Folastin

Acella Pharmaceuticals, LLC

Folastin Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• FOLASTIN DESCRIPTION
  • INGREDIENTS:
• FOLASTIN INDICATIONS AND USAGE:
• PRECAUTIONS:
• FOLASTIN ADVERSE REACTIONS:
• FOLASTIN CONTRAINDICATIONS:
• DRUG INTERACTIONS:
• PATIENT INFORMATION:
• FOLASTIN DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:
• STORAGE:
• REFERENCES:
• PRINCIPAL DISPLAY PANEL - Film Coated Tablets

FULL PRESCRIBING INFORMATION

A medical food for the dietary management of low folate and/or hyperhomocysteinemia.

FOLASTIN DESCRIPTION

EACH ROUND COATED WHITE TABLET CONTAINS:

INGREDIENTS:

Dicalcium phosphate, microcrystalline cellulose, pyridoxine HCl, folic acid, stearic acid, titanium dioxide, aqueous coating, croscarmellose sodium, magnesium stearate, silicon dioxide, and cyanocobalamin.

INDICATIONS AND USAGE:

Folastin tablets are indicated for the distinct nutritional requirements of individuals under a physician’s treatment for homocysteinemia.

PRECAUTIONS:

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.

ADVERSE REACTIONS:

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.

CONTRAINDICATIONS:

Known hypersensitivity to any of the components in the product is a contraindication.

DRUG INTERACTIONS:

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.

PATIENT INFORMATION:

Folastin tablets are a medical food, for use only under medical supervision.

DOSAGE AND ADMINISTRATION:

Recommended adult dose is one or two tablets daily, or as directed by your medical practitioner.

HOW SUPPLIED:

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)Acella Pharmaceuticals, LLC does not represent this product code be an actual National Drug Code (NDC). NDC format codes are product codes adjusted to meet the formatting requirements of pharmacy and health insurance computer systems. is supplied in bottles of 90 tablets. Use under medical/physician supervision.

STORAGE:

Store at controlled room temperature between 15° – 30° C (59° – 86° F) (See USP). Protect from heat, light and moisture. Dispense in original container with child resistant closure.

REFERENCES:

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.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802
Rev. 02282012

PRINCIPAL DISPLAY PANEL - Film Coated Tablets

Medical Food                  42192-345-90

Folastin

For the dietary managment of low
folate and/or hyperhomocysteinemia

90 Tablets

Rx Only

Acella
PHARMACEUTICALS, LLC