Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Corticosteroid.
For use in certain endocrine and non-endocrine disorders responsive to corticosteroid therapy.
Dexamethasone solution for injection is recommended for systemic administration by intravenous or intramuscular injection when oral therapy is not feasible or desirable in the following conditions:
Endocrine disorders: Primary or secondary adrenocortical insufficiency (Hydrocortisone or cortisone is the first choice, but synthetic analogues may be used with mineralocorticoids where applicable and, in infancy, mineralocorticoid supplementation is particularly important)
Non-endocrine disorders: Dexamethasone solution for injection may be used in the treatment of non-endocrine corticosteroid-responsive conditions, including: Allergy and anaphylaxis, Angioneurotic oedema and anaphylaxis, Gastrointestinal disorders, Crohn’s disease and ulcerative colitis, Infection (with appropriate chemotherapy), Miliary tuberculosis and endotoxic shock
Neurological disorders: Raised intracranial pressure secondary to cerebral tumours and infantile spasms. In addition, dexamethasone for injection is used as an adjunct in the control of cerebral oedema caused by brain tumours or associated with neurosurgery, but not in those cases where the oedema is caused by head injury.
Respiratory disorders: Bronchial asthma and aspiration pneumonitis.
Skin disorders: Toxic epidermal necrolysis
Shock: Adjunctive treatment where high pharmacological doses are needed. Treatment is an adjunct to and not a substitute for, specific and supportive measures the patient may require. Dexamethasone has been shown to be beneficial when used in the early treatment of shock, but it may not influence overall survival.
Dexamethasone solution for injection is suitable for intra-articular or soft-tissue injection as adjunctive therapy for short-term administration in:
Soft-tissue disorders: Such as carpal tunnel syndrome and tenosynovitis
Intra-articular disorders: Such as rheumatoid arthritis and osteoarthritis with an inflammatory component
Dexamethasone solution for injection may be injected intralesionally in selected skin disorders such as cystic acne vulgaris, localised lichen simplex, and keloids.
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.
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 0.4 mg–16.6 mg (0.1 ml–4.4 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 3.3 mg to 16.6 mg (0.9 ml to 4.4 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 1.7 mg to 3.3 mg (0.4 ml to 0.9 ml) should be repeated as necessary. The total daily dosage usually need not exceed 66.4 mg (17.5 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.
The usual dose is 1.7 to 5 mg/kg (0.4 ml – 1.3 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.
Initially 8.3 mg (2.2 mL) dexamethasone solution for injection intravenously followed by 3.3 mg (0.9 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:
| Adults | |
|---|---|
| Initial Dose | 41.5 mg (10.9 ml), I.V. |
| 1st day | 6.6 (1.7 ml) mg, I.V. every 2 hours |
| 2nd day | 6.6 (1.7 ml) mg, I.V. every 2 hours |
| 3rd day | (1.7 ml) mg, I.V. every 2 hours |
| 4th day | 3.3 mg (0.9 ml), I.V. every 2 hours |
| 5th to 8th day | 3.3 mg (0.9 ml), I.V. every 4 hours |
| Thereafter | decrease by daily reduction of 3.3 mg (0.9 ml) |
| Children (35 kg and over) | |
| Initial Dose | 20.8 mg (5.5 ml), I.V. |
| 1st day | 3.3 mg (0.9 ml), I.V. every 2 hours |
| 2nd day | 3.3 mg (0.9 ml), I.V. every 2 hours |
| 3rd day | 3.3 mg (0.9 ml), I.V. every 2 hours |
| 4th day | 3.3 mg (0.9 ml), I.V. every 4 hours |
| 5th to 8th day | 3.3 mg (0.9 ml), I.V. every 6 hours |
| Thereafter | decrease by daily reduction of 1.7 mg (0.4 ml) |
| Children (below 35 kg) | |
| Initial Dose | 16.6 mg (4.4 ml), I.V. |
| 1st day | 3.3 mg (0.9 ml), I.V. every 3 hours |
| 2nd day | 3.3 mg (0.9 ml), I.V. every 3 hours |
| 3rd day | 3.3 mg (0.9 ml), I.V. every 3 hours |
| 4th day | 3.3 mg (0.9 ml), I.V. every 6 hours |
| 5th to 8th day | 1.7 mg (0.4 ml), I.V. every 6 hours |
| Thereafter | decrease by daily reduction of 0.83 mg (0.2 ml) |
Maintenance therapy should be individualized with dexamethasone solution for injection or dexamethasone tablets. A dosage of 1.7 mg (0.4 ml) 2 or 3 times a day may be effective.
In acute self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:
| Total Daily Dosage | ||
|---|---|---|
| 1^st ^day | 0.9 ml to 1.7 ml of dexamethasone injection intramuscularly | 3.3 to 6.6 mg |
| 2nd day | two 0.5 mg dexamethasone tablets b.i.d. | 4 tablets |
| 3rd day | two 0.5 mg dexamethasone tablets b.i.d. | 4 tablets |
| 4th day | one 0.5 mg dexamethasone tablet b.i.d. | 2 tablets |
| 5th day | one 0.5 mg dexamethasone tablet b.i.d. | 2 tablets |
| 6th day | one 0.5 mg dexamethasone tablet. | 1 tablets |
| 7th day | one 0.5 mg dexamethasone tablet. | 1 tablets |
| 8th day | follow-up visit/reassessment day | |
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:
| Site of Injection | Volume of Injection(mL) | Amount of Dexamethasone(mg) |
|---|---|---|
| Large Joints (e.g., Knee) | 0.4 to 0.9 | 1.7–3.3 |
| Small Joints (e.g., Interphalangeal, Temporomandibular) | 0.17 to 0.21 | 0.66–0.8 |
| Bursae | 0.4 to 0.7 | 1.7–2.5 |
| Tendon Sheaths* | 0.09 to 0.21 | 0.33–0.8 |
| Soft-tissue Infiltration | 0.4 to 1.3 | 1.7–5.0 |
| Ganglia | 0.21 to 0.4 | 0.8–1.7 |
* 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.
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.
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, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life threatening reactions.
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.
It is difficult to define an excessive dose of a corticosteroid as the therapeutic dose will vary according to the indication and patient requirements. Massive IV corticosteroid doses given as a pulse in emergencies are relatively free from hazardous effects.
Exaggeration of corticosteroid related adverse effects may occur. Treatment should be asymptomatic and supportive as necessary.
As packaged for sale: 2 years.
The product should be used immediately after first opening.
Following dilution with infusion fluids (see section 6.6): Chemical and physical in-use stability of dilutions has been demonstrated for at least 24 hours, at 25°C (room temperature).
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
As packaged for sale: Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package.
Following dilution with infusion fluids: See section 6.3.
2 ml colourless glass vial containing 1 ml of solution. Available in cartons of 1 or 10 vials.
Not all pack sizes may be marketed.
Dexamethasone solution for injection may be diluted with the following solutions for injection or infusion:
Sodium Chloride 0.9% infusion
Glucose 5% Infusion
Compound Sodium Lactate Infusion
Hartmann’s Solution for Injection
Ringer-Lactate Solution for Injection
Ringer’s Solution for injection
Sorbitol 5% Injection
Invert Sugar 10% Injection
Rheomacrodex
Using these infusion fluids, Dexamethasone solution for injection can also be injected into the infusion line without causing precipitation of the ingredients. (See also section 4.2).
For single use only.
Discard any unused solution after use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The product should only be used when the solution is clear and particle free.
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