Package Insert
Néevo® Caplets
Néevo® caplets are a prescription medical food for the dietary management of those women under a physician's treatment for vitamin deficiency throughout pregnancy, postnatal and the lactating periods. Néevo® is specifically indicated for: patients with high risk pregnancies, older OB patients, and patients unable to fully metabolize folic acid.
Description
Each oval coated pink colored caplet contains:
Dietary Ingredients
| L-Methylfolate (6(s)-5-MtHF) (Metafolin®) | 1mg |
| Elemental Iron (polysaccharide iron complex) | 29mg |
| Vitamin C (ascorbic acid) | 80mg |
| Vitamin D3 (cholecalciferol) | 400IU |
| Vitamin E (dl-alpha-tocopheryl acetate) | 30IU |
| Vitamin B1 (thiamine mononitrate) | 3mg |
| Vitamin B2 (riboflavin) | 3.4mg |
| Vitamin B3 (niacinamide) | 20mg |
| Vitamin B5 (d-calcium panththenate) | 7mg |
| Vitamin B6 (pyridoxine HCl) | 2.6mg |
| Vitamin B9 (folic acid) | 400mcg |
| Vitamin B12 (cyanocobalamin) | 500mcg |
| Biotin | 30mcg |
| Copper (oxide) | 2mg |
| Zinc (oxide) | 15mg |
| Calcium (carbonate) | 200mg |
| Magnesium (oxide) | 40mg |
Other Ingredients:
Corn Starch, Mono & Diglycerides, Microcrystalline Cellulose, Gelatin, Hypromellose, Acacia, Crospovidone, Titanium Dioxide, Polydextrose, Dicalcium Phosphate, Magnesium Stearate, Sucrose, Polyethylene Glycol, Sodium Citrate, Silicon Dioxide, Citric Acid, Triacetin, Coconut Oil, Sorbic Acid, Sodium Benzoate, FD&C Red #40 Lake, Tricalcium Phosphate, FD&C Yellow #6 Lake, Carnauba Wax, dl-alpha Tocopherol.
Néevo™ caplets do not contain lactose, yeast or gluten.
Indication and Usage
Néevo® caplets are a prescription medical food for the dietary management of those women under a physician's treatment for vitamin deficiency throughout pregnancy, postnatal and the lactating periods. Néevo® is specifically indicated for: patients with high risk pregnancies, older OB patients, and patients unable to fully metabolize folic acid. It can be used prior to conception to improve nutritional status.
Contraindications
Known hypersensitivity to any of the components in this product is a contraindication.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Precautions
Folates, when administered as a single agent in doses above 0.1mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Adverse Reactions
While allergic sensitization has been reported following both oral and parenteral administration of folic acid, allergic sensitization has not been reported with the use of Metafolin®. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cyanocobalamin.
Drug Interactions
Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. While the concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness, no such decreased effectiveness has been reported with the use of Metafolin®. Capecitabine (Xeloda®) toxicity may increase with the addition of leucovorin (5-formyltetrahydrofolate) (folate).
Pharmacology
L-methylfolate
L-methylfolate or 6(S)-5-methyltetrahydrofolate [6(S)-5-MTHF], is the primary biologically active isomer of folate and the form of folate in circulation. It is also the form which is transported across membranes into peripheral tissues, particularly across the blood brain barrier. In the cell, 6(S)-5-MTHF is used in the methylation of homocysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon units for the synthesis of thymidine-DNA, purines (RNA and DNA) and methionine. About 70% of food folate and cellular folate is comprised of 6(S)-5-MTHF. Folic acid, the synthetic form of folate, must undergo enzymatic reduction by methylenetetrahydrofolate reductase (MTHFR) to become biologically active. Genetic mutations of MTHFR10 result in a cell's inability to convert folic acid to 6(S)-5-MTHF.
Patient Information
Néevo® is a medical food for use only under the direction and supervision of a licensed physician.
Dosage and Administration
Usual adult dose is one caplet daily or as directed by a physician.
How Supplied
Available as an oval coated pink colored caplet. Néevo™ caplet is debossed with a "fleur-de-lis" symbol on one side and an "N" on the other side. Commercial product is supplied in bottles of 90 caplets or 500 caplets. Sample product is supplied in a carton containing five blisters with one caplet in each blister.
