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  • Dexacort Forte
    / Teva


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 X 1 ml X 20 mg/ml

    full basket chart 17725 4296

    Dosage

    Notes: Corticosteroid therapy is an adjunct to, and not replacement for, conventional therapy. Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dosage requirements are variable, and must be individualized on the basis of the disease and the response of the patient. Dexacort Forte Injection, which is indicated for the adjunctive treatment of severe shock, must be given by i.v. administration only. Reported regimens range from 1-6 mg/kg body weight as a single i.v. injection, to 40 mg initially followed by repeated i.v. injections every 2-6 hours, while shock persists. Administration of high dose corticosteroid therapy should be continued only until the patient’s condition has stabilized, and usually not longer than 48-72 hours. Although adverse reactions associated with high dose, short-term corticosteroid therapy are uncommon, peptic ulceration may occur.


    Indications

    Intravenous use as adjunctive treatment of severe shock of hemorrhagic, traumatic, surgical or septic origin.


    Contra-Indications

    Known hypersensitivity to any ingredient of the product (including sulfites). Systemic infection unless specific anti-infective therapy is employed. Systemic fungal infections, bacteremia, unstable joints, infection at the injection site, e.g., septic arthritis resulting from gonorrhea or tuberculosis. Systemic viral infections and patients with peptic ulcer, osteoporosis and psychoses. Immunization procedures with live, or live-attenuated vaccines, including smallpox, in patients receiving immunosuppressive doses of corticosteroids, because of possible neurological complications and a lack of antibody response.


    Special Precautions

    Since complications of treatment with glucocorticoids 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 therapy should be used. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency. Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by the 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 this period, hormone therapy should be reinstituted. If the patient is receiving steroids already, the dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. Corticosteroids have an enhanced effect on patients with hypothyroidism and hepatic cirrhosis. Corticosteroids should be used with caution in patients with ocular herpes simplex because of possible corneal perforation. Psychic derangements may appear when corticosteroids are used. These can range from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. In addition, corticosteroids may aggravate existing emotional instability or psychotic tendencies. Co-administration of thalidomide with dexamethasone phosphate injection should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Corticosteroids should be used with caution in non-specific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism. Steroids may increase or decrease motility and number of spermatozoa in some patients. Growth and development of infants and children receiving prolonged corticosteroid therapy should be carefully observed. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray, should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia. Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary: Osteoporosis (post-menopausal females are particularly at risk), Hypertension or congestive heart failure, Existing or previous history of severe affective disorders (especially previous steroid psychosis), Diabetes mellitus (or a family history of diabetes), History of tuberculosis, since glucocorticoids may induce reactivation, Glaucoma (or a family history of glaucoma), Previous corticosteroid-induced myopathy, Liver failure,Renal insufficiency, Epilepsy, Gastro-intestinal ulceration, Migraine, Certain parasitic infestations in particular amoebiasis, Incomplete statural growth since glucocorticoids on prolonged administration may accelerate epiphyseal closure, Patients with Cushing’s syndrome In the treatment of conditions such as tendinitis or tenosynovitis care should be taken to inject into the space between the tendon sheath and the tendon as cases of ruptured tendon have been reported.
    For full details see prescribing information.


    Side Effects

    Fluid and electrolyte disturbances. Muscle weakness, steroid myopathy, loss of muscle mass, tendon rupture, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fractures of long bones. Peptic ulcer with possible subsequent perforation, pancreatitis, abdominal distension, ulcerative esophagitis. Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, suppress reactions to skin tests. Convulsions, increased intracranial pressure with papilledema, vertigo, headache. Menstrual irregularities, development of Cushingoid state, suppression of growth in children, adrenocortical and pituitary unresponsiveness, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements of insulin or oral hypoglycemic agents in diabetics. Negative nitrogen balance, myocardial rupture following recent myocardial infarction.
    For full details see prescribing information.


    Drug interactions

    Dexamthasone/Erythromycin/Indinavir: Dexamethasone is a moderate inducer of CYP 3A4.Co-administration of dexamethasone with other drugs that are metabolized by CYP 3A4 (e.g.,indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentrations.
    CorticosteroidsCytochrome P450 3A4 {CYP 3 A4} Enzyme Inducers (such as Phenytoin, Primidone, Phenylbutazone Carbamazepine, Phenobarbital, Rifampicin, Rifabutin, Aminoglutethemide ) : Cytochrome P450 3A4 (CYP 3A4) enzyme inducers, such as phenytoin, barbiturates (e.g., phenobarbital), carbamazepine, and rifampin may enhance the metabolic clearance of corticosteroids. resulting in reduced therapeutic effects, that require dosage adjustment of the corticosteroid to achieve the desired response. Corticosteroids/Ephedrine: Ephedrine may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring an increase in corticosteroid dosage.
    Corticosteroids/CYP Inhibitors such as Troleandomycin, Ketoconazole Isoniazid, Estrogen or Estrogen-Containing Contraceptives: Concurrent administration may lead to a significant decrease in the clearance of the corticosteroid, through inhibition of its metabolism. Therefore, the dose of the corticosteroid should be titrated to avoid steroid toxicity.
    Corticosteroids/Cyclosporine: Concurrent use leads to mutual inhibition of metabolism. It is possible that adverse events associated with individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use. Although the combination is therapeutically beneficial for organ transplants, toxicity may be increased, and should be taken into consideration. Corticosteroids/Digitalis Glycosides: Concurrent use may increase the possibility of digitalis toxicity associated with hypokalemia. Corticosteroids/Potassium-depleting Diuretics/Amphotericin B/Carbonic Anhydrase Inhibitors: Concurrent use may cause hypokalemia; serum potassium level should be determined at frequent intervals. Corticosteroids/Hypoglycemics/Streptozocin/Asparaginase: Corticosteroids may increase blood glucose levels; dosage adjustment of the antidiabetic agent is necessary.
    Corticosteroids/Anticoagulants: Corticosteroids may alter the response to coumarin anticoagulants. Therefore, caution is recommended when these drugs are used concurrently, especially in patients prone to gastrointestinal ulceration and hemorrhage. Therefore, coagulation indices should be frequently monitored during and after glucocorticoid therapy to maintain the desired anticoagulant effect. Corticosteroids/Aspirin: Corticosteroids may increase the clearance of chronic high-dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when the steroid is withdrawn. Special caution is required in patients presenting with hypoprothrombinemia.
    Corticosteroids/Anticholinesterases: Concurrent administration may antagonise the anticholinesterase effects in myasthenia gravis.


    Pregnancy and Lactation

    Pregnancy: Since adequate human reproduction studies have not been performed with corticosteroids, the use of these drugs in pregnant women or women of childbearing potential requires that the expected benefits of the drug be weighed against the possible hazards to mother and fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
    Breastfeeding: Corticosteroids appear in breast milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacological doses of corticosteroids should be advised not to breastfeed.


    Overdose

    Reports of acute toxicity and/or death following overdose of glucocorticoids are rare. In the event of overdose, no specific antidote is available; treatment is supportive and symptomatic. Significant lethality was observed in female mice at single oral doses of 3630mg/m2 (1210 mg/kg) and single intravenous doses of 2382 mg/m2 (794 mg/kg).


    Manufacturer
    Teva Hungary
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