Prescribing information (package insert) - Vitalux
Full Prescribing Information
DESCRIPTION:
ACTIVE INGREDIENTS:
Each caplet contains:
Vitamin A (as retinyl acetate)……………….. 1500 mcg RAE (5000 IU)
Vitamin C (as ascorbic acid)…………………………….........… 120 mg
Vitamin D3 (as cholecalciferol)………………….......... 20 mcg (800 IU)
dl-Alpha-Tocopheryl Acetate (Vitamin E)……………...... 30 mg (30 IU)
Thiamin (as thiamine mononitrate)………………………...........… 3 mg
Riboflavin ..............................……………………………………. 3.4 mg
Niacin (as niacinamide)………………………………...........…… 20 mg
Vitamin B6 (as pyridoxine hydrochloride)…………........………. 50 mg
Folate (as L-5-Methyltetrahydrofolate calcium salt )…. 1700 mcg DFE
(1000 mcg L-Methylfolate)
Vitamin B12 (as cyanocobalamin)………………........………… 10 mcg
Choline (as choline bitartrate)………………………...........…….. 55 mg
Calcium (as calcium carbonate)……………………..........……. 200 mg
Iron (as ferrous fumarate)………………………………............… 27 mg
Iodine (as potassium iodine)…………………………...........… 150 mcg
Magnesium (as magnesium oxide)…………………..........…… 200 mg
Zinc (as zinc oxide)…………………………………............…….. 25 mg
Selenium (as selenium amino acid chelate)………......………. 70 mcg
Manganese (as manganese sulfate)………………........……… 2.6 mg
Chromium (as chromium polynicotinate)…………..........…….. 45 mcg
Molybdenum (as molybdenum amino acid chelate)…......…… 50 mcg
OTHER INGREDIENTS:
Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400).
INDICATIONS AND USAGE:
Vitalux™ caplets are a prescription multivitamin formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed. Vitalux™ caplets may be beneficial in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS:
This product 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 folate may obscure its signs and symptoms.
WARNING:
Accidental overdose of iron-containing products is a 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.
Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.
PRECAUTIONS:
Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
DRUG INTERACTIONS:
Vitalux™ caplets is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with antiplatelet agents (e.g., Aspirin, or Clopidogrel) and anticoagulants (e.g., Heparin).
ADVERSE REACTIONS:
Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate.
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. Administration of Vitalux TM caplets after meals may reduce occasional gastrointestinal disturbances.
Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
For use on the order of a licensed healthcare practitioner.
Call your licensed healthcare practitioner about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov-/medwatch.
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. Vitalux™ caplets 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.
DOSAGE AND ADMINISTRATION:
Adults (over 12 years of age): One (1) Vitalux™ caplet daily, preferably between meals, or as directed by a licensed healthcare practitioner. Do not administer to children under the age of 12.
HOW SUPPLIED:
Vitalux™ caplets are supplied as beige, oblong, film-coated caplets in bottles containing 30 caplets – NDC 59088-139-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture and avoid excessive heat.