Xasten Dexamethasone Tablets

XASTEN®
(Dexamethasone)
0.5mg tablet; 1mg tablet
For oral use only.

 

COMPOSITION

Each tablet of Xasten 0.5mg contains Dexamethasone 0.5mg.

Each tablet of Xasten 1mg contains Dexamethasone 1mg.

 

CLINICAL PHARMACOLOGY

Xasten is a corticosteroid with mainly glucocorticoid activity with none or virtually none mineralocorticoid properties. The glucocorticoid actions are wide ranging, they have potent anti-inflammatory and immunosuppressive effect, at least partly through inhibition of the release of various cytokinases. The anti-inflammatory and immunosuppressant properties are used to suppress the clinical manifestation of disease in a wide range of disorders considered to have inflammatory or immunological components. Its lack of mineralocorticoid properties makes Xasten suitable for treating conditions where water retention would be a disadvantage.

 

INDICATIONS

Xasten is indicated for:

• Suppression of inflammatory and allergic disorders

• Shock

• Diagnosis of cushing’s disease

• Congenital adrenal hyperplasia

• Cerebral oedema

• Nausea and vomiting with chemotherapy

• Rheumatic disease

 

CONTRAINDICATION

Xasten like any other corticosteroid is contraindicated in the presence of acute infections uncontrolled by appropriate antimicrobial therapy. Live vaccines should not be given to patients receiving high-dose systemic corticosteroid therapy not for at least 3 months afterwards.

 

INTERACTIONS

Concurrent use of barbiturates, carbamazepine, phenyltoin, primidone or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroid. Conversely oral contraceptives or ritonavir may increase plasma concentrations of xasten, like any other corticosteroids.

The use of thiazides or furosemide, may cause excessive potassium loss. There is an increased risk of hypokalaemia with concurrent amphotericin or bronchodilator therapy with xanthines or beta2 agonists. There may be an increased incidence of gastro-intestinal bleeding and ulceration when Xasten is given with NSAIDS.

Response to anticoagulants may be altered by Xasten and requirements of antidiabetic drugs and antihypertensives may be increased. Xasten may also increase serum concentrations of salicylates and may decrease the effect of anticholinesterases in myasthenia gravis.

 

PRECAUTIONS

Xasten should be used with great caution in the presence of heart failure, recent myocardial infarction or hypertension, in patients with diabetic mellitus, epilepsy, glaucoma, hypothyroidism, hepatic failure, osteoporosis, peptic ulceration, psychoses or severe affective disorders and renal impairment.

Children may be at increased risk of some adverse effects. In addition it may cause growth retardation and prolonged administration is rarely justified. The elderly too may be at greater risk from adverse effects. Patients with quiescent tuberculosis should be observed closely and should receive chemoprophylaxis if corticosteroid therapy is prolonged. Patients should be examined regularly during prolonged courses of corticosteroid therapy. Sodium intake may need to be reduced and calcium and potassium supplements may be necessary. Patients should be monitored for signs of fluid retention.

Following short courses at moderate doses, it may be approrpriate to withdraw Xasten without tapering the dose. However, after high-dose or prolonged therapy withdrawal should be gradual, the rate depending upon the individual patient’s response, the dose, the disease being treated, and the duration of therapy. Patients should carry cards giving full details of their corticosteroid therapy, and they and their relations should be conversant with implications of their therapy and the precautions to be taken. Xasten should be used with great caution in pregnant and lactating women.

 

ADVERSE REACTIONS

These should be minimized by using lowest effective dose for minimum period possible.

Gastro intestinal effects: These involve dyspepsia, Peptic ulceration, abdominal distension, acute pancreatitis, oesophageal ulceration and candidiasis.

Musculoskeletal effects include proximal myopathy, osteoporosis, vertebral and long bone fractures, vascular osteonecrosis, tendon rupture.

Endocrine effects include adrenal suppression, menstrual irregularities and amenorrhoea, Cushing’s syndrome, hirsutism, weight gain, negative nitrogen and calcium balance, increased appetite, increased susceptibility to and severity of infection.

Neupsychiatric effects include euphoria, psychological dependence, depression, insomnia, increased intracranial pressure with papilloedema in children (usually after withdrawal), psychosis and aggravation of schizophrenia, aggravation of epilepsy.

Ophthalmic effect includes glaucoma, papilloedema, posterior subcapsular cataracts, conical or scleral thinning and exacerbation of ophthalmic viral or fungal disease.

Other side effect includes impaired healing, skin atrophy, hypersensitivity, fluid and electrolyte disturbance, leucocytosis, nausea, malaise, hiccups.

 

TREATMENT OF OVERDOSE

Symptoms of overdosage are the adverse effects that resulted from its mineralocorticoid or glucocorticoid effects. Overdosage should be treated symptomatically.

 

DOSAGE AND ADMINISTRATION

Suppression of inflammatory and allergic disorder

Adult: 0.5mg to 10mg daily. The parental route is employed for severe condition or if an emergency arises.

 

PRESENTATION

Xasten 0.5mg is available in a box of 100 tablets.

Xasten 1mg is also available in a box of 100 tablets.

 

STORAGE

Store away from light in a cool and dry place below 30°C.

Keep all medicines out of reach of children.
Shelf validity: 3 years

 

Manufactured by

JIANGSU PENGYAO PHARMACEUTICAL CO., LTD.

10, CHAQUAN ROAD, YIXING JIANGSU, CHINA.