Corvite 150
CORVITE® 150 IRON SUPPLEMENTATION
FULL PRESCRIBING INFORMATION: CONTENTS*
- PRESCRIBING INFORMATION
- CORVITE 150 INDICATIONS AND USAGE
- CORVITE 150 CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- CORVITE 150 ADVERSE REACTIONS
- OVERDOSAGE
- CLINICAL PHARMCOLOGY
- DOSAGE ANO ADMINISTRATION
- CORVITE 150 DESCRIPTION
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
PRESCRIBING INFORMATION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet | ||
| Servings per Bottle: 30 | ||
| Amount per Serving | % DV | |
| Vitamin C (Calcium Ascorbate) | 120 mg | 200% |
| Calcium Threonate | 5 mg | <1% |
| Vitamin B6 (Pyridoxine HCl) | 10 mg | 500% |
| Vitamin B7 (Biotin 1%) | 100 mcg | 33% |
| Vitamin B12 (Cyanocobalamin) | 20 mcg | 333% |
| Folate | 1 mg | 250% |
| [as folic acid 700 mcg and Quatrefolic® ((6S)-5-methyltetrahydrofolic acid) 300 mcg, (equivalent to 600 mcg of (6S)-5-methyltetrahydrofolic acid, glucosamine salt)] |
||
| Iron (Ferronyl Carbonyl Iron) | 150 mg | 833% |
| Magnesium (oxide) | 10 mg | 3% |
| Zinc (citrate) | 25 mg | 167% |
Other Ingredients
Microcrystalline Cellulose, Pregelatinized Starch, di-Calcium Phosphate, Red Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, FD&C Red #40 Lake, Polyethylene Glycol, Talc, Titanium Dioxide), Croscarmellose Sodium, Stearic Acid, Magnesium Stearate..
Sugar, Lactose, and Gluten Free
Vegan Safe
CORVITE 150 INDICATIONS AND USAGE
CORVITE®150 is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
CORVITE 150 CONTRAINDICATIONS
CORVITE®150 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. |
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®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.
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 150 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.
DOSAGE ANO ADMINISTRATION
Usual adult dose is 1 tablet daily, or as directed by a physician.
CORVITE 150 DESCRIPTION
Corvite®150 are red, oval bisected tablets embossed "VP052".
HOW SUPPLIED
CORVITE®150 tablets are supplied in bottles of 30 units.
Product Code: 68025-052-30
STORAGE
Store at controlled room temperature 1 5°-30°C (59°-86°F) [see USP]. Protect from light, moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure.
KEEP OUT OF THE REACH OF CHILDREN.
Call your doctor about side effects. You may report side effects by calling 877-95-VERTI (877-958-3784).
Rx Only
Manufactured for:
Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872
www.verticalpharma.com
PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
68025-052-30
RX Only
CORVITE®
150
Now with
Quatrefolic®
TABLETS
Iron Supplementation
PATENT PENDING
Sugar, Lactose & Gluten Free
Vegan Safe
30 Tablets
VERTICAL
PHARMACEUTICALS, INC.
Corvite 150Calcium Ascorbate, Calcium Threonate, Pyridoxine Hydrochloride, Biotin, Cyanocobalamin, Folic Acid, 5-METHYLTETRAHYDROFOLIC ACID, IRON PENTACARBONYL, Magnesium Oxide, and Zinc Citrate TABLET, COATED
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