Each g contains:
(as hydrate 52.2 mcg)
Betamethasone Ph. Eur. 0.5 mg
(as dipropionate 0.643 mg)
One gram of Daivobet®ointment contains 50 micrograms of calcipotriol (as monohydrate) and 500 micrograms of betamethasone (as dipropionate).
Daivobet®ointment is indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy in adult patients 18 years and older.
Dosage and method of administration
Daivobet®ointment is indicated FOR TOPICAL USE ONLY and NOT FOR OPHTHALMIC USE.
All psoriasis-affected areas treated with Daivobet ®should be, where possible, protected from direct sunlight and UV-light with items of clothing. Topical calcipotriol should only beused with UV radiation if the physician and patient consider that the potential benefits outweigh the potential risks. The potential phototoxic effects of Daivobet®over long term exposure have notbeen fully investigated.
Daivobet®ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 grams.
The maximum recommended weekly dose of Daivobet®ointment is 100 g/week.
The treated area should not be more than 30% of the body surface.The recommended treatment period of Daivobet®ointment is 4 weeks. At the completion ofthe treatment period, repeated treatment with Daivobet®ointment can be initiated under medical supervision. There is no clinical experience with Daivobet®Ointment beyond 52 weeks
Daivobet®ointment is not recommended for use in children and adolescents below the age of 18 years.
Special warnings and special precautions for use
FOR EXTERNAL USE ONLY
Effects on endocrine system adverse reactions 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 of Daivobet®ointment to large areas of damaged skin, under occlusive dressings, to mucous membranes, or in skin folds should be avoided as these conditions increase the systemic absorption of both corticosteroids and calcipotriol. Elevated systemic absorption of calcipotriol could result in hypercalcemia in some patients
In a trial in patients with both extensive scalp and extensive body psoriasis Vulgaris using a combination of high doses of Daivobet®gel (scalp application) and high doses of Daivobet®ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroid.
Effects on calcium metabolism
In view of the risk of hypercalcemia secondary to excessive absorption of calcipotriol when there is extensive skin involvement, Daivobet®ointment should not be used on more than 30% of the body surface area.
The risk of hypercalcemia is minimal when the recommendations relevant to calcipotriol are observed. In adults, the maximum daily dose of 15 g or the maximum weekly dose of 100g ointment should not be exceeded.
Treatment with Daivobet®ointment in adults in the recommended amounts up to 100 g per week does not generally result in changes in laboratory values. Serum calcium and renal function should be monitored at 3 monthly intervals during periods of usage of topical calcipotriol, including that in Daivobet® ointment. If the serum calcium level is elevated, treatment withDaivobet®ointment should be discontinued and the condition should be treated appropriately. The levels of serum calcium should be measured once weekly until the serum calcium levels return to normal values
This combination medication is used to treat certain skin conditions such as psoriasis. It combines a chemical related to vitamin D (Daivobet) with a corticosteroid (Daivobet) that reduces swelling/inflammation and itching. This product is not recommended for use in children.
Each gram of ointment contains Betamethasone/Calcipotriol 50 mcg and Daivobet dipropionate 0.5 mg.
Each gram of Daivobet gel contains Betamethasone/Calcipotriol monohydrate 50 mcg and Daivobet 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.
Gel: Daivobet should be applied to the affected area once daily. The recommended treatment duration is 4 weeks. After this period, repeated treatment with Daivobet 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.
Daivobet 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 Daivobet gel can be initiated under medical supervision.
All the affected scalp areas may be treated with Daivobet gel. Usually, an amount between 1 g and 4 g daily is sufficient for the treatment of the scalp (4 g corresponds to 1 teaspoon).
When using Daivobet 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 Daivobet 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 the application of Daivobet gel. Daivobet gel should remain on the skin during the night or during the day.
No interaction studies have been performed.Incompatibilities: In the absence of compatibility studies, Daivobet gel must not be mixed with other medicinal products.
Daivobet side effects
The trial program for Daivobet ointment has so far included >2500 patients for Daivobet ointment and >4,700 patients for Daivobet Gel and has shown that approximately 10% and 8% of patients can be expected to experience a non-serious undesirable effect for Daivobet 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 Daivobet and Daivobet, respectively:
Daivobet: 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 hypercalcemia or hypercalciuria.
Daivobet (as Dipropionate): Daivobet contains a potent corticosteroid.
Local reactions can occur after topical use, especially during the 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 generalized pustular psoriasis.
Systemic effects due to topical use of corticosteroids are rare in adults, however, they can be severe. Adrenocortical suppression, cataract, infections and an 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.
Hypersensitivity to Daivobet monohydrate or Daivobet dipropionate gel or to any of the excipients of Daivobet.Due to the content of Daivobet, Daivobet gel is contraindicated in patients with known disorders of calcium metabolism.
Due to the content of corticosteroid, Daivobet 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.
