ERACOBAL INJECTION ( Methylcobalamin 500mcg. )
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1 ERACOBAL INJECTION ( Methylcobalamin 500mcg. ) DESCRIPTION : Methylcobalamin is a cobalamin (MeB12) used in peripheral neuropathy, diabetic neuropathy etc. It is a form of vitamin B12. This vitamer is one of two active coenzymes used by B-12 dependent enzymes in the body, and is specifically the B-12 form used by 5-methyltetrahydrofolate-homocysteine methyltransferase (MTR), also known as methionine synthase. Methylcobalamin is notable for being one of the few examples in nature of a bona fide organometallic bond. It is used in treating diseases of vitamin B12 deficiency (such as pernicious anemia), or diseases of effective B12 deficiency, such as vitamin B12 metabolic pathway pathologies. One study suggests that once absorbed, methylcobalamin may be retained in the body better than cyanocobalamin. Methylcobalamin is the more bio-available of the two, meaning that methylcobalamin is immedietly ready for the body to use once injected. Methylcobalamin cannot be made by plants or by animals; the only type of organisms that have the enzymes required for the synthesis of methylcobalamin are bacteria and archaea. Higher plants do not concentrate methylcobalamin from the soil, making them a poor source of the substance as compared with animal tissue. CHEMISTRY : Methylcobalamin is a water-soluble, organometallic compound with a trivalent cobalt ion bound inside a corrin ring which, although similar to the porphyrin ring found in heme, chlorophyll, and cytochrome, has two of the pyrrole rings directly bonded. The central metal ion is Co (cobalt). Methylcobalamin occurs as dark red crystals or crystalline powder. It is sparingly soluble in water, slightly soluble in ethanol, and practically insoluble in acetonitrile. It is affected by light. Chemical name of Methylcobalami is Coα- [α-(5,6-dimethylbenz-1h-imidazolyl)]-coβmethylcobamide. It contains not less than 98.0% of C63H91CoN13O14P, calculated on the anhydrous basis. Formula weight is g./mol. STRUCTURAL FORMULA OF METHYLCOBALAMIN MECHANISM OF ACTION : Pharmacodynamics Vitamin B12 is used in the body in two forms, methylcobalamin and 5-deoxyadenosyl cobalamin. The enzyme methionine synthase needs methylcobalamin as a cofactor. This enzyme is involved in the conversion of the amino acid homocysteine into methionine which is, in turn, required for DNA methylation. The other form, 5- deoxyadenosylcobalamin, is a cofactor needed by the enzyme that converts L-methylmalonyl-CoA to succinyl-
2 CoA. This conversion is an important step in the extraction of energy from proteins and fats. Furthermore, succinyl CoA is necessary for the production of hemoglobin, the substance that carries oxygen in red blood cells. Vitamin B12, or methylcobalamin, is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis. Cells characterized by rapid division (epithelial cells, bone marrow, myeloid cells) appear to have the greatest requirement for methylcobalamin. Vitamin B12 can be converted to coenzyme B12 in tissues; in this form it is essential for conversion of methylmalonate to succinate and synthesis of methionine from homocysteine (a reaction which also requires folate). In the absence of coenzyme B12, tetrahydrofolate cannot be regenerated from its inactive storage form, 5-methyl tetrahydrofolate, resulting in functional folate deficiency. Vitamin B12 also may be involved in maintaining sulfhydryl (SH) groups in the reduced form required by many SH-activated enzyme systems. Through these reactions, vitamin B12 is associated with fat and carbohydrate metabolism and protein synthesis. Vitamin B12 deficiency results in megaloblastic anemia, GI lesions, and neurologic damage (which begins with an inability to produce myelin and is followed by gradual degeneration of the axon and nerve head). Vitamin B12 requires an intrinsic factor-mediated active transport for absorption, therefore, lack of or inhibition of intrinsic factor results in pernicious anemia. Pharmacokinetics : Mecobalamin is the neurologically active form of vitamin B12 and occurs as a water-soluble vitamin in the body. It is readily absorbed in distal half of the ileum. Once absorbed, vitamin B12 is highly bound to transcobalamin II, a specific B-globulin carrier protein and is distributed and stored primarily in the liver as coenzyme B12. The bone marrow also stores a significant amount of the absorbed vitamin B12. This vitamin crosses the placenta and is distributed into breast milk. Enterohepatic recirculation conserves systemic stores. The half-life is about 6 days (400 days in the liver). Elimination is primarily through the bile. It is a cofactor in the enzyme methionine synthase, which functions to transfer methyl groups for the regeneration of methionine from homocysteine. In anaemia, it increases erythrocyte production by promoting nucleic acid synthesis in the bone marrow and by promoting maturation and division of erythrocytes. Absorption : Peak plasma concentrations after 3 hr (oral); 0.9 hr (IM); 3 min (IV). Excretion : Excess methylcobalamin is excreted unchanged in the urine. BENEFITS AND USAGE Methylcobalamin is indicated for the treatment of pernicious