BETADEXAMINE Liquid Ref.[51176] Active ingredients: Betamethasone Dexchlorpheniramine

BETADEXAMINE contains a potent, long-acting corticosteroid.

The recommended maximum treatment period should not be exceeded.

Long term use of corticosteroids such a BETADEXAMINE, particularly in high doses and in young children can lead to suppression of the HPA axis. This may lead to Cushingoid signs, growth and development retardation in children and increased susceptibility to stress and adrenal crisis in all patients (see CONTRAINDICATIONS).

Patients undergoing stress, such as major surgery, septicaemia or trauma, who have signs of HPA axis suppression, should receive replacement therapy to prevent a possible adrenal crisis.

Corticosteroids, such as BETADEXAMINE, should be used with caution in ulcerative colitis, increased intraocular pressure, active or latent peptic ulcer, abscess or other pyogenic infections, active tuberculosis, systemic fungal infections, renal failure, hypertension, osteoporosis, hyperthyroidism, cirrhosis, ocular herpes simplex infection and glaucoma, diverticulitis, fresh intestinal anastomoses, myasthenia gravis, congestive heart failure, patients with diabetes mellitus and elderly patients.

BETADEXAMINE may aggravate existing emotional instability or psychotic tendencies.

With corticosteroid therapy such as BETADEXAMINE, dietary salt restriction and potassium supplementation may be considered. BETADEXAMINE increases calcium excretion.

Prolonged BETADEXAMINE use may produce posterior subcapsular cataracts and glaucoma, and may enhance secondary ocular infections due to fungi or viruses.

BETADEXAMINE therapy may mask some signs of infection.

BETADEXAMINE may decrease blood salicylate concentrations.

Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinaemia.

Whilst on BETADEXAMINE therapy patients should not be vaccinated against smallpox. Other immunisation procedures should not be undertaken in patients receiving BETADEXAMINE, especially those receiving high doses.

Thromboembolic complications and muscular weakness have been reported.

BETADEXAMINE should be used with caution in patients with active or latent peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease including hypertension, and in patients with hyperthyroidism.

BETADEXAMINE should be avoided in patients with narrow angle glaucoma (see CONTRAINDICATIONS).

Antihistamines, as contained in BETADEXAMINE, may cause dizziness, sedation and hypotension, especially in patients over 60 years of age.

Incoordination can occur with antihistamines such as BETADEXAMINE, although paradoxical stimulation may occasionally occur, especially at high doses and in children or the elderly.

Reports of convulsions in patients taking BETADEXAMINE suggest a need for caution in patients with epilepsy.

Excipients

Patients with the rare hereditary condition of sorbitol intolerance should not take BETADEXAMINE.

BETADEXAMINE contains sorbitol and may have a laxative effect.

Dosage and therapeutic effects should be monitored closely when BETADEXAMINE is used concurrently with:

• Monoamine oxidase inhibitors may exacerbate the CNS depressant and anticholinergic effects of the dexchlorpheniramine in BETADEXAMINE.
• Phenobarbitone, phenytoin, rifampicin or ephedrine, as these can cause a reduced steroid effect.
• Oestrogen as this can cause an increased steroid effect.
• Potassium-depleting diuretic, digoxin and amphotericin B can cause increased hypokalaemia.
• Anticoagulants such as warfarin can cause an increase in PTT (increased INR).
• Nonsteroidal anti-inflammatory medicines can aggravate the ulcerogenic effect of betamethasone.
• Antidiabetic medicines, oral and insulin, may require a dosage adjustment of both medicines as betamethasone may increase blood glucose concentration.
• Other oral anticoagulants as these can result in either a decrease in anticoagulant effect due to dexchlorpheniramine, or in an increased anticoagulant effect due to the betamethasone. Close monitoring of the international normalized ratio (INR) or prothrombin time (PT) is required.
• Alcohol, tricyclic antidepressants, barbiturates or other central nervous system depressants may potentiate the sedative effect of BETADEXAMINE.
• Medicines with anticholinergic effects will potentiate the sedative effects of BETADEXAMINE.
• Corticosteroids, such as BETADEXAMINE, may decrease blood salicylate concentrations. Aspirin should be used cautiously in conjunction with BETADEXAMINE in hypoprothrombinaemia.
• Whilst on BETADEXAMINE therapy patients should not be vaccinated against smallpox or with live attenuated virus vaccines. Other immunisation procedures should not be undertaken in patients receiving corticosteroids, especially those receiving high doses.
• Concomitant glucocorticoid therapy may inhibit the response to somatotropin.

Safety and efficacy in pregnancy and lactation have not been established (see CONTRAINDICATIONS).

Infants born to mothers who had high doses of BETADEXAMINE during pregnancy should be carefully monitored for signs of hypoadrenalism.

Fertility

Corticosteroid therapy, such as BETADEXAMINE, may alter the motility and number of spermatozoa.

BETADEXAMINE may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

Betamethasone

Immune system disorders

Frequent: Increased risk of infection

Less frequent: Generalised allergic reactions

Endocrine disorders

Frequent: Decreased body growth

Less frequent: Cushing’s syndrome, hyperglycaemia, adrenocortical insufficiency

Metabolism and nutrition disorders

Less frequent: Sodium and fluid retention, negative protein, nitrogen and calcium balance, hypokalaemia

Psychiatric disorders

Frequent: Depression, euphoria

Nervous system disorders

Less frequent: Nervousness, restlessness

Eye disorders

Less frequent: Cataracts, glaucoma

Cardiac disorders

Frequent: Hypertension

Respiratory, thoracic and mediastinal disorders

Less frequent: Pulmonary tuberculosis

Gastrointestinal disorders

Frequent: Gastric irritation, nausea, vomiting, dyspepsia, increased appetite, indigestion, pancreatitis

Less frequent: Peptic ulcer

Skin and subcutaneous tissue disorders

Frequent: Atrophic condition of the skin, impaired skin healing

Musculoskeletal, connective tissue and bone disorders

Less frequent: Osteoporosis

Renal and urinary disorders

Less frequent: Fluid and electrolyte disturbances

Dexchlorpheniramine

Blood and lymphatic system disorders

Less frequent: Agranulocytosis, thrombocytopenia, pancytopenia, aplastic anaemia, leucopenia, haemolytic anaemia

Immune system disorders

Less frequent: Hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis)

Psychiatric disorders

Less frequent: Depression

Nervous system disorders

Frequent: Somnolence, slight drowsiness to sleep, lassitude, dizziness, incoordination, headache, psychomotor impairment

Less frequent: Convulsions, tremor, sleep disturbances, confusion, paraesthesia, neuritis, extrapyramidal effects

Eye disorders

Frequent: Blurred vision

Ear and labyrinth disorders

Less frequent: Tinnitus

Cardiac disorders

Less frequent: Cardiac dysrhythmias, palpitations, hypotension

Respiratory, thoracic and mediastinal disorders

Frequent: Thickening of the mucus, dry nasal mucosa

Gastrointestinal disorders

Frequent: Constipation and increased gastric reflux, xerostomia

Less frequent: Nausea, vomiting, diarrhoea, epigastric pain

Hepato-biliary disorders

Less frequent: Jaundice

Skin and subcutaneous tissue disorders

Less frequent: Rash, hair loss, sweating, urticaria

Musculoskeletal, connective tissue and bone disorders

Less frequent: Myalgia

Renal and urinary disorders

Frequent: Urinary difficulty or retention