Dosing and uses of Hemabate (carboprost tromethamine)
Adult dosage forms and strengths
injectable solution
- 250mcg/mL
Abortion
Initial: 250 mcg IM; THEN repeat PRN q1.5-3.5hr Or
An initial, optional test dose of 100 mcg IM; THEN increase dose to 500 mcg if response is inadequate with 250 mcg doses
No more than 1200 mcg total dose or 2 days of continuous administration
Refractory Postpartum Uterine Bleeding
Initial 250 mcg IM, repeat PRN q15-90min
No more than 2000 mcg or 8 doses
Pediatric dosage forms and strengths
Not applicable
Hemabate (carboprost tromethamine) adverse (side) effects
Frequency not defined
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
Local: injection site pain
Backache
Leg cramps
Muscular pain
Parethesia
Torticollis
Weakness
Blurred vision
Eye pain
Eyelid twitching
Tinnitus
Cough
Bronchospasm
Dyspnea
Hyperventilation
Pulmonary edema
Respiratory distress
Upper respiratory tract infection
Wheezing
Diaphoresis
Hiccups
Retained placental fragment
Septic shock
Warnings
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
Contraindications
Hypersensitivity
Acute pelvic inflammatory disease
Active cardiac, pulmonary, renal or hepatic disease
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 and lactation
Pregnancy category: C
Lactation: Excretion in milk unknown
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Hemabate (carboprost tromethamine)
Mechanism of action
Inhibits or stimulates smooth muscle contraction, which results in expulsion of the products of conception and is used to induce abortion between 13-20 weeks of pregnancy; inhibits release of norepinephrine or modulates its effects at neuroeffector sites
Pharmacokinetics
Peak plasma time: 20-30 min
Concentration: 1-1.6 ng/mL
Half-life: 3 hr
Protein bound: None
Excretion: Urine