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Dovobet gel

15-09-2010

Generic Name

Drug Class Description

One gram of gel contains 50 microgram of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). Excipient: 160 microgram butylated hydroxytoluene/g gel

Presentation

Gel. An almost clear, colourless to slightly off-white gel.

Indications

Topical treatment of scalp psoriasis. Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris.

Adult Dosage

Dovobet gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas. After this period repeated treatment with Dovobet gel can be initiated under medical supervision.

When using calcipotriol containing products, the maximum daily dose should not exceed 15 g, and the maximum weekly dose should not exceed 100 g. The body surface area treated with calcipotriol containing products should not exceed 30%.

Shake the bottle before use. In order to achieve optimal effect, it is not recommended to take a shower or bath, or to wash the hair in case of scalp application, immediately after application of Dovobet gel. Dovobet gel should remain on the skin during the night or during the day.

If used on the scalp

All the affected scalp areas may be treated with Dovobet gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon).

Paediatric patients:

Dovobet gel is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

Child Dosage

Contra Indications

Hypersensitivity to the active substances or to any of the excipients.

Due to the content of calcipotriol, Dovobet gel is contraindicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid, Dovobet gel is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.

Dovobet gel is contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis.

Dovobet gel is contraindicated in patients with severe renal insufficiency or severe hepatic disorders.

Special Precautions

Dovobet gel contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse effects found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids.

In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Dovobet gel (scalp application) and high doses of Dovobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment.

Due to the content of calcipotriol, hypercalcaemia may occur if the maximum weekly dose (100 g) is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed.

Treatment of more than 30% of the body surface should be avoided. Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Skin of the face and genitals are very sensitive to corticosteroids. These areas should only be treated with weaker corticosteroids. Uncommon local adverse reactions (such as eye irritation or irritation of facial skin) were observed, when the drug was accidentally administered in the area of face, or accidentally to the eyes or conjunctives. The patient must be instructed in correct use of the product to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.

When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.

When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.

With long-term use there is an increased risk of local and systemic corticosteroid undesirable effects. The treatment should be discontinued in case of undesirable effects related to long-term use of corticosteroid.

There is no experience with concurrent use of other anti-psoriatic products administered systemically or with phototherapy.

During Dovobet gel treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks.

Dovobet gel contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Interactions

No interaction studies have been performed.

Adverse Reactions

The following terminologies have been used in order to classify the frequencies of adverse drug reactions: 

Very common

GREATER-THAN OR EQUAL TO (8805)1/10

Common

GREATER-THAN OR EQUAL TO (8805)1/100 and <1/10

Uncommon

GREATER-THAN OR EQUAL TO (8805)1/1,000 and <1/100

Rare

GREATER-THAN OR EQUAL TO (8805)1/10,000 and <1/1,000

Very rare

<1/10,000

Not known (cannot be estimated from the available data)

The clinical trial programme for Dovobet gel has so far included more than 4,700 patients of whom more than 2,100 were treated with Dovobet gel. Approximately 8% of patients treated with Dovobet gel experienced a non-serious adverse drug reaction.

Based on data from clinical trials the only known common adverse drug reaction is pruritus. Uncommon adverse drug reactions are burning sensation of skin, skin pain or irritation, folliculitis, dermatitis, erythema, acne, dry skin, exacerbation of psoriasis, rash, pustular rash, and eye irritation. These adverse drug reactions were all non-serious local reactions.

The adverse drug reactions are listed by MedDRA SOC, and the individual adverse drug reactions are listed starting with the most frequently reported.

 

Eye disorders

Uncommon:

Eye irritation

 

Skin and subcutaneous tissue disorders

Common:

Pruritus

Uncommon:

Burning sensation of skin

Uncommon:

Skin pain or irritation

Uncommon:

Folliculitis

Uncommon:

Dermatitis

Uncommon:

Erythema

Uncommon:

Acne

Uncommon:

Dry skin

Uncommon:

Exacerbation of psoriasis

Uncommon:

Rash

Uncommon:

Pustular rash

Adverse drug reactions observed for calcipotriol and betamethasone, respectively:

Calcipotriol

Adverse drug reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema. Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria.

Betamethasone (as dipropionate)

Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis, there may be a risk of generalised pustular psoriasis.

Systemic effects due to topical use of corticosteroids are rare in adults, however, they can be severe. Adrenocortical suppression, cataract, infections and increase of intra-ocular pressure can occur, especially after long-term treatment. Systemic effects occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long-term treatment.

Manufacturer

Leo Laboratories Limited

Drug Availability

POM – Prescription Only Medicine