Storage
Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from light and moisture. Dispense commercial product (90 caplets) in original light-resistant container. Dispense sample product in original blister.
| Commercial Product (90 caplets) |
0525-2010-90 | Rx Only |
| Commercial Product (500 caplets) |
0525-2010-50 | Rx Only |
| Sample Product (5 caplets) |
0525-2010-05 | Professional Samples Not for sale. |
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Patents
Some or all of the following patents may apply:
| U.S. Patent No. 4,940,658 | U.S. Patent No. 6,207,651 |
| U.S. Patent No. 5,563,126 | U.S. Patent No. 6,254,904 |
| U.S. Patent No. 5,795,873 | U.S. Patent No. 6,297,224 |
| U.S. Patent No. 5,997,915 | U.S. Patent No. 6,528,496 |
| U.S. Patent No. 6,011,040 |
and other pending patent applications.
References
- Lamers Yvonne, Prinz-Langenohl Reinhild, Bramswig Susanne, and Pietrzik Klaus: Red blood cell folate concentrations increase more after supplementation with [6S]-5-methyltetrahydrofolate than with folic acid in women of childbearing age. Am J Clin Nutr 2006;84:156-61.
- Houghton Lisa A, Sherwood Kelly L, Pawlosky Robert, Ito Shinya, and O'Connor Deborah L: [6S]-5-methyltetrahydrofolate is at least as effective as folic acid in preventing a decline in blood folate concentrations during lactation. Am J Clin Nutr 2006;83:842-50.
- Botto Lorenzo D, and Yang Quanhe: 5,10-Methylenetetrahydrofolate Reductase Gene Variants and Congenital Anomalies: A HuGE Review. American Journal of Epidemiology 2000;Vol 151, No.9:862-77.
- Kirke Peadar N, Mills James L, Molloy Anne M, Brody Lawrence C, O'Leary Valerie B, Daly Leslie, Murray Sharon, Conley Mary, Mayne Philip D, Smith Owen, and Scott John M: Impact of the MTHFR C677T polymorphism on risk of neural tube defects: case-control study. BMJ 2004;Vol 328:1535-6.
- Molloy Anne M, Daly Sean, Mills James L, Kirke Peader N, Whitehead Alexander S, Ramsbottom Dorothy, Conley Mary R, Weir Donald G, and Scott John M: Thermolabile variant of 5,10-Methylenetetrahydrofolate reductase associated with low red-cell folates: implications for folate intake recommendations. The Lancet 1997;Vol 349:1591-93.
- Charles Deborah H. M., Ness Andy R., Campbell Doris, Smith George Davey, Whitley Elise, and Hall Marion H.: Folic acid supplements in pregnancy and birth outcome: re-analysis of a large randomized controlled trial and update of Cochrane review. Paediatric and Perinatal Epidemiology 2005;Vol 19:112-124.
- Cleary-Goldman Jane, Malone Fergal D., Vidaver John, Ball Robert H., Nyberg David A., Comstock Christine H., Saade George R., Eddleman Keith A., Klugman Susan, Dugoff Lorraine, Timor-Tritsch Ilan E., Craigo Sabrina D., Carr Stephen R., Wolfe Honor M., Bianchi Diana W., and D'Alton Mary for the FASTER Consortium. Obstetrics & Gynecology 2005;Vol. 105, No. 5:983-990.
- Relton Caroline L., Pearce Mark S., and Parker Louise: The influence of erythrocyte folate and serum vitamin B12 status on birth weight. British Journal of Nutrition 2005;Vol. 93:593-99.
- Tamura Tsunenobu and Picciano Mary Frances: Folate and human reproduction. Am J Clin Nutr 2006;83:993-1016.
- Meleady Raymond, Ueland Per M, Blom Henk, Whitehead Alexander S, Refsum Helga, Daly Leslie E, Vollset Emil, Donohue Cait, Giesendorf Belinda, Graham Ian M, Ulvik Arve, Zhang Ying, Monsen Anne-Lise Bjorke, and the EC Concerted Action Project: Homocysteine and Vascular Disease: Thermolabile methylenetetrahydrofolate reductase, homocysteine, and cardiovascular disease risk: the European Concerted Action Project. Am J Clin Nutr. 2003; 77:63-70.
Metafolin® is a registered trademark of Merck KGaA, Germany.
Manufactured For
PAMLAB, L.L.C. Covington, LA 70433
PC-0053
Revised 8/06
Néevo® caplets are a prescription medical food for the dietary management of those women under a physician's treatment for vitamin deficiency throughout pregnancy, postnatal and the lactating periods. Néevo® is specifically indicated for: patients with high risk pregnancies, older OB patients, and patients unable to fully metabolize folic acid.