Ferralet 90®

Precautions re: Pregnant or Nursing or Prescription Medications

Indications and Usage: Ferralet 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.

Precautions re: All Other

Contraindications: Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy. Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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 the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions re: All Other

Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with Ferralet 90 tablets. Ensure Hgb, Hct, and reticulocyte counts are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.

Precautions re: Allergies

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Precautions re: All Other

Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.

Precautions re: Children

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

Precautions re: All Other

Geriatric Use: Dosing for elderly patients should be administered with caution. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range. Adverse Reactions: Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient.

Precautions re: Allergies

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Precautions re: Pregnant or Nursing or Prescription Medications

Drug Interactions: Prescriber should be aware of a number or iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

Precautions re: All Other

Overdosage: Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

Precautions re: All Other

To report a serious adverse event or obtain product information, call (800) 298-1087.

Precautions re: All Other

Rx Only