HEMABATE- carboprost tromethamine injection, solution

Hemabate by

Drug Labeling and Warnings

Hemabate by is a Prescription medication manufactured, distributed, or labeled by Pharmacia & Upjohn Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Interactions

HEMABATE may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenic bioassay studies have not been conducted in animals with HEMABATE due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.

Pregnancy

Teratogenic Effects

Animal studies do not indicate that HEMABATE is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

  • 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:

    VomitingNervousness
    DiarrheaNosebleed
    NauseaSleep disorders
    Flushing or hot flashesDyspnea
    Chills or shiveringTightness in chest
    CoughingWheezing
    HeadachesPosterior cervical perforation
    EndometritisWeakness
    HiccoughDiaphoresis
    Dysmenorrhea-like painDizziness
    ParesthesiaBlurred vision
    BackacheEpigastric pain
    Muscular painExcessive thirst
    Breast tendernessTwitching eyelids
    Eye painGagging, retching
    DrowsinessDry throat
    DystoniaSensation of choking
    AsthmaThyroid storm
    Injection site painSyncope
    TinnitusPalpitations
    VertigoRash
    Vaso-vagal syndromeUpper respiratory infection
    Dryness of mouthLeg cramps
    HyperventilationPerforated uterus
    Respiratory distressAnxiety
    HematemesisChest pain
    Taste alterationsRetained placental fragment
    Urinary tract infectionShortness of breath
    Septic shockFullness of throat
    TorticollisUterine sacculation
    LethargyFaintness, light-headedness
    HypertensionUterine 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).

  • DOSAGE AND ADMINISTRATION

    1. Abortion and Indications 1–4

    An initial dose of 1 mL of HEMABATE Sterile Solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle with a tuberculin syringe. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response.

    An optional test dose of 100 micrograms (0.4 mL) may be administered initially. The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL).

    The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended.

    2. For Refractory Postpartum Uterine Bleeding

    An initial dose of 250 micrograms of HEMABATE Sterile Solution (1 mL of HEMABATE) is to be given deep, intramuscularly. In clinical trials it was found that the majority of successful cases (73%) responded to single injections. In some selected cases, however, multiple dosing at intervals of 15 to 90 minutes was carried out with successful outcome. The need for additional injections and the interval at which these should be given can be determined only by the attending physicians as dictated by the course of clinical events. The total dose of HEMABATE should not exceed 2 milligrams (8 doses).

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • HOW SUPPLIED

    HEMABATE Sterile Solution is available in the following packages:

    1 mL ampoules NDC: 0009-0856-05
    10 × 1 mL ampoules NDC: 0009-0856-08

    Each mL of HEMABATE contains carboprost tromethamine equivalent to 250 mcg of carboprost.

    HEMABATE must be refrigerated at 2° to 8° C (36° to 46° F).

  • SPL UNCLASSIFIED SECTION

    This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

    Rx only

    Logo

    LAB-0032-7.0
    April 2017

  • PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label

    1 mL

    NDC: 0009-0856-05
    Rx only

    Hemabate®
    carboprost tromethamine
    injection, USP

    250 mcg*

    FOR INTRAMUSCULAR USE ONLY
    Refrigerate at 2° to 8°C (36° to 46°F).
    DOSAGE AND USE:
    See accompanying
    prescribing information.
    * Equivalent to 250 mcg carboprost.
    Distributed by Pharmacia & Upjohn Co
    Division of Pfizer Inc, NY, NY 10017

    PAA093951

    LOT
    EXP

    PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label
  • PRINCIPAL DISPLAY PANEL - 10 Single-Dose Ampoule Carton

    NDC: 0009-0856-08
    Contains 10 of NDC: 0009-0856-05

    Rx only

    10–1 mL Single-Dose Ampoules

    Hemabate®
    carboprost tromethamine
    injection, USP

    250 mcg*

    FOR INTRAMUSCULAR USE ONLY

    Pfizer Injectables

    Principal Display Panel - 10 Single-Dose Ampoule Carton
  • INGREDIENTS AND APPEARANCE
    HEMABATE 
    carboprost tromethamine injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0009-0856
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOPROST TROMETHAMINE (UNII: U4526F86FJ) (CARBOPROST - UNII:7B5032XT6O) CARBOPROST250 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROMETHAMINE (UNII: 023C2WHX2V) 83 ug  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0009-0856-051 mL in 1 AMPULE; Type 0: Not a Combination Product01/09/1979
    2NDC: 0009-0856-0810 in 1 PACKAGE01/09/1979
    2NDC: 0009-0856-051 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01798901/09/1979
    Labeler - Pharmacia and Upjohn Company LLC (618054084)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia and Upjohn Company LLC618054084ANALYSIS(0009-0856) , API MANUFACTURE(0009-0856) , MANUFACTURE(0009-0856) , PACK(0009-0856)

  • Trademark Results [Hemabate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HEMABATE
    HEMABATE
    73755050 1549787 Live/Registered
    UPJOHN COMPANY, THE
    1988-09-28

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