calomist是第一个也是唯一FDA批准的，每日一次维生素B12的喷鼻剂为维生素B12缺乏症患者。
制造商：
弗莱明与公司
类药物：
补血药
活性成分（S）：
氰钴胺25micrograms/spray;鼻腔喷雾。
指示（S）：
维修的维生素。后正常化即时维生素B12的浓度。维生素B12与维生素患者的治疗。维生素B12缺乏，有没有神经系统的参与。
药理作用：
维生素B12对细胞的生长和繁殖，造血，核蛋白和髓鞘合成至关重要。迅速分裂的细胞（如上皮细胞，骨髓，髓细胞）有最大的维生素的要求。维生素B12。到琥珀酸的methylmalonate的转换和蛋氨酸合成从homocysteine.In血，维生素也是必不可少的。维生素B12势必transcobalamin II（载体蛋白），并分发到组织，主要在肝脏和骨髓中。一种维生素的缺乏。在人体内的维生素B12防止四氢叶酸缺乏功能正在恢复和结果。维生素。维生素B12可能也发挥了巯基活化的脂肪和碳水化合物的代谢和蛋白质合成有关的酶系统的作用。
临床试验：
一个试验，涉及25 VIT。维生素B12缺乏的患者进行了评估的有效性和安全Calomist。入学前，所有受试者需要有正常的维生素。肌肉注射维生素B12水平。 B12注射。 ，剂量与Calomist的25例被排除，因为维生素诊断疗效分析。维生素B12缺乏，无法得到证实。其余24例稳定肌肉注射维生素。维生素B12治疗，每日一次（50mcg）滴鼻与Calomist给药8周。血清维生素。维生素B12浓度在目标范围内（> 200ng / L），比2至4周后肌注维生素看到那些略高。维生素B12;平均血清维生素。 B12水平是审判的第8周时约570ng /大号。 24例患者中有24个Calomist 50mcg审判的持续时间和一个病人需要的Calomist剂量50mcg 100mcg每天增加一倍，每天在上周下降的维生素，因为研究。维生素B12的浓度。
法律分类：
RX
成人：
不适用于新诊断的维生素。 B12缺乏。最初在每个鼻孔每日（50micrograms/day）的喷雾;如果反应不足，可能会增加到每日两次给药（100micrograms/day）。肾或肝功能不全：可能需要增加剂量或频率。
儿童：
不推荐使用。
警告/注意事项：
避免在Leber氏病。维生素。维生素B12的浓度应该是正常的治疗前;开关肌肉注射，如果水平低或下降。鼻腔病理学;推迟到鼻部症状subside.Infections，尿毒症，并发铁，叶酸缺乏可能会削弱治疗反应。获得血细胞比容，网织红细胞计数，维生素。 B12，叶酸和铁的含量，之前和期间治疗。在激烈的巨幼细胞性贫血治疗监测钾和血小板计数。怀孕（Cat.C）。哺乳的母亲。
互动（补）：
铁补充剂或骨髓抑制（如氯霉素），可能会削弱治疗反应。抗生素，甲氨蝶呤，乙胺嘧啶可能会干扰实验室测试。不要使用为林女士测试。
不良反应（S）：
流鼻涕，咽炎，关节痛，头晕，头痛，鼻塞不适，疼痛，支气管炎，皮疹。
如何提供：
喷鼻剂30毫升（60喷雾剂）
最后更新：
1/14/2009
Manufacturer:
Fleming & Company
Pharmacological Class:
Hematinic
Active Ingredient(s):
Cyanocobalamin 25micrograms/spray; nasal spray.
Indication(s):
Maintenance of Vit. B12 concentrations after normalization with IM Vit. B12 therapy in patients with Vit. B12 deficiency who have no nervous system involvement.
Pharmacology:
Vitamin B12 is essential for cell growth and reproduction, hematopoiesis, and nucleoprotein and myelin synthesis. Rapidly dividing cells (e.g., epithelial cells, bone marrow, myeloid cells) have the greatest requirement for Vit. B12. It is also essential for the conversion of methylmalonate to succinate and for the synthesis of methionine from homocysteine.In the blood, Vit. B12 is bound to transcobalamin II (a carrier protein) and is distributed to tissues and stored primarily in the liver and bone marrow. A deficiency of Vit. B12 in the body prevents tetrahydrofolate from being regenerated and results in functional folate deficiency. Vit. B12 may also play a role in sulfhydryl-activated enzyme systems associated with fat and carbohydrate metabolism and protein synthesis.
Clinical Trials:
A trial involving 25 Vit. B12 deficient patients was conducted to assess the efficacy and safety of Calomist. Prior to enrollment, all subjects were required to have normal Vit. B12 levels with intramuscular Vit. B12 injections. One of the 25 patients dosed with Calomist was excluded from the efficacy analyses because a diagnosis of Vit. B12 deficiency could not be confirmed. The 24 remaining patients were stabilized on intramuscular Vit. B12 therapy and given once daily (50mcg) intranasal dosing with Calomist for 8 weeks. The serum Vit. B12 concentrations were within the target range (>200ng/L) and slightly higher than those seen 2 to 4 weeks after administration of intramuscular Vit. B12; the mean serum Vit. B12 level was about 570ng/L at week 8 of the trial. Twenty-three of the 24 patients received 50mcg of Calomist daily for the duration of the trial and one patient required doubling of the Calomist dose from 50mcg to 100mcg daily during the last week of the study because of declining Vit. B12 concentrations.
Legal Classification:
Rx
Adults:
Not for newly diagnosed Vit. B12 deficiency. Initially 1 spray in each nostril daily (50micrograms/day); if response inadequate, may increase to twice daily dosing (100micrograms/day). Renal or hepatic impairment: may require increased dosing or frequency.
Children:
Not recommended.
Warnings/Precautions:
Avoid in Leber’s disease. Vit. B12 concentrations should be normal prior to treatment; switch to IM injections if levels are low or decline. Nasal pathology; defer until nasal symptoms subside.Infections, uremia, concurrent iron, folic acid deficiency; may blunt therapeutic response. Obtain hematocrit, reticulocyte count, Vit. B12, folate, and iron levels prior to and during treatment. Monitor potassium and platelet count during intense megaloblastic anemia treatment. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
Iron supplements or bone marrow suppressants (e.g., chloramphenicol) may blunt therapeutic response. Antibiotics, methotrexate, pyrimethamine may interfere with lab tests. Do not use for Schilling Test.
Adverse Reaction(s):
Rhinorrhea, nasopharyngitis, arthralgia, dizziness, headache, nasal discomfort, pain, bronchitis, rash.
How Supplied:
Nasal spray—30mL (60 sprays)