Dinoprostone, Prostaglandin E2 vaginal insert

What is this medication?

DINOPROSTONE(dye noe PROST one) is used to help dilate the cervix in pregnant women who are at or near term. This will help to induce labor.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Cervidil

What should I tell my care team before I take this medication?

They need to know if you have any of the following conditions:

• active genital, vaginal, uterine, or pelvic infection
• anemia
• glaucoma
• heart disease
• high blood pressure
• kidney disease
• liver disease
• lung or breathing disease, like asthma
• placenta previa
• previous pregnancy with difficult labor, traumatic delivery or cesarean section
• previous surgery to the uterus
• seizure disorder
• uterine rupture or scars
• vaginal bleeding
• 6 or more previous pregnancies
• an unusual or allergic reaction to dinoprostone, prostaglandins, other medicines, foods, dyes, or preservatives
• breast-feeding

How should I use this medication?

This medicine is inserted into the vagina by a health-care professional in a hospital or clinic setting. Remain lying down for 2 hours after it is inserted. Your doctor will remove the insert after it has been in place for 12 hours or after active labor begins.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medication?

• oxytocin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

You will be closely monitored while you receive this medicine.

Contact your doctor or health care professional immediately if you get signs and symptoms of infection or other complications, such as pelvic or lower abdominal pain, an unpleasant vaginal discharge, fever, chills, or increase in vaginal bleeding several days after treatment.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain
• dizziness or fainting
• fever of 100.4 degrees F (38 degrees C) or higher
• unusual or foul-smelling vaginal discharge
• unusual vaginal bleeding, pelvic pain, or cramping

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• mild increase in body temperature that goes away
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.