Rx Item-Hemabate 250 Mcg/Ml Amp 10X1Ml By Pfizer Pharma

HEMABATE- carboprost tromethamine injection, solution
Pharmacia and Upjohn Company

DESCRIPTION

HEMABATE Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2? in a solution suitable for intramuscular injection.

Carboprost tromethamine is the established name for the active ingredient in HEMABATE. Four other chemical names are:

(15S)-15-methyl prostaglandin F2? tromethamine salt
7-(3?,5?-dihydroxy-2�-[(3S)-3-hydroxy-3-methyl-trans -1-octenyl]-1?-cyclopentyl]-cis -5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol
(15S)-9?,11?,15-trihydroxy-15-methylprosta-cis -5, trans -13-dienoic acid tromethamine salt
(15S)-15-methyl PGF2?-THAM


The structural formula is represented below:

Chemical Structure
(click image for full-size original)
The molecular formula is C25 H47 O8 N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95� and 105� C, depending on the rate of heating.

Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL.

Each mL of HEMABATE Sterile Solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.

CLINICAL PHARMACOLOGY

Carboprost tromethamine administered intramuscularly stimulates in the gravid uterus myometrial contractions similar to labor contractions at the end of a full term pregnancy. Whether or not these contractions result from a direct effect of carboprost on the myometrium has not been determined. Nonetheless, they evacuate the products of conception from the uterus in most cases.

RX ITEM-Hemabate 250 Mcg/Ml Amp 10X1Ml B
NDC 00009-0856-08 UPC/GTIN No.3-00090-85608-3 Mfg.Part No.1695

Hemabate 250 Mcg/Ml Amp 10X1Ml By Pfizer
BRAND: HEMABATE NDC: 00009-0856-08,9085608 UPC: 3-00090-85608-3,300090856083 Pfizer Pharmaceutical

CARBOPROST TROMETHAMINE I
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