Provera

What is Provera?

Provera is a medicine that contains medroxyprogesterone acetate, a progestin hormone. It is used to treat menstrual periods that have stopped or to treat abnormal uterine bleeding. Women with a uterus who are not pregnant, who stop having regular menstrual periods or who begin to have irregular menstrual periods may have a drop in their progesterone level. Talk with your healthcare provider about whether Provera is right for you.

It is also used to reduce your chances of getting cancer of the uterus (womb). In postmenopausal women with a uterus who use estrogens, taking progestin in combination with estrogen will reduce your chance of getting cancer of the uterus (womb).

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 200°C and 210°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 pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α-).

The structural formula is as follows:

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

Mechanism of Action

Depo-Provera CI (medroxyprogesterone acetate [MPA]) inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.

What is the most important information I should know about Provera?

• Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
• Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
• Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older.
• You and your healthcare provider should talk regularly about whether you still need treatment with Provera.

Who should not take Provera?

Do not start taking Provera if you:

• have unusual vaginal bleeding
• currently have or have had certain cancers
• Estrogen plus progestin may increase your chance of getting certain types of cancers, including cancer of the breast. If you have or have had cancer, talk with your healthcare provider about whether you should use Provera.
• had a stroke or heart attack
• currently have or have had blood clots
• currently have or have had liver problems
• are allergic to Provera or any of its ingredients. See the list of ingredients in Provera at the end of this leaflet.
• think you may be pregnant. Provera is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use Provera if the test is positive and talk to your healthcare provider. There may be an increased risk of minor birth defects in children whose mothers take Provera during the first 4 months of pregnancy. Provera should not be used as a test for pregnancy.

What should I tell my healthcare provider before taking Provera?

Before you take Provera, tell your healthcare provider if you:

• have any other medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis (severe pelvic pain), lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium in your blood.
• are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop taking Provera.
• are breast feeding. The hormone in Provera can pass into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Provera works. Provera may also affect how other medicines work.

How should I take Provera?

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. The lowest effective dose of Provera has not been determined. You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with Provera.

• Absence of menstrual period: Provera may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
• Abnormal Uterine Bleeding: Provera may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
• Overgrowth of the lining of the uterus: When used in combination with oral conjugated estrogens in postmenopausal women with a uterus, Provera may be given in doses ranging from 5 or 10 mg daily for 12 to 14 straight days per month.

What are the possible side effects of Provera?

The following side effects have been reported with the use of Provera alone:

• breast tenderness
• breast milk secretion
• breakthrough bleeding
• spotting (minor vaginal bleeding)
• irregular periods
• amenorrhea (absence of menstrual periods)
• vaginal secretions
• headaches
• nervousness
• dizziness
• depression
• insomnia, sleepiness, fatigue
• premenstrual syndrome-like symptoms
• thrombophlebitis (inflamed veins)
• blood clot
• itching, hives, skin rash
• acne
• hair loss, hair growth
• abdominal discomfort
• nausea
• bloating
• fever
• increase in weight
• swelling
• changes in vision and sensitivity to contact lenses

Call your healthcare provider right away if you get:

• hives
• problems breathing
• swelling of the face, mouth, tongue or neck

The following side effects have been reported with the use of Provera with an estrogen.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

• heart attack
• stroke
• blood clots
• dementia
• breast cancer
• cancer of the uterus
• cancer of the ovary
• high blood pressure
• high blood sugar
• gallbladder disease
• liver problems
• changes in your thyroid hormone levels
• enlargements of benign tumors (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• new breast lumps
• unusual vaginal bleeding
• changes in vision and speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
• memory loss or confusion

Less serious, but common side effects include:

• headache
• breast pain
• irregular vaginal bleeding or spotting
• stomach or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection

These are not all the possible side effects of Provera with or without estrogen. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have side effect that bothers you or does not go away. You may report side effects to Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with Provera?

• Talk with your healthcare provider regularly about whether you should continue taking Provera. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).
• See your healthcare provider right away if you get vaginal bleeding while taking Provera.
• Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chance of getting heart disease.

General information about the safe and effective use of Provera

• Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
• Do not take Provera for conditions for which it was not prescribed.
• Do not give Provera to other people, even if they have the same symptoms you have. It may harm them.

This guide provides a summary of the most important information about Provera. If you would like more information, talk with your health care provider or pharmacist. You can ask for information about Provera that is written for health professionals. You can get more information by calling the toll-free number, 1-800-438-1985.

How do I store Provera?

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Keep Provera out of the reach of children.

What are the ingredients in Provera?

Active ingredient: medroxyprogesterone acetate.

Inactive ingredients:

2.5mg tablet:

• calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc, FD&C Yellow No. 6

OR

• calcium stearate, corn starch, lactose, mineral oil, sucrose, talc, FD&C Yellow No. 6.

5mg tablet:

• calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc.

OR

• calcium stearate, corn starch, lactose, mineral oil, sucrose, talc, FD&C Blue No.2 – Aluminum Lake.

10mg tablet:

• calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc.

OR

• calcium stearate, corn starch, lactose, mineral oil, sucrose, talc.

Label

PRINCIPAL DISPLAY PANEL – 150 MG/ML VIAL CARTON

• Pfizer
• NDC 0009-0746-30
  Rx only
• Depo-Provera®
  Contraceptive
  Injection
• medroxyPROGESTERone
  acetate injectable
  suspension, USP
• 150 mg/mL
• 1 mL Single-Dose Vial
• For intramuscular use only

PRINCIPAL DISPLAY PANEL – 1 ML SYRINGE LABEL

• Pfizer
  NDC 0009-7376-11
  Rx only
• Depo-Provera®
  Contraceptive Injection
• 150 mg per mL
• medroxyprogesterone acetate
  injectable suspension, USP
• Intramuscular use only
  1 mL Single Dose Syringe
  Shake vigorously before use
  Pfizer Inc, NY, NY 10017
  819 361 101
• LOT/EXP:
• 8Q2671

SRC: NLM .