WARNINGS Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.
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warnings
WARNINGS Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. Dinoprostone does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by dinoprostone could exhibit transient life signs. Dinoprostone is not indicated if the fetus in utero has reached the stage of viability. Dinoprostone should not be considered a feticidal agent. Evidence from animal studies has suggested that certain prostaglandins may have some teratogenic potential. Therefore, any failed pregnancy termination with dinoprostone should be completed by some other means. PROSTIN E2 Vaginal Suppository should not be used for extemporaneous preparation of any other dosage form. Neither the PROSTIN E2 Vaginal Suppository, as dispensed nor any extemporaneous formulation made from the PROSTIN E2 Vaginal Suppository should be used for cervical ripening or other indication in the patient with term pregnancy. There have been post-marketing reports of serious and life-threatening hypersensitivity reactions including anaphylaxis and angioedema with PROSTIN E2 Vaginal Suppository (dinoprostone). Onset of these reported reactions occurred within minutes to hours after initiation with PROSTIN E2 Vaginal Suppository (dinoprostone). If a hypersensitivity reaction is suspected, if possible remove PROSTIN E2 Vaginal Suppository (dinoprostone), assess for other potential causes of the event, and institute symptomatic and supportive therapy, as needed.
ADVERSE REACTIONS 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).
adverse reactions table
<table styleCode="Noautorules" width="75%"><col width="7%"/><col width="36%"/><col width="30%"/><tbody><tr><td valign="top"/><td valign="top"><paragraph>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</paragraph></td><td valign="top"><paragraph>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</paragraph></td></tr></tbody></table>