INFeD (iron dextran injection USP) is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use.

Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. The pH of the solution is between 5.2 and 6.5.

The iron dextran complex has an average apparent molecular weight of 165,000 g/mole with a range of approximately ±10%.

Therapeutic Class: Hematinic

Last updated on RxList: 10/22/2008

Intravenous or intramuscular injections of iron dextran are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.

Oral iron should be discontinued prior to administration of INFeD.

Dosage

I.Iron Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy. It should be recognized that iron storage may lag behind the appearance of normal blood morphology. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state.

After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count.

Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex.

Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well.

Factors contributing to the formula are shown below.

mg blood iron =	=	mL blood	x	g hemoglobin	x	mg iron
lb body weight		lb body weight		mL blood		g hemoglobin

1. Blood volume..........................65 mL/kg of body weight
2. Normal hemoglobin (males and females)
   
   over 15 kg (33 lbs)...................14.8 g/dl
   15 kg (33 lbs) or less...............12.0 g/dl
3. Iron content of hemoglobin....................0.34%
4. Hemoglobin deficit
5. Weight

Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb).

Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss.

TOTAL INFeD® REQUIREMENT FOR HEMOGLOBIN RESTORATION AND IRON STORES REPLACEMENT*

PATIENT LEAN BODY WEIGHT		Milliliter Requirement of INFeD Based On Observed Hemoglobin of
kg	lb	3 (g/dl)	4 (g/dl)	5 (g/dl)	6 (g/dl)	7 (g/dl)	8 (g/dl)	9 (g/dl)	10 (g/dl)
5	11	3	3	3	3	2	2	2	2
10	22	7	6	6	5	5	4	4	3
15	33	10	9	9	8	7	7	6	5
20	44	16	15	14	13	12	11	10	9
25	55	20	18	17	16	15	14	13	12
30	66	23	22	21	19	18	17	15	14
35	77	27	26	24	23	21	20	18	17
40	88	31	29	28	26	24	22	21	19
45	99	35	33	31	29	27	25	23	21
50	110	39	37	35	32	30	28	26	24
55	121	43	41	38	36	33	31	28	26
60	132	47	44	42	39	36	34	31	28
65	143	51	48	45	42	39	36	34	31
70	154	55	52	49	45	42	39	36	33
75	165	59	55	52	49	45	42	39	35
80	176	63	59	55	52	48	45	41	38
85	187	66	63	59	55	51	48	44	40
90	198	70	66	62	58	54	50	46	42
95	209	74	70	66	62	57	53	49	45
100	220	78	74	69	65	60	56	52	47
105	231	82	77	73	68	63	59	54	50
110	242	86	81	76	71	67	62	57	52
115	253	90	85	80	75	70	64	59	54
120	264	94	88	83	78	73	67	62	57
*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs).

The total amount of INFeD in mL required to treat the anemia and replenish iron stores may be approximated as follows:

Adults and Children over 15 kg (33 lbs): See Dosage Table.

Alternatively the total dose may be calculated:

Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW)
Based on: Desired Hb = the target Hb in g/dl.
Observed Hb = the patient's current hemoglobin in g/dl.
LBW = Lean body weight in kg. A patient's lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.
For males: LBW = 50 kg + 2.3 kg for each inch of patient's height over 5 feet
For females: LBW = 45.5 kg + 2.3 kg for each inch of patient's height over 5 feet
To calculate a patient's weight in kg when lbs are known:

patient's weight in pounds	= weight in kilograms
2.2

Children 5 - 15 kg (11 - 33 lbs): See Dosage Table.

INFeD should not normally be given in the first four months of life. (See PRECAUTIONS: Pediatric Use)

Alternatively the total dose may be calculated:

Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W)
Based on: Desired Hb = the target Hb in g/dl. (Normal Hb for Children 15 kg or less is 12 g/dl)
W = Weight in kg.
To calculate a patient's weight in kg when lbs are known:

patient's weight in pounds	= weight in kilograms
2.2

II. Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. The table and formula described under I. Iron Deficiency Anemia are not applicable for simple iron replacement values. Quantitative estimates of the individual's periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose.

The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron:

Replacement iron (in mg) = Blood loss (in mL) x hematocrit
Example: Blood loss of 500 mL with 20% hematocrit
Replacement Iron = 500 x 0.20 = 100 mg

INFeD dose =	100 mg	= 2 mL
	50

Administration: The total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage).

1. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. (See PRECAUTIONS: General.) THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given.

Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.

2. Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. (See PRECAUTIONS: General.) The test dose should be administered in the same recommended test site and by the same technique as described in the last paragraph of this section. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given.

If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Each day's dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients.

INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas - and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended.

NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

INFeD® (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02).

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Watson Pharma, Inc. A subsidiary of Watson Pharmaceuticals, Inc. Morristown, NJ 07962 USA. FDA Rev date: 11/26/2002

Last updated on RxList: 10/22/2008

Severe/Fatal: Anaphylactic reactions have been reported with the use of iron dextran injection; on occasions these reactions have been fatal. Such reactions, which occur most often within the first several minutes of administration, have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. Because fatal anaphylactic reactions have been reported after administration of iron dextran injection, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available. (See BOXED WARNING and PRECAUTIONS: General, pertaining to immediate availability of epinephrine.)

