Corvita 150™

Precautions re: All Other

Contraindications: Corvita 150 should not be used by patients with a known hypersensitivity to any of the listed ingredients. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.

Precautions re: Children

Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions re: All Other

Precautions General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Corvita 150. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Precautions re: Allergies

Folic Acid: Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Precautions re: Pregnant or Nursing or Prescription Medications

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

Precautions re: Children

Pediatric Use: Safety and effectiveness in pediatric populations have not been established.

Precautions re: All Other

Geriatric Use: Safety and effectiveness in elderly populations have not been established.

Precautions re: Pregnant or Nursing or Prescription Medications

Drug Interactions There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

Precautions re: All Other

Adverse Reactions Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.

Precautions re: All Other

Overdosage The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

Precautions re: All Other

Call your doctor about side effects. To report side effects, call Trigen Laboratories at 1-888-9-TRIGEN (1-877-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.