Betamethasone/ Dexchlorpheniramine Maleate

Registered South African indications:

• Acute allergic rhinitis, not responsive to conventional therapy
• Steroid-responsive dermatological allergies and steroid-responsive dermatoses

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Hypersensitivity to similar medicines
• Not suitable for patients with systemic infections, including fungal infections
• Not recommended for newborns and premature infants
• Contraindicated in patients currently on monoamine oxidase inhibitors (MAOIs) or within two weeks after use of a MAOI
• Safety in children below 12 years has not been established
• Glaucoma (syr)

South African recommendations

Use with caution in specific conditions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Ulcerative colitis
• Active or latent peptic ulcer
• Pyogenic infections, like abscesses
• Active tuberculosis
• Systemic fungal infections
• Renal failure
• Hypertension
• Osteoporosis
• Thyroid disorders (hyperthyroidism, hypothyroidism)
• Cirrhosis
• Ocular herpes simplex infection
• Glaucoma
• Diverticulitis
• Fresh intestinal anastomoses
• Myasthenia gravis
• Congestive heart failure
• Patients with diabetes mellitus or family history of diabetes
• Existing or previous history of severe affective disorders, especially steroid-induced psychosis
• Previous corticosteroid-induced myopathy
• Liver failure (increased corticosteroid blood levels possible)
• Epilepsy

Considerations for elderly patients

• Elderly patients may experience more severe consequences from the common side effects of systemic corticosteroids in betamethasone/ dexchlorpheniramine maleate
• Particular risks include osteoporosis, hypertension, hypokalemia, diabetes, increased susceptibility to infections, and skin thinning.
• Close clinical monitoring is crucial to prevent potentially life-threatening reactions in older adults

Effects on drowsiness and concentration

• May cause drowsiness and impaired concentration, worsened by alcohol or CNS depressants

Use after recent myocardial infarction

• Use corticosteroids like betamethasone/ dexchlorpheniramine maleate cautiously in patients who recently suffered a myocardial infarction due to the risk of myocardial rupture

Considerations for immunisation

• Patients on corticosteroid therapy, including betamethasone/ dexchlorpheniramine maleate, should avoid smallpox vaccinations
• Other immunisations are also not recommended, particularly for those on high doses of corticosteroids

Increased susceptibility to infections

• Corticosteroid use, such as in betamethasone/ dexchlorpheniramine maleate, suppresses immune response, raising the risk and severity of infections
• Infections like septicaemia and tuberculosis may be masked and progress significantly before detection
• clinical presentation may often be atypical

Chickenpox and herpes zoster

• Chickenpox can be severe or fatal in immunosuppressed patients
• Those without a clear history of chickenpox should avoid close personal contact with chickenpox or herpes zoster and seek medical attention immediately if exposed
• Non-immune patients exposed to chickenpox and on systemic corticosteroids (or who have used them within the previous 3 months) should receive varicella zoster immunoglobulin (VZIG) within 10 days of exposure
• In confirmed cases, immediate specialist care and treatment are essential. Corticosteroid treatment should continue, possibly at an increased dose

Vaccinations

• Live vaccines are not advised for individuals with impaired immunity due to corticosteroid therapy
• The efficacy of other vaccines might be reduced

Measles exposure

• Patients should be cautious about measles exposure and seek medical advice if exposed
• Measles exposure may require prophylaxis with intramuscular normal immunoglobulin

Pheochromocytoma crisis

• Administration of systemic corticosteroids can trigger a potentially fatal pheochromocytoma crisis
• Corticosteroids should be given to patients with known or suspected pheochromocytoma only after careful risk/benefit evaluation

HPA-axis suppression

• Prolonged use of corticosteroids, especially in high doses and in young children, may suppress the hypothalamic-pituitary-adrenal (HPA) axis
• This suppression can result in Cushingoid features, growth retardation in children, and heightened susceptibility to stress and adrenal crisis in all patients
• In situations of stress, such as major surgery, septicaemia, or trauma, patients with signs of HPA-axis suppression should receive replacement therapy to prevent adrenal crisis

