Carboprost Tromethamine


Long Grove Pharmaceuticals, Llc
Human Prescription Drug
NDC 81298-5010
Carboprost Tromethamine is a human prescription drug labeled by 'Long Grove Pharmaceuticals, Llc'. National Drug Code (NDC) number for Carboprost Tromethamine is 81298-5010. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Carboprost Tromethamine drug includes Carboprost Tromethamine - 250 ug/mL . The currest status of Carboprost Tromethamine drug is Active.

Drug Information:

Drug NDC: 81298-5010
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Carboprost Tromethamine
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Carboprost Tromethamine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Long Grove Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CARBOPROST TROMETHAMINE - 250 ug/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAMUSCULAR
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 15 Oct, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA214499
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Long Grove Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:238014
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:U4526F86FJ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Prostaglandin Analog [EPC]
Prostaglandins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
81298-5010-310 CARTON in 1 BOX (81298-5010-3) / 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) / 1 mL in 1 VIAL, SINGLE-DOSE15 Oct, 2022N/ANo
81298-5010-51 CARTON in 1 BOX (81298-5010-5) / 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) / 1 mL in 1 VIAL, SINGLE-DOSE12 Dec, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Carboprost tromethamine carboprost tromethamine carboprost tromethamine carboprost benzyl alcohol hydrochloric acid sodium chloride sodium hydroxide tromethamine

Drug Interactions:

Drug interactions carboprost tromethamine may augment the activity of other oxytocic agents. concomitant use with other oxytocic agents is not recommended.

Boxed Warning:

Warnings carboprost tromethamine injection sterile solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. carboprost tromethamine injection should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Indications and Usage:

Indications and usage carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks 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. carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage an
d, unless contraindicated, intramuscular ergot preparations. studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. in a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.

Warnings:

Carboprost tromethamine does not appear to directly affect the fetoplacental unit. therefore, the possibility does exist that the previable fetus aborted by carboprost tromethamine could exhibit transient life signs. carboprost tromethamine is not indicated if the fetus in utero has reached the stage of viability. carboprost tromethamine injection should not be considered a feticidal agent. evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. although these studies do not indicate that carboprost tromethamine injection is teratogenic, any pregnancy termination with carboprost tromethamine injection that fails should be completed by some other means. this product contains benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants.

General Precautions:

General animal studies lasting several weeks at high doses have shown that prostaglandins of the e and f series can induce proliferation of bone. such effects have also been noted in newborn infants who have received prostaglandin el during prolonged treatment. there is no evidence that short term administration of carboprost tromethamine injection sterile solution can cause similar bone effects. in patients with a history of asthma, hypo- or hypertension, cardiovascular, renal, or hepatic disease, anemia, jaundice, diabetes, or epilepsy, carboprost tromethamine injection should be used cautiously. as with any oxytocic agent, carboprost tromethamine injection should be used with caution in patients with compromised (scarred) uteri.

Dosage and Administration:

Dosage and administration 1. abortion and indications 1-4 an initial dose of 1 ml of carboprost tromethamine injection 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 1 1/2 to 3 1/2 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 carboprost tromethamine injection sterile solution (1 ml of carboprost tromethamine injection) is to be given deep, intramuscularl
y. in clinical trials it was found that the majority of successful cases (73%) responded to single injections. in some selected cases, however, multiple closing 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 carboprost tromethamine injection 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.

Contraindications:

Contraindications hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection sterile solution [see adverse reactions, postmarketing experience ] acute pelvic inflammatory disease patients with active cardiac, pulmonary, renal or hepatic disease

Adverse Reactions:

Adverse reactions the adverse effects of carboprost tromethamine injection 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 carboprost tromethamine. of those patients experiencing a temperature elevation, approximately one- sixteenth had a clinical diagnosis of endometritis. the remaining temperature elevations returned to normal within seve
ral hours after the last injection. adverse effects observed during the use of carboprost tromethamine injection for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include: vomiting diarrhea nausea flushing or hot flashes chills or shivering coughing headaches endometritis hiccough dysmenorrhea-like pain paresthesia backache muscular pain breast tenderness eye pain drowsiness dystonia asthma injection site pain tinnitus vertigo vaso-vagal syndrome dryness of mouth hyperventilation respiratory distress hematemesis taste alterations urinary tract infection septic shock torticollis lethargy hypertension tachycardia pulmonary edema endometritis from iucd nervousness nosebleed sleep disorders dyspnea tightness in chest wheezing posterior cervical perforation weakness diaphoresis dizziness blurred vision epigastric pain excessive thirst twitching eyelids gagging, retching dry throat sensation of choking thyroid storm syncope palpitations rash upper respiratory infection leg cramps perforated uterus anxiety chest pain retained placental fragment shortness of breath fullness of throat uterine sacculation faintness, light- headedness uterine rupture the most common complications when carboprost tromethamine injection 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).

