Ferric Ammonium Citrate 400 mg/5 ml Mixture

Introduction

Ferric ammonium citrate 400 mg/5 ml mixture (FAC syrup) is a commonly prescribed medication for prevention and treatment of iron-deficiency anaemia in premature infants at Malaysia.

  • FAC mixture is commonly supplied for 3-4 months post discharge or until next review.



Extemporaneous Formulation (BPC 1973, page 742)

Ferric ammonium citrate BP 80 g

Compound orange spirit BP 2 ml

Syrup BP 100 ml

Double strength chloroform water BP 500 ml

Water q.s. to 1000 ml.

* This product would be recently prepared as double strength chloroform water BP acts as a preservative and therefore would attract a four-week discard date.

* The dose should be taken well diluted with water.



Dosage Calculation

Dosing of FAC syrup is based on elemental iron needed per day. As per Frank Shann Drug Doses, 2017, ferrous salts dosage is as below:

  • Prophylaxis, 2 mg/kg/day elemental iron oral
  • Treatment, 6 mg/kg/day elemental iron oral.

* In real practice, the dosing prescribed can be within the range of 2-6 mg/kg/day elemental iron.

To calculate the volume of FAC syrup needed, you should know the elemental iron content in Ferric Ammonium Citrate 400 mg/5 ml syrup.

The estimation of 86 mg elemental iron per 5 ml is probably based on ratio of molar mass.

  • Ferric ammonium citrate(C6H8FeNO7), molar mass 261.98 g/mol
  • Iron molar mass 55.845 g/mol
  • Hence 400 * (55.845/261.98) = 85.266

NOTE: Once a provisional registered pharmacist asked me a question that I do not have a final answer till today: In Martindale, it states that USP 42 (Ferric Ammonium Citrate): It contains between 16.5% and 18.5% of iron. Hence, by this estimation, should not FAC 400 mg/5 ml syrup has less than 86 mg/5 ml of elemental iron content?



Calculation Example

For a baby weighing 2.1 kg, having a target dose of 6 mg/kg/day of elemental iron,

Elemental iron needed = 2.1 kg * 6 mg/kg/day = 12.6 mg

Volume of Ferric Ammonium Citrate Mixture = 12.6 mg / 86 mg * 5 ml = 0.73 ml



The Alternative

There is currently no commercially available ferric ammonium citrate 400 mg/5 ml mixture in the Malaysia market.

A possible alternative source of elemental iron will be Maltofer (iron (III)-hydroxide polymaltose complex).

  • Maltofer + folic acid chewable tablet: 100 mg elemental iron and 0.35 mg folic acid per tablet
  • Maltofer drops: 2.5 mg elemental iron per drop
  • Maltofer syrups: 10 mg element iron per ml syrup

NOTE: Iron polymaltose is absorbed best if taken during or immediately after a meal.

Comments

  1. Hi, want to ask

    Sy. FAC is interchangeable with Sy. Folic Acid 1mg/mL?

    ReplyDelete
    Replies
    1. These two items are not interchangeable. Syrup FAC functions as a source of iron. On the other hand, folic acid is actually vitamin B9. Deficiency in any of the iron, folic acid or vitamin B12 can cause anemia (low in red blood cell).

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    2. I see, because my facility does not keep Sy. Folate, that day got one MO prescribe a Failure to Thrive pt with Sy. Folate, then the MO changed to Sy. FAC, I am just curious FTT management is Folic Acid/FAC? Why not Sy. MVT? Low iron content? Curious also why the MO changed to FAC from Folic Acid

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    3. For your case, I felt it is best to discuss with doctor. Treatment of failure to thrive (or known as "slow weight gain") depends upon the associated symptoms and the underlying reason for the poor growth, e.g. poor nutrition.

      Just a side note, may also take note that NOT all multivitamin syrup is suitable for infants below 1 year old, it is subjected to product leaflet recommendation.

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  2. Do you have the counselling points for this med?

    ReplyDelete
    Replies
    1. The dose should be taken well diluted with water to reduce stomach upset. Since the medication is an iron preparation, the stool may also turn black.

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    2. Thanks for your reply :) Is it true that we also can't mix it with milk as it can also affects the absorption of iron?

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    3. I felt, it is a valid concern. =)

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  3. Hi, my baby is 3 months old, Hb 9.1. Doctor prescribed this to her since last month with dosage 1.2ml per day (weight was 4.1kg). This week doctor increase dosage to 8.6ml per day (weight 4.9 kg). Is the dosage correct?

    ReplyDelete
    Replies
    1. Based on what I know, the dosage seems incorrect. Best to recheck with prescribing doctor or dispensing pharmacist to clarify any misunderstanding.

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    2. Thanks for advising. Already checked with the pharmacist, she did the wrong calculations.

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    3. I am glad that it is fixed. =)

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  4. Hi, thanks somuch for the useful notes =)

    Sorry, I have a question. May I know what is the maxi dose for Sy. FAC?

    ReplyDelete
    Replies
    1. Based on Ferrous Sulfate monograph in Lexidrug, the usual maximum dose is 150-200 mg elemental iron/day.

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    2. Thanks for the time and reply =)

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