Iron Salt

Repletion of total body iron content in patients with iron deficiency anemia who are undergoing hemodialysis in conjunction with erythropoietin therapy

B

There are no well-controlled studies available. Should be used in pregnancy only when the potential benefit to the mother clearly outweighs the potential risk to the fetus. It is not known if ferrous gluconate is excreted in human milk. Use caution if the drug is administered to women who are breast-feeding.

Hypersensitivity to ferric gluconate, benzyl alcohol, or any component of the formulation; use in any anemia not caused by iron deficiency, heart failure (of any severity)

Potentially serious hypersensitivity reactions may occur. Fatal immediate hypersensitivity reactions have occurred with other iron carbohydrate complexes. Avoid rapid administration - flushing and hypotension may occur. Administration rate should not exceed 2.1 mg/minute. Do not administer to patients with iron overload. Use with caution in elderly patients.

Major adverse reactions which are likely to be related ferrous gluconate include hypotension and hypersensitivity reactions. Hypersensitivity reactions have included pruritus, chest pain, hypotension, nausea, abdominal pain, flank pain, fatigue and rash. Fatal hypersensitivity reactions have occurred with other iron polysaccharide complexes. A test dose is recommended.

Cardiovascular: Hypotension (serious hypotension in 1.3%), chest pain, hypertension, syncope, tachycardia, angina, myocardial infarction, pulmonary edema, hypovolemia, peripheral edema

Central nervous system: Headache, fatigue, fever, malaise, dizziness, paresthesia, insomnia, agitation, somnolence

Dermatologic: Pruritus, rash

Endocrine & metabolic: Hyperkalemia, hypoglycemia, hypokalemia

Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea, rectal disorder, dyspepsia, flatulence, melena

Genitourinary: Urinary tract infection

Hematologic: Anemia, abnormal erythrocytes, lymphadenopathy

Local: Injection site reactions, pain

Neuromuscular & skeletal: Weakness, back pain, leg cramps, myalgia, arthralgia, paresthesia

Ocular: Blurred vision, conjunctivitis

Respiratory: Dyspnea, cough, rhinitis, upper respiratory infection, pneumonia

Miscellaneous: Hypersensitivity reactions (3%), infection, rigors, chills, flu-like syndrome, sepsis, carcinoma, increased sweating, diaphoresis (increased)

<1% Epigastric pain, groin pain

Symptoms of iron overdose include CNS toxicity, acidosis, hepatic and renal impairment, hematemesis, and lethargy. A serum iron level greater than or equal to 300 mg/mL requires treatment due to severe toxicity. Treatment is generally symptomatic and supportive, but severe overdoses may be treated with deferoxamine. Deferoxamine may be administered I.V. (80 mg/kg over 24 hours) or I.M. (40-90 mg/kg every 8 hours). Usual toxic dose of elemental iron: greater than or equal to 35 mg/kg.

Supplies a source to elemental iron necessary to the function of hemoglobin, myoglobin and specific enzyme systems; allows transport of oxygen via hemoglobin

Pharmacokinetic studies have not been conducted; the total body iron content normally ranges from 2-4 g of elemental iron

Adults:

Repletion of iron in hemodialysis patients: I.V.: 125 mg (10 mL) in 100 mL 0.9% sodium chloride over 1 hour during hemodialysis. Most patients will require a cumulative dose of 1 g elemental iron over approximately 8 sequential dialysis treatments to achieve a favorable response.

Hemoglobin and hematocrit, serum ferritin, iron saturation

No information available to require special precautions

Do not prescribe tetracyclines simultaneously with iron since GI tract absorption of both tetracycline and iron may be inhibited

This medication will be administered by I.V. in conjunction with your dialysis treatment. Report at once chest pain, rapid heart beat, or palpitations; difficulty breathing; headache dizziness, agitation, or inability to sleep; nausea, vomiting, abdominal or flank pain; or skin rash, itching, or redness. Breast-feeding precautions: Consult prescriber if breast-feeding.

Injection: 12.5 mg/mL (5 mL ampuls)