Provera - Instructions For Use, Reviews, Tablets 500 Mg, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Provera

Provera: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Provera

ATX code: L02AB02

Active ingredient: medroxyprogesterone (medroxyprogesterone)

Manufacturer: PFIZER ITALIA, Srl (Italy)

Description and photo update: 2018-27-11

Prices in pharmacies: from 2398 rubles.

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Provera is an antineoplastic agent.

Release form and composition

Dosage form - tablets: oblong, biconvex, white, with the code "Upjohn 717" on one side (10 pcs. In blisters, in a cardboard box 2, 3 or 10 packs; 20, 50 and 100 pcs. in polyethylene bottles, in a cardboard box 1 bottle and instructions for the use of Provera).

Composition of 1 tablet:

• active substance: medroxyprogesterone acetate (MPA) - 500 mg;
• auxiliary components: corn starch, polyethylene glycol (macrogol 400), hydrolyzed gelatin (Biko C), microcrystalline cellulose, magnesium stearate, sodium starch glycolate (type A), sodium docusate with sodium benzoate.

Pharmacological properties

Pharmacodynamics

The active substance of Provera - medroxyprogesterone acetate, is a synthetic derivative of progesterone, belongs to gestagens (progestins) without estrogenic activity.

The drug has the following effect on the endocrine system:

• reduces plasma concentrations of hydrocortisone and adrenocorticotropic hormone (ACTH);
• inhibits the secretion of pituitary gonadotropins - follicle-stimulating hormone (FSH) and luteinizing hormone (LH);
• reduces the concentration of testosterone in the blood plasma, suppresses the function of Leydig cells in men;
• reduces plasma concentrations of estrogens (due to inhibition of FSH secretion and enzymatic induction of hepatic reductase), as a result of which testosterone clearance increases, and the conversion of androgens to estrogens decreases.

When Provera is used in therapeutic doses for hormone-dependent malignant neoplasms, its antitumor activity is probably associated with the effect of MPA on progestin and estrogen receptors, the hypothalamic-pituitary-gonadal system and steroid metabolism at the cellular level.

Like progesterone, medroxyprogesterone acetate is pyrogenic. When using the drug in very high doses (from 500 mg per day, which is necessary for the treatment of certain types of cancer), itsenko-Cushing's syndrome may develop.

Pharmacokinetics

MPA is rapidly absorbed from the gastrointestinal tract. After 2-4 hours, it reaches the maximum plasma concentration. With the simultaneous intake of food, the bioavailability of the drug increases (without changing the half-life).

More than 90% of the active substance Provera in the blood is associated with proteins (mainly albumin). Unbound MPA also has pharmacological activity. The drug does not bind to a specific globulin that binds sex hormones.

Medroxyprogesterone acetate crosses the blood-brain barrier and into breast milk.

It is metabolized mainly in liver microsomes with the participation of cytochrome P ₄₅₀ 3A4 by hydroxylation followed by conjugation. Currently, at least 16 metabolites of medroxyprogesterone acetate are known. Most of them are excreted in the urine in the form of glucuronides, a small part in the form of sulfates.

The half-life is 12-17 hours.

Indications for use

Provera is used as part of complex treatment and as a palliative therapy drug for the following diseases:

• recurrent and metastatic kidney cancer;
• prostate cancer;
• endometrial cancer (including metastatic);
• breast cancer (hormone-dependent, recurrent, in the postmenopausal period);
• cancerous cachexia with advanced tumors of various localization.

Contraindications

Absolute:

• thromboembolic disorders;
• thrombophlebitis;
• severe liver dysfunction;
• early stages of breast cancer;
• vaginal bleeding;
• hemorrhage in the brain;
• pregnancy;
• the period of breastfeeding (the first 6 weeks of the postpartum period);
• age up to 18 years;
• hypersensitivity to any component of Provera tablets.

Relative:

• diabetes;
• migraine;
• epilepsy;
• depressive conditions;
• bronchial asthma;
• hypercalcemia;
• liver failure;
• renal failure;
• heart failure;
• conditions in which fluid retention in the body can be dangerous.

