Pimtrea is a combination oral contraceptive containing 2 hormones, ethinyl estradiol and desogestrel, that are used to prevent pregnancy.
Indications for use
- Oral contraception.
Mechanism of action
The drug inhibits gonadotropins and suppresses ovulation. In addition, it slows down the movement of spermatozoa through the cervical canal by increasing the viscosity of the cervical fluid and changes the state of the endometrium, which prevents a fertilized egg from implanting. Ethinylestradiol is a synthetic analogue of the follicular estradiol hormone. Desogestrel has a pronounced gestagenic and antiestrogenic action, weak androgenic and anabolic activity. The contraceptive has a beneficial effect on lipid metabolism: increases the level of HDL, reduces menstrual blood loss, normalizes periods, improves skin condition, especially in acne vulgaris.
Dosage and mode of application
Each Pimtrea pack contains 21 tablets containing desogestrel 0.15 mg / ethinyl estradiol 20 mcg, 2 inert tablets and 5 tablets containing desogestrel 0 mg / ethinyl estradiol 10 mcg.
The drug is taken orally. Begin taking pills on the first day of the period. Take 1 tablet / day for 28 days, at the same time of a day. Begin a new Pimtrea pack without interruption, even if the menstrual bleeding has not stopped. Follow such a regimen of taking tablets as long as there is a need for contraception. If the mode of admission is observed, the contraceptive effect is maintained even in the phase of taking inert tablets.
First use of the drug:
The first pill should be taken on the first day of the menstrual period. In this case, you do not need any additional methods of contraception. Taking tablets can be started on days 2-5 days of the period, but in this case, you need to use additional contraceptive methods for 7 days in the first cycle of drug use. Do not start taking pills 6 days after the onset of menstruation. In this case, it is necessary to postpone the start of hormonal contraception until the next period.
Taking Pimtrea after delivery:
Non-breastfeeding women can start taking birth control pills no earlier than 21 days after delivery (only after consulting a doctor). In this case, you do not need to use other methods of contraception. If you had unprotected sex after delivery, taking pills should be postponed until the first period. If you decide to take the contraceptive later than 21 days after delivery, you need to use additional methods of contraception in the first 7 days.
Taking Pimtrea after an abortion:
After an abortion, you can start taking tablets on the first day after the operation (in the absence of contraindications). In this case, you do not need to use additional methods of contraception.
Switching from another oral contraceptive:
After using another hormonal oral contraceptive containing, the first Pimtrea tablet should be taken the day after the completion of the previous contraceptive course. If you switch from a 21-tablet pack, it is not necessary to make a 7-day break or wait for the menstruation. There is no need to use additional methods of contraception. When switching from a 28-tablet pack, you should complete the previous drug pack and begin a Pimtrea pack immediately, without interruption.
Switching from oral hormone preparations containing only progestogen (mini-pills):
The first tablet should be taken on the 1st day of the period. There is no need for additional methods of contraception. If you do not have your period after the completing the course of taking mini-pills, you need to exclude pregnancy before starting Pimtrea. You can also start taking birth control pills on another day of the period, but in this case, you need to use additional methods of contraception in the first 7 days. The use of the calendar and temperature methods in these cases is not recommended.
Vomiting / diarrhea:
If vomiting or diarrhea occurs after taking an active pill, then the absorption of the drug may be inadequate. If the symptoms stop within 12 hours, you need to take an additional pill. After this, you should continue taking the tablets in the usual mode. If vomiting or diarrhea persist for more than 12 hours, you need to use additional methods of contraception for the next 7 days.
- Symptoms: nausea, vomiting, spotting from the vagina;
- Treatment: gastric lavage. A specific antidote does not exist, treatment is symptomatic.
Pimtrea pills can cause side effects that require the withdrawal of the drug:
- cardiovascular system: arterial hypertension, arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower limbs, thromboembolism of the pulmonary artery), arterial or venous thromboembolism of the liver, mesenteric, renal, retinal arteries and veins;
- sense organs: hearing loss due to otosclerosis, hemolytic-uremic syndrome, porphyria, exacerbation of reactive systemic lupus erythematosus. Sydenham’s chorea;
- reproductive system: acyclic bleeding / spotting from the vagina, amenorrhea after drug withdrawal, changes in the state of vaginal mucus, development of inflammatory processes of the vagina, candidiasis, pain, enlargement of the mammary glands, galactorrhea;
- digestive system: nausea, vomiting, Crohn’s disease, ulcerative colitis, the onset or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis;
- dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma;
- CNS: headache, migraine, mood lability, depression;
- organ of vision: increased sensitivity of the cornea (when wearing contact lenses);
- metabolism: fluid retention in the body, change (increase) in body weight, reduced tolerance to carbohydrates.
