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Hemabate
Overview
What is Hemabate?
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:
The structural formula is represented below:
The molecular formula is CHON. 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 does Hemabate look like?
What are the available doses of Hemabate?
Sorry No records found.
What should I talk to my health care provider before I take Hemabate?
Sorry No records found
How should I use Hemabate?
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:
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.
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.
What interacts with Hemabate?
- Hypersensitivity (including anaphylaxis and angioedema) to HEMABATE Sterile Solution []
- Acute pelvic inflammatory disease
- Patients with active cardiac, pulmonary, renal or hepatic disease
What are the warnings of Hemabate?
Sorry No Records found
What are the precautions of Hemabate?
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: | Within 1 to 16 hours after the first injection. |
| 2. | Duration: | Temperatures revert to pretreatment levels after discontinuation of therapy without any other treatment. |
| 3. | Retention: | Temperature elevation occurs whether or not tissue is retained. |
| 4. | Histology: | Although the endometrial stroma may be edematous and vascular, it is not inflamed. |
| 5. | The uterus: | Uterine involution normal and uterus is not tender. |
| 6. | Discharge: | Lochia normal. |
| 7. | Cervical culture: | |
| 8. | Blood count: |
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.
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
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.
What are the side effects of Hemabate?
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:
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.
| Vomiting | Nervousness |
| Diarrhea | Nosebleed |
| Nausea | Sleep disorders |
| Flushing or hot flashes | Dyspnea |
| Chills or shivering | Tightness in chest |
| Coughing | Wheezing |
| Headaches | Posterior cervical perforation |
| Endometritis | Weakness |
| Hiccough | Diaphoresis |
| Dysmenorrhea-like 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 infection |
| Dryness of mouth | Leg cramps |
| Hyperventilation | Perforated uterus |
| Respiratory distress | Anxiety |
| Hematemesis | Chest pain |
| Taste alterations | Retained placental fragment |
| Urinary tract infection | Shortness of breath |
| Septic shock | Fullness of throat |
| Torticollis | Uterine sacculation |
| Lethargy | Faintness, light-headedness |
| Hypertension | Uterine rupture |
| Tachycardia | |
| Pulmonary edema | |
| Endometritis from IUCD |
Post-marketing experience
Hypersensitivity reactions (e.g. Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction, Angioedema).
What should I look out for while using Hemabate?
What might happen if I take too much Hemabate?
Sorry No Records found
How should I store and handle Hemabate?
Store at 25°C (77° F); excursions permitted to 15-30 °C (59-86°F) [see USP Controlled Room Temperature].HEMABATE Sterile Solution is available in the following packages:Each mL of HEMABATE contains carboprost tromethamine equivalent to 250 mcg of carboprost.HEMABATE Sterile Solution is available in the following packages:Each mL of HEMABATE contains carboprost tromethamine equivalent to 250 mcg of carboprost.
Clinical Information
Chemical Structure
No Image foundClinical 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).
Non-Clinical Toxicology
HEMABATE may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.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.
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:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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