Provera, instructions for use: method and dosage

Provera tablets are taken orally, swallowed whole, with sufficient water.

The optimal dose of the drug is selected individually depending on the location and stage of the disease, the therapy regimen used and the response to treatment.

The daily doses used may vary:

• kidney cancer - 100-600 mg;
• metastatic prostate cancer - 100–500 mg;
• endometrial cancer - 100-600 mg;
• breast cancer - 400-1500 mg;
• cancerous cachexia - 1000 mg.

The use of Provera is continued as long as there is a positive response to therapy.

Side effects

• from the endocrine system: decreased glucose tolerance, decompensation of diabetes mellitus, changes in body weight, galactorrhea, glucosuria, Itsenko-Cushing's syndrome (moon face, hirsutism, osteoporosis, obesity, menstrual irregularities, decreased sexual function, hypokalemia, edema in the lower extremities, striae of various colors, hyperpigmentation of the skin in places of friction);
• from the hematopoietic system: an increase in the number of platelets and leukocytes in the blood plasma;
• on the part of the cardiovascular system: sensation of hot flashes, palpitations, increased blood pressure, thromboembolic disorders, pulmonary embolism, thrombophlebitis, tachycardia, chronic heart failure, myocardial infarction, stroke;
• from the nervous system: increased fatigue, drowsiness / insomnia, increased nervous excitability, decreased ability to concentrate, dizziness, confusion, headache, depression, euphoria, tonic or clinical seizures, adrenergic-like reactions (sweating, hand tremors, seizures calf muscles but at night);
• from the immune system: hypersensitivity reactions (anaphylaxis, angioedema, anaphylactoid reactions);
• from the digestive system: dryness of the oral mucosa, changes in appetite, flatulence, pain and discomfort in the abdomen, nausea, vomiting, constipation / diarrhea, jaundice, liver dysfunction;
• from the genitourinary system: increased sensitivity of the nipples of the mammary or mammary glands, soreness of the mammary or mammary glands, mastodynia, pain in the lower abdomen, changes in vaginal discharge, dysfunctional uterine bleeding (irregular, scanty, profuse), prolonged anovulation, amenorrhea, vaginitis, cervical erosion uterus, change in libido, erectile dysfunction;
• on the part of the organ of vision: visual impairment, diabetic cataract, retinal vascular thrombosis;
• from the skin and skin appendages: itching, rash, acne, urticaria, hirsutism, alopecia;
• others: hyperthermia, malaise, edema / fluid retention in the body, pain in the back and joints, hypercalcemia.

According to a post-marketing study, Provera may in rare cases contribute to the development of osteoporosis (including cases of osteoporotic bone fractures).

Overdose

When Provera is taken in doses significantly higher than recommended, various side reactions may develop, including increased fatigue, weight gain (with some fluid retention in the body) and the effects inherent in corticosteroids.

In case of overdose, the drug should be canceled. Taking doses up to 3000 mg per day is well tolerated. No specific treatment is usually required. If necessary, symptomatic and supportive therapy is performed.

special instructions

Antitumor therapy is carried out strictly according to the doctor's prescription and under his close supervision.

Women in the event of dysfunctional uterine bleeding should be further examined to establish the cause of the disorder.

MPA can reduce glucose tolerance, which should be taken into account in patients with diabetes mellitus.

It is necessary to temporarily cancel Prover and conduct an examination in the following cases: double vision, partial or complete loss of vision, development of exophthalmos, migraine attacks. If optic nerve edema or retinal vascular damage is detected, the drug should be discontinued and alternative therapy should be considered.

Careful observation during therapy is required in patients with a history of depression.

Women who are prescribed a histological or cytological examination of the endometrium / cervix should warn the pathologist about taking Provera.

