1. Name Of The Medicinal Product
Folic Acid 2.5mg/5ml Oral Solution
2. Qualitative And Quantitative Composition
Folic Acid 2.5mg/5ml
Excipients:
Methyl hydroxybenzoate (E218)
Ethyl hydroxybenzoate (E214)
Propyl hydroxybenzoate (E216)
Phenylalanine
For full list of excipients, see section 6.1.
3. Pharmaceutical Form
Oral Solution.
A clear, yellow, solution with a strawberry flavour and odour.
4. Clinical Particulars
4.1 Therapeutic Indications
1. Folate deficient megaloblastic anaemia
2. Folate deficient megaloblastic anaemia in infants
3. Treatment of folate deficiency in malabsorption syndromes (parenteral administration of folic acid may need to be considered if oral treatment is not effective)
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4. Megaloblastic anaemia in pregnancy
5. Megaloblastic anaemia associated with alcoholism
6. Megaloblastic anaemia associated with anti-convulsant therapy
7. Folic acid deficiency/megaloblastic anaemia associated with haemolytic anaemia e.g. Sickle Cell Anaemia
4.2 Posology And Method Of Administration
For oral administration only.
Children (persons aged 12 years and younger):
May be given 5 mg to 15 mg daily, in divided doses, according to the severity of the deficiency state.
Adults:
Initial dose of 10 mg to 20 mg daily, in divided doses, for 14 days or until a haemopotoietic response has been obtained.
Maintenance dose is 2.5 mg to 10 mg daily.
Prophylactic dose in pregnancy 0.5 mg (1ml) daily.
Elderly:
As for adults.
4.3 Contraindications
Known hypersensitivity to folic acid.
Known hypersensitivity to hydroxybenzoate esters.
Patients with folate dependent tumours.
Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency.
4.4 Special Warnings And Precautions For Use
If folic acid is used indiscriminately, there is a danger that patients with pernicious anaemia and other B12 deficiency states, despite a haematological remission, may develop irreparable neurological lesions. Therefore a full clinical diagnosis should be made before initiating treatment.
Folic acid is removed by haemodialysis.
Contains methyl- ethyl- and propyl- p-hydroxybenzoates; may cause allergic reactions (possibly delayed).
Contains 0.75 mmol (or 17.4mg) sodium per 20 ml dose, and is therefore essentially 'sodium-free'.
Contains phenylalanine. May be harmful for people with phenylketonuria.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Folic acid has been observed to reduce plasma levels of anticonvulsants, particularly phenytoin and primidone and therefore patients should be carefully monitored by the physician and the anticonvulsant drug dose adjusted as necessary.
4.6 Pregnancy And Lactation
There are no known hazards to the use of folic acid, indeed folic acid supplements are often necessary in pregnancy.
Folic acid is excreted in breast milk.
4.7 Effects On Ability To Drive And Use Machines
There are no known effects of this preparation on the ability to drive or use machines.
4.8 Undesirable Effects
Allergic reactions to folic acid have been reported.
Mild gastro-intestinal upsets are rare but may occur.
4.9 Overdose
No cases of acute overdosage appear to have been reported, but even extremely high doses are unlikely to cause harm to patients.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC Code: B03B B
After conversion into co-enzyme forms it is concerned in single carbon unit transfers in the synthesis of purines, pyrimidines and methionine.
5.2 Pharmacokinetic Properties
About 70 – 80 % of a 2 mg oral solution of folic acid is absorbed. Larger doses are probably equally well absorbed. It is distributed into plasma and extracellular fluid. In plasma, folate is bound weakly to albumin (70 %). There is a further high affinity binder for folate but this has a very low capacity and is barely detectable in normal sera. About 70 % of small doses of folate (about 1 mg) are retained and the rest excreted into the urine. With larger doses most is excreted into the urine. With a 5 mg dose of folate, urinary excretion will be complete in about five hours. There is an enterohepatic circulation of folate. The retained folate is taken into cells and reduced by dihydrofolate to tetrahydrofolate. Folic acid is a relatively poor substrate for folate reduction, the normal substrate being dihydrofolate.
Folic acid itself does not occur in natural materials, it is entirely a pharmacological form of the compound. Once reduced, folate has additional glutamic acid residues added, a folate pentaglutamate being the dominant intracellular analogue. These polyglutamates are the active co-enzymes.
5.3 Preclinical Safety Data
Folic Acid is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Mannitol (E421)
Glycerol (E422)
Methyl hydroxybenzoate (E218)
Ethyl hydroxybenzoate (E214)
Propyl hydroxybenzoate (E216)
Sodium dihydrogen phosphate dihydrate
Disodium hydrogen phosphate dodecahydrate
Disodium edetate
Strawberry flavour (contains phenylalanine, cherry juice concentrate and maltol)
Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf Life
Unopened: 18 months
After first opening: Three months.
6.4 Special Precautions For Storage
Store in a refrigerator (2°C - 8°C)
Store in the original bottle and outer cardboard carton in order to protect from light.
6.5 Nature And Contents Of Container
150 ml amber soda glass (type III) bottle fitted with a 28 mm white child resistant tamper evident screw cap, with expanded polyethylene (EPE) liner, and outer cardboard carton.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
U.K.
8. Marketing Authorisation Number(S)
PL 29831/0358
PA 1339/22/1
MA154/01302
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 09/04/2010
10. Date Of Revision Of The Text
09/04/2010
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