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carboprost tromethamine (Hemabate)

 

Classes: Prostaglandins, Endocrine; Abortifacient

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