Meradexone Injection

Meradexone Injection is used for: Ulcerative colitis, Rheumatoid arthritis, Multiple sclerosis, Nausea and vomiting, Multiple myeloma, Cerebral oedema, Shock, Inflammatory joint diseases, Idiopathic thrombocytopenic purpura, Dental surgery, Allergic anaphylactic shock, Brain tumors, Status asthmaticus

Injection For intravenous, intramuscular, intra-articular, intralesional, and soft tissue injection. Dexamethasone can be given parenterally at doses of 0.5-20 mg daily, either as a single IV/IM injection or by IV infusion. Cerebral Edema 10 mg IV, then 4 mg IM 6 hourly until clinical improvement is observed; may be reduced after 2-4 days and gradually discontinued over 5-7 days Adjunctive treatment of suspected bacterial meningitis (starting before or with first dose of antibacterial) Adult: 10 mg IV every 6 hours continued for 4 days in patients with pneumococcal meningitis, discontinue treatment if another cause of meningitis is suspected or confirmed Shock 1- 6 mg/kg IV once or 40 mg IV 2-6 hourly PRN Alternative: 20 mg IV, then 3 mg/kg/day by continuous IV infusion High-dose treatment not to be continued beyond 48-72 hours Inflammation 0.75-9 mg/day IV/IM divided 6-12 hourly Acute Allergic Conditions For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness Day 1: 4-8 mg IM Days 2-3: 3 mg/day PO divided q12hr Day 4: 1.5 mg/day PO divided q12hr Days 5-6: 0.75 mg/day PO in single daily dose Day 7: No treatment Intra-articular, intralesional, or soft tissue injection The usual dose is from 0.2 to 6 mg. The frequency usually ranges from once every three to five days to once every two to three weeks. Frequent intra-articular injection may result in damage to joint tissues.

Injection Airway Edema 0.5-2 mg/kg/day IV/IM divided q6hr, starting 24 hours before extubation and continued for 4-6 doses afterward Croup 0.6 mg/kg IV/IM once; not to exceed 16 mg Inflammation 0.08-0.3 mg/kg/day IV/IM divided q6hr or q12hr Meningitis >6 weeks: 0.6 mg/kg/day IV divided q6hr for first 2-4 days of antibiotic therapy, starting 10-20 minutes before or simultaneously with first antibiotic dose Cerebral Edema Associated With Brain Tumor 1-2 mg/kg IV/IM once; maintenance: 1-1.5 mg/kg/day IV/IM divided q4-6hr; not to exceed 16 mg/day Spinal Cord Compression 2 mg/kg/day IV divided q6hr

IV Preparation Standard diluent: 4 mg/50 mL D5W or 10 mg/50 mL D5W Minimum volume: 50 mL D5W IV/IM Administration Dexamethasone sodium phosphate: Administered by IV push, continuous or intermittent IV infusion, or IM

Ocular herpes simplex is an example of an absolute contraindication to corticosteroid therapy. Relative contraindications are: Gastrointestinal ulcer, acute or chronic infections, osteoporosis, pregnancy, diabetes mellitus, renal insufficiency, hypertension, systemic fungal infection, cerebral malaria, history of psychotic illness, immediate before prophylactic immunization and finally hypersensitivity to Dexamethasone. Administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids

Alterations in Endocrine Function: Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur. Monitor patients for these conditions with chronic use. Immunosuppression and Increased Risk of Infections: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections. Alteration in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels. Venous and Arterial Thromboembolism: Risk increased; consider anticoagulant prophylaxis and monitor for evidence of thromboembolism. Vaccination: Avoid the administration of live or live-attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. Ophthalmic Effects: May include cataracts, infections, and glaucoma. Gastrointestinal Perforation: Avoid use in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Osteoporosis: Increased risk; monitor for changes in bone density with chronic use. Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Monitor for signs and symptoms and manage promptly. Kaposi’s Sarcoma: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.

