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this medicine is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. this medicine is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of this medicine has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, this medicine used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.


1. Hypersensitivity to this medicine 2. Acute pelvic inflammatory disease 3. Patients with active cardiac, pulmonary, renal or hepatic disease this medicine does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by Hemabate could exhibit transient life signs. Hemabate is not indicated if the fetus in utero has reached the stage of viability. Hemabate should not be considered a feticidal agent. Evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. Although these studies do not indicate that Hemabate is teratogenic, any pregnancy termination with Hemabate that fails should be completed by some other means. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

Adverse reactions:

The adverse effects of this medicine are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle. In patients studied, approximately two-thirds experienced vomiting and diarrhea, approximately one-third had nausea, one-eighth had a temperature increase greater than 2° F, and one-fourteenth experienced flushing. The pretreatment or concurrent administration of antiemetic and antidiarrheal drugs decreases considerably the very high incidence of gastrointestinal effects common with all prostaglandins used for abortion. Their use should be considered an integral part of the management of patients undergoing abortion with this medicine. Of those patients experiencing a temperature elevation, approximately one-sixteenth had a clinical diagnosis of endometritis. The remaining temperature elevations returned to normal within several hours after the last injection. Adverse effects observed during the use of this medicine for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include: Vomiting Diarrhea Nausea Flushing or hot flashes Chills or shivering Coughing Headaches Endometritis Hiccough Dysmenorrhea-like pain Paresthesia Backache Muscular pain Breast tenderness Eye pain Drowsiness Dystonia Asthma Injection site pain Tinnitus Vertigo Vaso-vagal syndrome Dryness of mouth Hyperventilation Respiratory distress Hematemesis Taste alterations Urinary tract infection Septic shock Torticollis Lethargy Hypertension Tachycardia Pulmonary edema Endometritis from IUCD Nervousness Nosebleed Sleep disorders Dyspnea Tightness in chest Wheezing Posterior cervical perforation Weakness Diaphoresis Dizziness Blurred vision Epigastric pain Excessive thirst Twitching eyelids Gagging, retching Dry throat Sensation of choking Thyroid storm Syncope Palpitations Rash Upper respiratory infection Leg cramps Perforated uterus Anxiety Chest pain Retained placental fragment Shortness of breath Fullness of throat Uterine sacculation Faintness, light- headedness Uterine rupture The most common complications when this medicine was utilized for abortion requiring additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding, occurring in about one in every 50 patients.


Hemabate may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended


Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment. There is no evidence that short term administration of this medicine can cause similar bone effects. In patients with a history of asthma, hypo- or hypertension, cardiovascular, renal, or hepatic disease, anemia, jaundice, diabetes, or epilepsy, Hemabate should be used cautiously. As with any oxytocic agent, Hemabate should be used with caution in patients with compromised (scarred) uteri. Warnings this medicine , like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Hemabate should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.



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