Prostin E2

Prostin E2 is part of the drug class:

• Prostaglandin Oxytocics

Prostin E2, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Prostin E2 should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Dinoprostone is a prostaglandin, a hormone-like substance that is naturally produced by tissues in the body.

Dinoprostone topical is used in a pregnant woman to relax the muscles of the cervix (opening of the uterus) in preparation for inducing labor at the end of a pregnancy.

Dinoprostone topical may be used for purposes not listed in this medication guide.

You should not be treated with this medication if you are allergic to prostaglandins, or if you have:

• active genital herpes with a vaginal lesion;

• placenta previa (the placenta is below the fetus in your uterus); or

• if your water has broken.

Be sure your doctor knows your entire pregnancy history, especially:

• if you have ever had a C-section or major surgery on your uterus;

• if you have ever had a baby born in a breech position (not head-first); or

• if you have ever had a difficult labor or delivery of a previous child.

To make sure you can safely use dinoprostone topical, tell your doctor if you have any of these other conditions:

• kidney disease;

• liver disease;

• glaucoma;

• a history of asthma;

• if you are 30 years or older; or

• if your pregnancy is at full term (40 weeks).

This section provides information on the proper use of a number of products that contain dinoprostone. It may not be specific to Prostin E2. Please read with care.

After dinoprostone is given, you will need to lie down for 10 minutes to 2 hours so that the medicine can be absorbed. The length of time you must remain lying down will depend on what form of the medicine you are using.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cervical dosage form (gel):
  • To thin and widen the opening of the cervix just before labor:
    • Adults and teenagers—Your doctor will insert 0.5 milligram (mg) (one application) of dinoprostone into the canal of your cervix. You should remain lying on your back for at least ten to thirty minutes after it has been applied.
• For vaginal dosage form (gel):
  • To cause the uterus to contract for labor:
    • Adults and teenagers—Your doctor will insert 1 milligram (mg) (one applicatorful) of dinoprostone into your vagina. You should remain lying on your back for at least thirty minutes after it has been applied. You may need another dose of 1 to 2 mg six hours after the first dose.
• For vaginal dosage form (suppositories):
  • To cause the uterus to contract to abort a pregnancy:
    • Adults and teenagers—Your doctor will insert 20 milligrams (mg) (one suppository) into your vagina every three to five hours as needed. You should remain lying on your back for at least ten minutes after it has been inserted.
• For vaginal dosage form (system):
  • To thin and widen the opening of the cervix just before labor:
    • Adults and teenagers—Your doctor will insert 10 milligrams (mg) (one system) into your vagina. You should remain lying on your back for at least two hours after it has been inserted.

• It is used to end a pregnancy.
• It is used to treat certain tumors in the uterus.
• It may be given to you for other reasons. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Any unexplained bruising or bleeding.
• Very upset stomach or throwing up.
• Very bad belly pain.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Prostin E2 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prostin E2. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Prostin E2® 20 mg

dinoprostone vaginal suppository
MADE IN USA (includes foreign content)
Pharmacia & Upjohn Co., Division of Pfizer Inc, NY, NY 10017

NDC 0009-0827-03

520 mg Suppositories
Rx only

Prostin E2®
dinoprostone vaginal
suppository

20 mg

Pfizer Injectables