FOLBIC- pyridoxine and cyanocobalamin and folic acid tablet

Folbic by

Drug Labeling and Warnings

Folbic by is a Prescription medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Each rose colored tablet contains the following active ingredients: Folacin (Folic Acid) 2.5 mg, Pyridoxine (B6) 25mg, Cyanocobalamin (B12) 2mg, Folbic Tablets do not contain sugar or lactose.

Inactive Ingredients: Carmine, Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Riboflavin, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

INDICATIONS AND USAGE

Folbic Tablets are indicated for the distrinct nutritional requirements of individuals under a physician's supervision for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atheroscierotic vascular disease in the coronary, peripheral, or cerebral vessels, or vitamin B12 dificiency.

CONTRAINDICATIONS

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

WARNINGS

KEEP THIS  AND ALL MEDICATIO OUT OF THE REACH OF CHILDREN IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

All prescription substitutions using this product ahall be pursuant ot state statutes as applicable. This is not an Orange Book Product.

PRECAUTIONS

General

Folacin (folic acid) when administered as a single agent in doses above 0.1 mg daily may obscure pemicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 2mgs of cyanocobalamin contained in Folbic Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. 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.

Cyanocobalamin 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 cyanocobalamin 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 is an acceptable form for B12 supplementation in those with this disorder.

Drug Interactions

Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients recieving a a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

Pregnancy

Pregnant women and nursing mothers should only use 12 microgram doses of B12 (cyanocobalamin) from nutritional supplements. Doses higher than this should only be recommended by your physician. Administration of doses of vitamin B12 greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral an dparental administration of folacin (folic acid). Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine. Mild transient diarrhea, polycythemis vera, itching, transitory exanthema, and the feeling of swelling of the entire body has been associated with cyanocobalamin.

DOSAGE AND ADMINISTRATION

Usual adult dose is one to two tablets daily or as directed by a physician.

HOW SUPPLIED

Folbic Tablets are available as an oval, rose colored tablet, debossed B 384. Supplied in blisterpacks of 30 tablets, NDC# 0615-7575-39.

Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F). See USP Controlled Room Temperature. Protect from light and moisture.

Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF.

REFERENCES

Rx Only

Manufacitred by: Contract Pharmacal Corp. Hauppauge, NY 11788

Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487

Some or all of the following patents may apply: U.S Patent No. 4,940,658, U.S. Patent No. 5,563,126, U.S. Patent No. 5,795,873, U.S. Patent No. 6,207,651, U.S. Patent No. 6,297,224, U.S. Patent No. 6,528,496 and other pending patent applications.

References:

Elkelboom JW, Lonn Eva, Genest Jr Jaques, Hankey Graeme, Yusuf Salim: Homocysteine and Cardiovascular Disease: A Critical Review of the Epidemiologic Evidence. Ann Intern Med. 1999; 131:363-375.

The Homocysteine Studies Collaboration: Homocysteine and Risk of  Ischemic Heart Disease and Stroke, JAMA 2002; Vol 288, No 16:2015-2002.

Refusum Helga, Smith A. David: Ueland Per M. Nexo Ebba, Clarke Robert, McPartlin Joseph, Johnston Carole, Engbaek Frode, Schneede Jorn, McPartlin Catherine, and Scott John M: Facts and Recommendations about Total Homocysteine Determinations: An Expert Opinion. Clinical Chemisty 2004; 50:1 3-32.

Kuzminski AM, Del Giacco EJ, Aften RH, et ai: Effective Treatment of Cobalamin Defiiency with oral Cobalamin. Blood 1998; 92:1191-1198.

Troen AM, Mitchell B. Sorensen B. Wener MH, Hohnston A, Wood B. Selhub J. McTiernan A, Yasui Y, Oral E, Potter JD, and Ulrich CM, Unmetabolized Folic Acid in Plasma ia Associated with Reduced Natural Killer Cell Cytotoxicity among Postmenopausal Women. Jounal of Nutrition 2006 Jan; 136 (1): 189-194.

PRINCIPAL DISPLAY PANEL

Folbic Tabs 2.5mg/25mg/2mg

INGREDIENTS AND APPEARANCE

FOLBIC 
pyridoxine and cyanocobalamin and folic acid tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0615-7575(NDC: 51991-384)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	25 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	2 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
CARMINIC ACID (UNII: CID8Z8N95N)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
RIBOFLAVIN (UNII: TLM2976OFR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	PINK (Rose)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	B;384
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-7575-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/19/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL, REPACK