Ferrous Fumarate And Polysacchride Iron Vitamin Mineral Complex Supplement
FDA Drug Information • Also known as: Integra Plus
- Brand Names
- Integra Plus
- Drug Class
- Vitamin C [EPC], Nicotinic Acid [EPC]
- Route
- ORAL
- Dosage Form
- CAPSULE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) ......191.1 mg Polysaccharide Iron Complex... 135.9 mg (Equivalent to about 125 mg of elemental iron) Vitamin C (from ProAscorb C‡)....210 mg Folic Acid .....1 mg Thiamine Mononitrate (B1)...5 mg Riboflavin (B2)....5 mg Niacin (B3) . 20 mg d-Calcium Pantothenate (B5)..7 mg Pyridoxine HCl (B6) ...25 mg Biotin (B7)......300 mcg Cyanocobalamin (B12) .. 10 mcg CLINICAL PHARMACOLOGY: Integra PlusTM is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganèite), making available a total of 125 mg of elemental iron per capsule as follows: Ferrous Fumarate (anhydrous) 191.1 mg Polysaccharide iron complex (PIC) 135.9 mg 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 in a healthy populous, it is self-evident that the unwell person is particularly prone to thiamine avitaminosis. This is true of the anemic individual with his/her poor appetite and disturbed digestive functions. Folic acid is best known for its role in megaloblastic anemias. Zinc has been recognized in the nutrition of animals and humans, even though the evidence for an uncomplicated zinc deficiency in humans is limited. Ferrous Fumarate: Provides about 62.5 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate. Polysaccharide Iron Complex: Provides about 62.5 mg...
Dosage and Administration
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.
Side Effects (Adverse Reactions)
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) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Integra PlusTM after meals may control occasional G.I. disturbances. Integra PlusTM is best absorbed when taken at bedtime.
Contraindications
CONTRAINDICATIONS: Integra PlusTM is contraindicated in patients with a 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.
Overdosage
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. Integra PlusTM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the 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
HOW SUPPLIED: Integra Plus TM are Vcaps ® capsules with maroon caps printed in white with "Integra Plus" and cream body printed in red with "US" logo. Packed in child resistant caps and light resistant bottles of 90 capsules (52747-0712-60) and 30 capsules (52747-0712-30). The listed product numbers are not National Drug Codes. Instead, US Pharmaceutical Corporation has assigned these product codes formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. CAUTION: Rx only.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.