Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use
Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis, with probability of imminent perforation, abscess or other pyogenic infection, diverticulitis, recent intestinal anastomoses, active or latent peptic ulcer, renal failure, hypertension, osteoporosis, and myasthenia gravis. In patients receiving high doses of corticosteroids, signs of peritoneal irritation after gastrointestinal perforation may be minimal or absent. Fat embolism is a complication that can occur during hypercorticism.

In corticosteroid treatment, the lowest possible dose should always be used until the pathological situation is controlled; the subsequent dose reduction must be done gradually, since their withdrawal can give rise to the appearance of symptoms such as fever, myalgia, arthralgia, malaise, etc., typical of the acute adrenocortical insufficiency of the withdrawal syndrome. This can occur even in patients without evidence of adrenal insufficiency.

In patients with hypothyroidism or in patients with cirrhosis, corticosteroids have an increased pharmacological effect. Their use in stressful situations (infections, trauma, surgery, etc.) may require a dose increase.

Patients susceptible to infection with chickenpox or measles and who are being treated with immunosuppressive doses of corticosteroids should be carefully warned to avoid exposure to these germs.

The joint administration of antibiotics and corticosteroids should be controlled since it can spread the infection if the germ causing it is not sensitive to the antibiotic used.

When given in high doses, taking antacids between meals can help prevent peptic ulcer disease.

The presence of joint effusion during corticosteroid treatment requires examination to exclude a septic process. A marked increase in pain accompanied by local swelling, extensive restriction of joint mobility, fever, and malaise is suggestive of septic arthritis. If this complication occurs and the diagnosis of joint infection is confirmed, appropriate antimicrobial therapy should be instituted.

Systemic corticosteroids should not be discontinued in patients who are already being treated 
with systemic (oral) corticosteroids for other reasons (e.g. patients with chronic obstructive pulmonary disease), but who do not require supplemental oxygen.

It should be noted that intramuscular administration has a slower level of absorption.

Excipients
This medicinal product contains about 3 mg sodium per ml of solution, equivalent to 0.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

This medicinal product may be diluted with sodium-containing solutions (see section 6.6) and this should be considered in relation to the total sodium from all sources that will be administered to the patient.

In post marketing experience tumor lysis syndrome (TLS) has been reported in patients with hematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk for TLS, such as patients with a high proliferation rate, high tumor burden, and high sensitivity to cytotoxic agents, should be closely monitored and appropriate precautions taken.

In postmenopausal women, Dexamethasone Kalceks may reduce the intestinal absorption of calcium and the activity of bone-forming cells, which could worsen existing osteoporosis.

Children and the elderly
Chronic use of dexamethasone carries the risk of adrenal suppression and growth retardation, therefore, during its use in children, both body growth and development should be carefully evaluated.

In the elderly it should be considered that corticosteroids can inhibit the digestive absorption of calcium and osteoblastic activity, which could exacerbate incipient or declared osteoporosis. They can also increase hydrosaline retention and blood pressure.

Athletes
Athletes are informed that this medication can establish a positive analytical result in doping control.

Visual disturbances
Visual disturbances may occur with systemic and topical use of corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, an ophthalmologist should be consulted to evaluate possible causes which may include cataracts, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported following the use of systemic and topical corticosteroids.

Hypertrophic cardiomyopathy
Cases of hypertrophic cardiomyopathy have been reported after systemic administration of corticosteroids, including dexamethasone, to premature infants. In most reported cases, this effect was reversible after withdrawal of treatment. Preterm infants treated with systemic dexamethasone should undergo diagnostic evaluation and monitoring of cardiac structure and function (section 4.8).

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