Brands of Dexamethasone in Kenya
Deexa, Lincoln Pharmaceuticals Ltd
Dexa Injection, Renata Limited
Dexafil, Fourrts Laboratories (Pvt) Limited
Dexalab, Laborate Pharmaceuticals
Dexamedron, Globe Pharmacy Ltd
Dexamethasone, Dawa Ltd
Dexamethasone, Medisel Kenya
Dexasona, Careplus Limited
Eudexo, Umedica Laboratories Pvt Ltd
Omnidex, Aurochem Pharmaceuticals (India) Pvt Ltd
DEXAMETHASONE MODE OF ACTION
Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties and is therefore, particularly suitable for the use in patients with cardiac failure and hypertension.
Its anti-inflammatory potency is 7 times greater than prednisolone and, like other glucocorticoids, dexamethasone also has anti-allergic, antipyretic and immunosuppressive properties.
Dexamethasone has a biological half-life of 36 – 54 hours and therefore is suitable in conditions where continuous glucocorticoid action is required.
Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess.
Pulmonary and respiratory diseases
Acute asthma exacerbations when use of an oral corticosteroid (OCS) is appropriate, croup.
Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris.
Initial treatment of autoimmune disorders like systemic lupus erythematodes.
Active phases of systemic vasculitides like polyarteritis nodosa (treatment duration should be limited to two weeks in cases of concomitant positive hepatitis B serology).
Severe progressive course of active rheumatoid arthritis, e.g. fast proceeding destructive forms and/or extraarticular manifestations.
Severe systemic course of juvenile idiopathic arthritis (Still’s disease).
Idiopathic thrombocytopenic purpura in adults.
Tuberculous meningitis only in conjunction with anti-infective therapy.
Palliative treatment of neoplastic diseases.
Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment.
Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products.
Prevention and treatment of postoperative vomiting, within antiemetic treatment.
Dexamethasone treatment is recommended by the National Health Service in the UK and the National Institutes of Health (NIH) in the US for patients with COVID-19 who are mechanically ventilated or who require supplemental oxygen but are not mechanically ventilated.Dexamethasone is not recommended in patients with COVID-19 who do not require supplemental oxygen or hospitalization.
DOSAGE AND ADMINISTRATION
The below mentioned dosing recommendations are given for guidance only. The initial and daily doses should always be determined based on individual patient response and disease severity.
– Cerebral oedema: Initial dose and duration of treatment depending on the cause and severity, 6-16 mg (up to 24 mg) / day orally, divided into 3-4 individual doses.
– Acute asthma: Adults: 16 mg / day for two days. Children: 0.6 mg / kg body weight for one or two days.
– Croup: Children: 0.15mg/kg-0.6 mg/kg in a single dose.
– Acute skin diseases: Depending on the nature and extent of the disease daily doses of 8-40 mg, in some cases up to 100 mg, which should be followed by down titration according to clinical need.
– Active phase of rheumatic system disorders: Systemic lupus erythematosus 6-16 mg / day.
– Active rheumatoid arthritis with severe progressive course form: running at fast destructive forms 12-16 mg / day, with extra-articular manifestations 6-12 mg / day.
– Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles.
– Tuberculous meningitis: Patients with grade II or III disease received intravenous treatment for four weeks (0.4 mg per kilogram per day for week 1, 0.3 mg per kilogram per day for week 2, 0.2 mg per kilogram per day for week 3, and 0.1 mg per kilogram per day for week 4) and then oral treatment for four weeks, starting at a total of 4 mg per day and decreasing by 1 mg each week. Patients with grade I disease received two weeks of intravenous therapy (0.3 mg per kilogram per day for week 1 and 0.2 mg per kilogram per day for week 2) and then four weeks of oral therapy (0.1 mg per kilogram per day for week 3, then a total of 3 mg per day, decreasing by 1 mg each week).
– Palliative treatment of neoplastic diseases: Initial dose and duration of treatment depending on the cause and severity, 3-20 mg / day. Very high doses up to 96 mg may also be used for palliative treatment.
– Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment: 8-20 mg dexamethasone prior to chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
– Prevention and treatment of postoperative vomiting, within antiemetic treatment: single dose of 8 mg before the surgery.
– Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products: the usual posology is 40 mg or 20 mg once per day.
Patients undergoing active hemodialysis may show an increased clearance of drug via the dialysate and thus require an adjustment of steroid dose.
In patients with severe liver disease dose adjustment may be necessary. In patients with a severe liver impairment, the biological effects of dexamethasone may be potentiated due to its slower metabolism (prolonged plasma half-life) and hypoalbuminaemia (increased plasma levels of free drug), which may also cause more side effects.
