Composition:

Each 1ml solution for injaction contains 5.3mg of betamethasone sodium phosphate (equivalent to 4mg betamethasone)

Excipients:

Disodium edetate, Sodium metabisulphite, Sodium chloride, Hydrochloric acid, Sodium hydroxide and water for injection.

Mechanism of action:

Betamethasone sodium phosphate is an active corticosteroid with topical anti-inflammatoryactivity.

Pharmacokinetics:

• Corticosteroids are bound to plasma proteins in varying degrees.
• Biotransformation: Corticosteroids are metabolised primarily by the liver.
• Elimination: Corticosteroids are excreted by the kidneys

Indications:

It may be indicated in the following conditions:

• Status asthmaticus and acute allergic reactions, including anaphylactic reactions to drugs.
• Betaflason Injection supplements the action of adrenaline.
• Severe shock arising from surgical or accidental trauma or overwhelming infection.
• Acute adrenal crisis caused by abnormal stress in Addison's disease, Simmonds' disease,
• hypopituitarism following adrenalectomy, and when adrenocortical function has been suppressed by prolonged corticosteroid therapy.
• Soft tissue lesions such as tennis elbow, tenosynovitis and bursitis.

Dosage and administration:

Systemic therapy in adults:

4 to 20mg betamethasone (1 to 5ml) administered by slow intravenous injection over half to one minute. This dose can be repeated three or four times in 24 hours, or as required, depending upon the condition being treated and the patient's response.

The same dose can be given by deep intramuscular injection but the response is likely to be less rapid, especially in shock. This dose can be repeated three or four times in 24 hours depending upon the condition being treated and the patient's response.

Systemic therapy in paediatric population:

 Infants up to 1 year may be given 1mg betamethasone intravenously; children aged 1 to 5 years, 2mg; 6 to 12 years 4mg (1ml). This dose can be repeated three or four times in 24 hours, depending upon the condition being treated and the patient's response

Method of administration:

• The product may be administered by slow intravenous injection, deep intramuscular injection or subconjunctival injection.
• Alternatively may be given by intravenous infusion.
• Local injections of the product may be used when treating soft tissue lesions.
• Intrathecal use is not recommended.

Contraindications:

• Hypersensitivity to the active substance or to any of the excipients. 
• Systemic infections, unless specific anti-infective therapy is employed.
• It contains sodium metabisulphite and therefore it should not be used to treat patients with known hypersensitivity to bisulphite, metabisulphite.
• The product should not be injected directly into tendons.

Precautions:

• Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose
• Caution is advised with the use of corticosteroids in patients who have suffered a recent myocardial infarction because of the risk of myocardial rupture.
• Caution is advised on the use of corticosteroids in patients with hypothyroidism or myasthenia gravis.
• Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. Corticosteroids should not be stopped and the dose may need to be increased
• Corticosteroids should not be used for management of head injury or stroke because it is unlikely to be of benefit and may even be harmful.
• In the treatment of cerebral oedema due to tumour, gastrointestinal bleeding may occur and stool examination may be helpful in diagnosis.
• Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids.
• Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment.
• In patients who have received more than physiological doses of systemic corticosteroids (approximately 1mgbetamethasone or equivalent) for greater than 3 weeks, withdrawal should not be abrupt.
• Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse
• During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage
• Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary: Osteoporosis (post-menopausal females are particularly at risk), Hypertension or congestive heart failure, Existing or previous history of severe affective disorders, Diabetes mellitus, History of, or active, tuberculosis, Glaucoma, Previous corticosteroid-induced myopathy, Liver failure, Renal insufficiency, Epilepsy, History of, or active, peptic ulceration, Herpes simplex keratitis, Diverticulitis and Thromboembolic tendencies
• Patients should be warned that potentially severe psychiatric adverse reactions may occur with systemic Steroid, Symptoms typically emerge within a few days or weeks of starting treatment
• Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist
• Caution is advised in children as they are more susceptible to systemic toxicity from Betamethasone
• Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence, which may be irreversible.
•  Elderly: The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin.

Side-effects

Withdrawal symptoms and signs

Too rapid reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death

A “withdrawal syndrome” may also occur including; fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

Drug Interaction:

• Steroids may reduce the effects of anti-cholinesterases in myasthenia gravis and nonsteroidal anti-inflammatory agents.
• Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, aminoglutethimide and ephedrine enhance the metabolism of corticosteroids; thus the corticosteroid therapeutic effect may be reduced.
• The desired effects of hypoglycaemic agents anti-hypertensives and diuretics are antagonised by corticosteroids and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.
• The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid.
• The renal clearance of salicylates is increased by corticosteroids.
• The risk of hypokalaemia is increased with theophylline, ulcer healing drugs such as carbenoxolone and antifungals such as amphotericin B.
• Increased toxicity may result if hypokalaemia occurs in patients on cardiac glycosides.
• Ritonavir and oral contraceptives may result in increased plasma concentrations or corticosteroids.
• The effect of corticosteroids may be reduced for 3-4 days after mifepristone.
• The growth promoting effect of somatropin may be inhibited by corticosteroids.
• An increase in the incidence of gastrointestinal bleeding may occur if NSAIDS are taken concomitantly with Corticosteroids.
• Corticosteroids may antagonise the effects of neuromuscular blocking drugs such as vecuronium.
• Concurrent use of corticosteroids and fluoroquinolones may result in increased risk of tendon rupture.
• Concomitant use of betamethasone with quetiapine may result in the increased metabolism of quetiapine.
• Co-treatment with CYP3A inhibitors, is expected to increase the risk of systemic side-effects.
• Corticosteroids may enhance the metabolism of tretinoin resulting in decreased levels of tretinoin.

Pregnancy

The ability of corticosteroids to cross the placenta varies between individual drugs, however, betamethasone readily crosses the placenta. when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Breast-feeding

Corticosteroids may pass into breast milk, although no data are available for betamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression

Effects on ability to drive and use machines

Not relevant.

Overdosage:

Should overdosage occur, the possibility of adrenal suppression should be minimised by a gradual reduction of dosageover a period of time. The patient may need support during any further trauma.