Dexamethasone sodium phosphate injection

[Drug Name]

Generic name: Dexamethasone Sodium Phosphate Injection

English Name:Dexamethasone Sodium Phosphate Injection

Chinese Pinyin: Disaimisong Linsuanna Zhusheye

【Ingredients】

The active ingredient of this product is dexamethasone sodium phosphate, and its excipients are niacinamide, anhydrous sodium sulfite, sodium bisulfite, disodium edetate, and water for injection.

Chemical Name:16α-Methyl-11β,17α,21-Trihydroxy-9α-Fluoropregn-1,4-diene-3,20-dione-21-sodium phosphate.

【SexCondition】This product is a colorless, clear liquid.

【Symptoms】

Mainly used for allergic and autoimmune inflammatory diseases. Commonly used in connective tissue diseases, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is also used for the comprehensive treatment of certain severe infections, poisoning, and malignant lymphoma.

【Specification】 lml:2mg

[Adverse Reactions]

Glucocorticoids have no significant adverse reactions when used in physiological doses for replacement therapy. Adverse reactions mostly occur when pharmacological doses are used, and are closely related to the duration of treatment, dosage, type of medication, method of administration, and route of administration. The adverse reactions of this product can be classified into the following categories: 1. Infections: Complicated infections (such as fungal, bacterial, and viral infections) are the main adverse reactions of adrenal corticosteroids, especially in cases of long-term or high-dose use. 2. Gastrointestinal: Gastrointestinal irritation (nausea, vomiting), pancreatitis, peptic ulcers, or perforation. 3. Neuropsychiatric system: Patients may experience psychiatric symptoms: euphoria, agitation, insomnia, delirium, restlessness, disorientation, and may also present as suppression. Psychiatric symptoms are more likely to occur in individuals with chronic wasting diseases and those with a history of mental disorders. Benign intracranial hypertension syndrome. 4. Endocrine system and water, electrolyte disorders: Iatrogenic Cushing's syndrome appearance and physique, weight gain, lower limb edema, menstrual irregularities, hypokalemia, growth suppression in children, impaired glucose tolerance, and worsening diabetes. 5. Musculoskeletal: Ischemic bone necrosis, osteoporosis and fractures, muscle weakness, muscle atrophy. 6. Local application site: Acute inflammation after intra-articular injection. Tissue atrophy causing indentation after intramuscular and subcutaneous injections, as well as skin pigmentation or depigmentation, tendon rupture. 7. Skin and its appendages: Striae, poor wound healing, acne, perineal or perianal itching, fever, and tingling sensations. 8. Eyes: Glaucoma, cataracts. 9. Allergic reactions: Manifesting as rash, itching, facial flushing, palpitations, fever, chills, chest tightness, difficulty breathing, etc. In severe cases, anaphylactic shock may occur. 10. Glucocorticoid withdrawal syndrome: Sometimes patients may experience dizziness, fainting tendencies, abdominal or back pain, low fever, loss of appetite, nausea, vomiting, muscle or joint pain, headache, fatigue, weakness. After careful examination, if adrenal cortical insufficiency and recurrence of the original disease can be ruled out, it may be considered as glucocorticoid dependence syndrome. 11. Others: Hiccups, Charcot's joint disease, liver dysfunction, leukocytosis, thromboembolism.

【Contraindications】1.This product is contraindicated for those allergic to it, and should be used with caution in patients with a history of allergy to adrenal cortex hormones. 2. The excipients of this product contain sulfites, and it is contraindicated for those allergic to sulfites. 3. Generally, the following patients should not use this product; in special circumstances, the benefits and risks should be weighed, and attention should be paid to the possibility of worsening conditions: hypertension, thrombosis, myocardial infarction, gastric and duodenal ulcers, visceral surgery, mental illness, electrolyte metabolism disorders, glaucoma.

【Precautions】

1.Glucocorticoids can induce or exacerbate infections, and should be used with caution in patients with bacterial, fungal, viral, or parasitic infections (such as amoebiasis, nematodes); if necessary, appropriate anti-infection treatment must be provided. 2. Use with caution in patients with ulcerative colitis, diverticulitis, post-intestinal anastomosis, liver cirrhosis, renal dysfunction, epilepsy, migraine, myasthenia gravis, diabetes, osteoporosis, and hypothyroidism. 3. Long-term use of this product should involve a gradual reduction in dosage before discontinuation. 4. Athletes should use with caution. 5. For patients with ocular herpes simplex, glucocorticoid medications are recommended to be used with caution due to the risk of corneal perforation. 6. Long-term use of glucocorticoids can lead to posterior subcapsular cataracts and may damage the optic nerve, increasing the risk of secondary fungal and viral ocular infections. 7. Intra-articular injection of glucocorticoids increases the risk of joint infections. 8. Reports from abroad indicate that severe neurological adverse events (some leading to death) are associated with epidural injection of glucocorticoids. Adverse events include but are not limited to spinal cord infarction, paraplegia, limb paralysis, cortical blindness, and stroke. 9. Contracting chickenpox or measles while using this product may worsen the condition, and in severe cases, can be life-threatening. During the use of this product, careful observation and attention are required. 10. Patients who have used this product for a long time or have discontinued it within 6 months after long-term use should not receive live attenuated vaccines (such as oral polio vaccine) due to weakened immunity. 11. Patients with latent or old tuberculosis should be closely monitored during long-term glucocorticoid treatment and receive preventive treatment if necessary. 12. Hepatitis B virus carriers using adrenal corticosteroids may experience increased replication of the hepatitis B virus, leading to hepatitis. Liver function tests and monitoring of hepatitis virus markers should continue during and after the administration of this formulation.

