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Trade Names:
Chew Iron
- Tablets 135 mg (27 mg iron) as iron glycinate

Trade Names:
Chromagen
- Caplets 70 mg iron as ferrous asparto glycinate

Trade Names:
EzFe
- Capsules 200 mg iron as polysaccharide iron complex

Trade Names:
Fe-40
- Tablets 325 mg (40 mg iron) as ferrous gluconate

Trade Names:
Fer-Gen-Sol
- Drops 75 mg in 0.6 mL (15 mg iron per 0.6 mL) as ferrous gluconate

Trade Names:
Fer-In-Sol
- Drops 75 mg per 0.6 mL (15 mg iron per 0.6 mL) as ferrous gluconate

Trade Names:
Fer-Iron
- Drops 75 mg in 0.6 mL (15 mg in 0.6 mL) as ferrous gluconate

Trade Names:
Fer US PIC 150
- Capsules 150 mg iron as polysaccharide iron complex

Trade Names:
Ferrex 150
- Capsules 150 mg iron as polysaccharide iron complex

Trade Names:
Feratab
- Tablets 325 mg (65 mg iron) as ferrous sulfate

Trade Names:
Fergon
- Tablets 225 mg (27 mg iron) as ferrous gluconate

Trade Names:
Feronate
- Tablets 325 mg (40 mg iron as ferrous gluconate)

Trade Names:
FeroSul
- Tablets 325 mg (65 mg iron) as ferrous sulfate

Trade Names:
Ferretts
- Tablets 325 mg (106 mg iron) as ferrous fumarate

Trade Names:
Ferrocite
- Tablets 325 mg (106 mg iron) as ferrous fumarate

Trade Names:
Ferrous sulfate
- Tablets, enteric coated 325 mg (65 mg iron)
- Tablets 90 mg (18 mg iron)
- Elixir 220 mg per 5 mL (44 mg iron per 5 mL)

Trade Names:
Ferrousal
- Tablets 325 mg (65 mg iron) as ferrous sulfate

Trade Names:
Hemocyte
- Tablets 324 mg (106 mg iron) as ferrous fumarate

Trade Names:
Inferex 150
- Capsules 150 mg iron as polysaccharide iron complex

Trade Names:
Ircon
- Tablets 200 mg (66 mg iron) as ferrous fumarate

Trade Names:
Leader Iron
- Tablets, extended release 160 mg (50 mg iron) as ferrous sulfate exsiccated

Trade Names:
Mol-Iron
- Tablets 195 mg (39 mg iron) as ferrous sulfate

Trade Names:
Myferon 150
- Capsules 150 mg as polysaccharide iron complex

Trade Names:
Nephro-Fer
- Tablets 350 mg (115 mg iron) as ferrous fumarate

Trade Names:
Niferex
- Capsules 60 mg iron as ferrous bisglycinate and polysaccharide iron complex
- Elixer 100 mg iron per 5 mL as polysaccharide iron complex

Trade Names:
Niferex-150
- Capsules 150 mg iron as ferrous asparto glycinate and polysaccharide iron complex

Trade Names:
Nu-Iron 150
- Capsules 150 mg iron as polysaccharide iron complex

Trade Names:
Poly-Iron 150
- Capsules 150 mg iron as polysaccharide iron complex

Trade Names:
Ridosol
- Tablets 200 mg (40 mg iron) as ferrous sulfate

Trade Names:
Slow-Fe
- Tablets, slow-release 160 mg (50 mg iron as ferrous sulfate), exsiccated

Trade Names:
Slow Release Iron
- Tablets, slow-release 160 mg (50 mg iron) as ferrous sulfate, exsiccated

Mechanism of Action

Pharmacology

Iron is a major factor in oxygen transport and an essential mineral component of hemoglobin, myoglobin, and several enzymes.

Pharmacokinetics

Absorption

Primary site of absorption is the duodenum and upper jejunum. Food decreases absorption at least 50%.

Elimination

Daily loss of iron from urine, sweat, and sloughing of intestinal mucosal cells equals about 0.5 to 1 mg in healthy men and about 1 to 2 mg in menstruating women.

Indications and Usage

Prevention and treatment of iron deficiency and iron-deficiency anemias.

Unlabeled Uses

Use with epoetin to ensure hematologic response to epoetin.

Contraindications

Hypersensitivity to any ingredient, hemosiderosis, hemolytic anemia, hemochromatosis.

Dosage and Administration

Stated dose is for elemental iron. Dosage must be calculated based on salt form. Ferrous sulfate is 20% elemental iron. Ferrous sulfate, exsiccated, is approximately 32% elemental iron. Ferrous gluconate is about 12% elemental iron. Ferrous fumarate is 33% elemental iron.

PO 150 to 300 mg/day in 3 divided doses. Alternatively, 60 mg 2 to 4 times daily may lessen GI effects.

PO 3 to 6 mg/kg/day in 1 to 3 divided doses.

PO 2 to 4 mg/kg/day in 1 to 2 divided doses.

PO 60 mg/day in 1 to 2 divided doses.

PO 1 to 2 mg/kg/day in 1 to 3 divided doses (max, 15 mg/day).

PO 2 mg/kg/day in 1 to 3 divided doses (max, 15 mg/day).

PO 8 mg/day.

PO 11 mg/day.

PO 8 mg/day.

PO 8 mg/day.

PO 18 mg/day.

PO 15 mg/day.

PO 8 mg/day.

PO 10 mg/day.

PO 7 mg/day.

PO 11 mg/day.

PO 27 mg/day.

19 yr of age and older: PO 9 mg/day.