Adverse Reactions Table:

Vomiting Diarrhea Nausea Flushing or hot flashes Chills or shivering Coughing Headaches Endometritis Hiccough Dysmenorrhea-like pain Paresthesia Backache Muscular pain Breast tenderness Eye pain Drowsiness Dystonia Asthma Injection site pain Tinnitus Vertigo Vaso-vagal syndrome Dryness of mouth Hyperventilation Respiratory distress Hematemesis Taste alterations Urinary tract infection Septic shock Torticollis Lethargy Hypertension Tachycardia Pulmonary edema Endometritis from IUCD Nervousness Nosebleed Sleep disorders Dyspnea Tightness in chest Wheezing Posterior cervical perforation Weakness Diaphoresis Dizziness Blurred vision Epigastric pain Excessive thirst Twitching eyelids Gagging, retching Dry throat Sensation of choking Thyroid storm Syncope Palpitations Rash Upper respiratory infection Leg cramps Perforated uterus Anxiety Chest pain Retained placental fragment Shortness of breath Fullness of throat Uterine sacculation Faintness, light- headedness Uterine rupture

Drug Interactions:

Drug interactions carboprost tromethamine may augment the activity of other oxytocic agents. concomitant use with other oxytocic agents is not recommended.

Use in Pregnancy:

Pregnancy teratogenic effects: animal studies do not indicate that carboprost tromethamine 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:

Pediatric use safety and effectiveness in pediatric patients have not been established.

Description:

Description carboprost tromethamine injection, usp, an oxytocic, contains the tromethamine salt of the (15s)-15 methyl analogue of naturally occurring prostaglandin f2α in a solution suitable for intramuscular injection. carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, usp. four other chemical names are: (15s)-15-methyl prostaglandin f2α tromethamine salt 7-(3α,5α-dihydroxy-2β-[(3s)-3-hydroxy-3-methyl-trans-1-octenyl]-1α cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)- 1,3-propanediol (15s)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt (15s)-15-methyl pgf2α-tham the structural formula is represented below: the molecular formula is c 25 h 47 o 8 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 carboprost tromethamine injection, usp 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. structural formula

Clinical Pharmacology:

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. postpartum, the resultant myometrial contractions provide hemostasis at the site of placentation. carboprost tromethamine also stimulates the smooth muscle of the human gastrointestinal tract. this activity may produce the vomiting or diarrhea or both that is common when carboprost tromethamine is used to terminate pregnancy and for use postpartum. in laboratory animals and also in humans carboprost tromethamine can elevate body temperature. with the clinical doses of carboprost tromethamine used for the termination of pregnancy, and for use postpartum, some patients do experience transient
temperature increases. in laboratory animals and in humans large doses of carboprost tromethamine can raise blood pressure, probably by contracting the vascular smooth muscle. with the doses of carboprost tromethamine used for terminating pregnancy, this effect has not been clinically significant. in laboratory animals and also in humans carboprost tromethamine can elevate body temperature. with the clinical doses of carboprost tromethamine used for the termination of pregnancy, some patients do experience temperature increases. in some patients, carboprost tromethamine may cause transient bronchoconstriction. drug plasma concentrations were determined by radioimmunoassay in peripheral blood samples collected by different investigators from 10 patients undergoing abortion. the patients had been injected intramuscularly with 250 micrograms of carboprost at two hour intervals. blood levels of drug peaked at an average of 2060 picograms/ml one-half hour after the first injection then declined to an average concentration of 770 picograms/ml two hours after the first injection just before the second injection. the average plasma concentration one-half hour after the second injection was slightly higher (2663 picograms/ ml) than that after the first injection and decreased again to an average of 1047 picograms/ml by two hours after the second injection. plasma samples were collected from 5 of these 10 patients following additional injections of the prostaglandin. the average peak concentrations of drug were slightly higher following each successive injection of the prostaglandin, but always decreased to levels less than the preceding peak values by two hours after each injection. five women who had delivery spontaneously at term were treated immediately postpartum with a single injection of 250 micrograms of carboprost tromethamine. peripheral blood samples were collected at several times during the four hours following treatment and carboprost tromethamine levels were determined by radioimmunoassay. the highest concentration of carboprost tromethamine was observed at 15 minutes in two patients (3009 and 2916 picograms/ml), at 30 minutes in two patients (3097 and 2792 picograms/ml), and at 60 minutes in one patient (2718 picograms/ml).

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility carcinogenic bioassay studies have not been conducted in animals with carboprost tromethamine 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.

How Supplied:

How supplied carboprost tromethamine injection, usp is available in the following packages: 1 ml single dose vial ndc 81298-5010-5 10 x 1 ml single dose vial ndc 81298-5010-3 each ml of carboprost tromethamine injection contains carboprost tromethamine equivalent to 250 mcg of carboprost. carboprost tromethamine injection must be refrigerated at 2° to 8° c (36° to 46° f). rx only manufactured by pharmascience inc. canada for long grove pharmaceuticals, llc rosemont, il 60018 usa 1-855-642-2594 42362 october 2022

Package Label Principal Display Panel:

Principal display panel - 1 ml carton label ndc 81298-5010-3 contains 10 of ndc 81298-5010-1 rx only carboprost tromethamine injection, usp 250 mcg*/ml for intramuscular use only 10 x 1 ml single-dose vials long grove pharmaceuticals™ principal display panel - 1 ml carton label

Principal display panel - 1 ml vial label rx only ndc: 81298-5010-1 carboprost tromethamine injection, usp 250 mcg*/ml for intramuscular use only principal display panel - 1 ml vial label


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