Methylprednisolone Sodium Succinate for Injection 40mg

• Quality Standard: USP, Bp
• Usage Mode: Injection
• Factory Certified: GMP
• Transport Package: Carton
• Specification: 40mg
• Trademark: Sinolead
• Model NO.: injection
• Origin: China
• Production Capacity: 100000ctns Per Month

Product Description

Generic Name	Methylprednisolone Sodium Succinate For Injection
Strength	40 mg
Packing	10 vials /box
Origin	China

 

 

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Product name:
Methylprednisolone Sodium Succinate For Injection 40mg

Character:
The 40mg size of this product is a two-chamber bottle, the lower chamber is white to quasi-white freeze-dried lump or powder, and the upper chamber is colorless and clear liquid.

Indications:
Methylprednisolone sodium succinate for injection is indicated for use as an alternative treatment for certain endocrine disorders, where glucocorticoids are only symptomatic.

Drug interaction:
Methylprednisolone is a substrate of cytochrome P450 enzyme (CYP), which is metabolized primarily by CYP3A4 enzyme. CYP3A4 is the dominant enzyme in the most abundant CYP subfamily in the adult liver. It catalyzes the 6β-hydroxylation of steroids, which is the basic first stage of endogenous and synthetic corticosteroids metabolism. Many other compounds are also substrates for CYP3A4, and some of these (and other drugs) have been shown to alter glucocorticoid metabolism through induction (upregulation) or inhibition of the CYP3A4 enzyme.
CYP3A4 inhibitors - Drugs that inhibit CYP3A4 activity, typically reduce liver clearance and increase plasma concentrations of CYP3A4 substrate drugs, such as methylprednisolone. Due to the presence of CYP3A4 inhibitors, the dosage of methylprednisolone may need to be adjusted to avoid steroid toxicity.
CYP3A4 inducers - Drugs that induce CYP3A4 activity generally increase liver clearance, resulting in lower plasma concentrations of CYP3A4 substrate drugs. Taking it at the same time may require increasing the dose of methylprednisolone to achieve the desired effect.
CYP3A4 substrate - Hepatic clearance of methylprednisolone may be inhibited or induced due to the presence of another CYP3A4 substrate, requiring appropriate dose adjustment. Adverse reactions caused by the use of either drug may be more likely to occur when both drugs are used together.
To avoid compatibility and stability problems, methylprednisolone sodium succinate is recommended to be administered separately from other compounds that are administered intravenously. Drugs that are physically incompatible with methylpredone sodium succinate in solution include, but are not limited to: allopurinol sodium, doxapram hydrochloride, tigacycline, diltiazem hydrochloride, calcium gluconate, vecuronium bromide, rocuronium bromide, cisenesulfonate atracuronium, glyrobromide, and propofol.
The compatibility and stability of intravenous methylprednisolone sodium succinate solution and its mixing with other intravenous drugs depends on the pH, concentration, time, temperature of the mixture and the solubility of methylprednisolone itself. Therefore, in order to avoid compatibility and stability problems, it is recommended that methylprednisolone sodium succinate be administered separately from other drugs as much as possible, whether intravenously through an intravenous drug chamber or as an intravenous infusion of "piggy-back" solution.

Pharmacology and toxicology:
This product is methylprednisolone for intravenous and intramuscular injection. It is a synthetic glucocorticoid. This highly concentrated aqueous solution is particularly suitable for disease states requiring strong, fast-acting hormone therapy. Methylprednisolone has strong anti-inflammatory, immunosuppressive and anti-allergic activities.
Glucocorticoids diffuse through cell membranes and bind to specific receptors in the cytoplasm. This binding then enters the nucleus, binds to DNA(chromosomes), initiates transcription of mRNA, and then synthesizes various enzyme proteins, which are believed to be the ultimate source of glucocorticoids for their various systemic effects. Glucocorticoids not only play an important role in inflammation and immune processes, but also affect carbohydrate, protein and fat metabolism, and also have an effect on the cardiovascular system, the skeletal musculoskeletal system and the central nervous system.
-- Acts on inflammatory and immune processes:
Most of the therapeutic effects of glucocorticoids are related to its anti-inflammatory, immunosuppressive, and anti-allergic properties, which lead to the following outcomes:
- Reduce inflammation around the lesions of immune active cells
- Reduces blood vessel dilation
- Stable lysosomal membrane
- Inhibition of phagocytosis
- Reduces the production of prostaglandins and related substances
4mg of methylprednisolone has the same glucocorticoid effect (anti-inflammatory effect) as 20mg Methylprednisolone has only a very low salt corticosteroid effect (200mg of methylprednisolone is equivalent to 1mg of deoxycorticosterone).
- Effects on carbohydrate and protein metabolism:
Glucocorticoids have the function of breaking down protein, and the released amino acids are converted into glucose and glycogen in the liver through gluconeogenesis. At the same time, the absorption of glucose by peripheral tissues is reduced, resulting in elevated blood sugar and glycosuria. This is especially true for those who are predisposed to diabetes.
-- Effects on fat metabolism:
Glucocorticoids have the function of breaking down fat, which mainly affects the limbs; In addition, glucocorticoids also have a fat synthesis effect, which is particularly obvious in the chest, neck and head. All this leads to a redistribution of fat.
The maximum pharmacological effect of glucocorticoids occurred after peak blood concentrations, suggesting that most of their effects were induced by altering enzyme activity rather than by direct action of the drug.
[u] Preclinical safety data [/u]
According to routine safety pharmacology studies, repeated dose toxicity studies were performed on mice, rats, rabbits, and dogs administered intravenously, intraperitoneally, subcutaneously, intramuscular, and orally, and no unexpected hazards were found. Methylprednisolone is a powerful steroid with the same pharmacological activity as glucocorticoids, These include effects on carbohydrate metabolism, electrolyte and water balance, physical components of blood, lymphoid tissue, protein metabolism resulting in loss or deficiency of weight gain, lymphocytopenia, atrophy of the spleen, steatosis of the thymus, lymph nodes, adrenal cortex and testis, as well as liver and islet cell proliferation. A 30-day reversibility study in rats treated with methylprednisolone showed that normal organ function was restored within about a month after discontinuation of the drug. After 52 weeks of treatment with methylprednisolone, many parameters returned to normal after a 9-week reversible period. The toxicities found in repeated administration toxicity studies are those expected to be induced by sustained exposure to exogenous adrenocorticosteroids.
Carcinogenic effect:
Because the drug is only suitable for short-term treatment, and there is no indication that it is potentially carcinogenic, no long-term studies evaluating its carcinogenic effect have been conducted in animals. There is currently no evidence that corticosteroids cause cancer.
Teratogenic effects:
DNA damage/alkaline elution assay tests were performed on Chinese hamster V79 cells and there was no evidence of possible genetic and chromosomal mutations. Methylprednisolone does not induce chromosome damage in the absence of the liver activating system.
Reproductive toxicity:
In animal studies of embryonic toxicity of methylprednisolone, no teratogenic effects were found in mice or rats given daily intraperitoneal doses of 125mg/kg/ day or 100mg/kg/ day, respectively. Methylprednisolone 20mg/kg/ day by subcutaneous injection has teratogenic effect on rats. Rats were given 1.0mg/kg/ day of methylprednone acetate by subcutaneous injection, and methylprednone acetate had teratogenic effect.

Storage:
Undissolved medicine, sealed, 15-25ºC store
The solution dissolved with the included diluent can be stored at room temperature (15-25 ° C) for 48 hours.