SOLDESAM ® Dexamethasone

SOLDESAM ® a drug based on Dexamethasone

THERAPEUTIC GROUP: Unassociated corticosteroids

Indications SOLDESAM ® Dexamethasone

SOLDESAM ® through its various formulations lends itself to the treatment of pathological conditions characterized by inflammatory and allergic processes such as to require the use of corticosteroids.

Mechanism of action SOLDESAM ® Dexamethasone

SOLDESAM ® is a drug based on "synthetic" hormones belonging to the category of corticosteroids.
Dexamethasone, the active ingredient of this medicine, is in fact used with the primary therapeutic objective of protecting various districts and systems from the damage induced by the activation of both local and systemic inflammatory processes.
The mechanism by which dexamethasone performs this function is due to its ability as a modulator of protein synthesis, such as to induce the expression of proteins such as lipocortin, useful for repressing the activity of phospholipase A2 and the subsequent downstream mechanisms responsible for production of inflammatory mediators such as thromboxanes, leukotrienes, prostaglandins and prostacyclines, and at the same time inhibiting the protein synthesis of antibodies, reducing the number of circulating lymphocytes, eosinophils and basophils.
However, these and other biological mechanisms make corticosteroid drugs particularly effective from the therapeutic point of view but equally dangerous due to the high number of side effects.

Studies carried out and clinical efficacy

1. DESAMETHASONE AND SEPTIC ARTHRITIS

J Pediatr Orthop. 2011 Mar; 31: 211-5.

Dexamethasone therapy for septic arthritis in children: results of a randomized double-blind placebo-controlled study.

Harel L, Prais D, Bar-On E, Livni G, Hoffer V, Uziel Y, Amir J.

The addition of desemetasone to antibiotic therapy for the treatment of septic arthritis can guarantee an improvement in symptoms already on the fourth day of therapy, which translates into a reduction in the duration of hospitalization compared to antibiotic therapy alone.

2. DESAMETHASONE NEW EVIDENCE

Blood. 2011 Apr 28.

Dexamethasone and lenalidomide have distinct functional effects on erythropoiesis.

Narla A, Dutt S, McAuley JR, Al-Shahrour F, Hurst S, McConkey M, Neuberg D, Ebert BL.

Recent study that demonstrates how dexamethasone therapy can play an important role in "inducing cell differentiation towards the erythroid line. The" increase in erythroid precursors could represent an important effect from a therapeutic point of view, and open new trials for dexamethasone .

3. DESAMETHASONE AND POST-OPERATIVE PAIN

BMC Cancer. 2010 Dec 23; 10: 692.

Preoperative dexamethasone reduces postoperative pain, nausea and vomiting following mastectomy for breast cancer.

Gómez-Hernández J, Orozco-Alatorre AL, Domínguez-Contreras M, Oceguera-Villanueva A, Gómez-Romo S, Alvarez Villaseñor AS, Fuentes-Orozco C, González-Ojeda A.

Taking dexamethasone before mastectomy surgery has been shown to be useful in reducing nausea, vomiting and post-operative pain, significantly improving prognosis.

Method of use and dosage

SOLDESAM ®

• solution for injection 4 mg ampoules of dexamethasone sodium phosphate per ml;
• Forte: 8mg injectable solution of dexamethasone sodium phosphate per 2ml;
• 200 mg oral drops of dexamethasone sodium phosphate per 100 ml of solution;
• Ointment of 200 mg of dexamethasone sodium phosphate per 100 g of ointment.

The numerous and various pharmacological formulations foreseen for SOLDESAM ® significantly increase the potential uses and the relative dosages.
The choice of formulation and dosage is therefore exclusively up to the doctor, after he has carefully assessed the patient's state of health, his clinical picture and after having defined the therapeutic objectives to be achieved.

SOLDESAM ® Dexamethasone warnings

Corticosteroid therapy requires medical supervision both in the dosage formulation phase and in the subsequent treatment period.
This is particularly important in minimizing potential health risks for the patient while supporting the efficacy of therapy.
Particular attention should be paid to patients suffering from osteoporosis, neurological and psychiatric manifestations, diabetes, hypertension and cardiovascular diseases, given the ability of dexamethasone to aggravate the related clinical picture.
It is also useful to remember that taking corticosteroid drugs could reduce the protective effect of immunizing therapies and at the same time increase the risk of infections.
The numerous adverse reactions affecting the nervous system, such as to significantly reduce the patient's perceptive abilities, could make the use of machinery, driving cars and all other possible activities that require an intellectual commitment dangerous.

PREGNANCY AND BREASTFEEDING

Although the safety profile of dexamethasone when taken during pregnancy has not yet been defined, administration of SOLDESAM ® throughout pregnancy and the subsequent lactation period should only be carried out in case of real need and under close medical supervision.
In this case it is necessary to subject the newborn to an assessment of the state of adrenal function.

Interactions

Administration of anticonvulsants, antibiotics, anticoagulants, bronchodilators, antacids and non-systemic anti-inflammatories may alter the pharmacokinetic characteristics of oral dexamethasone, requiring dosage adjustment.
Safer and free from clinically and pharmacokinetically important interactions is the administration of SOLDESAM ® in the form of an ointment.

Contraindications SOLDESAM ® Dexamethasone

SOLDESAM ® is contraindicated in case of hypersensitivity to the active substance or to one of its excipients, in case of active tuberculosis, peptic ulcer, ocular herpes simplex, systemic fungal infections and psychosis.

Undesirable Effects - Side Effects

Long-term therapy with corticosteroid drugs such as dexamethasone exposes the patient to numerous side effects widespread among the various systems and systems.
The greatest risk arises during "systemic" therapy with corticosteroids, although topical and epicutaneous administration can, especially in the case of occlusive dressings, mimic the side effects of systemic therapy.
Among the most common adverse reactions it is possible to remember those affecting the cardiovascular system with the onset of hypertension and heart failure, the osteo-articular and muscular system with osteoporosis and myopathies, the nervous system with neurological and psychiatric manifestations, the gastrointestinal tract. enteric with increased risk of ulcers and lesions of the mucosa, of the endocrine and metabolic structure with variations in the nitrogen and carbohydrate balance and with the increased risk of hypoadrenalism.
To these are added dermatological manifestations, particularly frequent following the epicutaneous intake of dexamethasone.

Note

SOLDESAM ® can only be sold under medical prescription.
The use of SOLDESAM ® without therapeutic need during sports competitions constitutes doping.

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