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FOLIC ACID is a brand name for Folic Acid, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FOLIC ACID (folic acid) is indicated for: The prevention and treatment of folate deficiency due to inadequate dietary intake, absorption or utilization or increased excretion or need as in tropical sprue (not in all forms of sprue), chronic haemodialysis, chronic haemolytic anaemia, nutritional megaloblastic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Cobalamin deficiency should be ruled out before initiating treatment. High serum folate levels in individuals with low cobalamin have been associated with anemia and cognitive impairment in older individuals, an increased risk of diabetes mellitus in the offspring of pregnant women, and high levels of the cobalamin-dependent metabolites methylmalonic acid (MMA) and homocysteine.
Additionally, folate supplementation in the setting of cobalamin deficiency may also impair fetal growth and brain development. Folic acid should not be used alone in undiagnosed megaloblastic anaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown etiology, unless administered with adequate amounts of cobalamin.
For the prevention of neural tube defects for woman planning a pregnancy and known to be at risk (red blood cell folate concentrations below 906 nmol/L—the threshold associated with increased NTD prevalence). 2 Recommended Dose and Dosage Adjustment To prevent deficiency: Adequate dietary intake of folic acid is preferred over supplementation whenever possible.
Adults (including the elderly) In folate deficient megaloblastic anaemia: 5 mg daily for 4 months; up to 15 mg daily may be necessary for malabsorption states. In drug induced folate deficiency: 5 mg daily for 4 months; up to 15 mg daily may be necessary for malabsorption states.
For prophylaxis in chronic haemolytic states or in renal dialysis: 5 mg every 1-7 days depending on underlying disease. Prevention of neural tube defects in women known to be at risk: 5 mg daily started before conception and continued throughout the first trimester.
In sickle cell disease: 1-5 mg of folic acid daily Pregnancy:
In established folate deficiency: 5 mg daily continued to term. Higher doses have been recommended for the treatment of tropical sprue: 3 to 15 mg daily. Pediatrics For young children a more suitable dosage form should be used.
In folate deficient megaloblastic anaemia:
Child 1-18 years 5 mg daily for 4 months; maintenance 5 mg every 1-7 days. 5 mg-5 mg once daily. Child 12-18 years 5-10 mg once daily.
Prophylaxis of folate deficiency in renal dialysis:
1 Adverse Reaction Overview Folic acid is relatively non-toxic but has rarely caused allergic reactions including erythema, pruritus, and/or urticaria. g. 15 mg/day) have rarely been associated with various gastrointestinal symptoms such as anorexia, nausea, abdominal distention, flatulence and bitter taste and CNS effects such as altered sleep patterns, difficulty concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment.
5 Post-Market Adverse Reactions Information is not available.
General Megavitamin therapy is a cause of vitamin toxicity (hypervitaminosis) for folic acid (folate). Folic acid is not effective in the rescue treatment or overdosage of folic acid antagonists such as methotrexate. When cholestyramine and folic acid are administered together, there may be a reduction or delay in the folic acid absorption.
If concomitant therapy is required, folic acid should be administered at least 1 hour before and 4 hours after cholestyramine. Avoid supplements containing herbs and various other non-medicinal ingredients. Large amounts of folate can correct the megaloblastic anemia, but not the neurological damage, that can result from vitamin B12 deficiency.
Some experts have therefore been concerned that high intakes of folate supplements might “mask” vitamin B12 deficiency until its neurological consequences become irreversible. Concerns have also been raised that high folic acid intakes might accelerate the progression of preneoplastic lesions, increasing the risk of colorectal and possibly other cancers in certain individuals.
Studies have found unmetabolized folic acid in blood from children, adolescents, and adults; breastmilk; and cord blood from newborns. Limited research suggests that single doses of 300 mcg or 400 mcg folic acid (a common amount in folic acid-containing supplements or servings of fortified foods, such as breakfast cereals) result in detectable serum levels of unmetabolized folic acid, whereas doses of 100 mcg or 200 mcg do not.
In addition, a dose -frequency interaction appears to occur in which smaller amounts of folic acid consumed more frequently produce higher unmetabolized folic acid concentrations than the same total dose consumed in larger, less frequent amounts.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral tablet 5 mg of folic acid croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose FOLIC ACID (folic acid) Page 9 of 24 Hematologic Use only as an adjunct to treatment with vitamin B12 whenever pernicious anemia is present or suspected.