- other: allergic reactions.
Pimtrea pills are contraindicated for use in the presence of the following conditions / diseases:
- multiple risk factors for venous or arterial thrombosis;
- thrombosis precursors (including a history);
- migraine with focal neurological symptoms (including a history);
- venous or arterial thrombosis / thromboembolism (including a history);
- venous thromboembolism (including a history);
- diabetes mellitus (with angiopathy);
- pancreatitis accompanied by severe hypertriglyceridemia (including a history);
- severe liver disease;
- cholestatic jaundice (including pregnancy);
- hepatitis (including a history) – before normalization of functional and laboratory parameters;
- jaundice when taking combination oral contraceptives;
- gallstone disease (including a history);
- Gilbert syndrome;
- Dubin-Johnson syndrome;
- Rotor syndrome;
- liver tumors (including a history);
- severe itching;
- otosclerosis or its progression during the previous pregnancy or use of combination oral contraceptives;
- hormone-dependent malignant neoplasms of genital organs and mammary glands
- vaginal bleeding of unclear etiology;
- smoking over the age of 35 (more than 15 cigarettes a day);
- pregnancy or suspicion of it;
- lactation period;
- hypersensitivity to ethinyl estradiol, desogestrel or other components of the drug;
- severe liver disease;
- cholestatic jaundice (including during the previous pregnancy);
- hepatitis (including a history) – before normalization of functional and laboratory parameters.
The interaction between Pimtrea and other drugs can lead to acyclic bleeding and / or a decrease in the effectiveness of birth control pills.
- Drugs that induce microsomal enzymes of the liver (barbiturates, carbamazepine, griseofulvin, phenytoin, primidone, rifabutin, rifampicin) may decrease the activity of ethinyl estradiol and desogestrel;
- Amoxicillin, benzylpenicillin, doxycycline, tetracycline, ampicillin may reduce the effectiveness of the contraceptive;
- Atorvastatin may increase the concentration of estrogens in blood plasma;
- Ascorbic acid, paracetamol may increase the concentration of estrogens in blood plasma (possibly due to inhibition of conjugation);
- Sugar reduction drugs (insulin, drugs taken orally) may increase glucose tolerance, especially in patients with diabetes mellitus;
- Clofibrate may become less effective when combined with Pimtrea;
- Smoking may reduce the concentration of estrogens and increase the risk of cardiovascular diseases;
- Ritonavir may reduce the concentration of estrogens in blood plasma;
- Tricyclic antidepressants, neuroleptics may cause an increased risk of motor disorders, chorea).
If you simultaneously take another drug that may decrease the effectiveness of birth control pills, you need to use additional contraceptive methods.
Pregnancy and breastfeeding
Pimtrea is contraindicated for use in pregnancy and lactation (breastfeeding).
What if I miss a pill?
Missing an active pill increases your risk of becoming pregnant.
- If you miss 1 active pill, take 2 pills on the day you remember about your mistake. Then take 1 pill a day until the pack is empty;
- If you miss 2 active pills in a row during Week 1 or 2, take 2 pills a day for 2 subsequent days. Then take 1 pill a day until the pack is empty. Use an additional birth control method for subsequent 7 days;
- If you miss 2 active pills in a row during Week 3, discard the rest of the pills and begin a new Pimtrea pack the same day if you started taking birth control pills on the first day of your period. If you started taking birth control pills on Sunday, continue taking 1 pill per day until Sunday. On Sunday, discard the rest of the pills and begin a new pack immediately;
- If you miss 3 active pills in a row during Week 1, 2, or 3, discard the rest of the pills and begin a new pack on the same day if you started taking birth control pills on the first day of your period. If you started taking birth control pills on Sunday, continue taking 1 pill per day until Sunday. On Sunday, discard the rest of the pills and begin a new pack immediately;
- If you miss 2 or more active pills, you may not have a period in the month. If you do not have a period for 2 months in a row, visit your doctor as soon as possible because you might be already pregnant;
- If you miss an inert pill, discard it and keep taking one 1 pill per day until the pack is empty. You do not need to use an additional birth control method if you miss an inert pill since it contains no medication and serves as a reminder.
Before taking combination oral contraceptives, it is necessary to conduct general medical and gynecological examination (including examination of mammary glands, pelvic organs, cytological analysis of cervical smear). Such a survey should be carried out regularly, every 6 months (during the period of taking the drug).
Pimtrea is a reliable contraceptive: the Perl index is about 0.05 (when used properly).
