Depo-SubQ Provera

DRUG DESCRIPTION

depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), 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 205°and 209°C. 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 17-hydroxy-6?-methylpregn-4ene-3,20-dione 17-acetate. The structural formula is as follows:

depo-subQ provera 104™ (medroxyprogesterone acetate) Structural Formula Illustration

depo-subQ provera (medroxyprogesterone acetate) 104 for subcutaneous (SC) injection is available in pre-filled syringes (160 mg/mL), each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Each 0.65 mL contains:

Medroxyprogesterone acetate 104 mg
Methylparaben 1.040 mg
Propylparaben 0.098 mg
Sodium Chloride 5.200 mg
Polyethylene Glycol 18.688 mg
Polysorbate 80 1.950 mg
Monobasic Sodium Phosphate. H2O 0.451 mg
Dibasic Sodium Phosphate . 12H2O 0.382 mg
Methionine 0.975 mg
Povidone 3.250 mg
Water for Injection qs

When necessary, the 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-SubQ Provera »

What are the precautions when taking medroxyprogesterone acetate (Depo-SubQ 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: abnormal/unexplained vaginal bleeding, breast cancer, cancer of the reproductive organs (e.g., cervix, uterus), current problem with blood clots, past history of stroke or blood clots, severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, lumps in the breast, family history of breast cancer, daily use of alcohol/tobacco, depression, diabetes, eye disease,...

Read All Potential Precautions of Depo-SubQ Provera »


Depo-SubQ Provera Consumer (continued)

SIDE EFFECTS: Irregular menstrual bleeding, headache, weight gain, swelling, acne, fatigue, dizziness, nausea, bloating, hot flashes, breast tenderness, changes in appetite, or irritation/pain at injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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, prolonged/complete stopping of menstrual bleeding, bone pain, unusual breast discharge, severe/persistent vaginal bleeding, unusual weakness/tiredness, fainting, persistent nausea/vomiting, severe abdominal pain, yellowing skin/eyes, seizures.

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: sudden/severe headache, chest pain, difficulty breathing, sudden vision changes, numbness in arms/legs, slurred speech, pain in the calf muscles with redness/warmth/swelling.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: 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: abnormal/unexplained vaginal bleeding, breast cancer, cancer of the reproductive organs (e.g., cervix, uterus), current problem with blood clots, past history of stroke or blood clots, severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, lumps in the breast, family history of breast cancer, daily use of alcohol/tobacco, depression, diabetes, eye disease, heart disease (e.g., heart failure, high blood pressure), kidney/liver disease, high cholesterol, migraine, personal or family history of bone disease (e.g., osteoporosis), seizures.

This medication may cause a delay in your ability to get pregnant after you stop using this medication. Consult your doctor for more information.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.

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


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

What is medroxyprogesterone (Depo-SubQ 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-SubQ 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-SubQ 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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