June 28, 2016
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Prostin E2

"Short-term (usually less than 48 hours) use of magnesium sulfate in obstetric care is appropriate for certain conditions and durations of treatment, according to a committee opinion from the American College of Obstetricians and Gynecologists and"...

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Prostin E2




Prostin E2 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/12/2016

Prostin E2 (dinoprostone) Vaginal Suppository is a hormone-like substance (prostaglandin) that the body makes in preparation for labor used in a pregnant woman to relax the muscles of the cervix (opening of the uterus) in preparation for inducing labor at the end of a pregnancy. Common side effects of Prostin E2 Vaginal Suppository include:

  • nausea
  • vomiting
  • diarrhea
  • fever
  • chills
  • stomach or abdominal pain
  • back pain
  • flushing (warmth, redness, or tingly feeling)
  • dizziness, and
  • feeling of warmth in the vaginal area

A suppository containing 20 mg of dinoprostone should be inserted high into the vagina. The patient should remain in the supine position for ten minutes following insertion. Other drugs may interact with Prostin E2. Tell your doctor all medications and supplements you use. Before using Prostin E2 during pregnancy, discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Prostin E2 (dinoprostone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Prostin E2 in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if your contractions slow down or become uneven, or if you have:

  • fever;
  • sudden vaginal bleeding;
  • cough, wheezing, chest tightness, trouble breathing; or
  • pale skin, blue colored lips.

After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, such as:

  • weakness or fainting;
  • unusual bleeding from your nose, mouth, vagina, or rectum;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • unusual bruising, purple or red pinpoint spots under your skin;
  • bleeding from a wound, surgical incision, or vein where an IV was placed;
  • any bleeding that will not stop.

Less serious side effects may include:

  • nausea, stomach pain;
  • back pain; or
  • feeling of warmth in the vaginal area.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prostin E2 (Dinoprostone Vaginal Suppository)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Prostin E2 Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, fever, chills, abdominal pain, flushing, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Most women will experience a fever 15-45 minutes after the suppository is inserted. Sponge baths and drinking lots of fluids may help lower the fever. Aspirin will not usually lower the fever. The fever usually goes away within 6 hours after the last dose. Seek immediate medical attention if you have a high fever (e.g., higher than 101 degrees F or 38 degrees C) after the abortion. Fever may be a sign of a serious infection.

Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, strong contractions that are very close together (uterine overstimulation), severe abdominal pain.

Seek immediate medical attention if this rare but very serious side effect occurs: chest pain.

This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Your doctor will be monitoring you for signs of uterine overstimulation.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Prostin E2 (Dinoprostone Vaginal Suppository)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prostin E2 FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequent adverse reactions observed with the use of dinoprostone for abortion are related to its contractile effect on smooth muscle.

In the patients studied, approximately two-thirds experienced vomiting, one-half temperature elevations, two-fifths diarrhea, one-third some nausea, one-tenth headache, and one-tenth shivering and chills.

In addition, approximately one-tenth of the patients studied exhibited transient diastolic blood pressure decreases of greater than 20 mmHg.

Two cases of myocardial infarction following the use of dinoprostone have been reported in patients with a history of cardiovascular disease.

It is not known whether these events were related to the administration of dinoprostone.

Adverse effects in decreasing order of their frequency, observed with the use of dinoprostone, not all of which are clearly drug related include:

Vomiting
Diarrhea
Nausea
Fever
Headache
Chills or shivering
Backache
Joint inflammation or pain new or exacerbated
Flushing or hot flashes
Dizziness
Arthralgia
Vaginal pain
Chest pain
Dyspnea
Endometritis
Syncope or fainting sensation
Vaginitis or vulvitis
Weakness
Muscular cramp or pain
Tightness in chest
Nocturnal leg cramps
Uterine rupture
Breast tenderness
Blurred vision
Coughing
Rash
Myalgia
Stiff neck
Dehydration
Tremor
Paresthesia
Hearing impairment
Urine retention
Pharyngitis
Laryngitis
Diaphoresis
Eye pain
Wheezing
Cardiac arrhythmia
Skin discoloration
Vaginismus
Tension

Post-Marketing Surveillance

Immune system disorders: Hypersensitivity reactions (e.g., Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction).

Read the entire FDA prescribing information for Prostin E2 (Dinoprostone Vaginal Suppository)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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