Dinoprostone (Vaginal)

Dinoprostone helps the cervix to become thinner and open up, and it causes the uterus to cramp like it does during labor.

Dinoprostone may also be used for other reasons as decided by your doctor.

Dinoprostone should only be given by your doctor or under their direct supervision.

In deciding to use a medicine, you and your doctor must consider the risks against the benefits. For this medicine, consider the following:

Allergies

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

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a risk of interaction. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while you are receiving this medicine. The following interactions have been chosen for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Ephedrine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

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

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

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

• Glaucoma—Rarely, eye pressure may increase and pupils may constrict during the use of medicines like dinoprostone; this could also happen with dinoprostone when 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 bloodstream at the usual rate, which may make dinoprostone work longer or increase the chance of side effects, especially when 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 a higher risk of problems arising with dinoprostone when used in doses that stimulate the uterus to contract.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Fast or slow heartbeat
• hives
• increased pain of the uterus
• pale, cool, blotchy skin on arms or legs
• pressing or painful feeling in chest
• shortness of breath
• swelling of face, inside the nose, and eyelids
• tightness in chest
• trouble in breathing
• weak or absent pulse in arms or legs
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach cramps
• diarrhea
• fever
• nausea
• vomiting

Less common or rare

• Chills or shivering
• constipation
• flushing
• headache
• swelling of the genital area (vulva)
• tender or mildly bloated abdomen or stomach

This procedure may still result in some effects that occur after the procedure is completed, which need medical attention. Check with your doctor if any of the following side effects occur:

• Chills or shivering (continuing)
• fever (continuing)
• foul-smelling vaginal discharge
• pain in lower abdomen
• unusual increase in bleeding of the uterus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Cervidil
• Prepidil
• Prostin E2

Available Dosage Forms:

• Gel/Jelly
• Insert, Extended Release

Therapeutic Class: Uterine Stimulant

Pharmacologic Class: Prostaglandin

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.