Each 1 ml Dexamethasone, solution for injection, contains 4.37 mg of Dexamethasone sodium phosphate (equivalent to 4 mg dexamethasone phosphate).

For a full list of excipients, see section 6.1.

Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

In neonates, especially the premature infant, only preservative-free solutions should be administered.

Posology

Intravenous and Intramuscular Injection

Usually the parenteral dose is one-third to one half the oral dose, given every 12 hours. The usual initial dosage of dexamethasone solution for injection is 0.48 mg – 20 mg (0.12 ml – 5.0 ml) and varies depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice. However, in certain overwhelming, acute, life- threatening situations, dosages exceeding the usual recommended dosages have been used. In these circumstances, the slower rate of absorption by intramuscular administration should be recognized.

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. After a favourable response is noted, the proper maintenance dosage should be determined by decreasing the initial dosage by small amounts at appropriate intervals to the lowest dosage which will maintain an adequate clinical response. Chronic dosage should preferably not exceed 500 micrograms dexamethasone daily. Close monitoring of the drug dosage is needed.

If the drug is to be stopped after it has been given for more than a few days, it is recommended that it be withdrawn gradually rather than stopped abruptly.

Whenever possible, the intravenous route should be used for the initial dose and for as many subsequent doses as are given while the patient is in shock (because of the irregular rate of absorption of any medicament administered by any other route in such patients). When the blood pressure responds, use the intramuscular route until oral therapy can be substituted. For the comfort of the patient, not more than 2 ml should be injected intramuscularly at any one site.

In emergencies, the usual dose is 4.0 mg to 20.0 mg (1.0 ml to 5.0 ml) I.V. or I.M. (in shock use only the I.V. route). This dose may be repeated until adequate response is noted.

After initial improvement, single doses of 2.0 mg to 4.0 mg (0.5 ml to 1.0 ml) should be repeated as necessary. The total daily dosage usually need not exceed 80.5 mg (20.1 ml), even in severe conditions.

When constant maximal effect is desired, dosage must be repeated at three-hour or four-hour intervals, or maintained by slow intravenous drip.

Intravenous and intramuscular injections are advised in acute illness. When the acute stage has passed, substitute oral steroid therapy as soon as feasible.

Adults and Elderly

Once the disease is under control the dosage should be reduced or tapered off to the lowest suitable level under continuous monitoring and observation of the patient (see section 4.4).

For acute life-threatening situations (e.g. anaphylaxis, acute severe asthma) substantially higher dosages may be needed.

Cerebral oedema (adults): initial dose 8-16 mg IV followed by 5 mg IV or IM every 6 hours,until a satisfactory result has been obtained. In brain surgery these dosage may be necessary until several days after the operation. Therafter,the dosage has to be tapered off gradually. Increase of intracranial pressire associated with brain tumors can be counteracted by continuous treatment

Shock (Of Haemorrhagic, Traumatic, or Surgical Origin)

The usual dose is 2 to 6 mg/kg (0.5 ml – 1.5 ml/kg) body weight given as a single intravenous injection. This may be repeated in 2 to 6 hours, if shock persists. As an alternative, this may be followed immediately by the same dose in an intravenous infusion. Therapy with dexamethasone solution for injection is an adjunct to, and not a replacement for, conventional therapy.

Administration of high dose corticosteroid therapy should be continued only until the patient’s condition has stabilized and usually no longer than 48 to 72 hours.

Cerebral Oedema

Associated with primary or metastatic brain tumour, pseudo-tumour cerebri or preoperative preparation of patients with increased intracranial pressure secondary to brain tumour: Initially 10.0 mg (2.5 ml) dexamethasone solution for injection intravenously followed by 4 mg (1.0 ml) intramuscularly every 6 hours until symptoms of cerebral oedema subside. Response is usually noted within 12 to 24 hours: dosage may be reduced after 2 to 4 days and gradually discontinued over a period of 5 to 7 days.

High doses of dexamethasone solution for injection are recommended for initiating short- term intensive therapy for acute life-threatening cerebral oedema. Following the high loading dose schedule of the first day of therapy, the dose is scaled down over the 7 to 10 day period of intensive therapy and subsequently reduced to zero over the next 7 to 10 days. When maintenance therapy is required, this should be changed to oral dexamethasone as soon as possible.

Suggested high dose schedule in cerebral oedema is listed in the chart below:

For palliative management of patients with recurrent or inoperable brain tumours. Maintenance therapy should be individualized with dexamethasone solution for injection or dexamethasone tablets. A dosage of 2 mg (0.5 ml) 2 or 3 times a day may be effective.

Dual Therapy

In acute self-limited allergic disorders or acute exacerbations of chronic allergic disorders , the following dosage schedule combining parenteral and oral therapy is suggested:

Intra-Articular, Intralesional, and Intra-Bursal Injection

Intra-articular, intralesional, and intra-bursal injections generally are employed when affected joints or areas are limited to one or two sites.

Some of the usual single doses are:

*Injection should be made into the tendon sheath and not directly into the tendon.

The frequency of injection varies from once every 3 to 5 days to once every 2 to 3 weeks, depending on the response to treatment.

Special Populations

Paediatric population

Dosage requirements are variable and may have to be changed according to individual needs. Dosage should be limited to a single dose on alternate days to lessen retardation of growth and minimise suppression of the hypothalamo-pituitary adrenal axis.

Use in the elderly

Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious sconsequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life threatening reactions.

Method of administration

Dexamethasone solution for injection may be administered intravenously, intramuscularly, or by local injection (intra-articular or soft tissue). For administration by intravenous infusion: see section on compatibility with infusion fluids. With intravenous administration high plasma levels can be obtained rapidly.

Rapid intravenous injection of massive doses of glucocorticoids may sometimes cause cardiovascular collapse; the injection should therefore be given slowly over a period of several minutes.

Intra-articular injections should be given under strictly aseptic conditions.

ATC code: H02AB02.

Pharmacotherapeutic group: Glucocorticoids

List of excipients

Creatinine,

Sodium citrate,

Sodium metabisulfite,

Methylparaben,

Propylparaben,

Sodium hydroxide,

Water for injection.

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