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:

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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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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