Index of drugs

Long-acting contraceptive for women. Each subcutaneous injection prevents ovulation and ensures contraception for at least 13 weeks (+/- 1 week).

1 single-dose pre-filled syringe contains 104 mg medroxyprogesterone acetate (MPA). The drug contains methyl and propyl parahydroxybenzoate.

Progesterone derivative with anti-estrogen, antiandrogen and anti-gonadotropy. Inhibits the secretion of gonadotropins, preventing ovarian follicle maturation and ovulation. In addition, the basic mechanism of ovulation suppression leads to a reduction in the thickness of the endometrium. The contraceptive effect gives all of the above-mentioned activities. After subcutaneous injection, medroxyprogesterone acetate (MPA) is absorbed fairly quickly from the injection site. The maximum concentration of the drug in the blood occurs on average about one week after the injection of the drug. It is 86% bound to plasma proteins, mainly to albumin; it is not associated with SHBG. It is extensively metabolised in the liver by cytochrome P450 enzymes. Metabolites are excreted in the urine. Final T_0,5 after subcutaneous administration it is about 40 days.

Hypersensitivity to medroxyprogesterone acetate or any of the excipients of the drug. Pregnancy or suspected pregnancy. Diagnosed or suspected malignant tumor of the breast or reproductive system. Undiagnosed bleeding from the genital tract. Severe liver dysfunction. Metabolic bone diseases. Thromboembolic or cerebrovascular disease currently or in history.

The use of the drug leads to a decrease in serum estrogen concentration and is associated with a statistically significant reduction in BMD, which results from the known effect of estrogen deficiency on the bone tissue remodeling. The reduction in bone mineral density increases with the length of the drug, but bone mineral density increases after the end of the drug and increased production of estrogen by the ovaries. For women of all ages who use the medicine for a long time, a risk assessment should be considered for the benefit of the medicine, also taking into account the reduction of BMD during pregnancy and / or lactation. Due to the lack of data on the long-term effects of using the drug to reduce bone density during the critical period to increase bone mass, the drug can be used in adolescent girls only when other methods of contraception are inappropriate or impossible to use. The use of the drug has not been studied in women> 18 years of age, however, there are data available on the use of medroxyprogesterone acetate (MPA) in an intramuscular form in this group of patients. For women who want to continue treatment for more than 2 years, regardless of the age of the patient, a careful re-evaluation of the risk-benefit of using the medicine should be performed. The use of other methods of contraception should be considered before starting treatment, particularly in patients with significant risk factors for osteoporosis associated with lifestyle and / or health. Risk factors relevant for the occurrence of osteoporosis include: alcohol abuse and / or tobacco use; chronic use of drugs that reduce bone mass, e.g. anticonvulsants or corticosteroids; low body mass index or appetite disorders, e.g. anorexia nervosa (anorexia nervosa) or bulimia; slight injury; family history of osteoporosis; slight injury; family history of osteoporosis. All patients using MPA should take the right doses of Calcium and vitamin D. During treatment, menstrual cycle disorders and potential delay in the return of ovulation occur - please inform your patient. In the event of prolonged or severe nature of bleeding abnormalities, appropriate diagnostics should be performed and appropriate treatment should be required.In long-term observational case-control studies involving women using the MPA depot formulation for intramuscular injections at a dose of 150 mg, there was no increase in the overall risk of ovarian, hepatoma or cervical cancer, while a long-lasting protective effect was found to reduce the risk of occurrence of endometrial cancer. The medicine should not be re-administered to patients who develop a disorder such as pulmonary embolism, cerebrovascular disease, retinal thrombosis or deep vein thrombosis during its use. Clinical trials have not been conducted in women with a history of thromboembolic disturbances and there is no information available that would demonstrate the safety of the medicine in this group of patients. In the event of sudden, partial or complete loss of vision or sudden exophthalmomegaly, double vision or migraine, the medicine should not be re-administered until appropriate tests have been performed. If you are diagnosed with an edema of the optic disc or if you notice changes in the retinal vessels, do not continue to use the medicine. There is evidence that progestagens may cause more or less fluid retention, therefore caution should be exercised when treating patients with co-morbid conditions in which fluid retention may have an adverse effect. The return of fertility (ovulation) after the use of the drug may occur with a delay, regardless of the length of its use. After 14 weeks from the last administration of MPA, ovulation return was noted at the earliest one week and the average waiting time for ovulation return was 30 weeks. It should be taken into account that the return of ovulation may be delayed up to one year. Patients with a history of depression and a patient with diabetes should be closely monitored. Discontinuation of treatment should be considered if jaundice develops. If hypertension develops during the period of use, and (or) the severity of hypertension can not be adequately controlled with antihypertensive medicinal products, discontinue use. Caution should be exercised when treating patients with one or more of the following risk factors for arterial thrombotic events: hypertension, smoking, age, dyslipidemia, migraine, obesity, family history of such disorders, valvular heart disease, atrial fibrillation. The drug contains methyl and propyl parahydroxybenzoate, which may cause allergic reactions (may be delayed in nature) and in exceptional cases bronchospasm.

The use of the drug in pregnancy is contraindicated. The use of the drug in the first trimester of pregnancy may cause developmental disorders within the genital system in fetuses of both sexes. In addition, there is a small risk of low birth weight, which in turn is associated with an increased risk of death in the neonatal period. There are no signs of physical, mental, sexual or social disorders in children exposed to MPA during intrauterine development. Traces of the preparation are excreted into human milk. It was not stated that their presence could pose a threat to the child.

Very common: weight gain, weight loss. Common: abdominal pain, headache, lack of menstruation, pain and / or breast tenderness, bleeding during the cycle, abundant, irregular bleeding, excessive menstrual bleeding, acne, tiredness, injection site reactions, anorgasmia, depression, emotional disturbances , weakness of libido, mood disorders, irritability. Uncommon: dizziness, migraine, bloating, nausea, vaginitis, decreased appetite, increased appetite, fluid retention, backache, muscle cramps, limb pain, vaginal discharge, dry vulva and vagina, painful menstruation, breast size changes, painful relationships genital, ovarian cyst, pelvic pain, premenstrual syndrome, hot flushes, hypertension, varicose veins, thrombophlebitis, pulmonary embolism, abnormal liver enzymes, chloasma, dermatitis, subcutaneous episodes, rash, alopecia, hypertrichosis, abnormal result smear from the cervix, anxiety, insomnia.In addition, you may experience: arthralgia, osteoporosis - including osteoporotic fractures and loss of bone mineral density, seizures, drowsiness, abnormal uterine bleeding (irregular, abundant, scanty), mellitus, thromboembolism, tachycardia, hypersensitivity reactions (e.g. anaphylactic and anaphylactoid), angioneurotic edema, jaundice, hepatic dysfunction, pruritus, urticaria, dermatoses, asthenia, fever, reduced Glucose tolerance, nervousness, breast cancer.

Subcutaneously (in the area of ​​the anterior surface of the thigh or in the abdomen). Adults: the first injection should be given during the first 5 days of the menstrual cycle; if used after delivery - within 5 days of delivery. The second and subsequent injections should be administered at intervals of 13 weeks. If the injection is given no later than within 7 days of this date, no additional contraception is necessary. If the period from the previous injection exceeds 14 weeks (13 weeks + 7 days), pregnancy should be excluded before the Next injection. In the case of switching other methods of contraception, MPA should be administered in a way that ensures continuous contraceptive protection, taking into account the mechanism of action of both methods (eg in patients who have used oral contraceptives so far, the first MPA injection should be given within 7 days since the last tablet containing active substances has been taken). There is no need to change the dosage in patients with renal insufficiency.