FOLIC ACID (folic acid) is contraindicated in: Patients with hypersensitivity to folic acid products and/or any of the inactive ingredients present in the drug product, including any non-medicinal ingredient, or component of the container.
For a complete listing, See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. People who have diseases of the small intestine, especially Crohn’s disease and Sprue, may have trouble absorbing folic acid. In the following situation, FOLIC ACID should not be used because the risk outweighs any potential therapeutic benefit: in any patient with untreated cobalamin deficiency (evidence suggests that long term folate therapy in these subjects precipitates cobalamin neuropathy and/or the degeneration of the spinal cord).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Child 1-12 years 250 microgram/kg (max 10 mg) once daily. Children 12-18 years 5-10 mg once daily. Geriatrics High MMA and homocysteine levels are more common in elderly adults even when serum cobalamin levels are normal, and higher doses of cobalamin supplements are required to correct MMA levels in older individuals.
Advanced age is a risk factor for folate-associated functional cobalamin Deficiency since vitamin B deficiency is a lot more common among the elderly population. 9% of the population had unrecognized and untreated pernicious anemia.
FOLIC ACID (folic acid) Page 7 of 24 Prophylaxis of Neural Tube Defects (NTD):
Women with a history of pregnancy complicated by NTD are considered at high risk for recurrence and are advised to take 5 mg folic acid daily under physician supervision while not using reliable birth control (or 3 months prior to conception), continuing for 10 to 12 weeks after the last menstrual period.
4 mg to 1 mg daily throughout pregnancy and 4 to 6 weeks postpartum or as long as breastfeeding continues is recommended. High doses (5 mg/ day) should not be made up from taking multivitamins/ supplements because of the risk of intake of harmful amounts of other components such as retinol and vitamin D.
Excessive intake of folate may obscure and potentially delay the diagnosis of vitamin B12 deficiency; which could translate into delayed diagnosis and can result in an increased risk of progressive, unrecognized neurological damage.
g. , type I diabetes, therapy with valproic acid or carbamazepine, BMI >35 kg/m2, malabsorption disorders). Such women should consider taking folic acid 5 mg daily under physician supervision when not using reliable birth control (or 3 months prior to conception), continuing until 10 to 12 weeks after the last menstrual period.
4 to 1 mg daily. 4 Administration Do not use if seal is broken. 5 Missed Dose Women should not take more than the prescribed daily dose. If a dose is missed, for one or more days, do not try to ‘catch up’ by taking the missed dose(s) all at one time.
However, proper diagnosis of the condition of the patient and evaluation of the underlying etiology of the deficiency state is required. The use of folic acid in pernicio us anemia patients without adequate vitamin B12 therapy may result in hematological improvement, while neurologic manifestations continue to progress.
Food-Bound Cobalamin Malabsorption (FBCM) is seen in 20-40% of those >60 years of age. FBCM is caused by either lack of gastric acid or H. Pylori infection. Occasionally it can be seen in younger people especially those with long-term use of drugs (such as histamine (H2) blockers, proton pump inhibitors, or metformin) or gastric resection.
0 mg. Vitamin B12 levels may be monitored before and during FOLIC ACID therapy if in the opinion of the healthcare professional it is warranted. 4 Drug-Drug Interactions). , chronic malaise, sore tongue, numbness of the fingers), potentially allowing more irreversible symptoms of nerve damage to develop.
For this reason, when taking more than 400 mcg daily, it is important to check the level of B12. , chronic malaise, sore tongue, numbness of the fingers) should be investi gated before starting supplementation with folic acid. 1 Pregnant Women There are no known hazards to the use of folic acid in pregnancy, supplements of folic acid are often beneficial.
Non-drug - induced folic acid deficiency, or abnormal folate metabolism, is related to the occurrence of birth defects and some neural tube defects. Interference with folic acid metabolism or folate deficiency induced by drugs such as anticonvulsants and some antineoplastics early in pregnancy results in congenital anomalies.
Lack of the vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation. 3 Pharmacokinetics, Special populations and conditions, Pregnancy and Breast-feeding. 2 Breast-feeding Folic acid is actively excreted in human breast milk.
Accumulation of folate in milk takes precedence over maternal folate needs. Levels of folic acid are relatively low in colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.
3 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of FOLIC ACID in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use.
2 Recommended Dose and Dosage Adjustment. 4 Geriatrics Geriatrics: Red cell folate levels and serum folate levels as well as the existence of a cobalamin deficiency, especially in elderly patients should be determined upfront initiating the treatment.