DEXSOL Oral solution Ref.[2733] Active ingredients: Dexamethasone

Posology

Adults

General considerations

The dosage should be titrated to the individual response and the nature of the disease. In order to minimise side effects, the lowest effective possible dosage should be used (see ‘Side effects’).

The initial dosage varies from 0.5 – 9mg a day depending on the disease being treated. In more severe diseases, doses higher than 9mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. Both the dose in the evening, which is useful in alleviating morning stiffness, and the divided dosage regimen are associated with greater suppression of the hypothalamo-pituitary-adrenal axis. If satisfactory clinical response does not occur after a reasonable period of time, discontinue treatment with dexamethasone and transfer the patient to another therapy.

If the initial response is favourable, the maintenance dosage should be determined by lowering the dose gradually to the lowest dose required to maintain an adequate clinical response. Chronic dosage should preferably not exceed 1.5mg dexamethasone daily.

Patients should be monitored for signs that may require dosage adjustment. These may be changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness and the effect of stress (e.g. surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily.

If the drug is to be stopped after more than a few days of treatment, it should be withdrawn gradually.

The following equivalents facilitate changing to dexamethasone from other glucocorticoids:

Milligram for milligram, dexamethasone is approximately equivalent to betamethasone, 4 to 6 times more potent than methylprednisolone and triamcinolone, 6 to 8 times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone.

Acute, self-limiting allergic disorders or acute exacerbations of chronic allergic disorders.

The following dosage schedule combining parenteral and oral therapy is suggested:

First day: Dexamethasone sodium phosphate injection 4mg or 8mg (1ml or 2ml) intramuscularly.

Second day: 1mg (2.5ml) Dexamethasone Oral Solution twice a day.

Third day: 1mg (2.5ml) Dexamethasone Oral Solution twice a day.

Fourth day: 500micrograms (1.25ml) Dexamethasone Oral Solution twice a day.

Fifth day: 500micrograms (1.25ml) Dexamethasone Oral Solution twice a day.

Sixth day: 500micrograms (1.25ml) Dexamethasone Oral Solution.

Seventh day: 500micrograms (1.25ml) Dexamethasone Oral Solution.

Eighth day: Re-assessment.

If a dose of less than 5ml is required, an oral dosing device should be employed.

This schedule is designed to ensure adequate therapy during acute episodes whilst minimising the risk of overdosage in chronic cases.

Raised intracranial pressure: Initial therapy is usually by injection. When maintenance therapy is required, this should be changed to dexamethasone oral solution as soon as possible. For the palliative management of patients with recurrent or inoperable brain tumours, maintenance dosage should be calculated individually. A dosage of 2mg two or three times a day may be effective. The smallest dosage necessary to control symptoms should always be used.

Dexamethasone suppression tests:

1. Tests for Cushing’s syndrome:

2mg (5ml) Dexamethasone Oral Solution should be administered at 11pm. Blood samples are then taken at 8am the next morning for plasma cortisol determination.

If greater accuracy is required, 500 micrograms (1.25ml) Dexamethasone Oral Solution should be administered every 6 hours for 48 hours. Blood should be drawn at 8am for plasma cortisol determination on the third morning.

24-hour urine collection should be employed for 17-hydroxycorticosteroid excretion determination.

2. Test to distinguish Cushing’s syndrome caused by pituitary ACTH excess from the syndrome induced by other causes:

2mg (5ml) Dexamethasone Oral Solution should be administered every 6 hours for 48 hours. Blood should be drawn at 8am for plasma cortisol determination on the third morning.

24-hour urine collection should be employed for 17-hydroxycorticosteroid excretion determination.

Childhood Croup

A single dose of 0.15mg/kg Dexamethasone Oral Solution is recommended. A second dose may be administered after 12 hours, if considered necessary by the treating physician.

Doses of up to 0.6mg/kg dexamethasone have been used safely in clinical studies. However, a maximum dose of 10mg (25ml Dexsol Oral Solution) is recommended.

The following dosage chart should be followed for the treatment of childhood croup at a dose of 0.15mg/kg.

For the treatment of Covid-19

Adult patients 6 mg orally, once a day for up to 10 days.

Paediatric population

Paediatric patients (adolescents aged 12 years and older with body weight at least 40kg) are recommended to take 6mg orally, once a day for up to 10 days.

Duration of treatment should be guided by clinical response and individual patient requirements.

Elderly, renal impairment, hepatic impairment

No dose adjustment is needed.

Elderly

Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age.

Paediatric population

Dosage should be limited to a single dose on alternate days to lessen retardation of growth and minimize suppression of hypothalamo-pituitary-adrenal axis.

Method of administration

For oral use.

Alternatively, this product is suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. For further information see section 6.6.

Reports of acute toxicity and/or deaths following overdosage with glucocorticoids are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him unusually susceptible to ill effects from corticosteroids. In this case, the stomach should be emptied and symptomatic treatment should be instituted as necessary. Anaphylactic and hypersensitivity reactions may be treated with epinephrine (adrenaline), positive-pressure artificial respiration and aminophylline. The patient should be kept warm and quiet. The biological half life of dexamethasone in plasma is about 190 minutes.

2 years.

Shelf life after first opening the container: 3 months.

Do not store above 25°C. Do not refrigerate.

The storage at temperatures higher than 25°C could allow precipitation inside the solution. Do not use the product if solid particles are observed inside the solution.

This product is sensitive to light. Store in the original package.

Bottles: 75ml and 150ml in Amber (Type III) glass.

Closures: HDPE, EPE wadded, tamper evident, child resistant closure.

No special requirement for disposal.

Instructions for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes.

Dexsol Oral Solution is suitable for use with the following type of NG and PEG tubes:

Ensure that the enteral feeding tube is free from obstruction before administration.

1. Flush the enteral tube with water, a minimum flush volume of 5 ml is required.
2. Administer the required dose of Dexsol Oral Solution with a suitable measuring device.
3. Flush the enteral tube with water again, using a minimum volume of 5ml of water.

With respect to tubal administration, this product should be administered with silicone, PVC, polyurethane NG or PEG tubes only.

Healthcare professional should be aware that with air flushing procedure there is a risk of under dosing (up to 50%). It is therefore recommended that only water flush is used.