Carboprost Tromethamine

DAE Class; Rx

Common Brand Names; Hemabate

• Prostaglandins, Endocrine; 
• Abortifacient

Prostaglandin F2-alpha analogue; oxytocic; abortifacient and refractory postpartum uterine bleeding treatment; sales restricted to hospitals only.

Indicated for pregnancy termination. For pregnancy termination between weeks 13—20 gestation dated from the first day of the last menstrual period.

For second trimester pregnancy termination in women with intact intrauterine membranes.

For second trimester pregnancy termination when there is failure of expulsion of the fetus during the course of treatment by another method

For second trimester pregnancy termination with the premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity.

For the treatment of refractory hemorrhagic cystitis.

For the treatment of postpartum bleeding due to uterine atony that is unresponsive to conventional management.

Contraindications

Hypersensitivity

Acute pelvic inflammatory disease

Active cardiac, pulmonary, renal or hepatic disease

Effects due to increased smooth muscle contractility most common

Nausea (1/3 patients), Vomiting (~2/3 patients)

Diarrhea (~2/3 patients)

Nervousness

Epistaxis

Sleep disorder

Hyperthermia

Flushing

Asthma

Wheezing

Coughing

Chest pain

Flushing

Hypertension

Syncope

Palpation

Tachycardia

Chest tightness

Anxiety

Chills/shivering

Dizziness

Drowsiness

Dystonia

Faintness

Headache

Lethargy

Lightheadedness

Nervousness

Sleep disturbance

Temperature elevation

Vasovagal syndrome

Vertigo

Rash

Breast tenderness

Dysmenorrhea-like pain

Endometritis

Hot flashes

Thyroid storm

Gagging/retching

Drowsiness

Dry throat

Choking sensation

Thirst

Taste alterations

Perforated uterus

Posterior cervical perforation

Urinary tract infection

Uterine bleeding (excessive)

Uterine rupture

Uterine sacculation

Black Box Warning

Potent oxytocic agent; use strict aderence to recommended dosing

Only medically-trained personnel should administer the product in a hospital setting that can provide immediate care and acute surgical facilities

Cautions

History of glaucoma or raised IOP

Asthma, hypertension/hypotension, cardiovascular disease

Transient fever observed with treatment possibly as a result of carboprost’s effect on hypothalamic thermoregulation

Caution in patients with anemia, jaundice, renal impairment, hepatic impairment diabetes or epilepsy

To decrease GI side effects pretreatment or concomitant use with antiemetic and antidiarrheal agents recommended

Not for IV

Rare cases of cardiovascular collapse reported with prostaglandins

Pregnancy Category: C

Lactation: Excretion in milk unknown

Adults

Maximum dosage limits are indication specific. 12 mg IM total dose, up to a maximum recommended duration of 48 hours for pregnancy termination; 2 mg IM for postpartum bleeding.

Elderly

Safety and efficacy have not been established.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Carboprost Tromethamine