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Carboprost tromethamine: Drug information

Carboprost tromethamine: Drug information
(For additional information see "Carboprost tromethamine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Appropriate use:

Carboprost should be used only with strict adherence to recommended dosages.

Experienced physician:

Carboprost should be used by medically trained personnel in a hospital that can provide immediate intensive care and acute surgical facilities.

Brand Names: US
  • Hemabate
Brand Names: Canada
  • Hemabate
Pharmacologic Category
  • Abortifacient;
  • Prostaglandin
Dosing: Adult
Refractory postpartum uterine bleeding

Refractory postpartum uterine bleeding: IM: Initial: 250 mcg; if needed, may repeat at 15- to 90-minute intervals; maximum total dose: 2 mg (8 doses)

Termination of pregnancy

Termination of pregnancy: IM: 250 mcg, then 250 mcg at 1.5- to 3.5-hour intervals, depending on uterine response; a 500 mcg dose may be given if uterine response is not adequate after several 250 mcg doses; do not exceed 12 mg total dose or continuous administration for >2 days. Note: A 100 mcg test dose may be considered.

Dosing: Kidney Impairment: Adult

Use with caution in patients with a history of renal disease; use is contraindicated in patients with active renal impairment.

Dosing: Hepatic Impairment: Adult

Use with caution in patients with a history of hepatic disease; use is contraindicated in patients with active hepatic impairment.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not always defined. Effects due to increased smooth muscle contractility are most common and are generally transient and reversible upon discontinuation of therapy.

Cardiovascular: Chest pain, chest tightness, flushing, hypertension, palpitations, septic shock syncope, tachycardia, vasodepressor syncope

Central nervous system: Anxiety, chills, choking sensation, disturbed sleep, dizziness, drowsiness, dystonia, headache, increased body temperature (may be drug-induced or due to postabortion endometritis), lethargy, nervousness, paresthesia, shivering, vertigo

Dermatologic: Diaphoresis, skin rash

Endocrine & metabolic: Hot flash, increased thirst, thyroid storm

Gastrointestinal: Diarrhea (approximately 67%), vomiting (approximately 67%), nausea (approximately 33%), dysgeusia, epigastric pain, gag reflex, hematemesis, hiccups, retching, xerostomia

Genitourinary: Breast tenderness, cervical perforation (posterior), endometritis (from intrauterine device [IUD]), gynecological pain (dysmenorrhea-like pain), retained placenta (fragment), urinary tract infection, uterine perforation, uterine rupture, sacculation of uterus, uterine hemorrhage

Local: Pain at injection site

Neuromuscular & skeletal: Back pain, leg cramps, myalgia, torticollis, weakness

Ophthalmic: Blepharospasm, blurred vision, eye pain

Otic: Tinnitus

Respiratory: Asthma, bronchospasm, cough, dry throat, dyspnea, epistaxis, hyperventilation, pulmonary edema, respiratory distress, throat irritation (fullness of throat), upper respiratory tract infection, wheezing

<1%, postmarketing, and/or case reports: Hypersensitivity reaction (includes anaphylactic shock, anaphylactoid reaction, anaphylaxis, angioedema)

Contraindications

Hypersensitivity to carboprost tromethamine or any component of the formulation; acute pelvic inflammatory disease; active cardiac, pulmonary, renal, or hepatic disease.

Warnings/Precautions

Concerns related to adverse effects:

• Fever: Transient fever may be observed with treatment and is believed to be due to carboprost’s effect on hypothalamic thermoregulation; use caution to distinguish between fever induced by the drug and fever associated with postabortion endometritis.

• Gastrointestinal effects: Pretreatment or concomitant use of antiemetic and antidiarrheal agents is recommended to decrease the incidence of gastrointestinal effects.

• Hypertension: Increased blood pressure may be observed with treatment; degree of hypertension observed is generally moderate and does not require treatment.

Disease-related concerns:

• Anemia: Use with caution in patients with anemia.

• Asthma: Use with caution in patients with a history of asthma; therapy may cause transient bronchoconstriction.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease, including hypotension or hypertension.

• Compromised uteri: Use oxytocic agents with caution in patients with compromised (scarred) uterus.

• Diabetes: Use with caution in patients with diabetes mellitus.

• Hepatic impairment: Use with caution in patients with hepatic disease, including jaundice.

• Renal impairment: Use with caution in patients with renal disease.

