Dovobet Ointment

Each gram of ointment contains Calcipotriol (Dovobet Ointment) 50 mcg and Betamethasone (Dovobet Ointment) dipropionate 0.5 mg.

Each gram of Dovobet Ointment gel contains Calcipotriol (Dovobet Ointment) monohydrate 50 mcg and Betamethasone (Dovobet Ointment) dipropionate 0.5 mg. It also contains the following excipients: Liquid paraffin, butylhydroxytoluene (E321), polyoxypropylene-15 stearyl ether, all-rac-α-tocopherol, hydrogenated castor oil.

This combination medication is used to treat certain skin conditions such as psoriasis. It combines a chemical related to vitamin D (Calcipotriol (Dovobet Ointment)) with a corticosteroid (Betamethasone (Dovobet Ointment)) that reduces swelling/inflammation and itching. This product is not recommended for use in children.

Gel: Dovobet Ointment should be applied to the affected area once daily. The recommended treatment duration is 4 weeks. After this period, repeated treatment with Dovobet Ointment can be initiated under medical supervision. The maximum daily dose should not exceed 15 g, the maximum weekly dose should not exceed 100 g and the treated area should not be >30% of the body surface area.

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

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

When using Calcipotriol (Dovobet Ointment) 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 (BDA) treated with Calcipotriol (Dovobet Ointment) containing products should not exceed 30%.

Administration: Gel: Shake the bottle before use. In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Dovobet Ointment gel. Dovobet Ointment gel should remain on the skin during the night or during the day.

Hypersensitivity to Calcipotriol (Dovobet Ointment) monohydrate or Betamethasone (Dovobet Ointment) dipropionate gel or to any of the excipients of Dovobet Ointment.

Due to the content of Calcipotriol (Dovobet Ointment), Dovobet Ointment gel is contraindicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid, Dovobet Ointment gel is contraindicated in the following conditions: Viral (eg, 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 and wounds.

Dovobet Ointment gel is contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis. It is also contraindicated in patients with severe renal insufficiency or severe hepatic disorders.

No interaction studies have been performed.

Incompatibilities: In the absence of compatibility studies, Dovobet Ointment gel must not be mixed with other medicinal products.

The trial programme for Dovobet Ointment ointment has so far included >2500 patients for Dovobet Ointment ointment and >4,700 patients for Dovobet Ointment Gel and has shown that approximately 10% and 8% of patients can be expected to experience a non-serious undesirable effect for Dovobet Ointment Gel and Ointment, respectively.

Based on data from clinical trials and post-market use, the common undesirable effects are pruritus, rash and burning sensation of skin. Uncommon undesirable effects are skin pain or irritation, dermatitis, erythema, exacerbation of psoriasis, folliculitis and application site pigmentation changes. Pustular psoriasis is a rare undesirable effect.

The individual undesirable effects are listed as follows, starting with the most frequently reported:

Skin and Subcutaneous Tissue Disorders: Common (>1/100 and <1/10): Pruritus, rash, burning sensation of skin. Uncommon (>1/1000 and <1/100): Skin pain or irritation, dermatitis, erythema, exacerbation of psoriasis, folliculitis, application site pigmentation changes. Rare (>1/10,000 and <1/1000): Pustular psoriasis.

Undesirable effects observed for Calcipotriol (Dovobet Ointment) and Betamethasone (Dovobet Ointment), respectively:

Calcipotriol (Dovobet Ointment): Undesirable effects include application site reactions, pruritus, skin irritation, burning and stinging sensations, dry skin, erythema, rash, dermatitis, eczema, aggravated psoriasis, 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 (Dovobet Ointment) (as Dipropionate): Dovobet Ointment contains a potent corticosteroid.

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 intraocular 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.