Potential aggravation of psychiatric disorders

• Corticosteroids in betamethasone/ dexchlorpheniramine maleate may worsen emotional instability or psychotic tendencies

Eye disorders

• Long-term corticosteroid use can lead to posterior subcapsular cataracts and glaucoma
• Increases the risk of secondary eye infections from fungi or viruses

Visual disturbances

• Systemic and topical corticosteroid use may cause visual issues
• Symptoms like blurred vision or other visual changes should prompt consideration for an ophthalmologist referral
• Potential causes include cataracts, glaucoma, and rarer conditions like central serous chorioretinopathy (CSCR), reported in association with corticosteroid use

Acetylsalicylic acid interaction

• Corticosteroids in betamethasone/ dexchlorpheniramine maleate can reduce blood salicylate levels
• Use acetylsalicylic acid cautiously with corticosteroids, especially in hypoprothrombinaemia

Duration of treatment

• Betamethasone/ dexchlorpheniramine maleate contain a potent, long-acting corticosteroid
• The recommended treatment period should not be exceeded

General considerations

• Dietary salt restriction and potassium supplementation may be advisable during corticosteroid therapy
• Corticosteroids increase calcium excretion
• Concurrent use may affect the response to somatotropin

Impact on growth in children

• Corticosteroids in betamethasone/ dexchlorpheniramine maleate can lead to dose-related growth retardation in infants, children, and adolescents, potentially irreversible
• Limit treatment to the minimum effective dosage and shortest duration possible

Ability to drive and use machines

• Betamethasone/ dexchlorpheniramine can significantly affect the ability to drive and operate machinery
• Due to possible side effects like drowsiness, patients should not engage in driving, using machinery, or performing tasks requiring concentration until they are sure that their abilities are not impaired by the medication
• Performing potentially hazardous tasks where loss of concentration could lead to accidents

Excipient cautions

• Avoid in patients with the rare hereditary condition of sorbitol intolerance (syr)
• Betamethasone/ dexchlorpheniramine maleate contains sorbitol and may have a laxative effect (syr)
• Not suitable for patients with rare hereditary conditions such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption (tab)

Dexchlorpheniramine maleate

Use cautiously in patients with

• Narrow-angle glaucoma or increased ocular pressure
• Stenosing peptic ulcer
• Pyloroduodenal obstruction
• Prostatic hypertrophy or bladder neck obstruction
• Cardiovascular disease, including hypertension
• Hyperthyroidism
• Renal or hepatic impairment
• Seizure disorders

Forms avail. in SA and covered in this monograph: syr, tab

South African registered indications and dosages

Acute allergic rhinitis, not responsive to conventional therapy
Steroid-responsive dermatological allergies and steroid-responsive dermatoses

Betamethasone/ Dexchlorpheniramine Maleate
0.25/2 (mg)

• Oral (tab): 1-2 tab, 4 times daily after meals and at bedtime; Max: 8 tab/24hrs; Treatment duration: Maximum 5 days

0.25/2 (mg/5ml)

• Oral (syr): 5-10ml, 4 times daily after meals and at bedtime; Max: 40ml/24hrs; Treatment duration: Maximum 5 days

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Dosage should be individualised and adjusted according to the condition under treatment and the response obtained. As improvement occurs, the dosage should be reduced gradually to the minimum maintenance level and discontinued if at all possible

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Betamethasone/ dexchlorpheniramine maleate tablets are intended for short-term use, limited to less than 5 days and should be used only for specific, well-defined medical indications. Should not be combined with other mixtures

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A course of treatment should not be repeated within 28 days unless specifically indicated and prescribed by the medical practitioner

Forms avail. in SA and covered in this monograph: syr, tab

South African registered indications and dosages

Acute allergic rhinitis, not responsive to conventional therapy
Steroid-responsive dermatological allergies and steroid-responsive dermatoses

Betamethasone/ Dexchlorpheniramine Maleate
0.25/2 (mg)

