Medroxyprogesterone Acetate tablet is a progestin used to treat secondary amenorrhea and abnormal uterine bleeding caused by hormonal imbalance, when no underlying organic conditions (such as uterine fibroids or cancer) are present. It is also prescribed to lower the risk of endometrial hyperplasia in postmenopausal women who still have their uterus and are taking daily oral conjugated estrogens (0.625 mg).

Medroxyprogesterone acetate (MPA), when given orally or by injection in recommended doses to women with sufficient natural estrogen, converts the proliferative endometrium into a secretory endometrium. It may show mild androgenic and anabolic effects, but it has little to no significant estrogen-like activity. When administered by injection, MPA suppresses gonadotropin production, which prevents follicle development and ovulation. However, current evidence suggests that this suppression does not usually occur with standard once-daily oral dosing.

Secondary Amenorrhea: Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of this tablet daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing this tablet therapy

Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of this tablet may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of this tablet daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with this tablet. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with this tablet.

Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens: When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Medroxyprogesterone acetate tablet tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of this tablet has not been determined.

Medroxyprogesterone Acetate should not be used in women who have any of the following conditions:

• Unexplained abnormal genital bleeding
• Known, suspected, or previous history of breast cancer
• Known or suspected hormone-dependent tumors (estrogen- or progesterone-related)
• Active or past history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
• Active or previous arterial thromboembolic disease (such as stroke or myocardial infarction)
• History of severe allergic reactions such as anaphylaxis or angioedema to this drug
• Liver disease or impaired liver function
• Known or suspected pregnancy

The following side effects have been reported in women taking Medroxyprogesterone Acetate tablets without concurrent estrogen therapy:

• Genitourinary system: Irregular uterine bleeding (increased, decreased, or irregular), changes in menstrual pattern, breakthrough bleeding, spotting, absence of menstruation (amenorrhea), and changes in cervical condition or secretions.
• Breasts: Breast tenderness, breast pain (mastodynia), and in some cases milk secretion (galactorrhea).
• Cardiovascular: Blood clot-related conditions such as thrombophlebitis and pulmonary embolism.
• Gastrointestinal: Nausea and cholestatic jaundice.
• Skin: Allergic reactions including hives (urticaria), itching, swelling (edema), and generalized rash. Acne, hair loss (alopecia), and excessive hair growth (hirsutism) may occur.
• Eyes: Eye-related nerve problems such as retinal thrombosis and optic neuritis.
• Central nervous system: Depression, insomnia, drowsiness, dizziness, headache, and nervousness.

Medroxyprogesterone Acetate should not be used during pregnancy. Exposure during the first trimester may increase the risk of conditions such as hypospadias, clitoral enlargement, and labial fusion in newborns; however, a definite causal relationship has not been firmly established.This medication is also not recommended during breastfeeding, as measurable amounts of progestin can pass into breast milk in mothers receiving this therapy.

Use of progestin with estrogen (in women without hysterectomy): Adding a progestin for at least 10 days per cycle, or continuously with estrogen, reduces the risk of endometrial hyperplasia compared to estrogen alone. Since endometrial hyperplasia can lead to cancer, this combination may be beneficial. However, combined therapy may increase the risk of breast cancer compared to estrogen alone.

Unexpected vaginal bleeding: Any unexplained abnormal vaginal bleeding should be properly investigated.

High blood pressure: Blood pressure should be checked regularly during combined estrogen-progestin therapy.

Hypertriglyceridemia: Women with high triglyceride levels may experience further increases, which can lead to pancreatitis. Treatment should be stopped if pancreatitis develops.

Liver impairment or history of cholestatic jaundice: This therapy should be used cautiously in women with liver problems. If jaundice reappears, treatment must be discontinued.

Fluid retention: Progestins may cause fluid retention, so patients with heart or kidney disease should be closely monitored.

Hypocalcemia: Use cautiously in women with hypoparathyroidism, as estrogen may lower calcium levels.

Worsening of existing conditions: Conditions such as asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, and liver hemangiomas may worsen and require caution.

Pediatric use: Not recommended for children; safety and effectiveness have not been established.

Geriatric use: There is insufficient clinical data in women over 65 years to determine differences in response compared to younger women.

Excess intake of estrogen-progestin therapy may cause nausea, vomiting, breast discomfort, dizziness, abdominal pain, drowsiness, fatigue, and withdrawal bleeding. Management involves stopping the medication and providing supportive treatment.

Female sex hormones

Store below 30°C, protected from light and moisture. Keep out of reach of children.