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L-METHYL-B6-B12 tablet(多种维生素复方片)

2016-07-08 05:34:25  作者:新特药房  来源:互联网  浏览次数:0  文字大小:【】【】【
简介: 部份中文多种维生素B6-B12处方资料(仅供参考)药品名称:复合维生素B片适应症1-甲基B6-B12片剂显示为患者的不同营养要求与内皮dysfunction9-11带保护sensation12和糖尿病周围神经病变相关的神经性pai ...

 部份中文多种维生素B6-B12处方资料(仅供参考)
药品名称:复合维生素B片
适应症
1-甲基B6-B12片剂显示为患者的不同营养要求与内皮dysfunction9-11带保护sensation12和糖尿病周围神经病变相关的神经性pain13-15损失呈现谁。
1-甲基B6-B12片剂显示为患者的不同营养要求与内皮功能障碍和/或hyperhomocysteinemia16下肢溃疡(多个).17-19呈现谁
1-甲基B6-B12片应始终在医生监督下使用
用法用量
推荐剂量是一粒,每日两次(一天两次),或遵医嘱。 1-甲基B6-B12片必须在医生监督下使用。
不良反应
而变应性致敏已报道下列叶酸口服和肠胃外给药,变应性致敏尚未见报道与使用的L- Methylfolate钙。感觉异常,嗜睡,恶心,头痛,已报告有吡哆醛5'-磷酸。轻度腹泻瞬间,真性红细胞增多症,瘙痒,皮疹短暂和整个身体的肿胀的感觉,已经与相关的甲钴胺
注意事项
一般
叶酸,在剂量为0.1mg以上每日作为单剂施用时,可能掩盖B12缺乏(具体而言,叶酸的施用可能逆转B12缺乏的血液学表现,包括恶性贫血,而不是解决神经系统表现的检测)。左旋methylfolate可能比叶酸不太可能单独掩蔽维生素B12 deficiency.20,21叶酸治疗是不充分的B12缺乏的治疗
L-METHYL-B6-B12- levomefolate calcium, pyridoxal 5-phosphate, and methylcobalamin tablet, coated 
Virtus Pharmaceuticals
L-Methyl-B6-B12
Tablets
Rx
Prescription Dietary Supplement
DESCRIPTION
L-Methyl-B6-B12 is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.
L-Methyl-B6-B12 should be administered under the supervision of a licensed medical practitioner.
Each coated, round, purple tablet contains the following dietary ingredients:
Supplement Facts 

Serving Size: 1 tablet    Servings Per Container: 90 (NDC 76439-218-90)
Serving Size: 1 tablet    Servings Per Container: 500 (NDC 76439-218-50)
Amount Per Serving % Daily Value
L-Methylfolate Calcium, or 6(S)-5-MTHF-Ca 3 mg
Pyridoxal 5' Phosphate 35 mg
Methylcobalamin 2 mg
This product is a dietary supplement that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.
contains less than 1% d-methylfolate.
Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
Other ingredients: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid and film coat (FD&C blue #1 lake, FD&C red #3, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide).
FOLATE REGULATION
The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.
Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.
Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.
The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:
Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.
Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).
1 It is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.
INDICATIONS AND USAGE
L-Methyl-B6-B12 is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. L-Methyl-B6-B12 should be administered under the supervision of a licensed medical practitioner.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNINGS
Caution is recommended in patients with a history of bipolar illness.
PRECAUTIONS
General
Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations).
Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.
PATIENT INFORMATION
L-Methyl-B6-B12 is a prescription dietary supplement to be used only under licensed medical supervision.
DRUG INTERACTIONS
Drugs which may interact with folate include:
•Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate.
•Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants.
•Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
•Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
•Colestipol: Reduces folic acid absorption and reduces serum folate levels.
•Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
•Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
•Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
•Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
•L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
•Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
•Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
•Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
•Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase.
•Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
•Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
•Smoking and Alcohol: Reduced serum folate levels have been noted.
•Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
•Metformin treatment in patients with type 2 diabetes decreases serum folate.
•Warfarin can produce significant impairment in folate status after a 6-month therapy.
•Folinic acid may enhance the toxicity of fluorouracil.
•Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
•Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.
Drugs which may interact with vitamin B12:
•Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12.
•Nitrous oxide can produce a functional vitamin B12 deficiency.
Drugs which interact with vitamin B6:
•Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
PREGNANCY and NURSING MOTHERS
L-Methyl-B6-B12 is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins in active form. Talk with your medical practitioner before using if pregnant or lactating.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.
DOSAGE AND ADMINISTRATION
One tablet twice daily or as directed by a licensed medical practitioner.
HOW SUPPLIED
L-Methyl-B6-B12 tablets are coated, round, purple tablets debossed with "BP 0.3" on top and a bisect on bottom, and are supplied in bottles of 90 tablets and 500 tablets.
NDC2 76439-218-90 (90 ct. bottle / 90 tablets)
NDC2 76439-218-50 (500 ct. bottle / 500 tablets)
2 This product is a dietary supplement that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.
STORAGE
Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2fac1a04-070e-4516-86f7-441302e8d70b

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