Betamethasone/ Calcipotriol

Registered South African indications:

• Psoriasis vulgaris
• Scalp psoriasis

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Erythrodermic psoriasis
• Exfoliative psoriasis
• Pustular psoriasis
• Known calcium metabolism disorders
• Viral lesions of the skin
• Fungal or bacterial skin infections
• Parasitic infections
• Skin manifestations in relation to tuberculosis
• Perioral dermatitis
• Atrophic skin
• Striae atrophicae
• Fragility of skin veins
• Ichthyosis
• Acne vulgaris
• Acne rosacea
• Rosacea
• Ulcers and wounds 

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Severe hepatic impairment
• Elderly
• Diabetes mellitus
• High doses
• Application to large areas of damaged skin
• Application to mucous membranes or skin folds
• Occlusive dressings
• Application to skin of face and genitals
• Prolonged use
• Phototherapy

Forms avail. in SA and covered in this monograph: gel, oin

Psoriasis vulgaris

Betamethasone/ Calcipotriol
0.5mg/50μg

• Topical (oin): Apply small quantity to affected area, dly; Treatment duration: 4 weeks; Max: 15g/day, 100g/week

The treated area should not be more than 30% of the body surface

If it is necessary to continue or restart treatment after 4 weeks, treatment
should be continued under medical review and under regular medical supervision

Scalp psoriasis

Betamethasone/ Calcipotriol
0.5mg/50μg

• Topical (gel): Apply small quantity to affected area, dly; Maintenance: 1-4g/day; Treatment duration: 8 weeks; Max: 100g/week

In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application, and the gel should remain on the scalp for the full night or day

Not established for use in children below 18 years

Pregnancy

• Caution
• There are no adequate data from the use of calcipotriol/betamethasone in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies (less than 300 pregnancy outcomes) have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, calcipotriol/betamethasone should only be used when the potential benefit justifies the potential risk

Breastfeeding

• Caution
• Betamethasone passes into breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing calcipotriol/betamethasone to women who breastfeed. The patient should be instructed not to use Dcalcipotriol/betamethasone on the breast when breastfeeding

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no information available

Hepatic Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Pruritis
• Skin infection
• Folliculitis
• Exacerbation of psoriasis
• Dermatitis
• Erythema
• Rash
• Acne
• Skin burning sensation
• Skin irritation
• Dry skin
• Skin striae
• Skin exfoliation
• Hair colour change
• Application site pain

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Eye irritation

No information available

Serum calcium levels 

Betamethasone
Betamethasone is a glucocorticoid receptor agonist, which acts as an anti-inflammatory agent via multiple mechanisms to inhibit late phase allergic reactions. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. 

Calcipotriol
Calcipotriol induces differentiation and suppresses proliferation of keratinocytes, which is thought to account for its antipsoriatic effect. 

COMBINATION PREPARATIONS

Betamethasone/ Calcipotriol

Ointment (per g) 0.5mg/50μg

• Dovobet (Adcock)

Gel (per g) 0.5mg/50μg

• Dovobet Gel (Adcock) 
• Xamiol ( Adcock) originator