Drugs Details

Drugs Info of Hemabate
Drugs Details
  • Drugs Type  : FDA
  • Date : 6th Jan 2015 06:53 am
  • Brand Name : Hemabate
  • Generic Name : carboprost (Pronunciation: KAR boe prost)
Descriptions

HEMABATE Sterile Solution, 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 HEMABATE. Four other chemical names are:

  1. (15S)-15-methyl prostaglandin F2α tromethamine salt
  2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α- cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol
  3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt
  4. (15S)-15-methyl PGF2α-THAM

The structural formula is represented below:

 

Hemabate® (carboprost tromethamine)  Structural Formula Illustration

The molecular formula is C25H47O8N. 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.

What are the possible side effects of carboprost (Hemabate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pelvic pain, cramping, or vaginal bleeding;
  • high fever;
  • feeling light-headed or short of breath;
  • severe nausea, vomiting, or diarrhea; or
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects...

Read All Potential Side Effects and See Pictures of Hemabate »

This monograph has been modified to include the generic and brand name in many instances.

Indications

HEMABATE Sterile Solution 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:

  1. Failure of expulsion of the fetus during the course of treatment by another method;
  2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;
  3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;
  4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.

HEMABATE 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 and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of HEMABATE 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, HEMABATE used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.

Dosage Administration

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.

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 x 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).

Distributed by: Pharmacia & Upjohn Co. Division of Pfizer Inc., New York, NY 10017. Revised January 2014

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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:

 

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

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).

Read the Hemabate (carboprost tromethamine) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

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

Read the Hemabate Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

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

HEMABATE does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by HEMABATE could exhibit transient life signs. HEMABATE is not indicated if the fetus in utero has reached the stage of viability. HEMABATE 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 HEMABATE is teratogenic, any pregnancy termination with HEMABATE 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.

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 E1 during prolonged treatment. There is no evidence that short term administration of HEMABATE 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, HEMABATE should be used cautiously.

As with any oxytocic agent, HEMABATE should be used with caution in patients with compromised (scarred) uteri.

Abortion

As with spontaneous abortion, a process which is sometimes incomplete, abortion induced by HEMABATE may be expected to be incomplete in about 20% of cases.

Although the incidence of cervical trauma is extremely small, the cervix should always be carefully examined immediately post-abortion.

Use of HEMABATE is associated with transient pyrexia that may be due to its effect on hypothalamic thermoregulation. Temperature elevations exceeding 2° F (1.1° C) were observed in approximately one-eighth of the patients who received the recommended dosage regimen. In all cases, temperature returned to normal when therapy ended. Differentiation of post-abortion endometritis from drug-induced temperature elevations is difficult, but with increasing clinical experience, the distinctions become more obvious and are summarized below:

 

Endometritis pyrexia Pyrexia induced by HEMABATE
1. Time of onset: Typically, on third post-abortional day (38° C or higher). Within 1 to 16 hours after the first injection.
2. Duration: Untreated pyrexia and infection continue and may give rise to other pelvic infections. Temperatures revert to pretreatment levels after discontinuation of therapy without any other treatment.
3. Retention: Products of conception are often retained in the cervical os or uterine cavity. Temperature elevation occurs whether or not tissue is retained.
4. Histology: Endometrium is infiltrated with lymphocytes and some areas are necrotic and hemorrhagic. Although the endometrial stroma may be edematous and vascular, it is not inflamed.
5. The uterus: Often remains boggy and soft with tenderness over the fundus, and pain on moving the cervix on bimanual examination. Uterine involution normal and uterus is not tender.
6. Discharge: Often associated with foulsmelling lochia and leukorrhea. Lochia normal.
7. Cervical culture: The culture of pathological organisms from the cervix or uterine cavity after abortion alone does not warrant the diagnosis of septic abortion in the absence of clinical evidence of sepsis. Pathogens have been cultured soon after abortion in patients with no infections. Persistent positive culture with clear clinical signs of infections are significant in the differential diagnosis.
8. Blood count: Leukocytosis and differential white cell counts do not distinguish between endometritis and hyperthermia caused by HEMABATE since total WBC’s may increase during infection and transient leukocytosis may also be drug-induced.

Fluids should be forced in patients with drug-induced fever and no clinical or bacteriological evidence of intrauterine infection. Any other simple empirical measures for temperature reduction are unnecessary because all fevers induced by HEMABATE have been transient or self-limiting.

Postpartum Hemorrhage

Increased blood pressure. In the postpartum hemorrhage series, 5/115 (4%) of patients had an increase of blood pressure reported as a side effect. The degree of hypertension was moderate and it is not certain as to whether this was in fact due to a direct effect of HEMABATE or a return to a status of pregnancy associated hypertension manifest by the correction of hypovolemic shock. In any event the cases reported did not require specific therapy for the elevated blood pressure.

Use in patients with chorioamnionitis. During the clinical trials with HEMABATE, chorioamnionitis was identified as a complication contributing to postpartum uterine atony and hemorrhage in 8/115 (7%) of cases, 3 of which failed to respond to HEMABATE. This complication during labor may have an inhibitory effect on the uterine response to HEMABATE similar to what has been reported for other oxytocic agents.1

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 - Pregnancy Category C

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.