anemia (due to lack of or inhibition of intrinsic factor) and for prevention and treatment of Vitamin B12 deficiency. It helps the body use fats and carbohydrates for energy, assists it in making new proteins, and is also important for the production of normal cells, nerves, blood, and DNA. Methylcobalamine (MeCbl) may provide better treatments for nervous disorders through effective systemic or local delivery. As an auxiliary agent, MeCbl has been always used to treat many diseases, such as Alzheimer s disease syndromes. In addition, MeCbl improved nerve conduction in either patient of diabetic neuropathy or streptozotocin-diabetic rats and experimental acrylamide neuropathy. MeCbl also improved visual function, rheumatoid arthritis, Bell s palsy, and sleep-wake rhythm disorder. Other usage Methylcobalamin is the only active form of B12 found within the Central Nervous System (CNS). Benefits of Methylcobalamin supplementation include: Assists in the reduction of elevated Homocysteine. Elevated Homocysteine has been linked to increased cardiovascular risk of disease. Proven beneficial for symptoms of depression (i.e., supporting the production of serotonin and melatonin), acts as a methyl donor and participates in the synthesis of SAM-e (S-adenosylmethionine), a nutrient that has powerful mood elevating properties. Supports Immune system regulation. Repair of damaged myelin sheath acts to reverse nerve damage and promote nerve cell regeneration. Increased metabolic function. Supports healthy red blood cells and is used to treat Anemia. Protects against neurological disease and aging. Improvement of mental dysfunction in the elderly. Supportive treatment in HIV.
3 The Analgesic Effect of MeCbl MeCbl is one active form of vitamin B12 which can directly participate in homocysteine metabolism. More and more researches showed that MeCbl has beneficial effects on clinical and experimental peripheral neuropathy. Diabetic Peripheral Neuropathic Pain Clinical symptoms in legs, such as paresthesia, burning pains, and spontaneous pain, were ameliorated by MeCbl. Clinical evidence proved that MeCbl had the capacity to inhibit the neuropathic pain associated with diabetic neuropathy. Low Back Pain The causes of low back pain are extensive, cancer, infection, inflammatory disorders, structural disorders of the spine itself, and disk herniation, are somewhat more common, and together account for back pain. Now a days MeCbl is becoming a decent choice for the therapy to the chronic low back pain. Neurogenic claudication distance was improved significantly after the application of MeCbl. However Waikakul s research demonstrated that MeCbl was not good for pain on lumbar spinal stenosis. Further studies are needed to determine the effect of MeCbl on low back pain. CONTRAINDICATION AND PRECAUTION : Patients with early hereditary optic nerve atrophy, cyanocobalmin hypersensitivity. Patients who has kidney disease; Leber's disease; megaloblastic anemia. Having unusual or allergic reaction to methylcobalamin, cobalt, other medicines, foods, dyes, or preservatives. Peoples who are pregnant or trying to get pregnant and breast-feeding. Methylcobalamin is contraindicated in patients with methylcobalamin hypersensitivity or hypersensitivity to any of the medication components. Methylcobalamin is also contraindicated in patients with cobalt hypersensitivity because methylcobalamin contains cobalt. In the case of suspected cobalt hypersensitivity, an intradermal test dose should be administered because anaphylactic shock and death have followed parenteral administration of methylcobalamin. Eracobal Injection contain benzyl alcohol as a preservative. Benzyl alcohol may cause allergic reactions. Methylcobalamin injections should be used cautiously in those patients with benzyl alcohol hypersensitivity. Methylcobalamin, vitamin B12 preparations containing benzyl alcohol should be avoided in premature neonates because benzyl alcohol has been associated with 'gasping syndrome,' a potentially fatal condition characterized by metabolic acidosis and CNS, respiratory, circulatory, and renal dysfunction. Certain conditions may blunt or impede therapeutic response to methylcobalamin therapy. These include serious infection, uremia or renal failure, drugs with bone marrow suppression properties (e.g., chloramphenicol), or concurrent undiagnosed folic acid or iron deficiency anemia. The mechanism appears to be interference with erythropoiesis. Patients with vitamin B12 deficiency and concurrent renal or hepatic disease may require increased doses or more frequent administration of methylcobalamin. Clinical reports have not identified differences in responses between elderly and younger patients. Generally, dose selection for elderly patients should be done with caution. Elderly patients tend to have a greater frequency of decreased hepatic, renal, or cardiac function, and also have concomitant disease or receiving other drug therapy. Start with doses at the lower end of the dosing range. INTERECTION Several drugs, including para-aminosalicylic acid, have been reported to reduce the absorption of methylcobalamin, vitamin B12. Monitor for the desired therapeutic response to vitamin B12.