Pregnancy Corticosteroids readily cross the placenta Adverse developmental outcomes including orofacial clefts (cleft lip with or without cleft palate), intrauterine growth restriction, and decreased birth weight have been reported with maternal use of corticosteroids during pregnancy Pregnancy testing is recommended for females of reproductive potential before initiating treatment Contraception Use effective contraception during treatment and for at least 1 month following final dose Infertility in males Steroids may increase or decrease motility and number of spermatozoa in some patients In animals, dexamethasone affects male spermatogenesis Lactation Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects Advise women not to breastfeed during treatment and for 2 weeks after the last dose

Strong CYP3A4 inhibitors Coadministration of strong and moderate CYP3A4 inhibitors increased dexamethasone exposure, which may increase the risk of adverse reactions Avoid coadministration of strong CYP3A4 inhibitors or consider alternatives that are not strong CYP3A4 inhibitors If coadministration cannot be avoided, closely monitor for adverse drug reactions Strong CYP3A4 inducers Coadministration of strong CYP3A4 inducers may decrease dexamethasone exposure, which may result in loss of efficacy Avoid coadministration of strong CYP3A4 inducers or consider alternative medication that are not CYP3A4 inducers If coadministration cannot be avoided, consider increasing the dexamethasone dose Cholestyramine Cholestyramine may increase clearance of corticosteroids and potentially decrease corticosteroid exposure Avoid coadministration and consider alternative agents Anticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis If possible, anticholinesterase agents should be withdrawn at least 24 hr before initiating corticosteroid therapy Ephedrine Ephedrine may decrease dexamethasone exposure and may result in loss of efficacy Consider increasing the dexamethasone dose when used with ephedrine Estrogens Estrogens may decrease the hepatic metabolism of certain corticosteroids and increase exposures, which may increase the risk of adverse reactions CYP3A4 substrates Coadministration of dexamethasone with substrates may decrease the concentration of these drugs, resulting in loss of efficacy of these drugs Oral anticoagulants Coadministration of anticoagulants with corticosteroids may reduce the response to anticoagulants; frequently monitor coagulation indices to maintain the desired anticoagulant effect Amphotericin B injection and potassium-depleting agents Sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroid; closely monitor potassium levels Antidiabetics Corticosteroids may increase blood glucose concentrations; consider adjusting the dose of antidiabetic agents, as necessary Isoniazid Serum concentrations of isoniazid may be decreased with corticosteroids Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently Convulsions have been reported with this concurrent use Digitalis glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other NSAIDS) and corticosteroids increases the risk of gastrointestinal side effects; clearance of salicylates may be increased with concurrent use of corticosteroids; monitor for toxicity Phenytoin In postmarketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone coadministration, leading to alterations in seizure control Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines If possible, defer routine administration of vaccines or toxoids until therapy is discontinued Concomitant therapies that may increase the risk of thromboembolism Erythropoietic agents, or other agents that may increase the risk of thromboembolism, such as estrogen containing therapies, coadministered with dexamethasone may increase the risk of thromboembolism; monitor for risk of thromboembolism Thalidomide Toxic epidermal necrolysis has been reported with concomitant use of thalidomide Closely monitor for toxicity Skin tests Corticosteroids may suppress reactions to skin tests Potentially Fatal: Reduced efficacy in combination with ephedrine, cholestyramine, phenytoin, phenobarbital and rifampicin. Contraindicated (18) apixaban artemether/lumefantrine cariprazine cobimetinib dienogest/estradiol valerate elbasvir/grazoprevir elvitegravir/cobicistat/emtricitabine/tenofovir DF lumacaftor/ivacaftor lumefantrine lurasidone mifepristone naloxegol ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) panobinostat praziquantel regorafenib rilpivirine roflumilast

Side effects of Dexamethasone Sodium Phosphate Injections : Frequency Not Defined Allergic reactions: Anaphylactoid reaction, anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, tumor lysis syndrome Gastrointestinal: Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis Metabolic: Negative nitrogen balance due to protein catabolism Musculoskeletal: Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures Neurological/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, vision blurred Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

Meradexone 5mg/ml Injection manufactured by G. A. Company Ltd.. Its generic name is Dexamethasone Sodium Phosphate Injections. Meradexone is availble in Bangladesh. Farmaco BD drug index information on Meradexone Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.