Prefest

DRUG DESCRIPTION

The PREFEST (estradiol, norgestimate) regimen provides for a single oral tablet to be taken once daily. The pink tablet containing 1.0 mg estradiol is taken on days one through three of therapy; the white tablet containing 1.0 mg estradiol and 0.09 mg norgestimate is taken on days four through six of therapy. This pattern is then repeated continuously to produce the constant estrogen/intermittent progestogen regimen of PREFEST (estradiol, norgestimate) .

The estrogenic component of PREFEST (estradiol, norgestimate) is estradiol, USP. It is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17?-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:

Estradiol  Structural Formula Illustration

The progestational component of PREFEST (estradiol, norgestimate) is micronized norgestimate, a white powder which is chemically described as 18,19-dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17?)-(+)-. It has an empirical formula of C23H31NO3 and a molecular weight of 369.50. The structural formula is:

Each tablet for oral administration contains 1.0 mg estradiol alone or 1.0 mg estradiol and 0.09 mg of norgestimate, and the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, magnesium stearate, ferric oxide red, and lactose monohydrate.

What are the possible side effects of estradiol and norgestimate (Prefest)?

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:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or...

Read All Potential Side Effects and See Pictures of Prefest

What are the precautions when taking estradiol, norgestimate (Prefest)?

Before taking this medication, 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high blood cholesterol/triglyceride levels,...

Read All Potential Precautions of Prefest


Prefest Consumer (continued)

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell 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 (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

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 taking this medication, 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high blood cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop this medication for a time or take special precautions.

This drug may cause blotchy, dark areas of the skin on the face (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

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

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.


Prefest Patient Information Including Side Effects

Brand Names: Prefest

Generic Name: estradiol and norgestimate (Pronunciation: ess tra DYE all and nor JESS tih mate)

  • What is estradiol and norgestimate (Prefest)?
  • What are the possible side effects of estradiol and norgestimate (Prefest)?
  • What is the most important information I should know about estradiol and norgestimate (Prefest)?
  • What should I discuss with my healthcare provider before taking estradiol and norgestimate (Prefest)?
  • How should I take estradiol and norgestimate (Prefest)?
  • What happens if I miss a dose (Prefest)?
  • What happens if I overdose (Prefest)?
  • What should I avoid while taking estradiol and norgestimate
  • What other drugs will affect estradiol and norgestimate (Prefest)?
  • Where can I get more information?

What is estradiol and norgestimate (Prefest)?

Estradiol is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norgestimate is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Estradiol and norgestimate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estradiol and norgestimate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of estradiol and norgestimate (Prefest)?

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:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in your lower leg;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes); or
  • a lump in your breast.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;
  • swollen breasts;
  • swelling of your hands or feet;
  • problems with wearing contact lenses;
  • acne or skin color changes;
  • migraine headaches or dizziness;
  • vaginal pain, dryness, itching, or discharge;
  • swelling of your ankles or feet;
  • depression;
  • enlargement of uterine fibroids; or
  • changes in your menstrual periods, break-through bleeding.

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 estradiol and norgestimate (Prefest)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol and norgestimate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol and norgestimate may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol and norgestimate.

Long-term estradiol and norgestimate treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol and norgestimate long-term. Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.

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