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HEMABATE®Adverse Reactions (carboprost tromethamine)

ADVERSE REACTIONS

The adverse effects of HEMABATE 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.

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 for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include:

VomitingNervousness
DiarrheaNosebleed
NauseaSleep disorders
Flushing or hot flashesDyspnea
Chills or shiveringTightness in chest
CoughingWheezing
HeadachesPosterior cervical perforation
EndometritisWeakness
HiccoughDiaphoresis
Dysmenorrhea-like painDizziness
ParesthesiaBlurred vision
BackacheEpigastric pain
Muscular painExcessive thirst
Breast tendernessTwitching eyelids
Eye painGagging, retching
DrowsinessDry throat
DystoniaSensation of choking
AsthmaThyroid storm
Injection site painSyncope
TinnitusPalpitations
VertigoRash
Vaso-vagal syndromeUpper respiratory infection
Dryness of mouthLeg cramps
HyperventilationPerforated uterus
Respiratory distressAnxiety
HematemesisChest pain
Taste alterationsRetained placental fragment
Urinary tract infectionShortness of breath
Septic shockFullness of throat
TorticollisUterine sacculation
LethargyFaintness, light-headedness
HypertensionUterine rupture
Tachycardia
Pulmonary edema
Endometritis from IUCD

The most common complications when HEMABATE 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.

Post-marketing experience

Hypersensitivity reactions (e.g. Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction, Angioedema).

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