• Younger than 12 years: Contraindicated
• 12 years and older: See adult dosage

Pregnancy

South African recommendations

• Caution
• The safety of betamethasone/ dexchlorpheniramine maleate in pregnancy has not been established
• Betamethasone in betamethasone/ dexchlorpheniramine maleate can cross the placenta. Corticosteroids may cause foetal abnormalities in animals, including cleft palate, intra-uterine growth retardation and effects on brain growth and development
• No proven increase in congenital abnormalities like cleft palate/lip in humans
• Prolonged or repeated corticosteroid use during pregnancy may risk intra-uterine growth retardation
• Neonatal hypoadrenalism may occur following prenatal exposure but typically resolves spontaneously after birth
• In-utero exposure to betamethasone may be linked to myocardial hypertrophy and gastroesophageal reflux
• When necessary, corticosteroids can be administered in normal pregnancies, but patients with pre-eclampsia or fluid retention need close monitoring
• Betamethasone may transiently suppress foetal heart rate and biophysical activities used for foetal assessment. These characteristics can include a reduction in foetal breathing movements, body movements and heart rate
• Infants born to mothers who received high doses of corticosteroids during pregnancy should be monitored for hypoadrenalism

Breastfeeding

South African recommendations

• Caution
• Safety in lactation has not been established
• Corticosteroids in betamethasone/ dexchlorpheniramine maleate may pass into breast milk; specific data for betamethasone is not available
• Infants of mothers on high doses of systemic corticosteroids for extended periods may experience adrenal suppression
• Dexchlorpheniramine, a component of betamethasone/ dexchlorpheniramine maleate, is excreted in breast milk
• Caution is advised when administering betamethasone/ dexchlorpheniramine maleate to nursing mothers

Fertility

South African recommendations

• Betamethasone, as contained in betamethasone/ dexchlorpheniramine maleate may alter the motility and number of spermatozoa

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no dose adjustment recommended
  Close clinical supervision is required to avoid life-threatening reactions

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

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 Maleate

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, 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

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Betamethasone/ Dexchlorpheniramine Maleate

• Monoamine oxidase inhibitors (MAOIs)

Betamethasone

• Phenobarbitone
• Phenytoin
• Rifampicin
• Carbamazepine
• Primidone
• Aminoglutethimide
• Rifabutin
• Ephedrine
• Antihypertensives
• Diuretics
• Oestrogen (such as in oral contraceptives)
• Potassium-depleting diuretics
• Thiazides
• Loop diuretics
• Cardiac glycosides
• Digoxin
• Acetazolamide
• Carbenoxolone
• Ulcer healing medicines
• Theophylline
• Amphotericin B
• Warfarin
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Antidiabetic medicines
• Insulin
• Salicylates
• Ritonavir
• Mifepristone
• Neuromuscular blocking medicines
• Vecuronium
• Fluoroquinolones
• Quetiapine
• CYP3A inhibitors
• Cobistat containing medicines
• Tretinoin
• Anticholinesterases

Other interactions

• Cholecystographic X-ray media

Dexchlorpheniramine Maleate

• Alcohol
• Tricyclic antidepressants
• Barbiturates
• Central nervous system depressants
• Oral anticoagulants
• Monoamine oxidase inhibitors (MAOIs)

Other interactions

• Skin test procedures

None routine. Specific cases may require

• Growth (children)
• Prothrombin time (PTT)

Skin testing procedures

• Antihistamines, as contained in betamethasone/ dexchlorpheniramine maleate should be discontinued approximately 48 hours prior to skin testing procedures since these medicines may prevent or diminish otherwise positive reactions to dermal reactivity indicators

Betamethasone/ dexchlorpheniramine maleate combines the anti-inflammatory and anti-allergic effects of the corticosteroid betamethasone with the antihistaminic activity of dexchlorpheniramine maleate.

COMBINATION PREPARATIONS

Betamethasone/ Dexchlorpheniramine

Tablet 0.25mg/2mg

• Celestamine (MSD) originator
• Betadexamine (Pharmacare)

Syrup (per 5ml) 0.25mg/2mg

• Betadexamine (Pharmacare)
• Celestamine (MSD) originator