Dexamethasone Sodium Phosphate Injection USP (DBL)

Generic Name: Dexamethasone sodium phosphate
Product Name: Dexamethasone Sodium Phosphate Injection USP (DBL)

Indication

Dexamethasone sodium phosphate is used for the treatment of adrenal insufficiency, a condition where the adrenal glands do not produce enough adrenal hormones (cortisol and aldosterone). It is effective in replacing the cortisol deficiency, but must be used in combination with another agent (a mineralocorticoid) to replace the aldosterone. Dexamethasone is also useful for the symptomatic treatment of the following diseases:

• Collagen diseases (eg: SLE, polyarteritis nodosa, giant cell arteritis)
• Pulmonary disorders (eg: status asthmaticus, chronic asthma, sarcoidosis)
• Blood disorders (eg: leukaemia, ITP, autoimmune haemolytic anaemia)
• Rheumatic diseases (eg: rheumatoid arthritis, osteoarthritis)
• skin diseases (eg: psoriasis, pemphigus, various types of dermatitis)
• Ulcerative colitis
• Cerebral oedema
• Laryngeal oedema associated with acute non-infective laryngospasm
• Eye disorders (eg: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis)
• Neoplastic states (eg: cerebral neoplasms, hypercalcaemia associated with cancer)
• The 120mg/5ml vial of Dexamethasone Sodium Phosphate for Injection USP is specifically designed as an adjunct for use in shock, including excessive blood loss during surgery.

Action

Dexamethasone is a hormone similar to those produced by the adrenal glands, called glucocorticoids. It is very powerful, having 25-30 times the activity of hydrocortisone, another well-known glucocorticoid. Dexamethasone is used in the treatment of adrenal insufficiency, where it replaces hormones that are not being produced for one reason or another. In this situation, it can be curative. All other uses of Dexamethasone (antiinflammatory, anti-allergy and metabolic actions) are for symptom relief and do not aim to cure disease.

Dose advice

Dexamethasone Sodium Phosphate for Injection USP is for intravenous or intramuscular injection when systemic effects are required, or intrasynovial or soft tissue injection for local effects.

IV and IM administration:

• dosage requirement depends on severity and nature of disease being treated.
• doses range from 0.5-24mg daily.
• duration of treatment is dependent on clinical response and dosage should be adjusted to minimum required as soon as possible.
• gradual withdrawal of therapy is necessary.
• IV Dexamethasone is generally reserved for patients who cannot take it orally, or for use in an emergency situation.

Shock:

• 3mg/kg/day as continuous infusion
• 120mg/5ml vial may be diluted with sodium chloride or glucose for intravenous infusion.
• solution for infusion should be used as soon as possible, or stored for no longer than 24 hours at 2-8C.
• high dose therapy should continue only until the patient is stable (48-72 hours maximum).
• usual dose is 2-6mg/kg as a single IV injection, followed by:

Cerebral oedema:

• initial dose of 10mg IV followed by 4mg IM every six hours.
• treatment should continue until signs of oedema subside (12-24 hours).
• reduce dosage after 2-4 days and withdraw over 5-7 days.
• 2mg IV or IM 2-3 times daily can be used for maintenance of patients with cerebral malignancy.

Intrasynovial and soft tissue injection:

• dose depends on area and degree of inflammation
• large joints: 2-4mg
• small joints: 800mcg-1mg
• tendon sheaths: 400mcg-1mg
• soft tissue infiltration: 2-6mg
• joints should be injected once every 2-3 weeks while bursa can be injected once every 3-5 days

Schedule

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Common side effects

Most side effects associated with Dexamethasone are seen when high doses are administered for long periods of time. The following minor effects are seen:

Skin changes

• thin fragile skin
• increased sweating
• stretch marks
• easy bruising
• increased hair growth
• acne

General effects:

• menstrual irregularities
• muscle weakness
• restlessness
• anxiety
• trouble sleeping
• headache
• increased appetite/weight gain
• hiccups
• nausea and vomiting
• diarrhoea

Uncommon side effects

The following are some more effects that may be seen with high dose, long term therapy:

• suppression of natural adrenal hormone secretion
• increased requirements for hypoglycaemic medications in diabetics
• development of diabetes
• growth suppression in children
• osteoporosis
• muscle and joint problems
• impaired wound healing
• abdominal distension
• ulcerative oesophagitis
• burning or tingling, especially in perineal area
• glaucoma (changes in vision, trouble seeing, eye discomfort)
• cataracts
• euphoria
• mental disturbance (behaviour changes, unusual thoughts)
• convulsions
• vertigo

The following are symptoms that may indicate allergy and should be immediately reported to your doctor:

• allergic dermatitis
• hives
• widespread purple rash
• itching
• swelling in face or hands
• swelling or tingling in mouth or throat
• chest tightness
• trouble breathing

For further information talk to your doctor.