Drug Interaction:
Interacting drugs- summary
+ Folic acid
Aminosalicylic acid
decreased serum folate levels ocur during concurrent use
Oral Contraceptives
oral contraceptives impair folate metabolism and produce folate
depletion, but the effect is mild and unlikely to cause anemia or
megaloblastic changes
Dihydrofolate reductase inhibitors (eg, methotrexate / trimethoprim)
a dihydrofolate reductase defiency caused by administration of
folic acid antagonists interfere with folic acid utilization
Sulfasalzine
signs of deficiency have occurred
Folic acid +
Hydantoins
an increase in seizure frequency and decrease in serum concentration
to subtherapeutic levels have been reported in patients receiving folic
acid particularly 5 to 30mg/day ) with phenytoin. Phenytoin may cause
a decrease in serum folate levels and may produce symptoms of folic
acid deficiency on long term therapy
It folic acid is required, a higher dose of phenytoin may be needed
Indication:
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Folic acid 0.5mg + Jan -1969
Ferrous Sulphate 150mg Capsule
Adverse Reaction:
GI- anorexia, nausea, abdominal distention,flaulence, and a bitter taste or bad taste have been reported in patients receiving 15mg of folic acid adily for a month.
CNS- altered sleep patterens, difficulty in concentrating , irritability, overactivity, excitement, mental depression, confusion and impaired judgement were reported in patients receiving 15mg daily.
Miscellaneous- allergic senstization hads been reported. Decreased serum level may occur in patients receiving prolonged folic acid therapy
Contra-Indications:
Not effective in the treatment of pernicious aplastic or normocytic anaemias.
Special precautions:
Patients with untreated pernicious anemia may show hemotologic improvements. Pregnant women are more prone to develop folate defciency. Folate deficient mothers may be more prone to complications of pregnancy and fetal complications. Pernicious anemia- folic acid indoses > 0.1mg daily may obscure pernicious anemias in that hemotologic remission can occur while neurologic manifestations remain progressive.
Elderly- it may be prudent to consider the status offolate in persons > 65 years of age.
Pregnancy- women whoooohad a prior NTD-affected pregnancy are aty high riskof having a subsequent affeted pregnancy.When these women are planning to become pregnant they should consult their physician for advice.
Lactation- during lactation foilic acid requirements are markedly increased, however amounts present in human milk are adequate to fulfill infant requirements
Dosages/ Overdosage Etc:
Indications:
Megaloblastic anaemia of nutrional origin, pregnancy, infancy, childhood.
Dosage:
Upto 1mg daily.
Missed dose
1. If you miss taking a vitamin for 1 or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins
2. However, if your health care professional has recommended that you take this vitamin, try to remember to take it as directed every day.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
1. Take only under medical supervision
2. Give orally except in severe intestinal malabsorption. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally
3. Parentral administartion is nort advocated but may be necessary in some individuals (eg. patients receiving parentral or enteral alimentation).
4. Give IM , IV or SC if disease is very severe or GI absorption is very severely impaired
5. Doses > 0.1mg should not be used unless anemia due to Vitamin B12 deficiency has been ruled out or is being adequately treated with cobalamin.
6. Daily dose >1mg do not anhance the hematologic efect, and most of the excess is excreted unchanged in the urine.
7. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to folic acid or related medicines. Also tell your doctor if your are allergic to any other substances such as foods, preservatives or dyes.
8.Children- problems in children have not been reported with normal intake of recommended amounts
9. Elderly- problems in older adults have not been reported with normal intake of recommended amounts
11. Tell your doctor if you are taking any of the following- ifyou are taking non prescription or OTC medicines
12. Other medical problems- presence of other medical problems may affect the use of this medicine- Pernicious anemia - taking folic acid while you are having pernicious anema may cause serios side effects 12. Missed dose- If you miss a dose of this medicine take it as soon as possible. However if it is almost time for your next dose go back to your regular dosing schedule. Do not double dose
Pharmacology/ Pharmacokinetics:
Pharmacology:
Folic is required for neucleprotein synthesis and maintenance of normal erythropoiesis. Folic acidstimulates producyion of red and white blood cells and platelet in certain megoblastic anemias.
Pharmacokinetics:
Folic acid appears in the plasma approx 15 to 30 minutes after an oral dose, peak levels are reached witin 1 hour. folic acid is metabolised in the liver.
Pregnancy and lactation:
Pregnancy:
Pregnant women are more prone to folate deficiency and folate-deficient mothers may be more prone to complications of pregnancy and fetal abnormalities.
Lactation:
Folic acid is excreted in breast milk, however amounts present in human milk are adequate to fulfill infant requirements.