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The adverse effects of HEMABATE (carboprost tromethamine) Sterile Solution 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 HEMABATE (carboprost tromethamine) .
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 HEMABATE (carboprost tromethamine) for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include:
|Flushing or hot flashes||Dyspnea|
|Chills or shivering||Tightness in chest|
|Headaches||Posterior cervical perforation|
|Muscular pain||Excessive thirst|
|Breast tenderness||Twitching eyelids|
|Eye pain||Gagging, retching|
|Dystonia||Sensation of choking|
|Injection site pain||Syncope|
|Vaso-vagal syndrome||Upper respiratory infection|
|Dryness of mouth||Leg cramps|
|Taste alterations||Retained placental fragment|
|Urinary tract infection||Shortness of breath|
|Septic shock||Fullness of throat|
|Endometritis from IUCD|
The most common complications when HEMABATE (carboprost tromethamine) 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.
Read the Hemabate (carboprost tromethamine) Side Effects Center for a complete guide to possible side effects »
HEMABATE (carboprost tromethamine) may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.
Last reviewed on RxList: 5/7/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Hemabate Information
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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