Universal reference book for medicines
Product name: DEPO-PROVUER ® (DEPO-PROVERA ® )

Active substance: medroxyprogesterone

Type: Gestagen - depot form.
Antitumor preparation
Manufacturer: PFIZER MFG.
BELGIUM (Belgium)
Composition, form of production and packaging
Suspension for injection of
white color.

1 f.

medroxyprogesterone acetate 500 mg

Excipients: polyethylene glycol 3350, polysorbate 80, sodium chloride, methylparaben, propylparaben, water d / u.

3.3 ml - bottles (1) - packs of cardboard.

Suspension for injection of white color.

1 f.

medroxyprogesterone acetate 1 g

Excipients: polyethylene glycol 3350, polysorbate 80, sodium chloride, methylparaben, propylparaben, water d / u.

6.7 ml - bottles (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

The description of the drug was approved by the manufacturer for the 2006 print edition.

PHARMACHOLOGIC EFFECT

Antitumor drug.
Depo-Provera is a gestagen that does not have estrogenic activity, its androgenic activity is considered to be minimal.
At appropriate doses, inhibits the secretion of pituitary gonadotropins, which in turn prevents the maturation of follicles, causing anovulation in women of childbearing age.

In addition, the drug in appropriate doses suppresses the function of Leydig cells in men, i.e.
endogenous formation of testosterone.
In high doses has antitumor effect with hormone-sensitive malignant neoplasms.
This effect of the drug is due to its effect on the hypothalamic-pituitary-gonadal system, the receptors of progestins and estrogens, and the metabolism of steroids at the cellular level.
The drug has a pyrogenic effect, in very high doses has corticosteroid activity.

PHARMACOKINETICS

Suction

After i / m administration, the drug is absorbed slowly, as a result of which the constant concentrations of medroxyprogesterone acetate are maintained for a long time.
C max in blood plasma is achieved 4-20 days after the / m administration.
Distribution

Binding to plasma proteins is 90-95%.
Medroxyprogesterone acetate penetrates through the BBB, excreted in breast milk. Cumulates in the body, the residual concentrations of medroxyprogesterone acetate are detected in the plasma after 7-9 months.
Metabolism

Medroxyprogesterone acetate is metabolized in the liver.
Currently, many metabolites of medroxyprogesterone acetate have been described.
Excretion

Most of medroxyprogesterone acetate is excreted by biliary secretion with feces.
Approximately 44% of the drug in unchanged form is excreted in the urine. T 1/2 is 6 weeks.
INDICATIONS

- recurrent and / or metastatic endometrial cancer;

- hormone-dependent forms of recurrent breast cancer in women in menopause;

- recurrent and / or metastatic kidney cancer.

DOSING MODE

With endometrial cancer and kidney cancer, the initial dose is 400-1000 mg per week IM.
If within several weeks or months there has come an improvement and stabilization of the process is achieved, then a maintenance therapy is prescribed at a dose of 400 mg per month.
In breast cancer, the drug is given in / m at an initial dose of 500 mg / day for 28 days.
Then apply maintenance doses - 500 mg twice a week. Treatment continues until signs of disease progression appear.
Immediately before use, the vial should be shaken well to make the drug appear as a homogeneous suspension.

SIDE EFFECT

Allergic reactions: anaphylaxis and anaphylactoid reactions, urticaria.

From the side of the blood coagulation system: thromboembolism, thrombophlebitis.

From the side of the central nervous system: increased nervous excitability, insomnia, drowsiness, fatigue, depression, dizziness, headache.

Dermatological reactions: itching, rashes, acne, hirsutism and alopecia.

On the part of the reproductive system: dysfunctional uterine bleeding, spotting from the genital tract, amenorrhea, decreased libido or anorgasmia, vaginitis, whitecaps, tidal pains, lower abdominal pain, breast tenderness, galactorrhea.

From the digestive system: pain or discomfort in the abdomen, nausea, flatulence.

From the musculoskeletal system: spasms of the calf muscles, pain in the back and joints.

Other: asthenia, hyperthermia, change in body weight and moonlike face.

CONTRAINDICATIONS

- Pregnancy;

- lactation period;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With the development of jaundice, it is necessary to stop using the drug.

SPECIAL INSTRUCTIONS

Before prescribing the Depo-Provera drug, a thorough examination of the patient should be carried out.

If signs and / or symptoms of thromboembolism occur, before continuing the use of the drug, it is necessary to evaluate the relationship between risk and benefit.

When the Itzko-Cushing symptom complex appears on the background of a high-dose preparation of the Itzenko-Cushing syndrome (a moonlike face, fluid retention, a decrease in glucose tolerance, an increase in blood pressure), it is necessary to reduce the dose as far as possible and to carefully monitor the patient's condition.

The use of the drug in high doses can cause an increase in body weight and fluid retention.
In this regard, care must be taken in the treatment of patients whose condition may be adversely affected by weight gain or fluid retention.
It should be carefully monitored patients who have a history of indication of therapy for depressive conditions.
During therapy with Depo-Provera, some patients complain of depression similar to premenstrual depression.
When carrying out a cytological or histological study of the endometrium or cervix, the histologist should be warned about the therapy.

The drug should be used with caution in the postpartum period due to the increased risk of copious and prolonged uterine bleeding.

It is believed that the use of Depo-Provera drug may increase the risk of osteoporosis.

It should stop using the drug with sudden partial or complete loss of vision, or with the development of eyelashes, double vision, migraine attacks.
If the examination reveals damage to the blood vessels of the cellulose or swelling of the nipple of the optic nerve, do not use Depo-Provera drug.
With the development of jaundice, it is necessary to stop using the drug.

The use of the drug may influence the results of the following laboratory tests: determination of gonadotropin levels (downward);
determination of plasma levels of progesterone, cortisol, estrogens (downwards); determination of the level of pregnaniol in the urine (downward); determination of testosterone level in the blood plasma (downwards); determination of the level of a specific globulin that binds the sex hormones (downwards); carrying out of the test with sugar loading (test of tolerance to glucose); metapyrone test; can change the results of the test for prothrombin (factor II) and clotting factors VII, VIII, IX, X (upwards); increases the value of liver function indicators.
OVERDOSE

Symptoms: weight gain (with some fluid retention), increased fatigue, and also in some cases, effects characteristic of glucocorticoids are observed.

Treatment: discontinue use of the drug.
Specific treatment is not required.
DRUG INTERACTION

The drug interaction of Depo-Provera is not described.

When combined, aminoglutethimide can significantly reduce the bioavailability of medroxyprogesterone acetate.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored at room temperature (20-25 ° C), out of the reach of children.
Shelf life - 5 years.
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