The effect of high-dose medroxyprogesterone on bone density has not been studied. The drug reduces the concentration of estrogen in the blood plasma, which leads to a decrease in the density of bone tissue in women before menopause. In this case, the risk of developing osteoporosis increases in later years of life. For this reason, all women receiving Provera are advised to additionally take vitamin D and calcium supplements (unless contraindicated). With long-term treatment with MPA, it is recommended to periodically monitor bone density.

There are cases of suppression of the function of the adrenal cortex against the background of the use of MPA.

Medroxyprogesterone in high doses used in oncology can cause partial adrenal insufficiency (decreased response of the pituitary-adrenal system). Therefore, if it is necessary to conduct a metapyrone test before administration of metapyrone, it is necessary to check the ability of the adrenal cortex to respond to ACTH.

Provera can change the concentrations of the following endocrine biomarkers: specific globulin that binds sex hormones, gonadotropins in blood plasma and urine (LH and FSH), steroids in urine and blood plasma (progesterone, estrogens, testosterone, cortisol, pregnandiol). This should be taken into account when conducting laboratory research.

Influence on the ability to drive vehicles and complex mechanisms

The effect of medroxyprogesterone on human cognitive and psychophysical functions has not been studied. It is known that the drug can cause visual impairment and dizziness, therefore, during the period of therapy, special care should be taken when driving and performing other potentially hazardous activities.

Application during pregnancy and lactation

The use of Provera is contraindicated during pregnancy.

There is evidence that, under certain conditions, intrauterine exposure of progestogens in the first trimester of pregnancy is the cause of abnormalities in the development of the genitals in the fetus.

If pregnancy occurs 1–2 months after the injection of the drug, newborns are at high risk of malnutrition, which increases the likelihood of intrapartum and neonatal mortality. It should be noted that such complications are very rare, since the probability of conception against the background of the use of medroxyprogesterone acetate is low. However, the doctor should warn women about the possible risks to the fetus in case of pregnancy during the period of anticancer therapy.

Medroxyprogesterone acetate passes into breast milk. There are no data confirming the negative effect of the drug on the child, but it is not recommended to use Provera in the first 6 weeks after delivery.

Pediatric use

Provera is not used in pediatrics (for the treatment of children and adolescents under 18 years of age).

With impaired renal function

The drug should be used with caution in renal failure.

For violations of liver function

Provera 500 mg tablets are contraindicated for severe liver dysfunction.

With hepatic insufficiency, it is used with caution.

Drug interactions

Aminoglutethimide, when used simultaneously, significantly reduces the bioavailability of MPA and, as a result, its effectiveness.

Medroxyprogesterone acetate is metabolized primarily by hydroxylation via the CYP3A4 isoenzyme. Special studies to study the effect of inducers and inhibitors of this isoenzyme on the pharmacokinetics of Provera have not been conducted. The likelihood of such an interaction is high, but the clinical effects with the use of such combinations are unknown.

Rifampicin, phenobarbital, griseofulvin, phenytoin and carbamazepine have the ability to increase the clearance of gestagens (progestogens).

Provera can alter the effectiveness of hypoglycemic drugs, as well as inhibit the metabolism of cyclosporine, which increases its concentration in blood plasma and increases the risk of toxicity.

Analogs

Provera's analogs are Veraplex, Megeis.

Terms and conditions of storage

Keep out of reach of children at temperatures up to 25 ° C.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Provera

There are practically no reviews of Provera on specialized medical sites and forums, which is due to the specifics of the drug's use.

There are no reports to characterize the effectiveness of this anticancer agent. The most commonly mentioned side effects are: headache, dizziness, nervousness, impaired ability to concentrate, feeling hot flashes, sweating, pressure surges, significant weight gain. Given the severity of the diseases for which Provera is prescribed, patients believe that the importance of taking the drug outweighs adverse reactions.

Price for Provera in pharmacies

The approximate price for Provera 500 mg (30 tablets per pack) is 2085–3200 rubles.

Provera: prices in online pharmacies

Drug name Price Pharmacy

Provera 500 mg tablets 30 pcs. 2398 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!