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Product Information Reference Library
     
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Product Information

Folpace® Rx Tablets

DESCRIPTION: Each round white coated tablet contains folacin (as folic acid USP) 2.05mg, hydroxocobalamin (B12a) 425mcg, pyridoxine (B6) 25mg, d-alpha tocopheryl succinate (as vitamin E) 100IU, magnesium (as magnesium oxide) 100mg. Folpace® Rx tablets do not contain sugar, lactose or dyes.

INDICATIONS AND USAGE: Folpace® Rx tablets are indicated for the distinctive nutritional requirements of individuals under a physician's treatment with or at risk for: cardiovascular disease, cerebrovascular disease, peripheral vascular disease, arteriosclerotic vascular disease, dementia and cognitive impairment.

FOLIC ACID SUPPLEMENTATION: The supplemental use of folacin (folic acid) may be indicated in patients with increased requirements of this vitamin. Folic acid administration may (i) reduce the risk of neural tube defects in the developing fetus, (ii) reduce circulating plasma homocysteine levels, and (iii) reduce the toxic side effects of low dose methotrexate without decreasing its effectiveness.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Magnesium is contraindicated in those with renal failure, those with high-grade atrioventricular blocks (AV) unless those with high-grade AV blocks have an artificial pacemaker.

PRECAUTIONS: General: Folic acid when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts.

PATIENT INFORMATION: Folpace® Rx tablets are a medical food, for use only under the direction and supervision of a licensed physician.

DRUG INTERACTION: Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin 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.

PEDIATRICS: The safety and effectiveness of Folpace® Rx in pediatric patients have not been established.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching transitory exanthema and feeling of swelling of entire body have been associated with cobalamins. There are occasional reports of hypersensitivity reactions (rash, pruritis, urticaria) in those receiving parenteral hydroxocobalamin and possibly oral hydroxocobalamin.

DOSAGE AND ADMINSTRATION: Usual adult dose is one or two tablets daily or as directed by a physician.

HOW SUPPLIED: Folpace® Rx is supplied as a round white coated tablet. Each tablet is debossed with "AP 18" on the scored side. Folpace® Rx is supplied in bottles of 90 tablets (NDC 68220-0018-90). Keep Out of Reach of Children. Dispense in a tight, light-resistant container.

STORAGE:  Store at controlled room temperature, 20-25°C (68-78°F). Protect from light and moisture.

Rx Only.

Manufactured for:  Alaven™  Pharmaceutical LLC,  Marietta, GA 30067
Folpace™ is a trademark of AlavenTM Pharmaceutical LLC.
Patents pending.                       
6636  Rev. 08/04 

Availability
Folpace® Rx tablets are a medical food, for use only under the direction and supervision of a licensed physician. Ask your doctor if Folpace® Rx is right for you.

Reference Library

  1. Fairfield et al. JAMA 2002; 287(23): 3116-3126
  2. Fletcher et al. JAMA 2002; 287(23): 3127-3129
  3. Ma et al. J Clin Epidemiol. 1995; 48(7): 927-940
  4. Ascherio et al. Circulation. 1998; 98(12): 1198-1204
  5. M den Heijer et al. Arterioscler Thromb Vasc Biol 1998:
    18: 356-361
  6. http://cerhr.niehs.nih.gov/genpub/topics/folic_acid-ccae.html
  7. http://www.cc.nih.gov/ccc/supplements/folate.html
  8. McEvoy at al. AHFS Drug Information, p. 2667-2669, Am. Soc. Hosp. Pharm., Bethesda, 1996
  9. Franken et al. J Inherit Metab Dis 1994: 17:159-62
  10. Brattstrom et al. Atherosclerosis 1990; 81:2004-6
  11. Seshadri et al. N Eng J Med 2002;346:476-83
  12. Lehmann et al. Dement Ger Cog Dis 1999;10:12-20
  13. Nilsson et al. Int J Ger Psych 2001;16:609-14

For questions about Folpace® Rx, contact: folpace@alavenpharm.com.

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