G Dexamtthasone Injection
Dexamethasone Sodium Phosphate Injections
5mg/ml
Gonoshasthaya Pharmaceuticals Ltd.
| Pack size | 10 amps pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 14.99 AED |
Available as:
Indications
G Dexamtthasone 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
Adult Dose
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.
Child Dose
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
Renal Dose
Administration
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
Contra Indications
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
Precautions
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-Lactation
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
Interactions
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
Adverse Effects
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
Mechanism of Action
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.
Note
G Dexamtthasone 5mg/ml Injection manufactured by Gonoshasthaya Pharmaceuticals Ltd.. Its generic name is Dexamethasone Sodium Phosphate Injections. G Dexamtthasone is availble in Bangladesh.
Farmaco BD drug index information on G Dexamtthasone Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.