you a various types [6)::<1% (Limited to important or life-threatening): Amnionitis, amniotic fluid embolism (anaphylactoid syndrome of pregnancy), disseminated intravascular coagulation (postpartum), hypersensitivity reaction (including anaphylaxis, anaphylactic shock, and anaphylactoid reaction), premature rupture of membranes, uterine rupture (with intracervical administration) Suppository: Frequency not defined: Cardiovascular: Cardiac arrhythmia, chest pain, chest tightness, hypotension, syncope Central nervous system: Chills, dizziness, headache, paresthesia, shivering, tension Dermatologic: Diaphoresis, skin discoloration, skin rash Endocrine & metabolic: Dehydration, hot flash Gastrointestinal: Diarrhea, endometritis, nausea, vomiting Genitourinary: Breast tenderness, urinary retention, uterine rupture, vaginal pain, vaginismus, vaginitis, vulvitis Neuromuscular & skeletal: Arthralgia, arthritis (new or exacerbated), back pain, leg cramps (nocturnal), muscle cramps, myalgia, neck stiffness, tremor, weakness Ophthalmic: Blurred vision, eye pain Otic: Auditory impairment Respiratory: Cough, dyspnea, laryngitis, pharyngitis, wheezing Miscellaneous: Fever> <1% (Limited to important or life-threatening): Myocardial infarction Tablets (oral) [Canadian product]: Frequency not always defined: Cardiovascular: Amniotic fluid embolism (pulmonary), cardiac arrest Central nervous system: Malaise (transient vasovagal symptoms) Gastrointestinal: Vomiting (with or without nausea/diarrhea: 21% to 50%; dose dependent) Genitourinary: Hypertonic uterine contractions (3%), cervical dilation (rapid), placental abruption, uterine contractions (abnormal), uterine rupture Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, anaphylactic shock, and nonimmunologic anaphylaxis [formerly known as anaphylactoid reaction]) Neuromuscular & skeletal: Back pain Respiratory: Asthma> <1% (Limited to important or life-threatening): Disseminated intravascular coagulation Vaginal gel [Canadian product]: Frequency not always defined: Cardiovascular: Cardiac arrest Central nervous system: Localized warm feeling (vagina) Gastrointestinal: Diarrhea, nausea, vomiting Genitourinary: Hypertonic uterine contractions (3%), uterine contractions (abnormal), uterine rupture Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, anaphylactic shock, and nonimmunologic anaphylaxis [formerly known as anaphylactoid reaction]) Neuromuscular & skeletal: Back pain Miscellaneous: Fever> <1% (Limited to important or life-threatening): Disseminated intravascular coagulation Vaginal insert: 1% to 10%: Genitourinary: Hypertonic uterine contractions ( without fetal distress 2% to 5%, with fetal distress 3%)> <1% (Limited to important or life-threatening): Amniotic fluid embolism (anaphylactoid syndrome of pregnancy), disseminated intravascular coagulation (postpartum), hypersensitivity reactions, hypotension, uterine rupture ALERT: U.S. Boxed Warning Appropriate use: Use dinoprostone, as with other potent oxytocic agents, only with strict adherence to recommended dosages. Experienced physician: Dinoprostone should be used by medically trained personnel in a hospital that can provide immediate intensive care and acute surgical facilities. Warnings/Precautions Concerns related to adverse effects: Anaphylactoid syndrome of pregnancy: Intracervical placement of endocervical gel, vaginal gel or vaginal insert may lead to anaphylactoid syndrome of pregnancy (rare). Disseminated intravascular coagulation (DIC): Postpartum DIC has been reported following dinoprostone for labor induction. Risk may be increased in women 30 years of age, gestation age> 40 weeks, or women with pregnancy complications. Hypersensitivity reactions: Serious life-threatening hypersensitivity reactions, including anaphylaxis and angioedema, have been noted. Onset of reactions may occur within minutes to hours following initiation of therapy. Disease related concerns: Cardiovascular disease: Use caution in patients with cardiovascular disease; manufacturer labeling for some dosage forms contraindicate use in active cardiovascular disease (refer to contraindications field). Epilepsy: Use with caution in patients with epilepsy. Glaucoma: Use caution in patients with glaucoma. Hepatic impairment: Use caution in patients with hepatic impairment; manufacturer labeling for some dosage forms (eg, suppository, tablet, vaginal gel) contraindicate use in active hepatic disease. Pulmonary disease: Use caution in patients with a history of asthma; manufacturer labeling for some dosage forms (eg, suppository, tablet, vaginal gel) contraindicate use with active pulmonary