In the U.S.—

In Canada—

Other commonly used names are prostaglandin E₂; PGE₂.

• Abortifacient
• Antihemorrhagic, postabortion uterine bleeding
• Antihemorrhagic, postpartum uterine bleeding
• Oxytocic
• Prostaglandin

Dinoprostone ( dye-noe-PROST-one) works by causing the cervix to thin and dilate (open) and the uterus to contract (cramp) the way it does during labor.

Dinoprostone may also be used for other purposes as determined by your doctor.

Dinoprostone is to be administered only by or under the immediate care of your doctor. It is available in the following dosage forms:

Cervical
• Gel (U.S. and Canada)

Vaginal
• Gel (Canada)
• Suppositories (U.S.)
• System (U.S.)

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 dinoprostone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dinoprostone, misoprostol, oxytocin or other medicines that stimulate the uterus to contract.

Other 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. When you are receiving dinoprostone, it is especially important that your doctor knows if you are using any other vaginal prescription or nonprescription (over-the-counter [OTC]) medicine.

• 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

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 dinoprostone will be different for different patients. The following information includes only the average doses for dinoprostone. Your doctor will give you the dose of this medicine and follow your care in a hospital or other health care setting.

• 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.

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

Tell the health care professional 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 
  
  

Other side effects may occur that usually do not need medical attention. These side effects usually go away after the medicine is stopped. However, let the health care professional know if any of the following side effects continue or are bothersome:

• 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, which occur after the procedure is completed, that 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 above may also occur in some patients. If you notice any other effects, check with your health care professional.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, dinoprostone is used in certain patients with the following medical condition:

• Unusual increase in bleeding of the uterus after delivery (postpartum hemorrhage)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.