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age (osteoporosis, diabetes mellitus, hypertension, reduced immunity, psychological changes). In such patients, the plasma concentrations of dexamethasone may be higher and its excretion slower than in younger patients, therefore its dose should be reduced accordingly.
The usual dose is 0.01-0.1 mg/kg of body weight daily. The excretion of dexamethasone is approximately equal in children and adults if dosage is adjusted to their body area. Dosage should be planned bearing in mind possible effects upon growth and development and for signs of adrenal suppression.
Long term treatment
For the long-term treatment of several conditions, after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression on the function of the adrenal cortex.
Discontinuation of treatment
Acute adrenocortical failure may occur after abrupt discontinuation of long-term treatment with large doses of glucocorticoids. Therefore, glucocorticoid doses should be gradually reduced in such cases and treatment should be discontinued gradually.
- Hypersensitivity to the active substance or to any of the excipients
- Systemic infection unless specific anti-infective therapy is employed.
- Stomach ulcer or duodenal ulcer.
- Avoid live vaccines in patients receiving immuno suppressive doses (serum antibody response diminished).
- In general no contraindications apply in conditions where the use of glucocorticoids may be life saving.
- Patients taking NSAIDs should be monitored, as NSAIDs may increase the incidence and/or severity of gastric ulcers. Acetylsalicylic acid should be used carefully in combination with corticosteroids in hypoprothrombinaemia.
- The renal clearance of salicylates is increased by corticosteroids. Therefore, the dosage of salicylates may be reduced once the steroids are discontinued. Steroid withdrawal may result in salicylate intoxication due to the increase of salicylate concentration in the serum.
- Corticosteroids reduce the effect of antidiabetic agents such as insulin, sulfonylurea, and metformin. Hyperglycaemia and diabetic ketoacidosis may occur occasionally. Therefore, at the beginning of treatment, diabetics should have more frequent blood and urine tests.
- The hypokalemic effect of acetazolamide, loop diuretics, thiazide diuretics, kaliuretics, amphotericin B injections (glucomineral)-corticosteroids, tetracosactide and laxatives will increase. Hypokalemia promotes cardiac arrhythmias, especially torsade de pointes, and increases the toxicity of cardiac glycosides. Before the start of corticosteroid treatment, hypokalemia should be corrected and patients should be monitored clinically, for electrolytes and by electrocardiography. Furthermore, there are case reports in which the simultaneous use of amphotericin B and hydrocortisone led to an enlarged heart and heart failure.
- Antiulcer drugs: Carbenoxolone increases the risk of hypokalemia.
- Chloroquine, hydroxychloroquine and mefloquine: Increased risk of myopathies and cardiomyopathies.
- Concomitant administration of ACE inhibitors creates an increased risk of blood disorders.
- The blood pressure-lowering effects of antihypertensive drugs may be affected by corticosteroids. The dose of the anti-hypertensive treatment may have to be adjusted during the treatment with dexamethasone.
- Thalidomide: Great care should be taken during co-administration with thalidomide, a there have been reported cases of toxic epidermal necrolysis.
- The effect of vaccinations may be reduced during treatment with dexamethasone.
- Vaccination with live vaccines during treatment with large therapeutic doses of dexamethasone (and other corticosteroids) is contraindicated due to the possibility of viral infection. In this case, vaccination should be postponed for at least 3 months after the completion of treatment with corticosteroids. Other types of immunisation during treatment with large therapeutic doses of corticosteroids are dangerous due to the risk of neurological complications and decreased or absent increase in the antibody titers (in comparison with expected values) and therefore a smaller protective effect. However, patients who have received corticosteroids locally (parenteral) or for a short period of time (less than 2 weeks), in smaller doses may be immunised.
- Cholinesterase inhibitors: Concomitant use of cholinesterase inhibitors and corticosteroids may cause serious muscle weakness in patients with myasthenia gravis. If possible, cholinesterase inhibitors should be discontinued at least 24 hours before the start of corticosteroid therapy.
- The risk of tendinitis and tendon rupture is increased in patients treated concomitantly with glucocorticoids and fluoroquinolones.
- Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Effects of other medicinal products on dexamethasone:
- Dexamethasone is metabolized via the cytochrome P450 3A4 (CYP3A4).
- The administration of dexamethasone with inducers of CYP3A4, such as ephedrine, barbiturates, rifabutin, rifampicin, phenytoin, and carbamazepine can lead to reduced plasma concentrations of dexamethasone, so the dose must be increased.