18 yr of age and younger: PO 10 mg/day.

PO 15 to 30 mg/day should meet the daily requirements for last 2 trimesters.

PO 27 to 130 mg/day or as directed by health care provider.

PO As directed by health care provider.

General Advice

• Discomfort, such as nausea, may be minimized by taking with food.
• Multiple salt forms (eg, sulfate, gluconate, fumarate) containing different amounts of elemental iron are available. Ensure proper salt form is being used and doses are determined as elemental iron.
• Separate administration of iron supplements and antacids, tetracyclines, or fluoroquinolones by at least 2 h.
• Administer 1 h before or 2 h after a meal. Administer in divided doses if GI upset occurs. If GI upset does not resolve with divided dose administration, administer each dose with food.
• Advise patient receiving enteric-coated or timed-release tablets to swallow tablets whole and not to crush, chew, break, or split.
• Measure prescribed dose of elixir using dosing syringe, dosing spoon, or dosing cup. To reduce risk of temporary staining of teeth, dilute prescribed dose of elixir with water or juice and have patient drink directly or drink through a straw. Do not dilute elixir with milk or wine-based vehicles.
• Measure prescribed dose of iron supplement drops using calibrated dropper. Administer directly into mouth with dropper or mix with water or juice.
• Shake suspension well before measuring dose. Measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or dosing cup.

Storage/Stability

Store all dose forms at controlled room temperature (59° to 86°F). Protect from excessive heat and moisture. Protect elixir and drops from freezing.

Drug Interactions

Iron absorption may be decreased.

May increase iron absorption.

Coadministration within 2 h may promote formation of inactive captopril disulfide dimmer.

Absorption of cefdinir may be decreased. Administer cefdinir 2 h before or after iron.

May increase serum iron concentrations.

Serum iron response to oral iron may be decreased.

Effects of levodopa may be decreased.

Efficacy of levothyroxine may be reduced.

Absorption may be decreased by iron.

Absorption of both drugs may be decreased.

Absorption of both drugs may be decreased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

GI

Anorexia; constipation; dark stool; diarrhea; irritation; nausea; vomiting.

Miscellaneous

Teeth staining with liquid formulation.

Precautions

Pregnancy

Category A .

Tartrazine Sensitivity

Some products contain tartrazine, which may cause allergic-type reactions in susceptible individuals.

Sulfite Sensitivity

Some products contain sulfites, which cause allergic-type reactions in susceptible individuals.

GI effects

Discomfort, such as nausea, constipation, diarrhea, nausea, vomiting, indigestion, and gas may be minimized by taking with food. Monitor patient for GI adverse reactions.

Overdosage

Symptoms

Abdominal pain, acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, pulmonary edema, pyloric or antral stenosis, shock, tarry stool, weak/rapid pulse, vomiting.

Patient Information

• Advise patient dose may be changed periodically to obtain max benefit and minimize adverse reactions.
• Caution patient receiving iron supplements in conjunction with epoetin therapy that failure to take the iron supplement as prescribed may interfere with the beneficial effects of epoetin. Caution patient not to change the dose of, or stop taking, the iron supplement unless advised by health care provider.
• Caution patient or caregiver who is considering self-treatment of a suspected anemic state to seek medical advice before beginning treatment. Advise patient that other conditions could mimic an anemic state and using iron supplements could be harmful if taken when not clearly needed.
• Caution patient each iron product has specific dosing instructions, to read package label before using, and not to exceed dose or frequency of administration instructions unless advised differently by health care provider.
• Caution patient or caregiver multiple salt forms (eg, sulfate, gluconate, fumarate) containing different amounts of elemental iron are available and to check product label when purchasing replacement iron supplements to ensure proper salt form is being used and doses are the same based on elemental iron content.
• Advise patient with sulfite or tartrazine sensitivity to carefully read inactive ingredients listed on package to identify iron supplement that contains sulfites and/or tartrazine. Advise patients to avoid those products and consult with pharmacist if they have any questions or are not sure about the contents of the product.
• Advise patient to take on an empty stomach, 1 h before or 2 h after a meal.
• Advise patient to take in divided doses if GI upset occurs with single dose. If GI upset does not resolve with divided dose administration, advise patient to take each dose with food.
• Instruct patient who also is taking antacids, tetracycline antibiotic, or fluoroquinolone antibiotic to separate administration of iron supplement by at least 2 h.
• Advise patient using enteric-coated or timed-release tablets to swallow tablets whole and not to crush, chew, cut, or split the tablet.
• Advise patient using elixir to measure prescribed dose of elixir using dosing syringe, dosing spoon, or dosing cup. To reduce risk of temporary staining of teeth, advise patient to dilute prescribed dose of elixir with water or juice and drink directly or drink through a straw. Caution patient not to dilute elixir with milk or wine-based vehicles.
• Advise patient or caregiver using iron supplement drops to measure prescribed dose using calibrated dropper and to administer directly into mouth with dropper or mix with water or juice. Inform parent or caregiver that when iron-containing drops are given to infants, the membrane covering the teeth may darken; this is normal and of no consequence.
• Advise patient using suspension to shake suspension well before measuring dose and to measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or dosing cup.
• Advise patient or caregiver iron supplements may cause the stools to turn black and this is normal and of no consequence.
• Advise patient or caregiver stomach pain, constipation, diarrhea, stomach irritation, nausea, and vomiting are the most common adverse reactions. Instruct patient to notify health care provider if any occur and are intolerable.
• Caution parent or caregiver accidental overdose of iron-containing products is a leading cause of fatal poisoning in children and to take precautions to keep iron-containing products out of reach of children.