Patient Medication Information: uses, side effects, how to take - Folic Acid Injection, USP
What is Folic Acid Injection, USP used for?
Folic Acid Injection, USP is used to treat megoblastic anemia (a condition where you lack enough healthy large, abnormal red blood cells), caused by low levels of folic acid. The folate deficiency might be present when:
- You have low folate levels
- Your body does not use or absorb nutrients well
- Your body does not tolerate gluten
- You have anemias (low red blood cells) due to diet
You are pregnant, an infant or child
This will be confirmed by a healthcare professional.
How does Folic Acid Injection, USP work?
Folic acid is a vitamin (vitamin B9). It is essential for the body to make new cells. It helps the body to make red blood cells, white blood cells, and blood platelets.
What are the ingredients in Folic Acid Injection, USP?
Medicinal ingredients: Folic Acid as sodium folate
Non-medicinal ingredients: benzyl alcohol (preservative), edetate disodium, hydrochloric acid and/or sodium hydroxide for pH adjustment and water for injection.
Folic Acid Injection, USP comes in the following dosage forms:
Solution for Injection: 5 mg / mL
Do not use Folic Acid Injection, USP if:
- You are allergic to folic acid or any other ingredients in Folic Acid Injection, USP or its container.
- You have vitamin B12 deficiency and are not receiving treatment for it.
- It is for a newborn child. Folic Acid Injection, USP contains benzyl alcohol which can be toxic for your newborn child.
- You have kidney problems or it is for a premature newborn child with immature kidneys. Folic Acid Injection, USP contains aluminum which may be toxic in patients with kidney problems or immature kidneys.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Folic Acid Injection, USP. Talk about any health conditions or problems you may have, including if you:
- Have alcoholism
- Have blood problems
- Have seizures
- Have long term infections
- Do not feel well, have a sore tongue or your fingers feel numb. This can mean you have a vitamin B12 deficiency (pernicious anemia)
- Are older than 65 years old
Other warnings you should know about:
Effects on newborns:
Folic Acid Injection, USP contains benzyl alcohol which is a preservative. It can cause death in children less than 1 month of age. Get medical help for your newborn right away if they have:
- Vomiting, difficulty breathing, wheezing or coughing, change in heart rate, fits or seizures.
Cancer: High dose of folic acid may increase your risk for cancer of the colon or rectum. It may also increase the risk for other cancers in some people.
Cognitive (thinking) problems: Folic acid that is not used by your body could cause thinking problems.
Nervous system problems: High doses of folic acid may hide your low vitamin B12 levels and make its symptoms worse. This can cause nerve problems.
Immune System: Doses of folic acid higher than your body’s ability could affect your immune system.
Check-ups and Testing:
Your healthcare professional may check your:
- Vitamin B12 levels before and during treatment with Folic Acid Injection, USP.
- Folate levels during treatment with Folic Acid Injection, USP.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Folic Acid Injection, USP:
- Alcohol
- Pain-Killers such as indomethacin, naproxen, ibuprofen and mefenamic acid
- Medicines used to treat epilepsy and seizures such as phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone
- Medicines to prevent pregnancy such as estrogens, oral birth control
- Medicines that block acetylcholine such as hyoscyamine, atropine, scopolamine
- A medicine used to treat eye infections called chloramphenicol
- A medicine used to treat parasitic diseases called pyrimethamine
- A medicine used to lower the amount of water in your body (diuretic) called triamterene
- Medicines used to treat bacterial infections like trimethoprim
- Medicines used to treat cancer called capecitabine, methotrexate
How to take Folic Acid Injection, USP :
Folic Acid Injection, USP will be given to you by a healthcare professional in a healthcare setting.
Folic Acid Injection, USP will be injected intramuscularly (into a muscle), intravenously (into a vein) or subcutaneously (under the skin). Your healthcare professional will decide what to do.
Usual dose:
Your healthcare professional will decide what dose of Folic Acid Injection, USP you will receive and for how long.
Overdose:
| If you think you, or a person you are caring for, have been given too much Folic Acid Injection, USP, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose
- Folic Acid Injection, USP is given on a fixed schedule.
- If you miss an appointment, ask your healthcare professional for more information.
What are possible side effects from using Folic Acid Injection, USP ?
These are not all the possible side effects you may have when taking Folic Acid Injection, USP. If you have any side effects not listed here, tell your healthcare professional.
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 | ||
| RARE | |||
| Allergic reaction: shortness of breath, troubled breathing, tightness of chest, wheezing, reddened skin, fever, general weakness or discomfort, rash, itching | √ | ||
| VERY RARE | |||
| Nervous system problems: confusion, depression, difficulty in concentrating, excitement, irritability, impaired judgment, nausea, trouble sleeping, sore tongue, numb fingers | √ | ||
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 |
|---|---|
| Convulsion: seizure, spasms, shaking or fits, changes in brain electrical activity readings (electroencephalography or EEG) | |
| √ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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. |
Storage:
Store at room temperature (15°C to 30°C).
Discard unused portion of punctured vials within 28 days after first use.
Protect from light. Retain vial in box until contents are used.
Keep out of reach and sight of children.
If you want more information about Folic Acid Injection, USP:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); Fresenius Kabi Canada website (https://www.fresenius-kabi.com/en-ca/), or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8