Progesterone Micronized 4 % Vaginal Gel

COMMON BRAND(S): Prochieve

GENERIC NAME(S): Progesterone Micronized

Uses

Uses

This medication is used to restore menstrual cycles in women whose cycles have stopped. Progesterone is a natural female hormone that is needed to keep menstrual periods regular.

How to use Progesterone Micronized 4 % Vaginal Gel

Read the Patient Information Leaflet provided by your pharmacist before you start using progesterone gel and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

This medication is for vaginal use only. Remove the wrapper and prepare the applicator for use as shown in the instructions. There are additional instructions for preparing the applicator if you use this medication at altitudes above 2,500 feet (762 meters).

Use this medication usually every other day up to a total of 6 doses, or as directed by your doctor. Use it regularly in order to get the most benefit from it. Remember to use it at the same time of day.

If you are directed to use any other vaginal products, separate their application from progesterone gel by at least 6 hours.

Inform your doctor if your condition persists.

Side Effects

Side Effects

Bloating, cramps, stomach pain, constipation, diarrhea, nausea, breast swelling/pain, pain around the vaginal area, drowsiness, tiredness, decreased interest in sex, joint pain, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

You may develop a vaginal discharge containing little white balls of gel from using this medication. This is normal and harmless. However, if you develop any unusual vaginal discharge, itching, or odor, notify 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 any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, nervousness, mood swings), signs of water weight gain (e.g., swollen feet/ankles), increased urination at night, abnormal vaginal bleeding, breast lumps, yellowing of the eyes or skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: pain/redness/swelling of arms or legs, trouble breathing, chest pain, weakness on one side of the body, slurred speech, vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 or at www.fda.gov/medwatch.

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

Precautions

Before using progesterone, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unusual vaginal bleeding that has not been diagnosed by your doctor, liver disease, cancer of the breast or female reproductive organs, a miscarriage with some tissue remaining in the womb, blood clots.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, migraines, asthma, heart disease, kidney disease, depression, diabetes.

Although unlikely, this medication can cause blood clots. Your risk is increased if you will be having surgery or if you need to stay in a chair or bed for a long period of time (such as on a long plane flight). Notify your doctor beforehand of any of these events. Special precautions may need to be taken in these circumstances while you are using this drug.

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). In general, alcohol is not recommended for pregnant or possibly pregnant women due to the increased risk of harm to the baby.

This medication may be used in pregnancy as directed by your doctor. Tell your doctor right away if you become pregnant or think you may be pregnant. Consult your doctor for more details.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs affecting liver enzymes that remove progesterone from your body (such as rifampin, St. John's wort, azole antifungals including itraconazole, certain anti-seizure medicines including carbamazepine/phenobarbital/phenytoin).

If you are directed to use any other vaginal products, separate their application from progesterone gel by at least 6 hours.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medicine may be harmful if swallowed.

Notes

Do not share this medication with others.

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (such as once a year) or as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps right away. You should also be regularly screened for cervical cancer (for example, by having a Pap test). Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised April 2019. Copyright(c) 2019 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.