PureFe Plus

PureTek Corporation

Prescribing Information

FULL PRESCRIBING INFORMATION: CONTENTS*

• CLINICAL PHARMACOLOGY:
• PUREFE PLUS CONTRAINDICATIONS:
• WARNING:
• PRECAUTIONS:
  • Pediatric Use:
  • Geriatric Use:
  • Adverse Reactions:
• PUREFE PLUS DOSAGE AND ADMINISTRATION:
• OVERDOSE:
• HOW SUPPLIED:
• Label

FULL PRESCRIBING INFORMATION

CLINICAL PHARMACOLOGY:

Subclinical B-Group vitamin deficiencies have greatly increased in recent years due to changes in dietetic habits, increase in the use of sugar, and the excessive milling of flour and cereals. With thiamine deficiencies so prevalent in a healthy populace, it is self evident that the unwell person is particularly prone to thiamine avitaminosis. This is true of the anemic individual with his or her poor appetite and disturbed digestive functions. Folic acid is best known for its role in megaloblastic anemias. Zinc has been recognized as an essential element in the nutrition of animals and humans, even though the evidence for an uncomplicated zinc deficiency in man is limited.

Uses

PureFe Plus is indicated for the treatment of iron deficiency anemia, and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress and in convalescence.

CONTRAINDICATIONS:

PureFe Plus is contraindicated in patients with known hypersensitivity to any of its ingredients. Also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

WARNING:

Accidental overdose of Iron-containing products is the 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.

Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B₁₂ is deficient.

PRECAUTIONS:

General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

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 over to determine whether older patients respond differently from younger patients. Dosage should always begin at the low end of the dosage scale and should consider that elderly patients may have decreased hepatic, renal, or cardiac function and/or concomitant disease.

Side Effects:

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

Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea and constipation) occur occasionally, but are usually mild and may subside with continuation of therapy and physician encouragement. Although the absorption of iron is best taken between meals, giving PureFe Plus after meals may control occasional gastrointestinal disturbances. PureFe Plus is best absorbed when taken at bedtime.

DOSAGE AND ADMINISTRATION:

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

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

OVERDOSE:

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. PureFe Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all drugs out of reach of children.

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.

HOW SUPPLIED:

PureFe Plus are green capsules imprinted horizontally "P-114", bottles of 100 capsules NDC 59088-114-59. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep in a cool, dry place.

Label