In each case, the benefits or possible negative effects of combination oral contraceptives should be assessed individually.
The state of women’s health must be carefully monitored. If any of the below-listed conditions / diseases appears or worsens during the reception of the drug, you must stop taking birth control pills and switch to another, non-hormonal method of contraception:
- diseases of the hemostasis system;
- conditions / diseases, predisposing to cardiovascular, renal failure;
- risk of developing estrogen-dependent tumors or estrogen-dependent gynecological diseases;
- diabetes mellitus not complicated by vascular disorders;
- severe depression;
- sickle cell anemia.
There is a link between the use of oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). The increased risk of venous thromboembolic diseases has been proven, but it is significantly less than in pregnancy (60 cases per 100,000 pregnancies). When using oral contraceptives, arterial or venous thromboembolism of hepatic, mesenteric, renal vessels or retinal vessels occur very rarely.
The risk of arterial or venous thromboembolic disease increases with:
- smoking (especially intensive smoking and age over 35);
- a family history of thromboembolic diseases (parents, brother or sister). If you suspect a genetic predisposition, you must consult a doctor before using Pimtrea;
- obesity (body mass index more than 30 kg / m2);
- arterial hypertension;
- heart valve diseases complicated by hemodynamic disorders;
- diabetes mellitus, complicated by vascular lesions;
- prolonged immobilization, after a large surgical intervention, after surgical intervention on the lower extremities, after a serious injury. In these cases, you should discontinue using birth control pills no later than 4 weeks before surgery and resume it no earlier than 2 weeks after remobilization.
The risk of venous thromboembolic disease increases after delivery.
Diabetes mellitus, systemic lupus erythematosus, haemolytic uremic syndrome, Crohn’s disease, ulcerative colitis, sickle cell anemia increase the risk of venous thromboembolic disease.
Resistance to activated protein C, hyperhomocysteinemia, deficiency of proteins C and S, deficiency of antithrombin III, antiphospholipid antibodies increase the risk of arterial or venous thromboembolic diseases. When assessing the benefit / risk of taking the drug, remember that targeted treatment of this condition reduces the risk of thromboembolism.
Symptoms of thromboembolism include:
- sudden pain in the chest, which radiates into the left arm;
- sudden shortness of breath;
- any unusually severe headache that lasts a long time or occurs for the first time, especially when combined with sudden total or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of the body, motor impairment, severe unilateral pain in the gastrocnemius muscle, sharp abdomen.
Some studies have reported an increased incidence of cervical cancer in those women who have long taken combination oral contraceptives, but the results of research are contradictory. In the development of cervical cancer, sexual behavior, infection with human papillomavirus and other factors play a significant role.
A meta-analysis of 54 epidemiological studies showed that there is a relative increase in the risk of breast cancer among women taking birth control pills, but a higher detection of breast cancer could be associated with a more regular medical examination. Breast cancer is rare among women younger than 40, regardless of whether they take oral hormonal contraceptives or not, and increases with age. The intake of tablets can be regarded as one of many risk factors. However, a woman should be advised of the risk of breast cancer, based on an assessment of the benefit-risk ratio (protection against ovarian cancer and endometrium).
There are few reports of the development of a benign or malignant liver tumor in women who take hormonal contraceptives for a loan time. This should be taken into account in the differential diagnosis of abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.
Chloasma can develop in women who had this disease during the previous pregnancy. Women who are at risk of developing chloasma are recommended to avoid contact with sunlight or ultraviolet light while taking birth control tablets.
The effectiveness of the contraceptive may decrease in the following cases: missed tablets, vomiting and diarrhea, interactions with other drugs that reduce the effectiveness of birth control pills. The effectiveness of the drug may decrease with irregular spotting or breakthrough bleeding. In such cases, it is recommended to complete the current Pimtrea pack. If menstrual bleeding does not occur at the end of the second period or acyclic spotting does not stop, discontinue using the pills and resume them only after the pregnancy is excluded.
Changes in laboratory indicators:
Oral contraceptive pills can change certain laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis, levels of lipoproteins and transport proteins).
After acute viral hepatitis, the drug should be taken after normalization of liver function (no earlier than 6 months).
With diarrhea or vomiting, the contraceptive effect of the drug may decrease. Do not stop taking the pills but use additional non-hormonal methods of contraception.
Smoking women have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on the age (especially in women over 35 ) and on the number of cigarettes smoked per day.
The drug does not protect patients against HIV infection (AIDS) and other sexually transmitted diseases.
Pimtrea does not affect the patient’s abilities to drive a car and work with mechanisms.