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Depo-Provera

Generic Name: Medroxyprogesterone Acetate Injection
Drug Category: Progestin
Litigation Alert Level: High
This drug has been approved for use by females over the age of 12 years old and under the age of 51 years old for a maximum duration of 2 years.

Approved Uses

Depo-Provera CI is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Depo-Provera CI long-term.

Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

Depo-Provera Contraceptive Injection should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.

The recommended dose is 150 mg of Depo-Provera CI every 3 months (13 weeks) administered by deep intramuscular (IM) injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection.

To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breastfeeding; and if exclusively breastfeeding, ONLY at the sixth postpartum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of Depo Provera CI depends on adherence to the dosage schedule of administration.

The use of Depo-Provera CI is contraindicated in the following conditions:

  • Known or suspected pregnancy or as a diagnostic test for pregnancy
  • Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease 
  • Known or suspected malignancy of breast 
  • Significant liver disease 
  • Undiagnosed vaginal bleeding    

Women who have or have had a history of breast cancer should not use hormonal contraceptives,  including Depo-Provera CI, because breast cancer may be hormonally sensitive.

A statistically non-significant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of Depo-Provera CI in women who were first exposed before the age of 35 years.

There have been a few reported cases of convulsions in patients who were treated with Depo-Provera CI.

Women tend to gain weight while on therapy with Depo-Provera CI.

Do not re-administer Depo-Provera CI pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Do not re-administer if examination reveals papilledema or retinal vascular lesions.

A decrease in glucose tolerance has been observed in some patients on Depo Provera CI treatment. Monitor diabetic patients carefully while receiving Depo Provera CI.

Anaphylaxis and anaphylactoid reaction have been reported with the use of Depo-Provera CI.

Monitor patients who have a history of depression and do not re-administer Depo-Provera CI if depression recurs.

Because progestational drugs including Depo-Provera CI may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.

If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, and topiramate.

Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors.

Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.

Depo-Provera CI should not be administered during pregnancy.

Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI.

GoToSource

Off-label Uses

• Catamenial seizures. GoToSource

• Hot flashes in male patients receiving androgen ablation therapy for prostate cancer. GoToSource

• Male sex-offending behavior. GoToSource

• Endometriosis. GoToSource

Adverse Events

Venous thrombosis (blood clot that forms in vein). GoToSource

Pseudotumor cerebri (increased pressure around brain). GoToSource  

Vaginal spotting, amenorrhea, delayed return of fertility, nausea, weight gain, decreased bone mineral density and mood fluctuations. GoToSource  

Increased risk of fracture, increased risk of acquiring various strains of simian immunodeficiency virus and increased viral shedding in the genital tract. GoToSource   

Increased triglyceride levels. GoToSource  

Increased risk of breast cancer. GoToSource   

Cervical dysplasia. GoToSource

Litigation

Lawsuits filed for pseudotumor cerebri. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024