Properties
What is it?
International Nonproprietary Name Dexamethasone Composition 1 ml contains: Active substance: Dexamethasone phosphate in the form of sodium salt – 4 mg. Excipients: Glycerin, Disodium edetate, Disodium hydrogen phosphate dihydrate, Water for injection. See blog: Dexamethasone — What to Know Before Using a Potent Active Substance? Description Transparent, colorless or slightly yellowish solution. Pharmacological Action The drug Dexamethasone is a long-acting synthetic glucocorticosteroid that lacks mineralocorticoid effect. The drug has anti-inflammatory, anti-allergic, and desensitizing effects, and possesses immunosuppressive activity. After intravenous administration, the drug begins to act rapidly, while after intramuscular administration, the clinical effect is achieved in 8 hours. The drug's action is prolonged and lasts from 17 to 18 days after intramuscular administration and from 3 days to 3 weeks after local application (in the affected area). A dose of 0.75 mg of Dexamethasone is equivalent to 4 mg of methylprednisolone and triamcinolone, 5 mg of prednisone and prednisolone, 20 mg of hydrocortisone, and 25 mg of cortisone. Indications - Endocrine disorders: Acute adrenal insufficiency; surgical interventions, severe trauma or diseases in patients with known or suspected adrenal insufficiency. - Shock of various etiologies: Shock resistant to standard therapy; anaphylactic shock; shock in patients with adrenal insufficiency. - Cerebral edema: Cerebral edema due to primary or metastatic brain tumors, neurosurgical intervention, or craniocerebral trauma. - Malignant diseases: Palliative treatment of leukemia and lymphoma in adults, acute leukemia in children; hypercalcemia in patients with malignant tumors when oral administration is not possible. - Exacerbation of chronic obstructive bronchitis and bronchial asthma, asthmatic status. - Severe allergic reactions. - Intra-articular administration: In cases of pronounced joint inflammation (excluding infectious), when conventional therapy is ineffective, as well as in other conditions with synovitis (after aspiration of synovial fluid). - Local application (in the affected area) is indicated in cases of indurative folliculitis, granuloma annulare, and sarcoidosis. - Subconjunctival, retrobulbar, or peribulbar administration: Indicated in cases where there is a risk to vision in inflammatory or allergic diseases of the eyes, systemic immunodeficiency, proliferative changes of the orbit, sympathetic ophthalmia, and after immunosuppressive treatment following corneal transplantation. Diagnostic examination for adrenal hyperfunction. In this dosage form, Dexamethasone is also indicated for the treatment of certain diseases when oral administration of Dexamethasone is not possible. Contraindications Hypersensitivity to the drug, osteoporosis, acute viral, bacterial, and systemic fungal infections (when appropriate treatment is not administered), Cushing's syndrome, lactation. Relative contraindications include chronic renal failure, liver cirrhosis and chronic hepatitis, acute psychoses. Intramuscular administration is contraindicated in patients with idiopathic thrombocytopenic purpura. For ophthalmic use: Viral and fungal diseases of the eyes, acute purulent infection of the eye in the absence of specific therapy, diseases of the cornea combined with epithelial defects, trachoma, glaucoma. Pregnancy and lactation Dexamethasone is used during pregnancy only for vital indications, if the potential positive effect of the drug on the mother's or fetus's organism outweighs the potential risks associated with treatment. Since the drug may affect the child's growth and endogenous corticosteroid secretion, lactation should be discontinued during Dexamethasone use. Dosage and Administration Parenteral administration: The drug is administered intramuscularly, intravenously by bolus or drip (with glucose or physiological saline). Dexamethasone should not be mixed with other medicinal products in the same syringe or infusion bottle. Recommended initial average daily doses for intravenous or intramuscular administration range from 0.5 to 9 mg per day, or more if necessary. 