Depo-Provera ® suspension for injection is used for the indications listed below.
Progestogen: for contraception.
The drug is indicated for long-term contraception in women. Each injection prevents ovulation and provides contraception for at least 12 weeks (+/- 5 days). However, it should be noted that the restoration of reproductive function (ovulation) may be delayed for up to one year.
The drug is a remedy suitable for use in women who have been appropriately informed about the possibility of menstrual disorders and potential delay in the restoration of full fertility.
The drug can be used for short-term contraception in the following cases:
for partners of men who have had a vasectomy, for protection until the vasectomy is effective; for women immunized against rubella, to prevent pregnancy during the period of virus activity; for women awaiting sterilization.
The drug can be used in adolescents, but only if other methods of contraception are deemed unsuitable or unacceptable after discussion with the patient.
Composition
The active substance is medroxyprogesterone (1 ml of suspension contains 150 mg of medroxyprogesterone acetate).
Excipients: polysorbate 80, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), macrogol 3350, sodium chloride, water for injections.
Contraindication
The drug is contraindicated in patients with known sensitivity to medroxyprogesterone acetate or to any other component of the drug. The use of the drug as a contraceptive in the dosage given below is contraindicated in the presence of confirmed or suspected hormone-dependent malignant tumors of the breast or genital organs. The drug is contraindicated in patients with the presence or history of severe liver disease in whom liver function tests have not returned to normal. When prescribed as monotherapy or in combination with estrogens, the drug should not be used in patients with abnormal uterine bleeding until the diagnosis is clarified and the possibility of malignant tumors of the genital tract is excluded.
Method of application
To ensure that the dose administered is a homogeneous suspension of Depo-Provera®, the injection suspension should be shaken thoroughly immediately before use.
Doses should be administered by deep intramuscular injection. Care should be taken to ensure that the depot injection is given into muscle tissue, preferably the gluteus maximus, but other muscles such as the deltoid can also be used.
Before injection, the injection site should be cleaned using standard methods.
First injection: To ensure contraceptive effect during the first cycle of use, a 150 mg intramuscular injection should be administered during the first 5 days of a normal menstrual cycle. If the injection was administered according to these instructions, additional contraceptive measures are not required.
Postpartum: To increase the certainty that the patient is not pregnant at the time of the first administration, the injection should be given within 5 days after delivery if the woman is not breastfeeding.
There is evidence that women who use Depo-Provera® immediately postpartum may experience prolonged and heavy bleeding. For this reason, the drug should be used with caution in the postpartum period. Women who decide to use the drug immediately postpartum or after abortion should be informed of the increased risk of heavy or prolonged bleeding. Physicians should be reminded that in women who are not breastfeeding, ovulation may occur as early as the 4th week postpartum.
If a woman will breastfeed her baby after giving birth, the first injection should be given no earlier than 6 weeks after delivery, when the newborn's enzymatic system is more fully developed. Subsequent injections should be given at 12-week intervals.
Subsequent doses: should be administered at 12-week intervals, however, if the injection is administered no later than 5 days after this time, additional contraceptive measures (e.g., barrier methods) are not required. If for any reason the time since the previous injection exceeds 89 days (12 weeks and 5 days), pregnancy should be excluded before the next injection and the patient should use additional contraceptive measures (e.g., barrier methods) for 14 days after this next injection.
Switching from other contraceptives. The drug should be used in such a way as to ensure continuous contraceptive effect. For this, the mechanism of action of the other agents should be taken into account (for example, patients switching from oral contraceptives should have the first injection of the drug within 7 days after taking the last active tablet).
Application features
Pregnant women
The drug should not be used during pregnancy, either for diagnosis or treatment. The drug is contraindicated in pregnant women.
Medroxyprogesterone acetate and/or its metabolites are excreted in human milk, but there is no evidence to suggest that this poses a risk to the infant. A study of infants exposed to medroxyprogesterone acetate during breast milk was conducted to assess the effects on development and behavior prior to puberty. No adverse reactions were noted.
The drug should not be prescribed for use before the onset of the menstrual period.
Drivers
The use of the drug may cause headache and dizziness. If such effects occur, patients are advised to avoid driving or operating other machinery.
Overdose
No special measures are required other than discontinuation of therapy.
Side effects
The most common adverse reactions (occurring in more than 5% of patients): weight gain (69%), weight loss (25%), headache (16%), nervousness (11%), abdominal pain or discomfort (11%), dizziness (6%), decreased libido (6%).
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze.
Shelf life - 5 years.