• Seizures: Use with caution in patients with a history of seizure disorder.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• Potent oxytocic agent: [US Boxed Warning] Potent oxytocic agent; use only with strict adherence to recommended dosing. Carboprost should be used only by medically-trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intramuscular [strength expressed as base]:

Hemabate: 250 mcg/mL (1 mL) [contains benzyl alcohol]

Generic: 250 mcg/mL (1 mL)

Solution Prefilled Syringe, Intramuscular:

Generic: 250 mcg/mL (1 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Carboprost Tromethamine Intramuscular)

250 mcg/mL (per mL): $158.40 - $382.79

Solution (Hemabate Intramuscular)

250 mcg/mL (per mL): $168.00

Solution Prefilled Syringe (Carboprost Tromethamine Intramuscular)

250 mcg/mL (per mL): $150.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intramuscular [strength expressed as base]:

Hemabate: 250 mcg/mL (1 mL) [contains benzyl alcohol]

Generic: 250 mcg/mL (1 mL)

Administration: Adult

IM: Administer deep IM (use a tuberculin syringe for termination of pregnancy); rotate site if repeat injections are required. Do not inject IV

Hazardous Drugs Handling Considerations

This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Carboprost may cause reproductive toxicity and has a structural/toxicity profile similar to existing hazardous agents.

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. Double gloving and a protective gown are recommended for IM administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Use: Labeled Indications

Termination of pregnancy: For aborting pregnancy between week 13 and 20 of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: Failure of expulsion of the fetus during the course of treatment by another method; premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.

Refractory postpartum uterine hemorrhage: Treatment of postpartum hemorrhage due to uterine atony that has not responded to conventional methods of management. Prior treatment should include the use of intravenously (IV) administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Oxytocic Agents: Carboprost Tromethamine may enhance the adverse/toxic effect of Oxytocic Agents. Specifically, oxytocic effects may be enhanced. Risk X: Avoid combination

Pregnancy Considerations

When used for termination of pregnancy, carboprost is not considered feticidal, but is used to terminate pregnancy due to its ability to stimulate uterine contractions; use is not indicated if the fetus has reached a stage of viability in utero. Complete termination of pregnancy may not be induced in ~20% of cases and should therefore be completed in another way.

Breastfeeding Considerations

It is not known if carboprost is excreted in breast milk.

Monitoring Parameters

Termination of pregnancy: Confirmation of fetal death; cervical exam after termination of pregnancy

Mechanism of Action

Carboprost is an analog of naturally occurring prostaglandin F2 alpha (dinoprost); carboprost stimulates uterine contractility which usually results in expulsion of the products of conception and is used to induce abortion between 13-20 weeks of pregnancy. When used postpartum, hemostasis at the placentation site is achieved through the myometrial contractions produced by carboprost.

Pharmacokinetics (Adult Data Unless Noted)

Time to peak, serum: IM: 30 minutes

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Hemabate;
  • (CN) China: An lie ke | Hemabate;
  • (CZ) Czech Republic: Prostin 15m;
  • (GB) United Kingdom: Hemabate;
  • (HK) Hong Kong: Hemabate;
  • (IN) India: Caboprost | Deviprost | Evacarb | Femiprost;
  • (KE) Kenya: Endoprost;
  • (KW) Kuwait: Hemabate;
  • (LB) Lebanon: Prostin 15m;
  • (NL) Netherlands: Prostin 15m;
  • (NO) Norway: Prostin 15M orifarm;
  • (NZ) New Zealand: Prostin 15m;
  • (PH) Philippines: Endoprost | Evacarb | Evaprost | Prostodin;
  • (PL) Poland: Prostinfenem;
  • (PR) Puerto Rico: Carboprost tromethamine | Hemabate;
  • (SA) Saudi Arabia: Hemabate;
  • (SG) Singapore: Hemabate;
  • (SI) Slovenia: Karboprost | Questran;
  • (TH) Thailand: Hemabate;
  • (TW) Taiwan: Hemabate;
  • (UG) Uganda: Endoprost
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 40-NF 35). Rockville, MD: United States Pharmacopeia Convention; 2017:83-102.
  2. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  3. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  4. Hemabate (carboprost tromethamine injection) [prescribing information]. New York, NY: Pfizer; January 2022.
  5. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  6. Ippoliti C, Przepiorka D, Mehra R, et al, “Intravesicular Carboprost for the Treatment of Hemorrhagic Cystitis After Marrow Transplantation,” Urology, 1995, 46(6):811-5. [PubMed 7502421]
  7. Levine LA, Jarrard DF. Treatment of cyclophosphamide-induced hemorrhagic cystitis with intravesical carboprost tromethamine. J Urol. 1993;149(4):719-723. doi:10.1016/s0022-5347(17)36192-x [PubMed 8455230]
  8. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed February 9, 2018.
  9. West NJ, “Prevention and Treatment of Hemorrhagic Cystitis,” Pharmacotherapy, 1997, 17(4):696-706. [PubMed 9250547]
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