Corvite FE
Corvite FE
FULL PRESCRIBING INFORMATION: CONTENTS*
- CORVITE FE INDICATIONS AND USAGE
- CORVITE FE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- CORVITE FE ADVERSE REACTIONS
- OVERDOSAGE
- CLINICAL PHARMCOLOGY
- CORVITE FE DESCRIPTION
- DOSAGE ANO ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton
FULL PRESCRIBING INFORMATION
PRESCRIBING INFORMATION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet Servings per Box: 30 |
||
| Amount per Serving | % Daily Value | |
| Vitamin C (Calcium Ascorbate) | 160 mg | 267% |
| Calcium Threonate | 5 mg | <1% |
| Sumalate® Ferrous Asparto Glycinate (Elemental Iron) U.S. Pat. No. 6,716,814; U.S. Pat. No. 5,516,925; U.S. Pat. No. 8,007,846 and patents pending including U.S. Pat. Appl. No. 13/189,893 and U.S. Pat. Appl. No. 61/538,028 |
25 mg | 139% |
| Ferronyl Carbonyl Iron (Elemental Iron) | 125 mg | 694% |
| Vitamin D3 (Cholecalciferol) | 1,000 IU | 250% |
| Vitamin B6 (Pyridoxine HCI) | 10 mg | 500% |
| Folate (Folic Acid) | 1 mg | 250% |
| Vitamin B12 (Cyanocobalamin) | 15 mcg | 250% |
| Magnesium (as di-Magnesium Malate) | 15 mg | 3.8% |
| Zinc (as TRAACS® Zinc Glycinate Chelate) Malates covered by U.S. Patent 6,706,904, Chelate covered by U.S. Patent 7,838,042; and patents pending. |
25 mg | 167% |
Other Ingredients
Microcrystalline Cellulose, Di Calcium Phosphate, Croscarmellose Sodium, Acacia, Isopropyl Alcohol, Povidone K30, Purified Water, Magnesium Stearate, TriPotassium Citrate, Citric Acid, Fumed Silica, Hypromellose, Ethyl Cellulose, Titanium Dioxide, Polyethylene Glycol, FD&C Red #40 Lake, Talc, Polysorbate 80, Hydroxypropyl Cellulose, Black Iron Oxide and Vegetable Oil.
CORVITE FE INDICATIONS AND USAGE
CORVITE® FE is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
CORVITE FE CONTRAINDICATIONS
CORVITE® FE is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
| 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. |
Call your doctor about side effects. You may report side effects by calling 877-95-VERTI (877-958-3784).
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 in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
CORVITE FE 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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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.
CLINICAL PHARMCOLOGY
Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport.
Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase. Vitamin B12 is required for the maintenance of normal erythropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of vitamin B12 from the gastrointestinal tract.
CORVITE FE DESCRIPTION
Red, oval bisected tablets embossed "VP042".
DOSAGE ANO ADMINISTRATION
Usual adult dose is 1 tablet daily, or as prescribed by a physician.
HOW SUPPLIED
CORVITE ® FE available in carton unit dose pack of 30 (3 child resistant blister cards of 10 tablets per card). 68025-042-30
STORAGE
Store at controlled room temperature 1 5°-30°C (59°-86°F) [See USP]. Protect from light, moisture and excessive heat. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure.
KEEP THIS PRODUCT OUT OF REACH OF CHILOREN.
Rx Only.
Manufactured for:
Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872
PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton
68025-042-30
Rx Only
CORVITE®
FE
Tablets
Iron Supplementation
VERTICAL
PHARMACEUTICALS, INC.
Corvite FECalcium Ascorbate, Calcium Threonate, Ferrous Asparto Glycinate, Iron, Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Magnesium Malate, and Zinc Glycinate TABLET, COATED
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
