Depo Provera

DRUG DESCRIPTION

Depo-Provera CI contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200C and 210C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.

The chemical name for medroxyprogesterone acetate is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6?-).

The structural formula is as follows:

DEPO-PROVERA CI (medroxyprogesterone acetate)  Structural Formula Illustration

Depo-Provera CI for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.

Each mL contains:

Medroxyprogesterone acetate 150 mg
Polyethylene glycol 3350 28.9 mg
Polysorbate 80 2.41 mg
Sodium chloride 8.68 mg
Methylparaben 1.37 mg
Propylparaben 0.150 mg
Water for injection quantity sufficient
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

What are the possible side effects of medroxyprogesterone (Depo-Provera, Depo-Provera Contraceptive, Depo-SubQ Provera 104)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fever;
  • jaundice (yellowing of the skin or eyes);
  • ...

Read All Potential Side Effects and See Pictures of Depo Provera

What are the precautions when taking medroxyprogesterone (Depo Provera)?

Before using medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have any of the following conditions: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), breast cancer, liver disease, current/suspected pregnancy, abnormal/unexplained vaginal bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, abnormal breast exam, family history of breast cancer, cancer of the reproductive organs (e.g., cervix, uterus), frequent use of alcohol/tobacco,...

Read All Potential Precautions of Depo Provera


Depo Provera Consumer (continued)

SIDE EFFECTS: Nausea, stomach cramping/bloating, dizziness, headache, tiredness, breast tenderness, decrease in breast size, acne, hair loss, or irritation/pain at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Your periods may be early or late, shorter or longer, or heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. Your periods may stop completely after you have been receiving this medication for about a year. If this occurs, your periods will normally return after you stop receiving this medication. If you miss a period and have missed an injection, or if more than 13 weeks pass between injections and you think you may be pregnant, see your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., depression), changes in sexual interest/ability, swelling of the ankles/feet, unusual/sudden weight gain, bone pain, unusual breast discharge/lumps in breast, abnormal severe/persistent vaginal bleeding, persistent nausea/vomiting, seizures, severe stomach/abdominal/pelvic pain, unusual weakness/tiredness, dark urine, yellowing skin/eyes.

This drug may rarely cause blood clots. Get medical help right away if you notice any of the following rare but very serious side effects: chest/jaw/left arm pain, sudden shortness of breath, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden/severe headache, slurred speech, vision changes/problems, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have any of the following conditions: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), breast cancer, liver disease, current/suspected pregnancy, abnormal/unexplained vaginal bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, abnormal breast exam, family history of breast cancer, cancer of the reproductive organs (e.g., cervix, uterus), frequent use of alcohol/tobacco, depression, diabetes, eating disorder (anorexia), heart disease (e.g., chest pain, heart failure), high blood pressure, kidney disease, high cholesterol, irregular/missed/light menstrual periods, migraine, personal/family history of bone disease (e.g., osteoporosis), seizures.

Before having surgery, including dental surgery, tell your doctor or dentist that you are using this medication.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. It may take longer for you to get pregnant after you stop using this medication. Consult your doctor for more information.

This drug passes into breast milk. Consult your doctor before breast-feeding.


Depo Provera Patient Information Including Side Effects

Brand Names: Depo-Provera, Depo-Provera Contraceptive, Depo-SubQ Provera 104

Generic Name: medroxyprogesterone (injectable) (Pronunciation: me DROX ee proe JES ter one)

  • What is medroxyprogesterone (Depo Provera)?
  • What are the possible side effects of medroxyprogesterone (Depo Provera)?
  • What is the most important information I should know about medroxyprogesterone (Depo Provera)?
  • What should I discuss with my healthcare provider before using medroxyprogesterone (Depo Provera)?
  • How should I use medroxyprogesterone (Depo Provera)?
  • What happens if I miss a dose (Depo Provera)?
  • What happens if I overdose (Depo Provera)?
  • What should I avoid while using medroxyprogesterone (Depo Provera)?
  • What other drugs will affect medroxyprogesterone (Depo Provera)?
  • Where can I get more information?

What is medroxyprogesterone (Depo Provera)?

Medroxyprogesterone is a form of progesterone, a female hormone that prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Medroxyprogesterone is used as contraception to prevent pregnancy. It is also used to reduce pain cause by endometriosis.

Medroxyprogesterone is also used to ease pain and other symptoms in women with metastatic uterine or kidney cancer. This medication is not a cure for these conditions.

Medroxyprogesterone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of medroxyprogesterone (Depo Provera)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fever;
  • jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • changes in your menstrual periods;
  • headache, nervousness, dizziness, tired feeling;
  • breast tenderness or discharge;
  • changes in weight or appetite;
  • mild stomach pain, bloating, nausea;
  • back pain or pelvic pain;
  • mild itching or skin rash;
  • increased acne, hair growth, loss of scalp hair;
  • sleep problems (insomnia);
  • vaginal itching or discharge;
  • decreased sex drive; or
  • skin color changes or a hard lump where the injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about medroxyprogesterone (Depo Provera)?

This medication can cause birth defects. Do not use medroxyprogesterone if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Do not use this medication if you are allergic to medroxyprogesterone, or if you have abnormal vaginal bleeding, breast cancer, liver disease, or a history of a stroke or blood clot.

Medroxyprogesterone may cause bone loss (osteoporosis) especially when used over long periods of time. Bone loss may not be reversible. Do not use this medication for longer than 2 years. Talk with your doctor about your specific risk of bone loss.

Medroxyprogesterone will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

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