Iron Sucrose
Generic Name: iron sucrose
Brand Names:
Iron Sucrose
11 DESCRIPTION Iron Sucrose Injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron Sucrose Injection, USP has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na 2 Fe 5 O 8 (OH) • 3(H 2 O] n • m(C 12 H 22 O 11 ) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide.
Overview
11 DESCRIPTION Iron Sucrose Injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron Sucrose Injection, USP has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na 2 Fe 5 O 8 (OH) • 3(H 2 O] n • m(C 12 H 22 O 11 ) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide.
Uses
1 INDICATIONS AND USAGE Iron Sucrose Injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron Sucrose Injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
Dosage
2 DOSAGE AND ADMINISTRATION Population Dose Adult Patients Hemodialysis Dependent- Chronic Kidney Disease (HDD-CKD) ( 2.2 ) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent- Chronic Kidney Disease (NDD-CKD) ( 2.3 ) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) ( 2.4 ) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD ( 2.5 ), PDD- CKD or NDD-CKD ( 2.6 ) 0.5 mg/kg slow intravenous injection or infusion 2.1 Mode of Administration Administer Iron Sucrose Injection only intravenously by slow injection or by infusion. The dosage of Iron Sucrose Injection is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] • Hypotension [ see Warnings and Precautions ( 5.2 ) ] • Iron Overload [ see Warnings and Precautions ( 5.3 ) ] • Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.1 ) • Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension.
Interactions
7 DRUG INTERACTIONS Iron Sucrose Injection may reduce the absorption of concomitantly administered oral iron preparations.
Warnings
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Iron Sucrose Injection administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Iron Sucrose Injection when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) • Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration ( 5.2 ) • Iron Overload: Regularly monitor hematologic responses during therapy. 4 CONTRAINDICATIONS Known hypersensitivity to Iron Sucrose Injection • Known hypersensitivity to Iron Sucrose Injection ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes ( see Data ). Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risk to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ).
Storage
16.2 Stability and Storage Contains no preservatives. Store in original carton at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Do not freeze.
Frequently Asked Questions
What is Iron Sucrose used for?▼
1 INDICATIONS AND USAGE Iron Sucrose Injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron Sucrose Injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
What are the side effects of Iron Sucrose?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] • Hypotension [ see Warnings and Precautions ( 5.2 ) ] • Iron Overload [ see Warnings and Precautions ( 5.3 ) ] • Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.1 ) • Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension.
Can I take Iron Sucrose during pregnancy?▼
8.1 Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes ( see Data ). Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risk to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ).
What are the important warnings for Iron Sucrose?▼
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Iron Sucrose Injection administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Iron Sucrose Injection when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) • Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration ( 5.2 ) • Iron Overload: Regularly monitor hematologic responses during therapy. 4 CONTRAINDICATIONS Known hypersensitivity to Iron Sucrose Injection • Known hypersensitivity to Iron Sucrose Injection ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.