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HEMABATE® (carboprost trometamol) Adverse Reactions

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:

Vomiting Nervousness
Diarrhea Nosebleed
Nausea Sleep disorders
Flushing or hot flashes Dyspnea
Chills or shivering Tightness in chest
Coughing Wheezing
Headaches Posterior cervical perforation
Endometritis Weakness
Hiccough Diaphoresis
Dysmenorrhea-like pain Dizziness
Paresthesia Blurred vision
Backache Epigastric pain
Muscular pain Excessive thirst
Breast tenderness Twitching eyelids
Eye pain Gagging, retching
Drowsiness Dry throat
Dystonia Sensation of choking
Asthma Thyroid storm
Injection site pain Syncope
Tinnitus Palpitations
Vertigo Rash
Vaso-vagal syndrome Upper respiratory infection
Dryness of mouth Leg cramps
Hyperventilation Perforated uterus
Respiratory distress Anxiety
Hematemesis Chest pain
Taste alterations Retained placental fragment
Urinary tract infection Shortness of breath
Septic shock Fullness of throat
Torticollis Uterine sacculation
Lethargy Faintness, light-headedness
Hypertension Uterine 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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