Dinoprostone

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Generic Name: Dinoprostone Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: Subcutaneous: X; Vaginal insert: Not assigned, Vaginal gel: C, Vaginal suppository: C

Uses

What is Dinoprostone used for?

Dinoprostone is used to cause an abortion during weeks 12-20 of pregnancy. It is also used up to week 28 of pregnancy to help vaginally remove any remaining material in the womb from a miscarriage/missed abortion. This medication causes the womb to contract and push out its contents, including the placenta and the fetus/unborn baby, whether living or not. Dinoprostone is a natural substance (prostaglandin) that your body makes in preparation for labor. It softens and widens the opening of the womb and increases contractions.

It is also used to treat a certain type of womb problem (benign hydatiform mole). This medication should not be used for cervical ripening or any other use in a pregnancy that is near the time of delivery.

How should I take Dinoprostone?

This drug is used vaginally. Allow the suppository to warm to room temperature and remove the foil before use. The suppository is inserted high in the vagina by a health care professional, and you must remain in a reclined or lying-down position for at least 10 minutes after insertion. More doses may be used every 3-5 hours until the desired effect occurs. Do not use for more than 48 hours.

This medication should only be used in a hospital setting with trained medical care available. You will be monitored for changes in your womb (e.g., water breaking, strong/long-lasting contractions). If the desired result has not occurred in 48 hours, or if the abortion is not complete, other treatment (e.g., surgical removal) may be needed. This medication may be used with a medication given by vein (oxytocin) to help strengthen the contractions. It is very important that all of the products of pregnancy are removed (e.g., fetal/unborn baby tissue, placenta) to prevent serious, rarely fatal problems such as severe infection and bleeding.

How do I store Dinoprostone?

Store in a freezer: between -20°C and -10°C. Dinoprostone Vaginal Insert is packed in foil and is stable when stored in a freezer for a period of three years. Vaginal inserts exposed to high humidity will absorb moisture from the air and thereby alter the release characteristics of dinoprostone. Once used, the vaginal insert should be discarded.

There may be different brands of Dinoprostone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Dinoprostone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Dinoprostone?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problem (e.g., uncontrolled asthma), current pelvic problem (active pelvic inflammatory disease), current heart disease (e.g., uncontrolled angina, recent heart attack), liver disease, kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, asthma, high or low blood pressure, diabetes, glaucoma, heart disease (e.g., angina, heart attack), infections in the vaginal/pelvic area (e.g., cervicitis, vaginal infection, genital herpes, pelvic inflammatory disease), seizure disorder, uterine surgery including previous cesarean section (c-section) birth, pelvic problems (e.g., womb scarring, fibroids, cervical stenosis).

This medication should not be used if the unborn baby is mature enough to survive outside the womb. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Dinoprostone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Dinoprostone. According to the US Food and Drug Administration (FDA), Dinoprostone is categorized as follow:

-Subcutaneous: X

-Vaginal insert: Not assigned

-Vaginal gel: C

-Vaginal suppository: C

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Dinoprostone?

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 38 degrees C) after the abortion. Fever may be a sign of a serious infection.

Tell your doctor right away 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Dinoprostone?

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other prostaglandins (e.g., misoprostol).

Dinoprostone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Dinoprostone?

Dinoprostone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Dinoprostone?

Dinoprostone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Dinoprostone.

What is the dose of Dinoprostone for an adult?

Usual Adult Dose for Labor Induction

VAGINAL INSERT:

-The dosage of the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour over a 12-hour period; the insert should be removed upon onset of active labor or 12 hours after insertion

-The manufacturer product information should be consulted for instructions relating to product preparation and proper insertion.

-Care should be taken to ensure the vaginal insert remains in place if the patient is ambulatory.

-Upon removal of the insert, it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient. The knitted polyester retrieval system should be visualized to confirm that it contains the slab. If the slab is not contained within the polyester retrieval system, a vaginal exam is recommended to remove the slab.

CERVICAL GEL:

-Vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. The 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced. The cervical gel should not be administered above the level of the internal os.

-This product should be handled carefully to prevent contact with skin. Hands should be washed thoroughly with soap and water after administration.

-The manufacturer product information should be consulted for instructions relating to product preparation and proper insertion.

-Following administration the patient should remain in the supine position for at least 15 to 30 minutes to minimize leakage from the cervical canal.

-If the desired response is obtained, the recommended interval before giving IV oxytocin is 6 to 12 hours.

-If there is no cervical/uterine response to the initial dose of the cervical gel, repeat dosing may be given. The recommended repeat dose is 0.5 mg with a dosing interval of 6 hours.

-The need for additional dosing and the interval should be determined by the attending physician based on the course of clinical events.

-The maximum recommended cumulative dose for a 24-hour period is 1.5 mg of this drug.

Use: For ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction

Usual Adult Dose for Abortion

VAGINAL SUPPOSITORY:

-A 20 mg suppository should be inserted high into the vagina; the patient should remain in the supine position for 10 minutes following insertion

-Additional intravaginal administration of each subsequent suppository should be at 3 to 5 hour intervals until abortion occurs. Within the recommended intervals administration time should be determined by abortifacient progress, uterine contractility response, and by patient tolerance.

-Continuous administration for more than 2 days is not recommended.

-The manufacturer product information should be consulted for instructions relating to product preparation and proper administration.

Uses:

-For the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period

-For evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period

-For the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole)

Usual Adult Dose for Trophoblastic Disease

VAGINAL SUPPOSITORY:

-A 20 mg suppository should be inserted high into the vagina; the patient should remain in the supine position for 10 minutes following insertion

-Additional intravaginal administration of each subsequent suppository should be at 3 to 5 hour intervals until abortion occurs. Within the recommended intervals administration time should be determined by abortifacient progress, uterine contractility response, and by patient tolerance.

-Continuous administration for more than 2 days is not recommended.

-The manufacturer product information should be consulted for instructions relating to product preparation and proper administration.

Uses:

-For the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period

-For evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period

-For the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole)

Renal Dose Adjustments

Cervical gel: Caution recommended

Vaginal suppository: Contraindicated

Liver Dose Adjustments

Cervical gel: Caution recommended

Vaginal suppository: Contraindicated

What is the dose of Dinoprostone for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Dinoprostone available?

Dinoprostone is available in the following dosage forms and strengths:

  • Vaginal suppository,
  • Vaginal gel,
  • Vaginal insert.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Dinoprostone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: November 6, 2018 | Last Modified: November 6, 2018

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