Mecobalamin Tablets Instructions

Approved on.

Revision Date.

 

Methylcobalamin Tablets Instructions

Please read the instruction manual carefully and use under the guidance of your physician

 

[Medication Name]

Generic Name: Methylcobalamin Tablets

English Name: Mecobalamin Tablets

Hanyu Pinyin: Jiagu’an Pian

 

[Ingredients]

The main ingredient of this product is methylcobalamin

The chemical name is: Coα-[α-(5,6)-dimethylbenzimidazolyl]-Coβ-Methylcobalamin

The structural formula is:

Molecular Formula:C_{63H91CON13O14P}

Molecular weight: 1344.40

 

[Traits]

This product is an orange film-coated tablet, which appears pink after removing the film coating.

 

[Indications

Peripheral neuropathy.

[Specifications

0.5mg

[dosage

Orally. Usually adults take 1 tablet (0.5mg) once, 3 times a day, may be increased or decreased according to age and symptoms as appropriate.

[Adverse Reactions

In total cases15,180cases,146cases(0.96%)had adverse reactions. (At the end of the survey on the frequency of adverse reactions)

Gastrointestinal: Occasional(5%~0.1%)loss of appetite, nausea, vomiting, diarrhea; “font-family:Times New Roman”>

Allergy: rare(<0.1%)(<0.1%)rash.

[Contraindicated

It is contraindicated in patients with a history of hypersensitivity to methylcobalamin or any of the excipients prescribed.

[Precautions

1. If not effective for more than one month, no further dosing is necessary.

2. Workers who work with mercury and its compounds should not take large amounts of this product for long periods of time.

[For Pregnant and Lactating Women

While methylcobalamin has not demonstrated teratogenic effects in animal studies, its safety in pregnant women is unclear.

It is unclear whether methylcobalamin is secreted through women’s milk, but animal studies have reported lactational secretion of methylcobalamin. The safety of this product in lactating women is not known.

[Pediatric use

This trial was not conducted and no references are available.

[Geriatric use

Due to decreased function in the elderly, it is recommended that the dosage be reduced under medical supervision as appropriate.

[Drug Interactions].

This trial was not performed and no references were available.

[Drug overdose

There is no experience with drug overdose. If an overdose occurs, symptomatic, supportive therapy should be administered.

[Pharmacology and Toxicology

Pharmacology

This product is an endogenous coenzymeB₁₂, participates in the one-carbon unit cycle and plays an important role in the transmethylation reaction for the synthesis of methionine from homocysteine. Animal experiments found that this product can easily enter neuronal organelles than cyanocobalamin and participate in the synthesis of thymidine nucleoside in brain cells and spinal cord neurons, promote the utilization of folic acid and nucleic acid metabolism, and promote the synthesis of nucleic acid and protein stronger than cyanocobalamin. It can promote axonal transport function and axonal regeneration, normalize the transport of axonal skeletal protein in streptozotocin-induced diabetic rats sciatic nerve, and has inhibitory effects on drug-induced neurodegeneration, such as neurodegeneration induced by adriamycin, acrylamide, vincristine and spontaneous hypertensive rat neuropathy. It was found to promote lecithin synthesis and neuronal myelin formation in rat tissue culture. It normalized delayed synaptic transmission and neurotransmitter reduction, restored end-plate potential induction by increasing nerve fiber excitability, and restored acetylcholine to normal levels in the brain of rats fed choline-deficient diets.

Toxicological studies

Reproductive toxicity: the product was given orally during the teratogenic sensitivity period in rats and mice0.2,2.0,20 mg/kg/d, and no abnormalities or teratogenic signs were observed in fetuses and newborns. .

[Pharmacokinetics].

1. One-time administration

One oral dose in a healthy individual120 μg, 1,500 μg^Note), regardless of the dose, after administration of The maximum blood concentration was reached at 3hours after drug administration, and its absorption was dose-dependent. Half-life, increased fraction of totalB₁₂serum concentration and△AUC₀¹²as shown in the figure and table below.

After taking the drug8hour, the urinary excretion of totalB₁₂isafter drug administration span style=”font-family:Times New Roman”>24hour excretion of 40to80%.

Note) A single oral dose of labeled1,500 μgDosing is in addition to the dosage approved by the Ministry of Health and Welfare of Japan.

 

Mean±< /span>S.E.,n=8

※ 1: Pre-dose value to post-dose12hour increase in the measured value, calculated by the trapezoidal rule formula.

* 2:
by the time after administration24～. /span>48hours are calculated as the average.

2. Continuous dosing

Observation of healthy individuals for 12 consecutive12weekly oral doses of1,500 μg per day until after discontinuation of the drug4weeks after discontinuation of the drug, total serumB₁₂week sub>value of the change in The value after 4weeks of administration was about 2fold and gradually increased thereafter to 1212fold. “font-family:Arial”>weeks later reached about 2.8fold, even after discontinuing the administration< span style="font-family:Times New Roman">4weeks later, it still showed approximately 1.8fold of the pre-dose level. Roman”>1.8fold.

[Storage]

Store under shade and seal.

[Packaging]

Polyester/Aluminium/Polyethylene pharmaceutical laminate film Packaging. Each plate16tablets, each box3plates; each plate16tablets, per box6plates.

[Expiration Date]

12months

[Execution Standard]

 

[Approval Number]

[Manufacturer]

Company name: Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co: Times New Roman”>

Production Address: Xianlin Avenue, Qixia District, Nanjing9No.

Postal Code: 210049

Tel: 025-83505999-6895

Fax Number: 025-84351897

Net
Address:http::< /span>//www.hailingyy.com