CORVITA 150

TRIGEN Laboratories, Inc.

CORVITA 150 TABLETS

FULL PRESCRIBING INFORMATION: CONTENTS*

• CLINICL PHARMACOLOGY
• CORVITA 150 INDICATIONS AND USAGE
• CORVITA 150 CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Folic Acid
  • Pediatric Use
  • Geriatric Use
• CORVITA 150 ADVERSE REACTIONS
• OVERDOSAGE
• CORVITA 150 DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Tablets Blister Label

FULL PRESCRIBING INFORMATION

CLINICL PHARMACOLOGY

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.

CORVITA 150 INDICATIONS AND USAGE

CORVITA^TM 150 is indicated for the prevention and treatment of iron deficiency anemia and / or nutritional megaloblastic anemias.

CORVITA 150 CONTRAINDICATIONS

CORVITA^TM 150 is is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindicated 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.

PRECAUTIONS

General

Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with CORVITA ^TM 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 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 this product since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use

Safety and effectiveness in pediatric patients has 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.

Inactive Ingredients:

Microcrystalline Cellulose, Di-calcium phosphate, Coating (Polyvinyl Alcohol, Polyethylene Glycol, FD&C Red #40 Lake, Talc, Titanium Dioxide), Croscarmellose Sodium, TriPotassium Citrate, Citric Acid, Povidone K30, Acacia, Magnesium Stearate, Stearic Acid.

CORVITA 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.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalences.

CORVITA 150 DOSAGE AND ADMINISTRATION

Usual adult dose is One (1) tablet daily, or directed by a physician.

HOW SUPPLIED

CORVITA^TM 150 are red, oval bisected tablets embossed “VP031” and are supplied in unit dose pack of 100 (10 blister cards of 10 tablets each).

PRODUCT CODE 13811-066-10.

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from light and moisture and avoid 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 CHILDREN.

Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).

R_x Only

Manufactured for:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
www.trigenlab.com

Rev. 05/13

PRINCIPAL DISPLAY PANEL - 100 Tablets Blister Label

13811-066-10
R_x Only

CORVITA ^TM150
TABLETS

Iron Supplimentation

Sugar, Lactose & Gluten Free