Product Information

Calafol^® Rx Tablets

DESCRIPTION: Each oval white-coated tablet contains folacin (as folic acid USP) 1.6mg, hydroxocobalamin (B12a) 425mcg, pyridoxine (B6) 25mg, calcium (as calcium carbonate) 600mg, cholecalciferol (D3) 400IU, policosanol 5mg. Calafol Rx tablets do not contain sugar, lactose or dyes.

INDICATIONS AND USAGE: Calafol 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, osteoporosis, micronutrient deficiencies associated with inflammatory bowel disease and dementia with particular emphasis on menopausal patients (including those patients treated with or eligible for hormone replacement therapies), patients with uterine fibroids, and patients with endometriosis.

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. Calcium supplementation is contraindicated in those with hypercalcemia. Conditions causing hypercalcemia include sarcoidosis, hyperparathyroidism, hypervitaminosis D. Vitamin D is contraindicated in those with hypercalcemia and in those with evidence of vitamin D toxicity.

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 using supplemental doses of vitamin D higher than RDA amounts. Supplemental calcium taken without food may increase the risk of kidney stones. Patients taking warfarin should exercise caution when using Calafol Rx. Calafol Rx supplementation should be stopped before surgery. Patients with hemophilia should avoid taking Calafol Rx.

Patient Information: Calafol 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. Concomitant intake of H2 blockers and proton-pump-inhibitors with calcium decrease the absorption of calcium salts.

Pediatrics: The safety and effectiveness of Calafol 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. Calcium carbonate may cause gastrointestinal side reactions such as constipation, bloating, gas and flatulence.

DOSAGE AND ADMINISTRATION: Usual adult dose is one tablet twice daily, with food, not to exceed 2 tablets in 24 hours.

HOW SUPPLIED: Calafol Rx is supplied as an oval white-coated tablet. Each tablet is debossed with "AP 99" on the scored side. Calafol Rx is supplied in bottles of 90 tablets (NDC 68220-099-90). Keep Out of Reach of Children. Dispense in a tight, light-resistant container.

STORAGE: Store at controlled room temperature, 20-25°C (68-77°F). Protect from light and moisture.

Rx Only.

Manufactured for:  Alaven™ Pharmaceutical LLC, Marietta, GA 30067
Patents pending.                       
7065 Rev. 12/06B 

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About This Disease

For more information on the conditions treated by Calafol Rx,
please visit www.webmd.com.

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Please See Full Prescribing Information PDF

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Availability

Calafol Rx tablets are a medical food, for use only under the direction and supervision of a licensed physician.

Ask your doctor if Calafol Rx is right for you.

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Reference Library

1. Fairfield et al. JAMA 2002; 287(23): 3116-3126
2. Fletcher et al. JAMA 2002; 287(23): 3127-3129
3. Marchesoni et al. Int J Gyn Obstet. 2003; 81:293-297
4. Brattstrom et al. Metabolism 1985; 34:1073-1077
5. Rossouw et al. JAMA 2002; 288(3): 321-333
6. Herrington et al. N Engl J Med. 2000; 343:522-529
7. M den Heijer et al. Arterioscler Thromb Vasc Biol 1998: 18: 356-361
8. http://cerhr.niehs.nih.gov/genpub/topics/folic_acid-ccae.html
9. McEvoy et al. AHFS Drug Information, p. 2667-2669, Am. Soc. Hosp. Pharm.,Bethesda, 1996
10. Franken et al J inherit Metab Dis 1994: 17:159-62
11. Brattstrom et al. Atherosclerosis 1990; 81: 2004-6
12. http://www.cc.nih.gov/ccc/supplements/folate.html
13. Seshadri et al. N Eng J Med 2002; 346:476-83
14. Lehmann et al. Dement Ger Cog Dis 1999; 10:12-20
15. Nilsson et al. Int J Ger Psych 2001;16:609-14
16. Jeejeebhoy, CMAJ 2002; 166:913-18
17. Chen et al. Pharmacotherapy 2005; 25:171-183
18. Noa et al. Drug Exp Clin Res 2004; 30:117-123

For questions about Calafol Rx, contact: calafol@alavenpharm.com.

Calafol^® is a trademark of Alaven™ Pharmaceutical LLC.

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