Folastin by is a Other medication manufactured, distributed, or labeled by Acella Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.
Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. The 2 mgs of B12 (cyanocobalamin), the amount contained in Folastin, has been shown to provide an adequate amount of B12 to address this precaution.1 Unmetabolized folic acid has been shown in one study of 105 postmenopausal women (50-75 yrs) to have the potential to reduce natural killer cells’ cytotoxicity, which may result in an impaired immune response.2
B12 should not be used in those with Leber’s optic atrophy. Decreased levels of B12 have been associated with reduced ability to detoxify the cyanide in exposed individuals and B12 may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder. Hydroxocobalamin can aid in the detoxification of cyanide. This form of B12, although not in this product, is an acceptable form for >B12 supplementation in those with this disorder.
Caution should be exercised when Folastin is administered to patients with diabetic nephropathy. One published study showed that among patients with diabetic nephropathy given high dose folic acid, vitamin B12, and vitamin B6 (pyridoxine) versus a placebo, there was a greater decrease in glomerular filtration rate (GRF).3
Pregnant women and nursing mothers may be recommended to use 12 microgram doses of B12 from nutritional supplements, although higher doses should only be taken on the recommendations of a prescribing medical professional.
Administration of doses of vitamin B12 greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Paresthesia, somnolence, nausea and headaches have been reported with B12. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body has been associated with B6.
B6 supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by B6. However, B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. Warfarin can produce significant impairment in folate status after a 6-month therapy.
Folastin is available as a round, coated, white tablet. The tablet is debossed with “345” on one side and blank on the other. Folastin (42192-345-90)1 is supplied in bottles of 90 tablets. Use under medical/physician supervision.
1Kuzminski AM, Del Giacco EJ, Allen RH, et al: Effective Treatment of Cobalamin Deficiency with Oral Cobalamin. Blood 1998; 92:1191-1198.
2Troen AM, Mitchell B, Sorensen B, Wener MH, Johnston A, Wood B, Selhub J, McTierman A, Yasui Y, Oral E, Potter JD, and Ulich CM: Unmetabloized Folic Acid in Plasma is Associated with Reduced Natural Killer Cell Cytoxicity among Postmenopausal Women. Journal of Nutrition 2006 Jan; 136(1): 189-194.
3House A, et al. Effect of B-Vitamin therapy on Progression of Diabetic Nephropathy. JAMA 2010; 303(16): 1603-1609.
FOLASTIN
folic acid, pyridoxine hydrochloride and cyanocobalamin tablet, film coated |
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
Labeler - Acella Pharmaceuticals, LLC (825380939) |