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Medroxyprogesterone information from DrugsUpdate  

See Available Brands of Medroxyprogesterone in India

P - Contraindicated in pregnancy
L - Caution when used during lactation
LI - Lab *

Medroxyprogesterone is a progestin, and is commonly a component of hormonal contraceptives.

Pharmacodynamics

Pharmacokinetics

Medroxyprogesterone is a synthetic progestogen which converts the proliferative phase of the endometrium into secretory phase. It has some androgenic and anabolic activities but no oestrogenic effects. Parenteral use leads to inhibition of pituitary gonadotropins, thus preventing follicular maturation and ovulation.

Absorption

Well absorbed from the GIT (oral).

Distribution
Enters the breast milk. Protein-binding: Highly bound to albumin.

Metabolism

Hepatic.

Excretion
Via the urine and faeces (as glucuronide conjugates); Elimination half-life: 24-30 hours (oral), 50 days (IM).

Medroxyprogesterone Indications / Medroxyprogesterone Uses

Information Not Available

Medroxyprogesterone Adverse Reactions / Medroxyprogesterone Side Effects

Depression, fluid retention. Fatigue, insomnia, dizziness, headache, nausea; breast tenderness; wt gain/loss, anorexia; cholestatic jaundice; pain at Inj site.

Potentially Fatal: Thrombophlebitis and pulmonary embolism.

Precautions

1. Physical Examination
It is good medical practice for all women to have annual history and physical examinations, including women using Medroxyprogesterone acetate injectable suspension. The physical examination, however, may be deferred until after initiation of Medroxyprogesterone acetate injectable suspension if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

2. Fluid Retention

Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

3. Weight Changes

There is a tendency for women to gain weight while on therapy with Medroxyprogesterone acetate injectable suspension. From an initial average body weight of 136 lb, women who completed 1 year of therapy with Medroxyprogesterone acetate injectable suspension gained an average of 5.4 lb. Women who completed 2 years of therapy gained an average of 8.1 lb.

Women who completed 4 years gained an average of 13.8 lb. Women who completed 6 years gained an average of 16.5 lb. Two percent of women withdrew from a large-scale clinical trial because of excessive weight gain.

4. Return of Fertility

Medroxyprogesterone acetate injectable suspension has a prolonged contraceptive effect. In a large US study of women who discontinued use of Medroxyprogesterone acetate injectable suspension to become pregnant, data are available for 61% of them. Based on Life-Table analysis of these data, it is expected that 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection. The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use. No data are available for 39% of the patients who discontinued Medroxyprogesterone acetate injectable suspension to become pregnant and who were lost to follow-up or changed their mind.

5. CNS Disorders and Convulsions
Patients who have a history of psychic depression should be carefully observed and the drug not be readministered if the depression recurs.

There have been a few reported cases of convulsions in patients who were treated with Medroxyprogesterone acetate injectable suspension. Association with drug use or pre-existing conditions is not clear.

6. Carbohydrate Metabolism
A decrease in glucose tolerance has been observed in some patients on Medroxyprogesterone acetate injectable suspension treatment. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy.

7. Liver Function
If jaundice develops, consideration should be given to not readministering the drug.

8. Protection Against Sexually Transmitted Diseases
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Special Precautions

Patients with depression, DM, epilepsy, asthma, migraine, hypertension, renal or cardiac dysfunction. Monitor patient closely for loss of vision, proptosis, diplopia and thromboembolic disorders. Lactation.

Other Drug Interactions

Aminoglutethimide and enzyme-inducing drugs (e.g. carbamazepine, griseofulvin, phenobarbital, rifampicin, phenytoin) may reduce plasma concentrations leading to reduced efficacy. Additional measures required when medroxyprogesterone is used for contraception during coadministration with these drugs.

Other Interactions

Information Not Available

Dosage

Oral
Menorrhagia
Adult: 2.5-10 mg daily for 5-10 days starting on the 16th-21st day of the menstrual cycle. Repeat for 2 cycles.

Oral
Mild to moderate endometriosis
Adult: 10 mg tid.

Oral
As progestogen component in menopausal hormonal replacement therapy
Adult: Dosage dependant on oestrogen component of therapy, several regimens are used: 1.5 mg, 2.5 mg or 5 mg daily; 5 or 10 mg daily for 12-14 days of a 28-day cycle; 20 mg daily for 14 days of a 91-day cycle.

Oral
Breast cancer
Adult: 0.4-1.5 g daily. Max: 2 g daily.

Oral
Palliative treatment of endometrial and renal carcinoma
Adult: 200-600 mg daily.

Oral
Secondary amenorrhoea
Adult: 2.5-10 mg daily for 5-10 days. Repeated for 3 cycles.

Oral
Palliative treatment of prostatic carcinoma
Adult: 100-600 mg daily.

Intramuscular
Endometriosis
Adult: 50 mg weekly or 100 mg every 2 weeks.

Intramuscular

Contraception
Adult: 150 mg every 12 weeks.

Intramuscular
Breast cancer
Adult: 0.5-1 g daily for first 4 weeks. Maintenance 0.5 g twice weekly.

Intramuscular

Palliative treatment of endometrial and renal carcinoma
Adult: Initially 0.4-1 g weekly. Reduce as necessary, maintenance may be as low as 0.4 g monthly.

Intramuscular

Palliative treatment of prostatic carcinoma
Adult: 0.5 g twice wkly for first 3 months. Maintenance 0.5 g weekly.

Subcutaneous
Contraception
Adult: 104 mg every 12-14 weeks.

Subcutaneous
Endometriosis
Adult: 104 mg every 12-14 weeks.

Food(before/after)

May be taken with or without food. (Incidence of minor indigestion may increase as dose increases. Take w/ meals if necessary.)

List of Contraindications

Medroxyprogesterone and Pregnancy

Contraindicated in pregnancy

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Medroxyprogesterone and Lactation

Caution when used during lactation

Medroxyprogesterone and Children

Medroxyprogesterone acetate injectable suspension is not indicated before menarche. Use of Medroxyprogesterone acetate injectable suspension is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of Medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

Medroxyprogesterone and Geriatic

Information Not Available

Medroxyprogesterone and Other Contraindications

Thromboembolic disorders; cerebral apoplexy; severe hepatic dysfunction; undiagnosed vaginal bleeding, incomplete abortion, hormone-dependent carcinoma; pregnancy.

Storage

Information Not Available

Lab interference

Information Not Available

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