Cardiovascular:Chest pain, chest tightness, shock, cardiac arrest, hypotension, hypertension, tachycardia, bradycardia, flushing, arrhythmias. (Flushing and hypotension may occur from too rapid injections by the intravenous route.)

Dermatologic: Urticaria, pruritus, purpura, rash, cyanosis.

Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea.

Hematologic/lymphatic: Leucocytosis, lymphadenopathy.

Musculoskeletal/soft tissue: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis - See PRECAUTIONS: General), myalgia; backache; sterile abscess, atrophy/ fibrosis (intramuscular injection site); brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites; cellulitis; swelling; inflammation; local phlebitis at or near intravenous injection site.

Neurologic: Convulsions, seizures, syncope, headache, weakness, unresponsiveness, paresthesia, febrile episodes, chills, dizziness, disorientation, numbness, unconsciousness.

Respiratory: Respiratory arrest, dyspnea, bronchospasm, wheezing.

Urologic: Hematuria.

Delayed reactions: Arthralgia, backache, chills, dizziness, fever, headache, malaise, myalgia, nausea, vomiting (See WARNINGS).

Miscellaneous: Febrile episodes, sweating, shivering, chills, malaise, altered taste.

Drug/Laboratory Test Interactions: Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration.

The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium.

Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran.

Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of INFeD and slowly returns to baseline after about 3 weeks.

Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells.

Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of iron dextran.

Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following iron dextran infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

Last updated on RxList: 10/22/2008

See BOXED WARNING.

A risk of carcinogenesis may attend the intramuscular injection of iron-carbohydrate complexes. Such complexes have been found under experimental conditions to produce sarcoma when large doses or small doses injected repeatedly at the same site were given to rats, mice, and rabbits, and possibly in hamsters.

The long latent period between the injection of a potential carcinogen and the appearance of a tumor makes it impossible to measure accurately the risk in man. There have, however, been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes.

Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse effects. The adverse effects frequently are delayed (1-2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. The onset is usually 24-48 hours after administration and symptoms generally subside within 3-4 days. These symptoms have also been reported following intramuscular injection and generally subside within 3-7 days. The etiology of these reactions is not known. The potential for a delayed reaction must be considered when estimating the risk/benefit of treatment.

The maximum daily dose should not exceed 2 mL undiluted iron dextran.

This preparation should be used with extreme care in patients with serious impairment of liver function.

It should not be used during the acute phase of infectious kidney disease.

Adverse reactions experienced following administration of INFeD may exacerbate cardiovascular complications in patients with preexisting cardiovascular disease.

General

Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias.

INFeD should be used with caution in individuals with histories of significant allergies and/or asthma.

Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administration of subsequent test doses during therapy should be considered. (See DOSAGE AND ADMINISTRATION: Administration.)

Epinephrine should be immediately available in the event of acute hypersensitivity reactions. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.) Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Isoproterenol or similar beta-agonist agents may be required in these patients.

Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD.

Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

See WARNINGS.

Pregnancy

Pregnancy Category C: Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose.

No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs and monkeys at doses of 50 mg iron/kg or less. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. The animals used in these tests were not iron deficient. There are no adequate and well-controlled studies in pregnant women. INFeD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Placental Transfer

Various animal studies and studies in pregnant humans have demonstrated inconclusive results with respect to the placental transfer of iron dextran as iron dextran. It appears that some iron does reach the fetus, but the form in which it crosses the placenta is not clear.

Nursing Mothers

Caution should be exercised when INFeD is administered to a nursing woman. Traces of unmetabolized iron dex-tran are excreted in human milk.

Pediatric Use

Not recommended for use in infants under 4 months of age (See DOSAGE AND ADMINISTRATION).

Last updated on RxList: 10/22/2008

Overdosage with iron dextran is unlikely to be associated with any acute manifestations. Dosages of iron dextran in excess of the requirements for restoration of hemoglobin and replenishment of iron stores may lead to hemosiderosis. Periodic monitoring of serum ferritin levels may be helpful in recognizing a deleterious progressive accumulation of iron resulting from impaired uptake of iron from the reticuloendothelial system in concurrent medical conditions such as chronic renal failure, Hodgkins disease, and rheumatoid arthritis. The LD₅₀ of iron dextran is not less than 500 mg/kg in the mouse.

Hypersensitivity to the product. All anemias not associated with iron deficiency.

Last updated on RxList: 10/22/2008

General

After intramuscular injection, iron dextran is absorbed from the injection site into the capillaries and the lymphatic system. Circulating iron dextran is removed from the plasma by cells of the reticuloendothelial system, which split the complex into its components of iron and dextran. The iron is immediately bound to the available protein moieties to form hemosiderin or ferritin, the physiological forms of iron, or to a lesser extent to transferrin. This iron which is subject to physiological control replenishes hemoglobin and depleted iron stores.

Dextran, a polyglucose, is either metabolized or excreted. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran.

