Patient Medication Information: uses, side effects, how to take - Carboprost Tromethamine Injection, USP
What the medication is used for:
Carboprost Tromethamine Injection, USP is used to stop excessive bleeding in women who have just given birth, when bleeding is due to the uterus (womb) failing to return to its normal size, and who have not responded to conventional treatments.
What it does:
Carboprost Tromethamine Injection, USP belongs to a group of medicines called prostaglandins that acts to increase the contractions of the uterus (womb). This helps to control bleeding after delivery.
When it should not be used:
You should not be given Carboprost Tromethamine Injection, USP if you:
are allergic to carboprost tromethamine or any of the other ingredients of Carboprost Tromethamine Injection, USP, in particular benzyl alcohol.
- have a heart, lung, kidney or liver disease.
- have an infection of your uterus, ovaries or fallopian tubes.
What the medicinal ingredient is:
Carboprost
What the nonmedicinal ingredients are:
Benzyl alcohol, sodium chloride, tromethamine, and water for injections. Small amounts of hydrochloric acid and sodium hydroxide (used to regulate the acidity or alkalinity of the solution) may also be present.
What dosage forms it comes in:
Carboprost Tromethamine Injection, USP is available as a sterile solution contained in a vial or pre-filled syringe. Each ml contains 250 micrograms of carboprost.
Carboprost Tromethamine Injection, USP must be given only by a health care professional experienced in the use of the drug in hospitals or clinics with specialized units for pregnancy and childbirth.
Carboprost Tromethamine Injection, USP may cause temporary high fever, and rarely, heart and blood circulation failure or airway constriction.
BEFORE you are given Carboprost Tromethamine Injection, USP, talk to your doctor or pharmacist if you currently have, or have had in the past any of the following conditions:
- lung disease, including asthma
- high or low blood pressure (including high blood pressure in pregnancy)
- heart disease or anaemia (low blood count)
- kidney or liver disease (including jaundice)
- glaucoma (raised pressure in your eyes)
- diabetes or epilepsy
- a caesarean section or any other operation on your womb
Carboprost Tromethamine Injection, USP is not indicated for use in children. Carboprost Tromethamine Injection, USP contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
Pregnancy
Carboprost Tromethamine Injection, USP will only be given shortly after you have delivered your baby and not while you are still pregnant as it could put the embryo or foetus at risk.
Breast-feeding
It is not known if carboprost tromethamine is excreted in human breast milk. However, breast-feeding is not recommended at least 6 hours after receiving the last dose of Carboprost Tromethamine Injection, USP.
Driving and using machines:
Do not drive, use any tools or operate machinery soon after receiving Carboprost Tromethamine Injection, USP as it may affect your ability to do so safely.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including any that you have bought without a prescription.
Tell your doctor if you are taking or have received oxytocin or ergometrine (ergonovine).
Usual dose:
Carboprost Tromethamine Injection, USP must be given to you as an injection deep into a muscle (intra-muscular). It must never be given by injection into a vein.
The first dose is usually 1 ml of solution (250 micrograms of carboprost). If needed the dose of 1 ml may be repeated between 15 to 90 minutes.
You should not be given more than 8 doses (8 x 250 micrograms of carboprost) altogether.
WARNINGS AND PRECAUTIONS
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
ABOUT THIS MEDICATION
IMPORTANT: PLEASE READ
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SERIOUS SIDE EFFECTS, AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Uncommon | Breathing difficulties, asthma, wheezing, hyperventilation | √ | ||||
| Septic shock | √ | |||||
| Uterine rupture, perforation of uterus | √ | |||||
| Vomiting of blood | √ | |||||
| Unknown | Anaphylactic shock/reactions: swelling of the neck area, throat tightness, choking sensation or any difficulty with breathing, not present before using this medicine. | √ | ||||
This is not a complete list of side effects. For any unexpected effects while taking Carboprost Tromethamine Injection, USP, contact your doctor or pharmacist. Vials or pre-filled syringes must be stored in a refrigerator between 2 – 8°C. Your pharmacist will check the vials or pre-filled syringes are still clear and colourless before use. Keep out of reach and sight of children. HOW TO STORE IT |
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IMPORTANT: PLEASE READ
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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If you want more information about Carboprost Tromethamine Injection, USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by contacting the manufacturer Dr. Reddy’s Laboratories Ltd., at 1-855-845-1739.
Manufactured by:
Dr. Reddy’s Laboratories Ltd.,
Bachupally – 500 090 India
Imported and Distributed by:
Dr. Reddy’s Laboratories Canada Inc.,
Mississauga, ON, Canada, L4W 4Y1