REFERENCES

1Duff, Sanders, and Gibbs; The course of labor in term patients with chorioamnionitis; Am. J. Obstet. Gynecol.; vol. 147, no. 4, October 15, 1983 pp 391–395.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

  1. Hypersensitivity (including anaphylaxis and angioedema) to HEMABATE Sterile Solution [see ADVERSE REACTIONS, Post-marketing Experience]
  2. Acute pelvic inflammatory disease
  3. Patients with active cardiac, pulmonary, renal or hepatic disease

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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).

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Hemabate

Generic Name: carboprost (Pronunciation: KAR boe prost)

  • What is carboprost (Hemabate)?
  • What are the possible side effects of carboprost (Hemabate)?
  • What is the most important information I should know about carboprost (Hemabate)?
  • What should I discuss with my health care provider before receiving carboprost (Hemabate)?
  • How is carboprost given (Hemabate)?
  • What happens if I miss a dose (Hemabate)?
  • What happens if I overdose (Hemabate)?
  • What should I avoid while receiving carboprost (Hemabate)?
  • What other drugs will affect carboprost (Hemabate)?
  • Where can I get more information?

What is carboprost (Hemabate)?

Carboprost is a form of prostaglandin (a hormone-like substance that occurs naturally in the body). Prostaglandins help to control functions in the body such as blood pressure and muscle contractions.

Carboprost is used to treat severe bleeding after childbirth (postpartum).

Carboprost is also used to produce an abortion by causing uterine contractions. It is usually given between the 13th and 20th weeks of pregnancy, but may be given at other times for medical reasons. Carboprost is often used when another method of abortion has not completely emptied the uterus, or when a complication of pregnancy would cause the baby to be born too early to survive.

Carboprost may also be used for other purposes not listed in this medication guide.

What are the possible side effects of carboprost (Hemabate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pelvic pain, cramping, or vaginal bleeding;
  • high fever;
  • feeling light-headed or short of breath;
  • severe nausea, vomiting, or diarrhea; or
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects include:

  • mild fever that may come and go;
  • chills, numbness, or tingly feeling;
  • mild nausea or diarrhea;
  • cough;
  • headache;
  • breast pain or tenderness;
  • menstrual type pain; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Hemabate (carboprost tromethamine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about carboprost (Hemabate)?

Carboprost usually causes nausea, vomiting, and/or diarrhea. You may be given to control these things before you are given carboprost.

You should not receive this medication if you are allergic to carboprost, or have certain conditions such as pelvic inflammatory disease, a breathing disorder, heart disease, liver disease, or kidney disease.

Serious side effects of carboprost may include severe pelvic cramping, vaginal bleeding, high fever, and severe vomiting or diarrhea.

Before you receive carboprost, tell your doctor if you have been treated with any other drugs that may cause contractions of the uterus. Carboprost can increase the effects of these other drugs, and they should not be used together.

Your cervix (opening of the uterus) will need to be checked after you receive carboprost. Do not miss any scheduled follow-up visits to your doctor.

In some cases, carboprost may not produce a complete abortion and the procedure must be repeated.

Side Effects Centers
  • Hemabate

Patient Detailed How Take

What should I discuss with my health care provider before receiving carboprost (Hemabate)?

You should not receive this medication if you are allergic to carboprost, or have certain conditions. Tell your doctor if you have:

  • pelvic inflammatory disease;
  • a lung disorder or breathing problem;
  • heart disease;
  • kidney disease; or
  • liver disease.

Before receiving carboprost, tell your doctor if you are allergic to any drugs, or if you have:

  • high or low blood pressure;
  • diabetes;
  • epilepsy or other seizure disorder;
  • any scarring in your uterus;
  • a history of asthma; or
  • a history of heart, kidney, or liver disease.

If you have any of these conditions, you may not be able to receive carboprost, or you may need dosage adjustments or special tests during treatment.

If you are receiving this medication for purposes other than abortion or postpartum bleeding, tell your doctor if you are pregnant.

How is carboprost given (Hemabate)?

Carboprost is given as an injection into a muscle. You will receive this injection in a clinic or hospital setting.

You may also be given medication to control nausea, vomiting, or diarrhea caused by carboprost.

To be sure this medication has been effective, your cervix (opening of the uterus) will need to be checked after the procedure. Do not miss any scheduled follow-up visits to your doctor.

In some cases, carboprost may not produce a complete abortion and the procedure must be repeated.

Side Effects Centers
  • Hemabate

Patient Detailed Avoid Taking

What happens if I miss a dose (Hemabate)?

Since this medication is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose (Hemabate)?

Tell your caregivers right away if you think you have received too much of this medicine. An overdose of carboprost is unlikely to occur in a hospital or clinic setting.

What should I avoid while receiving carboprost (Hemabate)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive carboprost.

What other drugs will affect carboprost (Hemabate)?

Before you receive carboprost, tell your doctor if you have been treated with any other drugs that may cause contractions of the uterus, such as:

  • dinoprostone (Prostin E2);
  • mifepristone (Mifeprex (RU-486)
  • misoprostol (Cytotec); or
  • oxytocin (Pitocin).

Carboprost can increase the effects of these other drugs, and they should not be used together.

This list it not complete and there may be other drugs that can affect carboprost. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about carboprost.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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