The major portion of intramuscular injections of iron dextran is absorbed within 72 hours; most of the remaining iron is absorbed over the ensuing 3 to 4 weeks.

Various studies involving intravenously administered ⁵⁹Fe iron dextran to iron deficient subjects, some of whom had coexisting diseases, have yielded half-life values ranging from 5 hours to more than 20 hours. The 5-hour value was determined for ⁵⁹Fe iron dextran from a study that used laboratory methods to separate the circulating ⁵⁹Fe iron dextran from the transferrin-bound ⁵⁹Fe. The 20-hour value reflects a half-life determined by measuring total ⁵⁹Fe, both circulating and bound. It should be understood that these half-life values do not represent clearance of iron from the body. Iron is not easily eliminated from the body and accumulation of iron can be toxic.

In vitro studies have shown that removal of iron dextran by dialysis is negligible.^1,2 Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux.

REFERENCES:

1. Hatton RC, Portales IT, Finlay A, Ross EA. Removal of Iron Dex-tran by Hemodialysis: An In Vitro Study. Am J Kid Dis. 1995; 26(2):327-330.

2. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Nephron. 1972;9:94-98.

Last updated on RxList: 10/22/2008

Patients should be advised of the potential adverse reactions associated with the use of INFeD.

Last updated on RxList: 10/22/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

IRON DEXTRAN - INJECTION

(EYE-urn DEX-tran)

COMMON BRAND NAME(S): Dexferrum, INFeD

WARNING: Infrequently, iron dextran for injection has caused severe (sometimes fatal) allergic reactions. It should be used only when clearly needed and when a patient is unable to take iron by mouth (oral forms).

Notify your doctor immediately if you experience signs of an allergic reaction such as trouble breathing, dizziness, rash, or itchy skin.

USES: This medication is used to treat "iron-poor" blood (anemia) in people who cannot take iron by mouth because of side effects or because their anemia has not been successfully treated by it. Low iron levels can occur when the body can't get enough iron from food (poor nutrition, poor absorption) or when there is a large or long-term blood loss (e.g., hemophilia, stomach bleeding). You may also need extra iron because of blood loss during kidney dialysis. Your body may need more iron if you use the drug erythropoietin to help make new red blood cells.

Iron is an important part of your red blood cells and is needed to carry oxygen in the body.

HOW TO USE: This medication is usually injected by a health care professional deep into the muscle of the buttock or slowly into a vein. When injecting into the buttock, give the next injection on the opposite side from the last injection. Iron dextran can also be mixed in a solution and given into a vein over a longer time. Inject this medication as directed by your doctor.

Before the first full dose, a smaller test dose is given slowly to check for possible allergic effects. If no reaction is seen after 15 minutes to 1 hour, the full dose may be given. You will be checked carefully for reactions by a health care worker while you are getting the iron.

Iron injections may be given once daily in small doses or as directed by your doctor. Large doses may be given in a solution and injected into a vein over several hours. Some side effects such as dizziness and flushing may be stopped by giving the drug more slowly. The dose and length of treatment is based on your age, weight, condition, and response to therapy. Your doctor will order blood tests to monitor your response.

Before using, check this product visually for particles. It should be dark brown before mixing and a light reddish-brown after mixing. If particles or discoloration are present, do not use the liquid.

Only newly opened containers (vials) should be used. Do not keep any medication left in the vial for future use.

SIDE EFFECTS: Flushing, tingling of the hands/feet, shivering, or dizziness may occur. The area around the injection site may be tender, irritated, or discolored (brown). If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Some people may experience a delayed reaction 1-2 days after their treatment. These side effects usually lessen within 3 to 4 days if the medication was injected into a vein or within 3 to 7 days if the medication was injected into a muscle. Tell your doctor if any of these side effects persist or worsen more than 4 to 7 days after your treatment: back/joint/muscle aches, chills, moderate to high fever, headache, nausea/vomiting.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: abdominal pain, fast/slow/irregular heartbeat, severe headache, blurred vision.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug may occur. Seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: low blood count not due to low iron (e.g., vitamin B12/folate deficiency), active kidney infection.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe allergic reactions, asthma, bleeding problems (e.g., hemophilia), heart disease (e.g., chest pain, heart attack, heart failure), Hodgkin's disease, autoimmune disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus), kidney disease/dialysis, liver disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: other iron products.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting iron dextran.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: beta blockers (e.g., atenolol, propranolol), "blood thinners" (e.g., heparin, warfarin), multivitamins with minerals.

This medication may interfere with certain laboratory tests (including bilirubin, calcium, and clotting times), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. If overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, iron) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

It is important to maintain a well-balanced diet to ensure adequate intake of iron, vitamins, and minerals. Good sources of iron include meats (especially liver), eggs, raisins, figs, broccoli, Brussels sprouts, beans, lentils, and iron-fortified or enriched cereals. Follow any diet recommendations given to you by your doctor.

MISSED DOSE: If you miss a dose, use it as soon as you remember unless it is near the time for the next dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store this medication at room temperature between 59-86 degrees F (15-30 degrees C) away from heat and light. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.