Progesterone

Pronunciation

Generic Name: progesterone (proe JESS te rone)
Brand Names: First Progesterone MC10, First Progesterone MC5, Progest, Prometrium

What is progesterone?

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

Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. This medicine is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

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

Important information

Do not use progesterone without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Some forms of this medication may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy.

Slideshow: Flashback: FDA Drug Approvals 2013

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Do not use this medication if you have any of the following conditions: a history of breast cancer, abnormal vaginal bleeding, liver disease, if you are pregnant, or if you have had a stroke, heart attack, or blood clot within the past year.

Progesterone is sometimes given for only a short period of time, such as 6 to 12 days at a time during each menstrual cycle. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

Progesterone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Before using progesterone

Some forms of progesterone may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy. Do not use this medicine if you have:

  • a history of breast cancer;

  • abnormal vaginal bleeding that a doctor has not checked;

  • liver disease;

  • if you are pregnant; or

  • if you have had a stroke, heart attack, or blood clot within the past year.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use progesterone:

  • heart disease, circulation problems;

  • risk factors for coronary artery disease (such as smoking, being overweight, and having high blood pressure or high cholesterol);

  • migraines,

  • asthma;

  • kidney disease;

  • seizures or epilepsy;

  • a history of depression; or

  • diabetes.

Do not use progesterone without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Progesterone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use progesterone?

Use progesterone exactly as it was prescribed for you. Do not use larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Progesterone is sometimes given for only a short period of time, such as 6 to 12 days at a time during each menstrual cycle. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take the pill form of progesterone with a full glass of water.

Apply progesterone cream to the skin as directed by your doctor.

Progesterone injection is given as a shot into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using progesterone.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any scheduled appointments.

Store progesterone at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than one dose of this medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Progesterone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Progesterone side effects

Get emergency medical help if you have any of these signs of an allergic reaction to progesterone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and 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, pain behind the eyes, problems with vision, speech, or balance;

  • fast or pounding heartbeats;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • unusual or unexpected vaginal bleeding;

  • migraine headache;

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • swelling in your hands, ankles, or feet;

  • fever, chills, body aches, flu symptoms;

  • a breast lump; or

  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious progesterone side effects may include:

  • mild nausea, diarrhea, bloating, stomach cramps;

  • dizziness, spinning sensation;

  • hot flashes;

  • mild headache;

  • joint pain;

  • breast pain or tenderness;

  • cough;

  • acne or increased hair growth;

  • changes in weight; or

  • vaginal itching, dryness, or discharge.

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.

See also: Side effects (in more detail)

Progesterone dosing information

Usual Adult Dose for Amenorrhea:

5 to 10 mg IM for six to eight consecutive days.

400 mg orally for 10 days. Give dose in the evening.

Secondary Amenorrhea:
90 mg intravaginally, 4% gel, every other day for a total of six doses. If no response observed, the administration of the 8% gel every other day for a total of six doses may be used.

Usual Adult Dose for Uterine Bleeding:

5 to 10 mg IM daily for 6 doses.

Usual Adult Dose for Endometrial Hyperplasia -- Prophylaxis:

200 mg orally for 12 consecutive days, per 28 day cycle. Give dose in the evening.

Usual Adult Dose for Progesterone Insufficiency:

Assisted Reproductive Technology (ART) - Gel:
90 mg of the 8% gel, once daily intravaginally, in women who require supplementation.
90 mg of the 8% gel, twice daily intravaginally, in women with partial or complete ovarian failure who require replacement.
If pregnancy occurs, therapy with the intravaginal gel may be continued until placental autonomy is achieved, up to 10 to 12 weeks.

Assisted Reproductive Technology (ART) - Vaginal Insert
100 mg administered vaginally two or three times daily starting at oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose in this age group has not been determined.

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: rub 1/4 to 1/2 teaspoon into the palms of the hands, soles of the feet, or other soft areas of skin once or twice daily.

Usual Adult Dose for Premature Labor:

Study (n=459) - National Institute of Child Health and Human Development (NICHD) - Prevention of Recurrent Preterm Delivery in Women at High Risk: 17-alpha-hydroxyprogesterone caproate (17P) 250 mg IM once weekly starting on the 21st week of gestation through time of delivery or week 36 of gestation.

Study (n=142) - Reduce Incidence of Spontaneous Preterm Birth in Women at Increased Risk: 100 mg vaginal suppository daily, between 24 and 34 weeks of gestation.

Usual Adult Dose for Seizures:

(Study=25) - Catamenial epilepsy [complex partial or secondary generalized motor seizures]:
200 mg lozenge three times daily administered in relation to pattern of seizure exacerbation during luteal phase of menstrual cycle. For patients with perimenstrual exacerbation, dose was provided on day 23 through day 25 of menstrual cycle. For patients with seizure exacerbation during entire luteal phase, dose was provided on day 15 through day 25 of each menstrual cycle. The desired progesterone serum level was between 5 and 25 ng/mL 4 hours after taking the lozenge. All patients continued taking their best antiseizure medication.

Usual Adult Dose for Perimenopausal Symptoms:

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: Rub 1/4 to 1/2 teaspoonful into the palms of the hands, soles of feet, or other soft area once or twice daily.

What other drugs will affect progesterone?

There may be other drugs that can interact with progesterone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about progesterone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 8.01. Revision Date: 06/24/2010 2:23:37 PM.

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