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.
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About This
Disease
For more information on the conditions treated by Folpace Rx, please visit www.webmd.com.
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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.
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Reference Library
- Fairfield et al. JAMA 2002; 287(23):
3116-3126
- Fletcher et al. JAMA 2002; 287(23):
3127-3129
- Ma et al. J Clin Epidemiol. 1995;
48(7): 927-940
- Ascherio et al. Circulation. 1998;
98(12): 1198-1204
- M den Heijer et al. Arterioscler Thromb
Vasc Biol 1998:
18: 356-361
- http://cerhr.niehs.nih.gov/genpub/topics/folic_acid-ccae.html
- http://www.cc.nih.gov/ccc/supplements/folate.html
- McEvoy at al. AHFS Drug Information,
p. 2667-2669, Am. Soc. Hosp. Pharm., Bethesda, 1996
- Franken et al. J Inherit Metab Dis
1994: 17:159-62
- Brattstrom et al. Atherosclerosis
1990; 81:2004-6
- Seshadri et al. N Eng J Med 2002;346:476-83
- Lehmann et al. Dement Ger Cog Dis
1999;10:12-20
- Nilsson et al. Int J Ger Psych 2001;16:609-14
For questions about Folpace Rx, contact: folpace@alavenpharm.com.
Folpace® is a registered trademark of Alaven™ Pharmaceutical LLC.
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