【Medication for Pregnant and Breastfeeding Women】Pregnant women using medication may increase the incidence of placental insufficiency, reduced neonatal weight, or stillbirth. Animal studies have shown teratogenic effects, so the benefits and risks should be weighed before use. If a nursing mother receives high doses of medication, she should not breastfeed to prevent the drug from being excreted in breast milk, which could lead to adverse reactions such as growth suppression and adrenal function suppression in the infant.

【Pediatric Medication】If children use adrenal corticosteroids, it must be done with great caution, as hormones can inhibit the growth and development of the child. If long-term use is indeed necessary, short-acting or intermediate-acting preparations should be used, and long-acting dexamethasone preparations should be avoided. Additionally, changes in intracranial pressure should be monitored.

【Medication for the Elderly】 can easily lead to hypertension and diabetes, and elderly patients, especially women after menopause, are more likely to exacerbate osteoporosis when using them.

【Drug Interactions】

1.Liver enzyme-inducing drugs such as barbiturates, rifampicin, rifabutin, carbamazepine, phenytoin, primidone, and amiodarone can promote the metabolism of glucocorticoids, and the dosage of glucocorticoids may need to be increased when taken together. Liver enzyme-inhibiting drugs such as erythromycin and ketoconazole may increase the blood concentration of glucocorticoids, so dosage should be monitored when used together.2. The simultaneous use of glucocorticoids and coumarin anticoagulants (such as warfarin) can increase or weaken the anticoagulant effect, so drug dosages may need to be adjusted.3. The combination of glucocorticoids with acetazolamide, loop diuretics, thiazide diuretics, and sodium gampers can exacerbate hypokalemia. The simultaneous use of glucocorticoids and cardiac glycosides may increase the risk of arrhythmias related to hypokalemia or digoxin toxicity. When using the above medications together, blood potassium levels should be closely monitored.4. Glucocorticoids can weaken the effects of antihypertensive drugs and oral hypoglycemic agents, and dosages should be adjusted as appropriate.5. The concurrent use of glucocorticoids and non-steroidal anti-inflammatory drugs can increase the incidence of peptic ulcers.6. Glucocorticoids can increase the renal clearance of salicylates, and discontinuing glucocorticoids when used together may lead to salicylate toxicity. For patients with low prothrombin, caution should be exercised when combining glucocorticoids with aspirin.

【Drug Overdose】can cause a syndrome of hypercortisolism.

【Pharmacology and Toxicology】

Adrenocortical hormone drugs. They have anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive effects, and their mechanism of action is:

(1)Anti-inflammatory effect: This product reduces and prevents tissue response to inflammation, thereby alleviating the manifestations of inflammation. It can inhibit the accumulation of inflammatory cells, including macrophages and leukocytes, at the site of inflammation, and suppress phagocytosis, the release of lysosomal enzymes, and the synthesis and release of inflammatory chemical mediators. (2)Immunosuppressive effect: This includes preventing or inhibiting cell-mediated immune responses, delayed hypersensitivity reactions, reducing the number of T lymphocytes, monocytes, and eosinophils, decreasing the binding capacity of immunoglobulins to cell surface receptors, and inhibiting the synthesis and release of interleukins, thereby reducing the conversion of T lymphocytes to lymphoblasts and alleviating the expansion of primary immune responses. This product also reduces the passage of immune complexes through the basement membrane and can decrease the concentration of complement components and immunoglobulins.

【Pharmacokinetics】

The intramuscular injection of this product reaches peak plasma concentration in l hours. The plasma protein binding rate of this product is lower than that of other corticosteroids.

【Storage】Shade and keep in sealed.

【Packaging】Ampoule packaging, l0 pieces/box

【Validity Period】24months

【Implementation Standards】《Chinese Pharmacopoeia》2020 Edition, Volume Two

【Approval Number】National Drug Standard CodeH52020733

【Drug Marketing Authorization Holder】/【Manufacturing Enterprise】

name：Guizhou Tiandi Pharmaceutical Co., Ltd.

address：No. 6 Baokang Road, Hongxing Pharmaceutical Industrial Park, Dingxiao Town, Xingyi City, Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province

 postal code：562400

 tel：0859-3119928

 fax：0859-3118152

 website：www.gztiandi.com