Patient Medication Information: uses, side effects, how to take - Carboprost Tromethamine Injection
ABOUT THIS MEDICATION
What the medication is used for:
Carboprost Tromethamine Injection 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 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 if you:
Are allergic to carboprost tromethamine or any of the other ingredients of Carboprost Tromethamine Injection, 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 non-medicinal ingredients are:
Benzyl alcohol, sodium chloride, tromethamine and Water for Injection. 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 is available as a sterile solution contained in a vial. Each mL contains 250 micrograms of carboprost.
WARNINGS AND PRECAUTIONS
Carboprost Tromethamine Injection must be given only by a healthcare professional experienced in the use of the drug in hospitals or clinics with specialized units for pregnancy and childbirth.
Carboprost Tromethamine Injection may cause temporary high fever, and rarely, heart and blood circulation failure or airway constriction.
BEFORE you are given Carboprost Tromethamine Injection, 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 is not indicated for use in children. Carboprost Tromethamine Injection contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
Pregnancy
Carboprost Tromethamine Injection 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 Injection 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.
Driving and using machines:
Do not drive, use any tools or operate machinery soon after receiving Carboprost Tromethamine Injection as it may affect your ability to do so safely.
INTERACTIONS WITH THIS MEDICATION
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).
PROPER USE OF THIS MEDICATION
Usual dose:
Carboprost Tromethamine Injection 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.
Overdose:
| If you think you, or a person you are caring for, have been given too much Carboprost Tromethamine Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, Carboprost Tromethamine Injection can cause some side effects.
The following side effects are listed by frequency.
Very common (may affect more than 1 in 10 patients): Diarrhoea, increased body temperature, pain behind the sternum that usually occurs on swallowing, nausea and vomiting.
Common (may affect up to 1 in 10 patients): Cough, chills and shivering, inflammation of the uterus, flushing and hot flushes, headache, bleeding from the uterus, retained placenta or membranes.
Uncommon (may affect up to 1 in 100 patients): Abdominal pain, pelvic pain, back pain, blurred vision, distortion of the sense of taste, dizziness, dry mouth, eye pain, fainting, hiccups, increased heart rate (tachycardia), increased blood pressure (hypertension), injection site pain, involuntary muscle contractions, muscle pain, ringing in the ears, shortness of breath, skin rash at injection site, sleep disorder, somnolence, stomach pain, sweating, tightness in chest and chest pain, torticollis, urinary tract infection, vertigo.
Unknown Allergic reactions such as: Redness, itching or swelling of skin, hives, burning, stinging,
Other side effects may include:
- Anxiety and nervousness
- Breast tenderness
- Dry throat
- Excessive thirst
- Leg cramps
- Loss of strength and energy
- Nosebleed
Palpitations
- Rash
- Retching
- Temporary loss of consciousness caused by a fall in blood pressure
- Twitching eyelids
- Upper respiratory tract infection
| 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, contact your doctor or pharmacist.
HOW TO STORE IT
Carboprost Tromethamine Injection vials must be stored in a refrigerator between 2-8°C. Your pharmacist will check the vials are still clear and colourless before use.
Keep out of reach and sight of children.
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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MORE INFORMATION
If you want more information about Carboprost Tromethamine Injection:
- 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); the manufacturer’s website (www.jamppharma.com), or by calling at 1-866-399-9091.
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada