Generic Name: progesterone vaginal (proe JESS te rone VAJ in al)
Brand Name: Crinone, Endometrin, FIRST-Progesterone VGS 200, 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 (for use in the vagina) 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.
Progesterone vaginal is also 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 prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.
Progesterone vaginal may also be used for purposes not listed in this medication guide.
What is the most important information I should know about progesterone vaginal?
You should not use this medicine if you have: a history of stroke or blood clot, circulation problems, liver disease, breast or uterine cancer, abnormal vaginal bleeding, or if you have recently had a tubal pregnancy or an incomplete abortion.
Some forms of vaginal progesterone may contain plant-based oils. Tell your doctor if you have any type of food allergy.
Do not use if you are pregnant, unless you are using progesterone as part of your fertility treatment.
What should I discuss with my healthcare provider before using progesterone vaginal?
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;
any type of food allergy (some forms of vaginal progesterone may contain plant-based oils); or
if you have recently had a tubal pregnancy or an incomplete or "missed" abortion.
To make sure this medicine is safe for you, tell your doctor if you have:
high blood pressure, heart disease, congestive heart failure;
seizures or epilepsy;
a history of depression; or
risk factors for coronary artery disease (such as diabetes, lupus, high cholesterol, family history of coronary artery disease, smoking, or being overweight).
Using progesterone vaginal can increase your risk of blood clots, stroke, heart attack, or breast cancer. Talk to your doctor about this risk.
Do not use progesterone vaginal if you are pregnant, unless you are using this medicine as part of your fertility treatment.
Tell your doctor if you become pregnant during treatment. If you are not being treated for infertility, use effective birth control to prevent pregnancy while using progesterone vaginal.
Progesterone vaginal can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I use progesterone vaginal?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Do not take by mouth. Progesterone vaginal is for use only in the vagina.
Insert this medicine directly into the vagina using only the applicator provided. Use a disposable applicator only once and then throw it away.
Progesterone vaginal suppositories are made at the pharmacy and provided in a special container. Your pharmacist can show you how to remove a suppository from the container. Avoid handling the suppository too long or it will begin to melt in your hand.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Use this medicine at bedtime if it causes dizziness or drowsiness.
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. Follow your doctor's dosing instructions very carefully.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using progesterone vaginal.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using progesterone vaginal.
It is normal to have vaginal discharge for several days after using this medicine. Talk with your doctor if you have concerns about any vaginal discharge.
Store progesterone vaginal inserts or gel at room temperature away from moisture, heat, and light.
Progesterone vaginal suppositories should be stored in a refrigerator. Follow the instructions provided with your medicine.
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.
What happens if I overdose?
An overdose of progesterone vaginal is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.
What should I avoid while using progesterone vaginal?
Do not use another vaginal medicine within 6 hours before or after using progesterone vaginal gel. Use only vaginal products that your doctor has recommended.
Avoid using vaginal yeast treatments unless your doctor tells you to.
This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Progesterone vaginal side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
unusual vaginal bleeding;
pain or burning when you urinate;
symptoms of depression (sleep problems, weakness, mood changes);
a breast lump;
sudden vision problems, severe headache or pain behind your eyes;
heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.
Common side effects may include:
dizziness, confusion, drowsiness, tiredness;
headache, mood changes, feeling nervous or irritable;
stomach pain, nausea, diarrhea, constipation;
bloating, swelling in your hands or feet;
breast pain, swelling, or tenderness;
cramps, pelvic pain; or
vaginal itching, burning, or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 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.
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?
Other drugs may interact with progesterone vaginal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
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: 2.04. Revision Date: 2015-03-13, 10:38:44 AM.