Cervidil

Generic name: dinoprostone topical
Brand names: Cervidil, Prepidil, Prostin E2
Drug class: Uterotonic agents

Medically reviewed by  A Ras MD.

What is Cervidil?

Cervidil is a prescription medicine that is used to get your cervix ready for childbirth. Cervidil may be given to you for other reasons.

Description

CERVIDIL (dinoprostone) vaginal insert contains dinoprostone, a prostaglandin analog. Each vaginal insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer (hydrogel polymer) that is semi-opaque, beige colored, flat, rectangular in shape with rounded corners and measuring 29 mm by 9.5 mm by 0.8 mm. The vaginal insert is contained within a pouch of an off-white knitted polyester yarn retrieval system. When placed in a moist environment, the yarn absorbs water, swells, and releases the enclosed dinoprostone. The knitted polyester retrieval system has a long tape-like end that is designed to aid retrieval of CERVIDIL at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled-release formulation that has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg per hour.

The chemical name for dinoprostone (known as prostaglandin E2 or PGE2) is 11α,15S-dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural formula is represented below:

Chemical Structure

The molecular formula is C20H32O5 and its molecular weight is 352.47. Dinoprostone occurs as a white to off-white crystalline powder. It has a melting point within the range of 65° to 69°C. Dinoprostone is soluble in ethanol and in 25% ethanol in water.

Mechanism of Action

Dinoprostone is found in low concentrations in most tissues of the body and functions as a local hormone. In pregnancy, dinoprostone is secreted continuously by the fetal membranes and placenta and plays an important role in the final events leading to the initiation of labor including cervical ripening. Dinoprostone stimulates the production of prostaglandin F2α (PGF2α), which sensitizes the myometrium to endogenous or exogenously administered oxytocin. Available evidence indicates that dinoprostone, in the concentrations found during the early part of labor, plays an important role in cervical ripening without affecting uterine contractions.

In most patients, local effects of CERVIDIL on the cervix include changes in the tissue consistency, dilatation and effacement. Some women experience systemic effects, including uterine tachysystole, and uterine hypersystole/hypertonicity, as a result dinoprostone or PGF mediated sensitization of the myometrium to oxytocin

Before taking Cervidil, tell your doctor:

  • If you are allergic to Cervidil; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have any of these health problems: Heart disease, kidney disease, liver disease, lung disease, or pelvic inflammatory disease.
  • If you have had any of these health problems: A C-section (cesarean section), uterine surgery, unexplained vaginal bleeding during this pregnancy, hard labor, tough delivery, or more than 6 pregnancies that have gone full term or the baby’s head did not deliver first.
  • If you have genital herpes.
  • If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cervidil with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Cervidil?

  • Tell all of your health care providers that you take Cervidil. This includes your doctors, nurses, pharmacists, and dentists.
  • Allergic reactions have happened with Cervidil. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Uterine rupture has happened with some forms of Cervidil. Some people have needed to have their uterus removed. When Cervidil has been used to help with childbirth, uterine rupture has led to loss of the unborn baby or newborn. Talk with your doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Cervidil best taken?

Use Cervidil as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given into the vagina or cervix.
  • After insert is put in, lie down for 2 hours.

What do I do if I miss a dose?

  • This medicine will be given on an as needed basis in a healthcare setting.

What are the side effects of Cervidil that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Very bad belly pain.

What are some other side effects of Cervidil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Diarrhea
  • Headache.
  • Fever or chills.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Cervidil?

  • If you need to store Cervidil at home, talk with your doctor, nurse, or pharmacist about how to store it.

 

Label

PRINCIPAL DISPLAY PANEL – 10 MG POUCH CARTON

  • NDC 55566-2800-1
  • Cervidil®DINOPROSTONE 10mg
  • VAGINAL INSERT
  • Contains: One Cervidil ® Vaginal Insert containing10 mg Dinoprostone in 241 mg hydrogel polymer

    (cross-linked polyethylene oxide/urethane)

    with polyester retrieval system.

    Store in a freezer:

    between -20°C and -10°C (-4°F and 14°F)

  • FERRINGPHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 10 mg Pouch Carton

SRC: NLM .