Tabulated list of adverse reactions
|– Infections and infestations||Increased susceptibility to, or exacerbation of, (latent) infections (including septicaemia, tuberculosis, eye infections, chickenpox, measles, fungal and viral infections) with masking of clinical symptoms, opportunistic infections|
|Blood and lymphatic system disorders||Leukocytosis, lymphopenia, eosinopenia, polycythemia, abnormal coagulation|
|Immune system disorders||Hypersensitivity reactions including anaphylaxis, immunosuppression (see also under “Infections and parasitic diseases”)|
|Endocrine disorders||Suppression of the hypothalamic-pituitary-adrenal axis and induction of Cushing’s syndrome (typical symptoms: full-moon face, plethora, truncal obesity), secondary adrenal and pituitary insufficiency (especially in stress such as trauma or surgery), growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea, hirsutism|
|Metabolism and nutrition disorders||Weight gain, negative protein and calcium balance, increased appetite, sodium and water retention, potassium loss (caution: rhythm disorders), hypokalemic alkalosis, manifestation of latent diabetes mellitus, impaired carbohydrate tolerance with increased dose requirements of antidiabetic therapy, hypercholesterolemia, hypertriglyceridaemia|
|Psychiatric disorders*||Psychological dependence, depression, insomnia, aggravated schizophrenia, mental illness, from euphoria to manifest psychosis|
|Nervous system disorders||Increased intracranial pressure with papilloedema in children (pseudotumor cerebri) usually following discontinuation of treatment; manifestation of latent epilepsy, increased seizures in overt epilepsy, vertigo, headache|
|Eye disorders||Elevated intraocular pressure, glaucoma, papilloedema, cataract, mainly with posterior subcapsular opacity, corneal and scleral atrophy, increased ophthalmic viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers, chorioretinopathy|
|Cardiac disorders||Cardiac muscle rupture after recent history of myocardial infarction, congestive heart failure in predisposed patients, cardiac decompensation*|
|Vascular disorders||Hypertension, vasculitis, increased atherosclerosis and risk of thrombosis/thromboembolism (increase in coagulability of blood may lead to thromboembolic complications)|
|Respiratory, thoracic and mediastinal disorders||Hiccough|
|Gastrointestinal disorders||Dyspepsia, abdominal distension, gastric ulcers with perforation and bleeding, acute pancreatitis, ulcerative esophagitis, oesophageal candidiasis, flatulence, nausea, vomiting|
|Skin and subcutaneous tissue disorders||Hypertrichosis, skin atrophy, telangiectasia, striae, erythema, steroid acne, petechiae, ecchymosis, allergic dermatitis, urticaria, angioneurotic oedema, thinning hair, pigment disorders, increased capillary fragility, perioral dermatitis, hyperhidrosis, tendency to bruise|
|Musculoskeletal and connective tissue disorders||Premature epiphyseal closure, osteoporosis, fractures of the spine and long bones, aseptic necrosis of the femoral and the humeral bones, tendon tears*, proximal myopathy, muscle weakness, loss of muscle mass|
|Reproductive system and breast disorders||Impotence|
|General disorders and administration site conditions||Reduced response to vaccination and skin tests. Delayed wound healing, discomfort, malaise, steroid withdrawal syndrome: a too rapid reduction in corticosteroid dose after prolonged treatment can lead to acute adrenal insufficiency, hypotension, and death. A withdrawal syndrome may present with fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss.|
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, email@example.com or clicking below button:
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Dexamethasone in Kenya
Dexamethasone in Kenya
Dexamethasone in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: C (risk not ruled out)
Routes of Administration: By mouth, intravenous therapy (IV), intramuscular injection (IM), subcutaneous injection (SC), intraosseous (IO)
Protein Binding: 77%
Onset of Action: Not Available
Elimination Half life: 190 minutes (3.2 hours)
Excretion: Urine (65%)
Legal Status | Dosage forms & Strengths
Prescription only medicine
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
|CompTox Dashboard (EPA)|
- PPB Drugs Retention Register
- De Gans, Jan, and Diederik Van de Beek. “Dexamethasone in adults with bacterial meningitis.” New England Journal of Medicine 347.20 (2002): 1549-1556.
- Carroll, Bernard J. “The dexamethasone suppression test for melancholia.” The British journal of psychiatry 140.3 (1982): 292-304.
- Dimopoulos, Meletios, et al. “Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma.” New England Journal of Medicine 357.21 (2007): 2123-2132.
- Loew, D., O. Schuster, and E. H. Graul. “Dose-dependent pharmacokinetics of dexamethasone.” European journal of clinical pharmacology 30.2 (1986): 225-230.