4 The heavy consumption of ethanol for greater than 2 weeks has been reported to reduce the absorption of Methylcobalamin, vitamin B12. Patients should be aware that heavy, chronic ethanol use may counteract the therapeutic effects of vitamin B12; such patients with regular and chronic ethanol consumption be monitored for the desired therapeutic response to vitamin B12. Several drugs, including colchicine, have been reported to reduce the absorption of methylcobalamin, vitamin B12. Colchicine has been shown to induce reversible mal-absorption of vitamin B12, apparently by altering the function of ideal mucosa. Although further study of these interactions is necessary, patients receiving these agents concurrently should be monitored for the desired therapeutic response to vitamin B12. From a study it has established that omeprazole, in doses of 20 mg 40 mg per day, caused a significant decrease in the oral absorption of methylcobalamin, vitamin B12. Theoretically this interaction is possible with other proton pump inhibitors (PPIs), although specific clinical data are lacking. Patients receiving long-term therapy with omeprazole or other proton pump inhibitors (PPIs) should be monitored for signs of B12deficiency. Chloramphenicol can antagonize the hematopoietic response to Methylcobalamin, vitamin B12 through interference with erythrocyte maturation. Chloramphenicol is known to cause bone marrow suppression, especially when serum concentrations exceed 25mcg/ml. Chloramphenicol should be discontinued if anemia attributable to chloramphenicol is noted during periodic blood studies, which should be done approximately every 2 days during chloramphenicol receipt. Aplastic anemia and hypoplastic anemia are known to occur after chloramphenicol administration. Peripherally, pancytopenia is most often observed, but only 1-2 of the major cell types (erythrocytes, leukocytes, platelets) may be depressed in some cases. Metformin may result in suboptimal oral vitamin B12 absorption by competitively blocking the calciumdependent binding of the intrinsic factor-vitamin B12 complex to its receptor. The interaction very rarely results in a pernicious anemia that appears reversible with discontinuation of metformin or with Methylcobalamin, vitamin B12 supplementation. Certain individuals may be predisposed to this interaction. Regular measurement of hematologic parameters is recommended in all patients on chronic metformin treatment; abnormalities should be investigated. Medications know to cause bone marrow suppression (e.g., myelosuppressive antineoplastic agents) may result in a blunted or impeded response to methylcobalamin, vitamin B12 therapy. Antineoplastics that are anti-metabolites for the vitamin may induce inadequate utilization of vitamin B12. However, cancer patients usually benefit from vitamin B12 supplementation. The use of methotrexate may additionally invalidate diagnostic assays for folic acid and vitamin B12; however, this is a diagnostic laboratory test interference and not a drug interaction. The intranasal forms of methylcobalamin, vitamin B12, should be administered at least 1 hour before or 1 hour after ingestion of hot food or liquids. Hot foods may cause nasal secretions and a resulting loss of medication or medication efficacy. Interactions between foods and oral or injectable forms of methylcobalamin are not expected. Depressed levels of methylcobalamin, vitamin B12, and abnormal Schilling's test have been reported in patients receiving octreotide. The use of antiinfective agents or pyrimethamine may invalidate diagnostic assays for folic acid and vitamin B12; however, these are diagnostic laboratory test interferences and not true drug interactions. ADVERSE REACTION AND SIDE EFFECTS In most cases, methylcobalamin is nontoxic, even in large doses. Adverse reactions reported following methylcobalamin administration include headache, infection, nausea/vomiting, paresthesias, and rhinitis. Adverse reactions following intramuscular (IM) injection have included anxiety, mild transient diarrhea, ataxia, nervousness, pruritus, transitory exanthema, and a feeling of swelling of the entire body. Some patients have also experienced a hypersensitivity reaction following intramuscular injection that has resulted in anaphylactic shock and death. In cases of suspected cobalt hypersensitivity, an intradermal test dose should be administered.
5 During the initial treatment period with methylcobalamin, pulmonary edema and congestive heart failure have reportedly occurred early in treatment with parenteral methylcobalamin. This is believed to result from the increased blood volume induced by methylcobalamin. Peripheral vascular thrombosis has also occurred. In post-marketing experience, angioedema and angioedema-like reactions were reported with parenteral methylcobalamin. Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic anemia to normal erythropoiesis with methylcobalamin therapy. Therefore, monitoring of the platelet count and serum potassium concentrations are recommended during therapy. Polycythemia vera has also been reported with parenteral methylcobalamin. Consult immediately to health care provider if patient experiencing any signs of an allergic reaction: skin rash, itching or hives, swelling of the face, lips, or tongue, blue tint to skin, chest tightness, pain, difficulty breathing, wheezing, dizziness, red, swollen painful area on the leg. DOSAGE : Parenteral : Peripheral neuropathies Adult: 500 mcg daily IM/IV 3 times/wk. Megaloblastic anaemia caused by vitamin B12 deficiency Adult: 500 mcg daily IM/IV 3 times/wk. Maintenance dose: After about 2 mth of therapy, reduce dose to single admin of 500 mcg every 1-3 mth. STORAGE Storage: Store in a dry place at room temperature. Keep container tightly closed and protected from light. Handle with great care since the substances is hygroscopic.
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