Ferotrin

Ferotrin is part of the drug classes:

• Vitamin B12 cyanocobalamin and analogues

• vitamin C products, plain

• Organic acids

• OTHER OPHTHALMOLOGICALS

• Iron bivalent, oral preparations

• Iron in combination with folic acid

• Folic acid and derivatives

This capsule (hematinic concentrate with intrinsic factor) is a multifactor preparation

effective in the treatment of anemias that respond to oral hematinics, including

pernicious anemia and other megaloblastic anemias and also iron deficiency

anemia. Therapeutic quantities of hematopoietic factors that are known to be

important are present in the recommended daily dose.

Accidental overdose of iron-containing products is a

leading cause of fatal poisoning in children under six. Keep this

product out of reach of children. In case of accidental overdose,

call a doctor or Poison Control Center immediately.

Controlled Substance

Abuse

Dependence

Symptoms: Those of iron intoxication, which may include pallor and cyanosis, vomiting,

hematemesis, diarrhea, melena, shock, drowsiness, and coma.

Treatment: For specific therapy, exchange transfusion and chelating agents. For general

management, gastric and rectal lavage with sodium bicarbonate solution or milk,

administration of intravenous fluids and electrolytes, and use of oxygen.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Black, tarry, or bloody stools.
• Fever.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Stomach cramps.

Applies to multivitamin with iron: injectable solution, oral capsule, oral capsule extended release, oral liquid, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects associated with oral iron therapy have included nausea, constipation, anorexia, heartburn, vomiting, and diarrhea. These effects are generally dose-related. In addition, stools may appear darker in color in patients taking products containing iron. Iron oral preparations may rarely cause Hemoccult-positive stools, patients with positive tests generally require further work-up.[Ref]

Other

Stained teeth have primarily occurred following ingestion of iron liquid preparation.

Iron overload (i.e., hemosiderosis) has been reported in patients genetically predisposed, or have underlying disorders, that augment the absorption of iron. It has also occurred following administration of excessive parenteral iron therapy, combination of oral and parenteral iron, or in patients with hemoglobinopathies that were erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with repeated phlebotomy or long-term administration of deferoxamine. The liver is particularly susceptible to toxicity in iron-overload states.[Ref]

Other side effects associated with oral iron products have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.[Ref]

Metabolic

Metabolic side effects associated with iron have included decreased absorption of thyroxine (T4).[Ref]

Some side effects of Ferotrin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.