CARBOPROST TROMETHAMINE (Page 2 of 2)
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 injection.
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 carboprost tromethamine injection 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 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 |
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).
DOSAGE & 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 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 carboprost tromethamine injection sterile solution (1 mL of carboprost tromethamine injection, USP) 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 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.
HOW SUPPLIED
Carboprost tromethamine injection USP, 250 mcg/mL sterile solution is available in the following packages:
1 mL single-dose vial NDC 46708-777-01
10 x 1 mL single-dose vials NDC 46708-777-10
Each mL of carboprost tromethamine injection USP, 250 mcg/mL contains carboprost tromethamine equivalent to 250 mcg of carboprost.
Carboprost tromethamine injection USP, 250 mcg/mL must be refrigerated at 2° to 8° C (36° to 46° F).
Discard unused portion.
1 Duff, 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.
Rx Only
Manufactured by:
Alembic Pharmaceuticals Limited
Karakhadi — 391450, Gujarat, India.
Issued: 01/2023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Carboprost Tromethamine Injection USP 250 mcg/mL — Vial Label
Carboprost Tromethamine Injection USP 250 mcg/mL — 10’s Carton Label
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Labeler — Alembic Pharmaceuticals Limited (650574663) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Alembic Pharmaceuticals Limited (F3) | 675480734 | MANUFACTURE (46708-777) |
Revised: 03/2024 Alembic Pharmaceuticals Limited
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