Cervidil

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Cervidil is a prescription medication used to soften and dilate the cervix (known medically as cervical ripening) for the induction of labor in pregnant women who are at or near term. This medication is a synthetic version of prostaglandin E2, a naturally occuring hormone important for preparing the cervix during labor.

Cervidil comes as a vaginal insert that is inserted into the vagina. It is administered by a healthcare professional.

Common side effects include strong uterine contractions, headache, and nausea.

Cervidil is a prescription medication used to soften and dilate the cervix (known medically as cervical ripening) for the induction of labor in pregnant women who are at or near term.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Cervidil is well tolerated by most patients, but side effects can occur including strong or frequent uterine contractions. In addition, Cervidil can cause headache, nausea, vomiting, and back pain.

Other side effects may occur. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (or history of)—Dinoprostone, when used in doses that stimulate the uterus to contract, may result in loss of blood in some patients that may require a blood transfusion

• Asthma (or history of, including childhood asthma) or
• Lung disease—Dinoprostone may cause narrowing of the blood vessels in the lungs or narrowing of the lung passages, especially when it is used in doses that stimulate the uterus to contract

• Epilepsy (or history of)—Rarely, seizures have occurred with dinoprostone when it is used in doses that stimulate the uterus to contract

• Glaucoma—Rarely, the pressure within the eye has increased and constriction of the pupils has occurred during the use of medicines like dinoprostone; this may also be a problem with dinoprostone when it is used in doses that stimulate the uterus to contract

• Heart or blood vessel disease (or history of) or
• High blood pressure (or history of) or
• Low blood pressure (history of)—Dinoprostone may cause changes in heart function or blood pressure changes; two patients with a history of heart disease had heart attacks when dinoprostone was used in doses that stimulated the uterus to contract

• Kidney disease (or history of) or
• Liver disease (or history of)—The body may not remove dinoprostone from the blood stream at the usual rate, which may make the dinoprostone work longer or cause an increased chance of side effects, especially when dinoprostone is used in doses that stimulate the uterus to contract

• Problems during delivery, history of or
• Surgery of uterus (history of) or
• Unusual vaginal bleeding—There is an increased risk of problems occurring with dinoprostone when it is used in doses that stimulate the uterus to contract

• Tell all of your health care providers that you take this medicine. 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 this medicine. 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.

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

Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor.

Cervidil is contraindicated in:

• Patients with known hypersensitivity to prostaglandins.
• Patients in whom there is clinical suspicion or definite evidence of fetal distress where delivery is not imminent.
• Patients with unexplained vaginal bleeding during this pregnancy.
• Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion.
• Patients in whom oxytocic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery (see PRECAUTIONS and ADVERSE REACTIONS).
• Patients already receiving intravenous oxytocic drugs.
• Multipara with 6 or more previous term pregnancies.

Cervidil is used as a single dosage in a single application. Overdosage is usually manifested by uterine hyperstimulation which may be accompanied by fetal distress, and is usually responsive to removal of the insert. Other treatment must be symptomatic since, to date, clinical experience with prostaglandin antagonists is insufficient.

The use of beta-adrenergic agents should be considered in the event of undesirable increased uterine activity.

NDC 55566-2800-1

Cervidil®
DINOPROSTONE 10mg

VAGINAL INSERT

Contains: One Cervidil® Vaginal Insert containing
10 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)

FERRING
PHARMACEUTICALS

Applies to dinoprostone topical: vaginal gel, vaginal insert, vaginal suppository

Gastrointestinal

Uncommon (0.1% to 1%): Nausea, vomiting, diarrhea, abdominal pain[Ref]

Other

Very common (10% or more): Any fetal heart rate abnormality
Frequency not reported: Hearing impairment, neonatal distress, neonatal death, stillbirths, low Apgar score[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, bradycardia
Frequency not reported: Flushing or hot flashes, chest pain, cardiac arrhythmia[Ref]

Nervous system

Uncommon (0.1% to 1%): Fever
Frequency not reported: Headache, dizziness, weakness, tremor, paresthesia[Ref]

Hematologic

Rare (0.01% to 0.1%): Postpartum disseminated intravascular coagulation
Frequency not reported: Elevated WBC[Ref]

Metabolic

Frequency not reported: Dehydration[Ref]

Musculoskeletal

Frequency not reported: Back pain, joint inflammation or pain new or exacerbated, muscle cramp or pain, nocturnal leg cramps[Ref]

Respiratory

Frequency not reported: Dyspnea, coughing, pharyngitis, laryngitis, wheezing, tightness in chest, pharyngitis, laryngitis[Ref]

Dermatologic

Frequency not reported: Rash, diaphoresis, skin discoloration[Ref]

Ocular

Frequency not reported: Blurred vision, eye pain[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reactions (including anaphylactic shock)[Ref]

Genitourinary

Common (1% to 10%): Uterine hyperstimulation (with or without fetal distress), fetal distress without uterine hyperstimulation, warm feeling in vagina
Frequency not reported: Uterine hypertonus, uterine rupture, placenta abruptio, rapid cervical dilatation, vaginal pain, vaginal irritation, vaginitis or vulvitis, breast tenderness, vaginismus, genital edema, transient vasovagal symptoms (flushing, shivering, headache, dizziness)[Ref]

Psychiatric

Frequency not reported: Tension[Ref]

Some side effects of Cervidil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.