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DOVOBET is a brand name for Betamethasone, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Overview Studies on the Body In a safety pool of randomized, multi-centre prospective vehicle- and/or active controlled clinical trials in subjects with plaque psoriasis on non-scalp areas, patients applied study product once daily for up to 8 weeks.
6g). Adverse drug reactions were adverse events that the investigators considered at least possibly related to study treatment. Approximately 6% of patients treated with DOVOBET gel experienced an adverse reaction. In this safety pool, the most common adverse reaction in the DOVOBET gel group was pruritus.
8% of patients. Patients discontinued treatment due to the following adverse reactions: application site pain, pain of skin, skin irritation, dermatitis contact, dry skin, pruritus and psoriasis. Studies on the Scalp The clinical trial programme for DOVOBET gel has included more than 1,900 patients with scalp psoriasis treated with DOVOBET gel.
Approximately 8% of patients treated with DOVOBET gel experienced an adverse reaction. Based on data from clinical trials, the most common adverse reaction is pruritus. 2% of patients. Patients discontinued treatment due to the following adverse reactions: pruritus, skin pain or irritation, dermatitis, eye irritation, rash, burning sensation, face oedema, folliculitis and dry skin.
0 Page 9 of 44 compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle and the gel vehicle-alone administered once daily in subjects with mild to moderate psoriasis vulgaris on non-scalp regions of the body (trunk and/or limbs).
The mean baseline extent of psoriasis was similar among the four treatment groups (approximately 11-13% of body surface area). The mean amount of study medication used per week over the course of the study was similar among the DOVOBET gel, betamethasone gel and gel vehicle groups (approximately 28-32 g/week) and greatest in the calcipotriol group (approximately 37g/week).
Adverse drug reactions were adverse events that the investigators considered at least possibly related to study treatment. 2%) vs. 6% in the DOVOBET gel group, 0% in the betamethasone gel group and 0% in the vehicle group. Among patients treated with DOVOBET gel, the adverse drug reactions leading to withdrawal were: application site pain, psoriasis, and dermatitis contact.
General DOVOBET gel should not be used on the face, axillae, flexures, groin, or genitals. (see WARNINGS AND PREACAUTIONS/Skin). Hypercalcemia, hypercalciuria and hypothalamic-pituitary-adrenal (HPA) axis suppression have been observed with the use of DOVOBET gel.
(see WARNINGS AND PRECAUTIONS/Endocrine and Metabolism). Carcinogenesis and Mutagenesis Calcipotriol when used in combination with ultraviolet radiation (UVR) may enhance the known skin carcinogenic effect of UVR. This potential risk is based on the pre-clinical finding in mice of a reduced time to tumor formation from long term exposure of UVR and topically applied calcipotriol (see TOXICOLOGY, Carcinogenicity).
g. g. ). Endocrine and Metabolism Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary- adrenal (HPA) axis suppression with the potential for clinical glucocorticoid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
e. 0 Page 5 of 44 therefore be avoided. The use of occlusion may increase penetration of the drug into the stratum corneum, increasing the risk of adverse events. g. hyperglycaemia, glucosuria) and unmasking of latent diabetes mellitus can also be produced in some patients by systemic absorption of topical corticosteroids.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression (see WARNINGS AND PRECAUTIONS/Monitoring and Laboratory Tests).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Signs of skin atrophy were assessed visually by the investigator. There were no reports in any treatment group that were related to skin atrophy, striae, telangiectasia, skin hypopigmentation or hypertrichosis. Table 1 lists adverse drug reactions reported in at least 1% of subjects in any treatment group in the pivotal trial of DOVOBET gel on the body.
1%). 0 Page 10 of 44 Table 1. 0 Clinical Studies on the Scalp Two pivotal and 4 supporting controlled clinical studies were conducted in scalp psoriasis. For the pivotal scalp studies, adverse drug reactions reported by at least 1% of patients in any treatment group are summarized in Table 2.
Overall, the incidence of patients with at least one ADR was lowest in the DOVOBET gel group. 0 Page 11 of 44 Table 2. 7) […]
Hypercalcemia and hypercalciuria have been observed with the use of DOVOBET gel. If hypercalemia or hypercalciuria develop, treatment should be discontinued until parameters of calcium metabolism have normalized. The effects of DOVOBET gel on calcium metabolism following treatment durations of more than 8 weeks have not been evaluated.
(see WARNINGS AND PRECAUTIONS/Monitoring and Laboratory). Ophthalmologic DOVOBET gel is not for ophthalmic use. DOVOBET gel may cause eye irritation. Avoid contact with the eyes or conjunctiva. Skin DOVOBET gel contains a potent World Health Organization (WHO) group III steroid and concurrent treatment with other corticosteroids on the same treatment area must be avoided.
DOVOBET gel should not be used on the face, axillae, flexures, groin, or genitals. g. washing their hands after each application) to avoid accidental transfer or application to these regions or to the mouth, mucous membranes or eyes (see DOSAGE AND ADMINISTRATON).
0 Page 6 of 44 Facial skin is very sensitive to Vitamin D analogues and corticosteroids. Dermatitis has been observed with the use of DOVOBET gel. Should facial dermatitis develop, treatment with DOVOBET gel on the scalp should be discontinued.
With long-term use, there is an increased risk of local and systemic corticosteroid adverse reactions. Treatment should be discontinued in the case of corticosteroid adverse reactions related to long-term use of DOVOBET gel. (see ADVERSE REACTIONS).
When treating psoriasis with topical corticosteroid containing products, including DOVOBET gel, it is recommended that treatment be interrupted periodically. There may be a risk of generalised pustular psoriasis or rebound psoriasis when discontinuing corticosteroids.
Medical supervision should therefore continue in the post-treatment period. Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection worsens, DOVOBET gel should be discontinued until the infection has been adequately treated.
Special Populations Pregnant Women:
The safety of calcipotriol and/or topical corticosteroids for use during pregnancy has not been established. Pregnant women were excluded from the clinical studies conducted with DOVOBET gel. When given systemically, calcipotriol has been shown to be fetotoxic and betamethasone dipriopionate has been shown to be teratogenic in animals (see PART II, TOXICOLOGY, Reproduction and Mutagenicity).
The use of DOVOBET gel is not recommended in pregnant women.
Nursing Women:
The safety of calcipotriol and/or topical corticosteroids for use in nursing women has not been established. It is not known whether calcipotriol can be excreted in breast milk. Betamethasone passes into breast milk, but it is not known if topical application of corticosteroid containing products, including DOVOBET gel, can lead to sufficient systemic absorption to produce detectable quantities in breast milk.
0 Page 7 of 44 Caution should be exercised when prescribing DOVOBET to women who breastfeed. The patient should be instructed not to use DOVOBET on the breast when breastfeeding.
Pediatrics (<18 years of age):
Since there is no clinical trial experience with the use of DOVOBET gel in children, use is not recommended. Children may demonstrate greater susceptibility to systemic corticosteroid related adverse effects due to a larger skin surface area to body weight ratio as compared to adults.
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