Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

Steroids should be used with caution in patients with: nonspecific ulcerative colitis, if thereis a probability of impending perforation, abscess or other pyogenic infection, diverticulitis, recent intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving high doses of corticosteroids may be minimal or absent. Fat embolism is a possible complication during hypercorticism.

In treatment with corticosteroids, the lowest possible dose should always be used until the condition under treatment is controlled; subsequent reduction in dosage must be gradual, since withdrawal may give rise to the appearance of symptoms such as fever, myalgia, arthralgia, malaise, etc. typical of acute adrenocortical insufficiency from withdrawal syndrome. This may occur in patients even without evidence of adrenal insufficiency.

There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Their use in stressful situations (infections, trauma, surgery, etc.) mayrequire a dose increase.

Patients susceptible to becoming infected with chickenpox or measles and who are on immunosuppressant doses of corticosteroids should be carefully warned to avoid exposureto these germs.

Co-administration of antibiotics and corticosteroids should be controlled since the infection may be disseminated if the causative germ is not sensitive to the antibiotic used.

When high doses are given, administration of antacids between meals may help prevent peptic ulcer.

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 presents a slower absorption rate.



This medicinal product contains less than 23 mg (<1 mmol) of sodium per dose; i.e., it is essentially 'sodium-free'.

In post marketing experience tumor 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 agents, should be monitored closely and appropriate precaution taken.

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

Children and the elderly

The chronic use of dexamethasone involves a risk of adrenal suppression and growth retardation, hence body growth and development should be carefully evaluated during use in children.

In the elderly it should be remembered that corticosteroids may inhibit the absorption of calcium in the GI tract and osteoblast activity, which might exacerbate an incipient or established osteoporosis. They may also increase salt and water retention and blood pressure.

Athletes
Athletes are informed that this medicine may cause a positive result on 'anti-doping' tests.

Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after 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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