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PMS-DEXAMETHASONE ELIXIR is a brand name for Dexamethasone, supplied as a elixir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-DEXAMETHASONE ELIXIR (dexamethasone elixir) is used orally in the management of disorders responsive to adrenocortical hormone therapy such as: Allergic States: Control of severe or incapacitating allergic conditions not responsive to adequate trials of conventional treatment: seasonal or perennial allergic…
Verbatim from this product's HC label. Tap a section to expand.
Individualize dosage according to the severity of the disease and the patient's response. The severity, prognosis, expected duration of the disease and the patient's reaction to medication are primary factors in determining dosage. (For infants and children, the recommended doses usually will have to be reduced, but dosage should be dictated by the severity of the condition rather than by age or body weight).
Hormone therapy is an adjunct to, not a replacement of, conventional therapy, which should be instituted as indicated. Decrease dosage or discontinue therapy gradually when administration has been continued for more than a few days.
Continued supervision of the patient after cessation of corticosteroids is essential, since there may be a sudden reappearance of severe manifestations of the disease for which the patient was treated, and it may take up to a year for adrenal function to return to normal.
In acute conditions where prompt relief is urgent, large doses are permissible and may be mandatory for a short period. In chronic conditions requiring long-term therapy, use the lowest dosage that provides adequate, but not necessarily complete, relief.
If a high dosage for prolonged periods is considered essential, observe patients closely for signs that might necessitate a dosage reduction or discontinuance of the hormone. Chronic conditions are subject to periods of spontaneous remission.
When such periods occur, discontinue corticosteroids gradually. Carry out routine laboratory studies such as urinalysis, two- hour post-prandial blood sugar, determinations of blood pressure and body weight, and a chest x- ray at regular intervals during prolonged therapy.
Periodic determinations of serum potassium are advisable if large doses are being used. Take upper gastrointestinal x -rays when treatment is prolonged, in patients with a history of ulcer or when there is gastric distress. 75 mg = methylprednisolone and triamcinolone 4 mg = prednisolone and prednisone 5 mg = hydrocortisone 20 mg = cortisone 25 mg.
5 to 1 mg a day) and gradually increase dosage to the smallest amount that gives the desired degree of symptomatic relief. Dosage may be pms-DEXAMETHASONE ELIXIR Page 6 of 31 administered 2, 3 to 4 times a day, at equally spaced intervals.
Blood and lymphatic system disorders:
Leukocytosis, lymphopenia, eosinopenia, polycythemia.
Cardiovascular disorders:
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.
Endocrine disorders:
Suppression of the hypothalamic-pituitary-adrenal axis*, 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*, moon face.
Eye disorders:
Chorioretinopathy, corneal and scleral atrophy, exophthalmos, glaucoma*, increased intraocular pressure, papilledema, posterior subcapsular cataracts*, worsening of symptoms associated with corneal ulcers. Increased ophthalmic viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers.
Fluid and electrolyte disturbances:
Sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension; hypotension or shock like reaction.
General While on corticosteroid therapy, patients should not be vaccinated against smallpox because of potential complications. Conversely, patients with vaccinia should not receive corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high doses, because of possible hazards of neurological complications and a lack of antibody response.
, for Addison's disease. Use the lowest possible dose of corticosteroid to control the condition under treatment, and when dosage reduction is possible, the reduction should be gradual. ), a temporary increase in dose may be required.
Since complications of treatment with corticosteroids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent the rapy should be used.
Use corticosteroid with caution in renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Regular checkups with doctors (including vision checkups in three -month intervals) are advised during long-term treatment. Even in cases of prolonged adrenocortical insufficiency after discontinuation of treatment, the administration of glucocorticoids can be necessary in physically stressful situations.
An acute therapy-induced adrenocortical insufficiency can be minimized by slow dose reduction until a planned discontinuation time. The following risks should be considered upon interruption or discontinuation of long -term glucocorticoid treatment: Exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, corticosteroid withdrawal syndrome; Certain viral diseases (chickenpox, measles) in patients treated with glucocorticoids, may be very severe; pms-DEXAMETHASONE ELIXIR Page 9 of 31 Children and immunocompromised persons without previous chickenpox or measles infection are particularly at risk.
pms-DEXAMETHASONE ELIXIR is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see section 5:
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 8 Systemic infection unless specific anti-infective therapy is employed
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dexamethasone should be taken with food or milk to minimize gastrointestinal irritation. When symptoms have been suppressed adequately, maintain dosage at the minimum amount capable of providing sufficient relief without excessive hormonal effects.
5 mg. In acute, nonfatal diseases, including allergic states, ophthalmic diseases, acute and subacute rheumatic disorders, dosage ranges between 2 and 3 mg a day; however, higher doses are necessary in some patients. Since the course of these conditions is self-limited, prolonged maintenance therapy is not usually necessary.
, acute allergic rhinitis, acute attacks of seasonal allergic bronchial asthma, urticaria medicamentosa, angioneurotic edema and contact dermatoses), see the schedule listed in the parenteral dosage section. 5 mg a day; higher doses are necessary in some patients.
As soon as adequate relief is obtained, reduce the dosage gradually to the minimum amount that will produce the desired therapeutic effect. , acute rheumatic carditis, crisis of systemic lupus erythematosus, severe allergic reactions, pemphigus, neoplastic diseases), the initial dosage is between 4 and 10 mg a day, administered in at least 4 divided doses; this dosage may have to be increased in some patients to establish control.
