FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if your child has ever had an allergic reaction to this product or any of its ingredients
liver disease
taking the blood thinning drug warfarin
do not exceed recommended dose (see overdose warning)
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- pain gets worse or lasts more than 5 days
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- redness or swelling is present
These could be signs of a serious condition.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- if your child has ever had an allergic reaction to this product or any of its ingredients
liver disease
Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin
Stop use and ask a doctor if- •
- pain gets worse or lasts more than 5 days
- •
- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- redness or swelling is present
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
temporarily:
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- reduces fever
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- relieves minor aches and pains due to:
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- the common cold
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- flu
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- headache
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- sore throat
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- toothache
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Ferrlecit Manufacturers
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Sanofi-aventis U.s. Llc
Ferrlecit | Wal-mart Stores Inc
• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1 ½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2 ½ tsp) 72-95 11 years 15 mL (3 tsp)*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
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Sanofi-aventis U.s. Llc
Ferrlecit | Sanofi-aventis U.s. Llc
The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-use vial contains 62.5 mg of elemental iron (12.5 mg/mL).
Do not mix Ferrlecit with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of Ferrlecit with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately.
Ferrlecit treatment may be repeated if iron deficiency reoccurs.
2.1 Adult Dosage and AdministrationThe recommended dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of Ferrlecit (125 mg of elemental iron). Ferrlecit may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session. Ferrlecit may also be administered undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session. For repletion treatment most patients may require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions. Ferrlecit has been administered at sequential dialysis sessions by infusion or by slow intravenous injection during the dialysis session itself.
Data from Ferrlecit postmarketing spontaneous reports indicate that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see Adverse Reactions (6.2)].
2.2 Pediatric Dosage and AdministrationThe recommended pediatric dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg Ferrlecit (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session. The maximum dosage should not exceed 125 mg per dose.
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