disease. Renal impairment: Use caution in patients with renal impairment; manufacturer labeling for some dosage forms (eg, suppository, tablet, vaginal gel) contraindicate use in active renal disease. Dosage form specific issues: Endocervical gel: Use caution with ruptured membranes. Suppository: When used for termination of pregnancy, dinoprostone is not considered feticidal, but is used to terminate pregnancy due to its ability to stimulate uterine contractions; do not use if fetus has reached the stage of viability. Transient pyrexia and decreased blood pressure may be observed with treatment. Use caution with history of hypotension or hypertension; cardiovascular disease; anemia; jaundice; diabetes; compromised uteri; cervicitis, endocervical infections or acute vaginitis. Measures should be taken to ensure complete abortion. Commercially available suppositories should not be used for extemporaneous preparation of any other dosage form of drug. Do not use for cervical ripening or other indications in patients with term pregnancy. Vaginal gel [Canadian product]: For intravaginal use only; not for intracervical use. Vaginal insert: Use caution with ruptured membranes; nonvertex or nonsingleton pregnancy or previous uterine hypertony. Must be removed prior to administration of oxytocin, in case of hyperstimulation or if labor begins, fetal distress, maternal distress (eg, hypotension, nausea, tachycardia, vomiting), and prior to amniotomy. Other warnings/precautions: Experienced personnel: [US Boxed Warning]: Dinoprostone should be used only by medically-trained personnel in a hospital with strict adherence to recommended doses. Monitoring Parameters Gel, insert: Fetal heart rate, uterine activity, progression of cervical dilation and effacement Tablet: Uterine activity; excessive uterine activity is contractions > 5 per 10 minutes and/or the internal tonus consistently > 15 mmHg. Suppository: Confirmation of fetal death Pregnancy Considerations Adverse events have been observed in animal reproduction studies. Although these effects would not be expected in humans when administered after the period of organogenesis, a sustained increase in uterine tone may have increased risks of adverse events to the fetus. Fetal distress without corresponding maternal uterine hyperstimulation was observed in 3% to 4% of infants exposed to Cervidil in utero . No adverse effects on physical or psychomotor function were observed in a 3 year follow-up study of exposed infants. Abnormal fetal heart rates were observed in 17% of infants exposed to Prepidil gel in utero . Deceleration, intrauterine fetal sepsis, fetal depression and fetal acidosis have also been reported with administration of the endocervical gel. Still births, abnormal fetal heart rate and fetal distress have been reported with administration of Prostin E 2 vaginal gel and oral tablets [Canadian product]. When used for termination of pregnancy, dinoprostone is not considered feticidal, but is used to terminate pregnancy due to its ability to stimulate uterine contractions; do not use if fetus has reached the stage of viability. A previable fetus may show transient life signs if aborted by dinoprostone. Failed pregnancy termination with dinoprostone should be completed by another method. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience diarrhea, headache, or chills. Have patient report immediately to prescriber severe dizziness, passing out, bruising, bleeding, severe nausea, vomiting, or severe abdominal pain (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about dinoprostone topical Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 6 Reviews Add your own review/rating Drug class: uterotonic agents Consumer resources Dinoprostone topical ... +4 more Professional resources Dinoprostone (AHFS Monograph) Dinoprostone (FDA) Other brands: Cervidil , Prostin E2 , Prepidil Related treatment guides Labor Induction Abortion Trophoblastic Disease ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Dinoprostone topical Rating 6 User Reviews 3.8 /10 6 User Reviews 3.8 Rate it! Drug Class Uterotonic agents Related Drugs uterotonic agents oxytocin , Methergine , Pitocin , mifepristone , Hemabate , Cervidil Abortion misoprostol , Cytotec , oxytocin , Pitocin , mifepristone , Hemabate , Cervidil , carboprost , More... Labor Induction misoprostol , Cytotec , oxytocin , Pitocin , Cervidil , Prostin E2 , Syntocinon , Prepidil , More... Trophoblastic Disease methotrexate , Trexall , Cervidil , Prostin E2 , Cosmegen , dactinomycin , More...} } exercise session
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