Data from FDA - Curated by EPG Health - Last updated 01 April 2018

Indication(s)

Indications and Usage: Calcium-Folic Acid Plus D Chewable Wafers are indicated, in addition to diet, to help satisfy the distinctive nutritional requirements of individuals under the supervision of a physician for the treatment of calcium deficiency, skeletal weakness and osteoporosis. Calcium-Folic Acid Plus D Chewable Wafers supplementation may be beneficial to individuals who have an insufficient dietary intake of the nutrients contained therein. Calcium and vitamin D supplementation may be useful in both preventing and treating osteoporosis. Vitamin D supplementation may be beneficial to those who are institutionalized and/or have reduced exposure to sunlight. Folic acid, vitamin B 6, and vitamin B 12, may help reduce the risk of cardiovascular disease by lowering blood levels of homocysteine. If dietary intake of calcium is inadequate, patients currently taking bisphosphonates for treatment of osteoporosis should be instructed to take calcium and vitamin D daily (Calcium-Folic Acid Plus D Chewable Wafers).

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Advisory information

contraindications
Contraindications: Calcium-Folic Acid Plus D Chewable Wafers are contraindicated in patients with hypersensitivity to any of its components. Calcium and vitamin D supplementation is contraindicated in those with hypercalcemia or conditions that may lead to hypercalcemia and those who form calcium containing stones are generally advised not to take supplemental calcium. Concomitant use of iron and calcium may inhibit the absorption of iron. Concomitant use of quinolones or tetracyclines with calcium may decrease the absorption of these medications. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. The use of folic acid doses above 1 milligram/day may precipitate or exacerbate the neurological damage of vitamin B 12 deficiency. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol and valproic acid.
Special warnings and precautions
Precautions: Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.
Adverse reactions
Adverse Reactions: Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Calcium-Folic Acid Plus D Chewable Wafers. However, allergic and/or idiosyncratic reactions to vitamins even at lower potencies or any ingredient are possible.

Usage information

Dosing and administration
Dosage and Administration: Chew one wafer twice daily or as prescribed by a physician.

Interactions

Drug Interactions: As little as 5 mg of pyridoxine (vitamin B 6) daily can decrease the efficacy of levodopa. Therefore, Calcium-Folic Acid Plus D Chewable Wafers are not recommended for patients undergoing such therapy.

More information

Category Value
Agency product number I38ZP9992A
Orphan designation No
Product NDC 42192-706
Date Last Revised 29-03-2018
Type HUMAN PRESCRIPTION DRUG
List of excipients Other Ingredients: Fructose, Natural Cocoa Dutch Chocolate, Stearic Acid, Plasdone, Natural Chocolate Flavor, Magnesium Stearate, Acacia Gum, Silicon Dioxide.
Marketing authorisation holder Acella Pharmaceuticals, LLC