3-4 injections of 4-20 mg of Dexamethasone can be administered per day. The duration of parenteral administration is usually 3-4 days, after which maintenance therapy with the oral form of the drug is initiated. Local application (in the affected area): Recommended doses are 0.4-4 mg intra-articularly once. Intra-articular injections can be repeated after 3-4 months. The drug can be administered a maximum of 3-4 times in the same joint per year. Administration into two joints simultaneously is possible. More frequent use can lead to damage of articular cartilage. The dose of the drug depends on the size of the affected joint. In large joints, 2-4 mg of Dexamethasone is usually administered, and 0.8-1 mg in small joints. Doses for administration into the synovial bursa are 2-3 mg, into the tendon sheath 0.4-1 mg, and into the tendon 1-2 mg. The dose of Dexamethasone administered into the affected area is equal to the dose administered into the joint. Simultaneous administration into a maximum of 2 affected areas is possible. For administration into soft tissues, a dose of 2-6 mg is recommended (around the joint). Doses for children (intramuscular): During replacement therapy (for adrenal insufficiency), the dose of the drug is 0.0233 mg/kg body weight or 0.67 mg/m² body surface area, divided into 3 doses every third day, or 0.00776-0.01165 mg/kg body weight or 0.233-0.335 mg/m² body surface area daily. For other indications, the recommended dose is 0.02776-0.16665 mg/kg body weight or 0.833-5 mg/m² body surface area every 12-24 hours. Special Instructions Caution should be exercised when treating patients with arterial hypertension, heart failure, diabetes mellitus, epilepsy, thromboembolism, severe myasthenia gravis, and glaucoma. The effect of glucocorticoids is enhanced in patients with liver cirrhosis or hypothyroidism. Dexamethasone treatment can mask signs of existing or new infections. Dexamethasone may exacerbate systemic fungal infections, latent amebiasis, and pulmonary tuberculosis. Vaccination with live viral vaccines is contraindicated during Dexamethasone treatment. Immunization with inactivated viral or bacterial vaccines does not induce expected antibody production and does not provide expected prophylactic effect. Dexamethasone is usually not administered 8 weeks before and within 2 weeks after vaccination. Caution should be exercised when treating patients after surgery or bone fracture, as Dexamethasone may slow wound healing and callus formation. Dexamethasone treatment in children should only be carried out with absolute indications. Interactions with other medicinal products The effectiveness of Dexamethasone is reduced when used with rifampicin, carbamazepine, phenobarbital, phenytoin (diphenylhydantoin), primidone, ephedrine, or aminoglutethimide. Dexamethasone reduces the therapeutic effect of hypoglycemic agents, hypotensive agents, coumarin anticoagulants, praziquantel, and natriuretics. It increases the activity of heparin, albendazole, and kaliuretics. Concomitant use of high doses of Dexamethasone and glucocorticoids or β2-receptor agonists increases the risk of hypokalemia. Patients with hypokalemia have a higher risk of cardiac glycoside-induced arrhythmias and toxicity. When used with oral contraceptives, the half-life of glucocorticoids may increase, leading to enhanced action and an increase in side effects. Concomitant use of ritodrine and Dexamethasone is contraindicated as it can cause death. Concomitant administration of Dexamethasone with metoclopramide, diphenhydramine, prochlorperazine, or ondansetron or granisetron is effective for the prevention of vomiting and nausea caused by chemotherapy with cisplatin, cyclophosphamide, methotrexate, fluorouracil. Side Effects Parenteral or local injection of glucocorticoids reduces the risk of systemic side effects. However, the risk of systemic and local side effects exists and increases with prolonged therapy and increased frequency of injections. Local: Redness, swelling, pain at the injection site, or other signs of inflammation or allergic reaction are less common side effects. With prolonged use, striae, atrophy of the skin or subcutaneous retina may occur at the injection site. Systemic: Rapid intravenous injection of high doses of the drug may cause generalized anaphylaxis, flushing of the face and cheeks, cardiac arrhythmias, convulsions. Rare side effects include generalized skin allergic reaction, sudden blindness, burning, numbness, pain or tingling sensation at or near the injection site, psychiatric disorders such as delirium (clouding of consciousness, agitation, anxiety), disorientation, euphoria, hallucinations, manic-depressive episodes, depression or paranoia, glaucoma, cataracts, increased intraocular pressure, and exophthalmos. Overdose Overdose, usually occurring after several weeks of treatment with high doses of the drug, can cause most of the side effects listed in the "Side Effects" section and Cushing's syndrome. There is no specific antidote. In case of overdose, the dose of the drug should be reduced or its use temporarily discontinued. Treatment is symptomatic. Hemodialysis is not an effective method for accelerating the elimination of Dexamethasone from the body. Dosage Form Solution for injection 4 mg/ml in ampoules. 25 ampoules of 1 ml in a package. Storage Conditions Store at a temperature not exceeding 25ºC, out of reach of children. Shelf Life 5 years. The drug cannot be used after the expiry date indicated on the packaging. Dispensing Prescription only. Manufacturer Krka, d.d., Novo mesto, Slovenia.
