversy about how much of the result should be attributed to confusion, such as official neck screening and sexual behavior, including the use of barrier contraceptives.
Meta analysis of 54 epidemiological studies showed that women who were using COCs were slightly more likely to diagnose breast cancer (RR = 1.24). The increased risk gradually disappeared in the 10 years after the use of COC was stopped. Since breast cancer is rarely seen in women under 40, there is a small increase in the number of breast cancer diagnoses in the patients who are using and recently using COC, relative to the overall risk of breast cancer. These studies do not provide causal evidence. The increased risk observed may be due to early diagnosis of breast cancer in COC users, biological effects of COCs, or both. Breast cancer in patients who used COC was often in early stages in clinical practice compared with those who had never used COC.
There have been rare benign liver tumors and even more rare malignant liver tumors in COCs users. In individual cases, these tumors cause life-threatening intraperitoneal hemorrhage. When the women taking COCs have severe abdominal pain, liver enlargement or signs of abdominal hemorrhage, the differential diagnosis should consider liver tumor.
Malignant tumors may endanger life or lead to death.
·Other situations
In patients with renal insufficiency, potassium excretion is limited. In a clinical study, the use of trospirone in patients with mild or moderate renal impairment showed no effect on serum potassium concentration. In theory, it is possible that patients with renal function injury with serum potassium in the upper limit of normal range and are using potassium conservator can be at risk in theory.
Women with hypertriglyceridemia or family history may be at increased risk of pancreatitis by taking COCs. Although mild increases in blood pressure have been reported in many women taking COCs, clinically significant increases are rare. The increase of blood pressure induced by ethinylestradiol in women with normal blood pressure may be counteracted by the anti salt corticosteroid effect of trospirone. However, if there is a continuous clinically significant hypertension during the use of a COC, doctors should consider discontinuing COC and treating hypertension with caution. If the blood pressure returns to normal after the treatment of hypotension, the COC can be resumed when the doctor considers it appropriate. It has been reported that during pregnancy and when taking COC, the following conditions occur or deteriorate, but the evidence related to the use of COC is uncertain: jaundice and / or pruritus related to cholestasis; Gallstone formation; Porphyria; Systemic lupus erythematosus; Hemolytic uremic syndrome; Little dance; Herpes gravis; Hearing loss associated with otosclerosis.
In women with hereditary vascular edema, exogenous estrogen can embroider or aggravate the symptoms of vascular edema.
The COC should be stopped in the case of acute or chronic liver dysfunction until the liver function index returns to normal. COCs should be stopped when cholestatic jaundice recurred for the first time during pregnancy or during previous use of steroids.
Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no sign that diabetic patients taking low dose COCs (ethinylestral < 0.05mg) need to change the treatment plan. However, the situation of women with diabetes should be carefully observed during COCs.
Clonal disease and ulcerative colitis are associated with the use of COC.
Occasionally, chloasma occurs, especially in women with a history of pregnancy. Women with browning tendency should avoid exposure to sunlight or ultraviolet radiation during COCs.
Each tablet contains 46mg lactose. For patients with rare genetic galactose intolerance, lapprolase deficiency or glucose galactose absorption disorder who cannot take lactose, it should be considered.
Medical examination / consultation
Before taking COC for the first time or taking again, complete medical history and comprehensive physical examination shall be collected according to the requirements of Taboo (see [taboo] and warning (see), and regular review shall be conducted. Regular medical assessment is also important because taboos (such as transient cerebral ischemia attacks, etc.) or risk factors (such as family history of venous or arterial thrombosis) may appear for the first time during COC use. The frequency and nature of these medical assessments should be conducted in accordance with established clinical norms and be littered for women individuals, but should generally focus on blood pressure, breast, abdomen and pelvic organs, including cervical cytology.
Women should be told that oral contraceptives cannot prevent HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficacy
If there is leakage of Administration (see [usage dosage], gastrointestinal disorders (see [usage dosage]), or taking other drugs at the same time, the efficacy of COC may be reduced (see [drug interaction]).
Influence cycle control
All COCs users may have irregular bleeding (drip or breakthrough bleeding), especially in the first few months of use. Therefore, it is important to evaluate any irregular bleeding after about 3 cycles of adaptation.
If irregular bleeding persists or occurs after a regular period, the non hormone causes should be considered and appropriate diagnostic measures should be taken to exclude malignant tumors or pregnancy. These measures may include curettage.
Some women may not have retreating bleeding during the period of withdrawal. If COC is taken in accordance with the method described in [usage] women are unlikely to have pregnancy. However, if the withdrawal bleeding is not taken before the first time, or if no withdrawal bleeding occurs twice, pregnancy must be excluded before continuing with COC.
·Laboratory inspection
The use of steroids may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, adrenal and renal functions, plasma (carrier) protein levels, such as corticosteroid binding globulin and lipid / lipoprotein fraction, carbohydrate metabolism index, and coagulation and fibrinolysis indicators. Changes are usually kept within the normal laboratory inspection range. The activity of renin in plasma was increased by trespirone, and the level of aldosterone was increased by its slight anti salt cortex activity.
No studies have been conducted on the impact of driving and mechanical operation capabilities. No effect of COCs on driving and mechanical operation capability was observed.
Store all drugs properly to avoid children's access.

Medication for pregnant and lactating women:
pregnant woman
It is forbidden during pregnancy. If pregnancy occurs during the period of taking this product, the drug must be stopped. However, a large number of epidemiological studies have shown that the incidence of birth defects in infants born to women taking COCs before pregnancy has not increased, and the teratogenicity of women taking COCs during early pregnancy has not increased. One case was born with esophageal atresia. The causal relationship between this event and this product is not clear.
The data about taking this product during pregnancy is very limited, and the conclusion of adverse effects on pregnancy, fetal or neonatal health can not be drawn. So far, there is no relevant epidemiological data.
lactation
Lactation may be affected by COCs, because they can reduce milk secretion and change milk composition. Therefore, the use of COCs is generally not recommended before complete weaning of lactating women. Small amounts of contraceptive steroids and / or their metabolites may be secreted from milk.
[medication for children and adolescents]
This product can only be used after menarche. There is no data to show that the dose needs to be adjusted.

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Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises  CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

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