Medicinal Products

DAIVOBET 50 μg / 0.5 mg / g

Generic drug of the therapeutic class: Dermatology
active ingredients: Calcipotriol, Betamethasone
laboratory: Leo Pharmaceutical Ltd

Ointment
60 g tube
All forms

Indication

Topical treatment of plaque psoriasis (psoriasis vulgaris) as part of a topical treatment in adults.

Dosage DAIVOBET 50 μg / 0.5 mg / g Ointment 60 g tube

Dosage

Daivobet ointment should be applied once a day on the lesions. The recommended duration of treatment is 4 weeks. There is data on the use of repeated courses of Daivobet up to 52 weeks. If it is necessary to continue or resume treatment after 4 weeks, treatment should be continued after medical advice and under regular medical supervision.

When using products containing calcipotriol, the maximum daily dose should not exceed 15 g. Body surface area treated with products containing calcipotriol should not exceed 30% (see Warnings and Precautions ) section.

Special Populations

Renal and hepatic insufficiency

The safety and effectiveness of Daivobet ointment in patients with severe renal impairment or severe hepatic impairment have not been evaluated.

Pediatric population

The safety and effectiveness of Daivobet ointment in children under 18 years of age have not been established. No data available.

Administration mode

Daivobet ointment should be applied to the lesions. To have an optimal effect, it is not recommended to take a shower or bath immediately after the application of Daivobet ointment.

Against indications

Known hypersensitivity to active ingredients or to any of the excipients.

Daivobet ointment is contraindicated in case of erythrodermic, exfoliating and pustular psoriasis.

Due to the presence of calcipotriol, Daivobet ointment is contraindicated in patients with a history of calcium metabolic disorders.

Because of the presence of corticosteroids, Daivobet ointment is contraindicated in the following cases: skin lesions of viral origin (eg herpes or chicken pox), infections of fungal or bacterial origin, parasitic infections, skin involvement in relation with tuberculosis or syphilis, perioral dermatitis, atrophy of the skin, stretch marks, fragility of the cutaneous venous network, ichthyosis, acne vulgaris, rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.

Daivobet side effects

The Daivobet ointment clinical trial program has so far included more than 2, 500 patients and has shown that approximately 10% of patients can expect to have a non-serious adverse reaction.

It's reactions are usually benign and mainly cover various skin reactions like rashes, pruritus and burning sensation of the skin. Pustular psoriasis has been reported infrequently. The rebound effect after the end of treatment has been reported but the frequency is not known.

Based on data from clinical studies and post-marketing use the following side effects are listed for Daivobet ointment.

The side effects are listed according to MedDRA System Orgna Class and individual side effects are listed starting with the most commonly reported. In each grouping of frequencies, the undesirable effects are listed by decreasing severity.

The following terminologies have been used to classify adverse event frequencies:

Very common ≥1 / 10

Frequent ≥1 / 100 and <1/10

Uncommon ≥1 / 1, 000 and <1/100

Rare ≥1 / 10, 000 and <1/1000

Very rare <1/10 000

Not known (can not be evaluated with available data)

Skin and subcutaneous reactions

Frequent

itching

Rashes

Burning sensation of the skin

Rare

Exacerbation of psoriasis

Skin pain or irritation

Dermatitis

Erythema

folliculitis

Modification of the pigmentation of the treated area

Rare

Pustular psoriasis

General disorders and administration sites

Frequency not known

Rebound effect - included in section Warnings and precautions for use

The following adverse reactions are considered in relation to the pharmacological classes of calcipotriol and betamethasone, respectively:

calcipotriol

Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, worsening of psoriasis, photosensitivity, and hypersensitivity reactions including very rare cases of angioedema and edema of the face.

Systemic effects after topical application may occur very rarely and cause hypercalcemia or hypercalciuria (see Warnings and Precautions section ).

Betamethasone (dipropionate)

Local reactions may occur after topical use, especially during prolonged exposure, including skin atrophy, telangiectasia, stretch marks, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, and colloid millium. When treating psoriasis, there may be a risk of generalized pustular psoriasis.

Systemic effects after topical application of corticosteroid are rare in adults, however they can be severe. Braking of the hypothalamic-pituitary axis, cataract, infections, impact on the metabolic control of diabetes mellitus and increased intraocular pressure may occur, especially after prolonged treatment. Systemic effects occur more frequently when applied under occlusion (plastic, skin folds), when applied over large areas and during long-term treatment (see section Warnings and precautions for use). ).

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