progesterone vaginal

Generic Name: progesterone vaginal (proe JESS te role VAJ in ul)
Brand Name: Crinone, Endometrin, FIRST-Progesterone VGS 100, FIRST-Progesterone VGS 200, FIRST-Progesterone VGS 25, FIRST-Progesterone VGS 400, FIRST-Progesterone VGS 50, Menopause Formula Progesterone, Prochieve

What is progesterone vaginal?

Progesterone is a female hormone important for ovulation and menstruation. Progesterone causes changes in the lining of your uterus, making it easier for a fertilized egg to attach to the uterus at the beginning of pregnancy. Progesterone then helps your body maintain the pregnancy.

Progesterone vaginal is used in fertility treatment as part of Assisted Reproductive Technology (ART) for women unable to get pregnant due to a lack of natural progesterone in the body.

Progesterone vaginal is also 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 medication also prevents overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

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

What is the most important information I should know about progesterone vaginal?

Do not use progesterone vaginal without your doctor's consent if you are pregnant, unless you are using the medication as part of your fertility treatment. Tell your doctor if you become pregnant during treatment. If you are not being treated for infertility, use an effective form of birth control while you are using this medication.

Some forms of this medication may contain plant-based oils. Do not use progesterone vaginal without telling your doctor if you have any type of food allergy.

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

You should not use this medication if you have: a history of stroke or blood clot, circulation problems, severe liver disease, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, or if you have recently had a tubal pregnancy or an incomplete abortion.

Progesterone vaginal is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, progesterone vaginal may be given for up to 12 weeks into a pregnancy. 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.

Progesterone vaginal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before using progesterone vaginal?

Some forms of this medication may contain plant-based oils. Do not use progesterone vaginal without telling your doctor if you have any type of food allergy.

You should not use progesterone vaginal if you have ever had an allergic reaction to it, or if you have:

  • a history of stroke, blood clot, or circulation problems;

  • breast or uterine cancer;

  • abnormal vaginal bleeding;

  • liver disease; or

  • if you have recently had a tubal pregnancy or an incomplete or "missed" abortion.

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely use progesterone:

  • high blood pressure, heart disease, congestive heart failure;

  • migraines,

  • asthma;

  • kidney disease;

  • seizures or epilepsy;

  • diabetes; or

  • a history of depression.

Do not use progesterone vaginal without your doctor's consent if you are pregnant, unless you are using the medication as part of your fertility treatment. Tell your doctor if you become pregnant during treatment. If you are not being treated for infertility, use an effective form of birth control while you are using this medication.

Progesterone vaginal 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 vaginal?

Use this medication 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 vaginal is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, progesterone vaginal may be given for up to 12 weeks into a pregnancy. 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.

Do not use other vaginal medications within 6 hours before or after using progesterone vaginal. Use only vaginal products that your doctor has recommended.

Progesterone vaginal gel should be applied directly into the vagina using only the applicator provided with the medicine. A disposable applicator should be used only once and then thrown away.

Progesterone vaginal suppositories are made at the pharmacy and provided to you in a dispensing cup fitted with a mold and a special tool to push each suppository out through the bottom of the mold. Your pharmacist can show you how to dispense the suppositories from the mold.

Before inserting the vaginal suppository, remove the wrapping and throw it away. Avoid handling the suppository too long or it will begin to melt in your hand.

It is normal to have vaginal discharge for several days after using this medication. Talk with your doctor if you have concerns about any vaginal discharge.

Store progesterone vaginal at room temperature away from moisture and heat.

Some brands of progesterone vaginal suppositories should be stored in a refrigerator. Follow the instructions provided with your medication.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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 if you think you have used too much of this medicine. Symptoms of a progesterone vaginal overdose are not known.

What should I avoid while using progesterone vaginal?

Progesterone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Progesterone vaginal side effects

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 headache, numbness or weakness (especially on one side of the body), shortness of breath, or problems with vision, speech, or balance;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder;

  • pain or swelling in one or both legs;

  • 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 side effects may include:

  • mild nausea, vomiting, bloating, stomach cramps;

  • diarrhea, constipation, bloating;

  • dizziness, drowsiness, tired feeling;

  • pain in your vaginal or rectal area;

  • pain during intercourse;

  • loss of interest in sex;

  • breast pain, swelling, or tenderness;

  • joint or muscle pain;

  • increased night-time urination; or

  • vaginal itching, burning, 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.

Progesterone vaginal 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 vaginal?

There may be other drugs that can interact with progesterone vaginal. 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 1996-2012 Cerner Multum, Inc. Version: 2.03. Revision Date: 2010-12-15, 5:01:39 PM.

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