As soon as control is attained, reduce the dosage gradually to the minimum amount that will maintain relief.
Croup:
To avoid potentially serious adverse effects, it is advised that pms-DEXAMETHASONE ELIXIR contains alcohol (5% v/v) and propylene glycol (93 mg/mL). The usual dose of dexamethasone is 2 to 5 mg depending on the child's age and weight.
Conventional croup therapy must be given concomitantly, including adequate doses of a suitable antibiotic. In particularly severe cases, steroid therapy may be continued in small doses for 2 to 3 days as a precaution against recurrence.
5 mg may keep children in remission and prevent the recurrence of abnormal excretion of 17-ketosteroids. As massive therapy in certain conditions, such as acute leukemia, the nephrotic syndrome, and pemphigus, the dosage is from 10 to 15 mg a day.
Observe patients receiving such a high dosage very closely for the appearance of severe reactions. 75 mg 3 times a day, for no more than 2 or 3 days. pms-DEXAMETHASONE ELIXIR Page 7 of 31 Dexamethasone suppression test: as a screening test for Cushing's Syndrome, give 0.
5 mg of dexamethasone orally every 6 hours for 48 hours. Determine 17-hydroxycorticosteroids in 24-hour urine collection. m. m. the following morning. To distinguish adrenal tumor from adrenal hyperplasia, give 2 mg of dexamethasone orally every 6 hours for 48 hours.
Make 24-hour urine collection for determination of 17-hydroxycorticosteroid excretion.
Gastrointestinal disorders:
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.
General disorders and administration site conditions:
Delayed wound healing, discomfort, steroid withdrawal syndrome, malaise. Steroid withdrawal syndrome: a too rapid reduction in corticosteroid dose after prolonged treatment can lead to acute adrenal insufficiency . pms-DEXAMETHASONE ELIXIR Page 17 of 31 Immune system disorders: Anaphylactoid reaction, anaphylaxis, angioedema.
Infections and infestations:
Decreased resistance to infection. Increased susceptibility to, or exacerbation of, (latent) infections with masking of clinical symptoms, opportunistic infections, reactivation of latent tuberculosis, exacerbation of eye infections, candidiasis.
Injury, poisoning and procedural complications:
Reduced response to vaccination and skin tests, tendency to bruise.
Metabolism and nutrition disorders:
Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, weight gain, abnormal fat deposits; negative nitrogen balance due to protein catabolism; manifestation of latent diabetes mellitus, impaired carbohydrate tolerance with increased dose requirements of antidiabetic therapy, hypercholesterolemia, hypertriglyceridemia.
Musculoskeletal and connective tissue disorders:
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; growth inhibition in infants, children and adolescents; premature epiphyseal closure.
Nervous system disorders:
Convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, neuritis, neuropathy, paresthesia, vertigo; manifestation of latent epilepsy, increased seizures in overt epilepsy.
Psychiatric disorders:
Depression*, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders.
Reproductive system and breast disorders:
Irregular menses, amenorrhea, impotence, increased or decreased motility and number of spermatozoa.
Respiratory, thoracic and mediastinal disorders:
Hiccups.
Skin and subcutaneous disorders:
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, impaired wound healing.
Vascular disorders:
Hypertension, vasculitis, increased atherosclerosis, risk of thrombosis / thromboembolism.
Adverse reactions related to parenteral corticosteroid therapy:
Rare instances of blindness associated with intralesional therapy around the face and head; hyperpigmentation or hypopigmentation; subcutaneous and cutaneous atrophy; sterile abscess; post injection flare (following intra-articular use); Charcot-like arthropathy.
*Terms marked with an asterisk are rated as more common (≥ 1%). pms-DEXAMETHASONE ELIXIR Page 18 of 31
If these people have contact with people infected with measles or chickenpox while undergoing treatment with dexamethasone, a preventative treatment should be introduced if necessary. Carcinogenesis and Mutagenesis Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions.
Discontinuation of corticosteroids may result in clinical improvement. In post marketing experience tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents.
Patient at high risk of TLS, such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic age nts, should be monitored closely and appropriate precaution taken. Cardiovascular / Cardio-Renal Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. At high doses, sufficient calcium intake and sodium restriction, as well as serum potassium levels should be monitored.
Depending on the length and dosage of the treatment, a negative influence on calcium metabolism can be expected. Because of the risk of deterioration, patients with severe cardiac insufficiency should be carefully monitored. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.
As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Dependence/Tolerance Psychological and/or physiological dependency may develop with long term use of corticosteroids.
Dis-continuance of therapy may lead to the development of withdrawal symptoms, including anorexia, vague pains, weakness, and lethargy. pms-DEXAMETHASONE ELIXIR Page 10 of 31 Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision.
As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise their healthcare professional that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection.
Driving and Operating Machinery Patients should be advised not to drive, use any tools or machines, or carry out any hazardous tasks if they experience side effects, such as confusion, hallucinations, dizziness, tiredness, sleepiness, fainting or blurred vision.
Endocrine and Metabolism Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage.
This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receivi ng steroids already, dosage may have to be increased.
Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. Since […]