Corvite Fe by Vertical Pharmaceuticals
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Statements
Direction for use
Take one tablet by mouth daily or as directed by a physician.
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.
Contraindications
Corvite Fe 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
General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Corvite Fe. 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.
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 neurological manifestations remain progressive.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
The patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
Pediatric Use: Safety and effectiveness in pediatric population have not been established.
Drug Interactions
There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., aspirin, heparin, clopidogrel).
Adverse Reactions
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain which are usually transient.
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.
Keep out of reach of children.
Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-877-95-VERTI (1-877-958-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage
Store at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F) [See USP]. Protect from light and moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined by the USP using a child-resistant closure.
Gluten, lactose and sugar free
Corvite Fe is a professionally prescribed hematinic multivitamin/multi mineral dietary supplement wed to improve the nutrition status of patients with iron deficiency; this includes women prior to conception throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.
Quatrefolic is a registered trademark of Gnosis, SpA.
U.S. Patent No. 7,947,662.
TRAACS is registered trademark of Albion International, Inc.
Malate covered by U.S. Patent No, 6,706,904;
Chelate covered by U.S. Patent No. 7,838,042.