Folivane-F

TRIGEN Laboratories, Inc.

Folivane™-F with Ascorbic Acid Precursors

FULL PRESCRIBING INFORMATION: CONTENTS*

• FOLIVANE-F DESCRIPTION
• Inactive Ingredients
• INDICATIONS
• FOLIVANE-F CONTRAINDICATIONS
• WARNING
• PRECAUTION
  • General
  • USAGE IN PREGNANCY
  • Pediatric Use
  • Geriatric Use
• FOLIVANE-F ADVERSE REACTIONS
  • Folic Acid
• Ferrous Fumarate
• OVERDOSAGE
  • Iron
  • Treatment
• FOLIVANE-F DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

R_x Only

FOLIVANE-F DESCRIPTION

Folivane™-F are maroon capsules imprinted "T538" in white. It is a prescription iron, folic acid, and vitamin supplement.

Supplement Facts Servings per Bottle: 90
Serving Size: 1 Capsule Each Capsule contains:	%DV for Adults Only
Ferrous Fumarate (elemental) From 223.214 mg Iron	62.5 mg
Polysaccharide Iron Complex (elemental) From 223.2 mg Iron.	62.5 mg	Total Iron: Ferrous Fumarate + Polysaccharide Iron Complex.694%
Folic Acid	1 mg	250%
Vitamin C (ascorbic acid) Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including niacinamide ascorbate, calcium ascorbate, magnesium ascorbate, potassium ascorbate, and sodium ascorbate; (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin complex, and (4) Glutathione.	40 mg	67%
Vitamin B3 Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including niacinamide ascorbate, calcium ascorbate, magnesium ascorbate, potassium ascorbate, and sodium ascorbate; (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin complex, and (4) Glutathione.	3 mg	15%

Inactive Ingredients

Microcrystalline Cellulose, Hypromellose, Magnesium Stearate, Titanium Dioxide, FD&C Red #40, Fumed Silica, and FD&C Blue #1.

INDICATIONS

Folivane™-F is indicated for the treatment of iron deficiency anemia and folate deficiency anemia. Folivane™-F is indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.

FOLIVANE-F CONTRAINDICATIONS

Folivane™-F is contraindicated in patients with a known hypersensitivity to any of the ingredients, also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindicated, as folic acid may obscure its signs and symptoms.

WARNING

Foli acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B₁₂ is deficient.

PRECAUTION

General

Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. No single regime fits all cases and the status of the patient observed in follow-up is the final criterion for adequacy of therapy. Periodic clinical and laboratory studies are considered essential. Blood examinations including hemoglobin and hematocrit should be done at the usual intervals to make certain that therapy is adequate. Use with care in the presence of peptic ulcers, regional enteritis, and ulcerative colitis. Folic acid, especially in doses over 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

USAGE IN PREGNANCY

Before Folivane™-F is prescribed for megaloblastic anemia in pregnancy, appropriate diagnostic exclusion of Addisonian pernicious anemia (due to faulty or blocked absorption of vitamin B₁₂, or extrinsic factor or either a genetic, immunological or surgical basis) should be carried out.

Pediatric Use

Safety and effectiveness of this product have not been established in pediatric patients.

Geriatric Use

No clinical studies have been performed in patients age 65 and older to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosing scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and/or concomitant disease.

FOLIVANE-F ADVERSE REACTIONS

Folic Acid

Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Ferrous Fumarate

Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation, heartburn and vomiting) occur occasionally, but are usually mild and may subside with continuation of therapy. Reducing the dose and administering it with meals will minimize these effects in the sensitive patient. Increasing fiber in the diet can relieve constipation. Iron may turn stools black. This is a harmless effect that is a result of unabsorbed iron. Although the absorption of iron is best when taken between meals, giving Folivane™-F after meals may diminish occasional G.I. disturbances. Folivane™-F is best absorbed when taken at bedtime.

OVERDOSAGE

Iron

Signs and Symptoms

Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Folivane™-F should be stored beyond the reach of children to prevent against accidental iron poisoning.

Treatment

For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

FOLIVANE-F DOSAGE AND ADMINISTRATION

Adults (persons over 12 years of age): One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

HOW SUPPLIED

Folivane™-F is supplied in bottles of 90 capsules.

Product Code: 13811-538-90

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

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

KEEP OUT OF THE REACH OF CHILDREN.

R_x Only

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

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

Rev. 03/13

PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label

13811-538-90
R_x Only

Folivane™ - F
with Ascorbic Acid Precursors

IRON / FOLIC ACID / VITAMIN
SUPPLEMENT CAPSULES

90 CAPSULES

TRIGEN
LABORATORIES