Daivobet gel is contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis. It is also contraindicated in patients with severe renal insufficiency or severe hepatic disorders.
Active ingredient matches for Daivobet:
Betamethasone/Calcipotriol in Australia, Bahrain, Bangladesh, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Estonia, Finland, France, Georgia, Germany, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Latvia, Lithuania, Malaysia, Malta, Norway, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Tunisia, Uruguay, Vietnam.
Betamethasone dipropionate/Calcipotriol in Thailand.
Betamethasone dipropionate/Calcipotriol hydrate in Malaysia.
Betamethasone dipropionate/Calcipotriol monohydrate in Singapore.
Calcipotriol in Romania.
Unit description / dosage (Manufacturer)Price, USD Ointment; Topical; Betamethasone Dipropionate 0.05%; Calcipotriol Hydrate 0.005% Daivobet Calcipotriol 50 mcg, Betamethasone 0.5 mg/1 g. OINT / 15g$ 12.91 Daivobet 15 g$ 22.24 Daivobet 15 g x 1’s$ 23.93 Daivobet 30 g$ 38.37 Daivobet 1 tube 15 g 15g$ 12.91 Daivobet Skin 15 gm Ointment$ 0.82 Daivobet oint 15 g x 1’s (LEO Pharma)$ 22.91 Daivobet oint 30 g x 1’s (LEO Pharma)$ 41.18 Daivobet gel 15 g x 1’s (LEO Pharma) Daivobet gel 30 g x 1’s (LEO Pharma)$ 41.98 Daivobet gel 60 g x 1’s (LEO Pharma) DAIVOBET oint 15g (Win Medicare)$ 12.29
List of Daivobet substitutes (brand and generic names):
Dacam RL (Chile) Daivobet 50 µg/0.5 mg/g (Hungary) Daivobet 50 µg/g 0,5 mg/g (Austria, Germany) Daivobet 50/500 (Australia, New Zealand) Daivobet D.A.C. (Iceland) Daivobetoi (Oman) Daivonex (Argentina, Australia, Bahrain, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Estonia, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovenia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Vietnam) Cream; Topical; Calcipotriol Hydrate 0.005% (Croslands (Ranbaxy Laboratories Ltd) Ointment; Topical; Calcipotriol Hydrate 0.005% (Croslands (Ranbaxy Laboratories Ltd) Solution; Topical; Calcipotriol Hydrate 0.005% (Croslands (Ranbaxy Laboratories Ltd) DAIVONEX Cream/ Gel/ Ointment / 50mcg per gm / 30gm units (Croslands (Ranbaxy Laboratories Ltd)$ 11.03 Daivonex 50 mcg/1 g x 30 g (Croslands (Ranbaxy Laboratories Ltd)$ 30.18 Daivonex 50 mcg/1 mL x 30 mL (Croslands (Ranbaxy Laboratories Ltd)$ 30.44 0.005 % w/w x 15g (Croslands (Ranbaxy Laboratories Ltd)$ 10.37 0.005 % w/w x 30g (Croslands (Ranbaxy Laboratories Ltd)$ 16.95 0.005 % w/v x 30ml (Croslands (Ranbaxy Laboratories Ltd)$ 16.95 Daivonex 0.005% w/v S-SOLN / 30ml (Croslands (Ranbaxy Laboratories Ltd)$ 16.95 Daivonex 0.005% w/v OINT / 15g (Croslands (Ranbaxy Laboratories Ltd)$ 10.37 Daivonex 0.005% w/v OINT / 30g (Croslands (Ranbaxy Laboratories Ltd)$ 16.95 Daivonex 50 mcg/1 g x 30 g x 1’s (Croslands (Ranbaxy Laboratories Ltd) Daivonex 50 mcg/1 mL x 30 mL x 1’s (Croslands (Ranbaxy Laboratories Ltd)$ 22.84 Daivonex 0.005 % x 30 g x 1’s (Croslands (Ranbaxy Laboratories Ltd)$ 23.93 Daivonex 50 mcg/1 g x 1 tube 30 g (Croslands (Ranbaxy Laboratories Ltd) Daivonex 50 mcg/1 mL x 1 Bottle 30 mL (Croslands (Ranbaxy Laboratories Ltd) Daivonex Skin 30 gm Ointment (Croslands (Ranbaxy Laboratories Ltd)$ 0.37 Daivonex Skin 30 gm Cream Cream (Croslands (Ranbaxy Laboratories Ltd)$ 15.84 Daivonex Skin 30 ml Solution (Croslands (Ranbaxy Laboratories Ltd)$ 15.84 Daivonex Skin 15 gm Ointment (Croslands (Ranbaxy Laboratories Ltd)$ 10.37 Daivonex oint 50 mcg/g 30 g x 1’s (Croslands (Ranbaxy Laboratories Ltd)$ 30.18 Daivonex scalp soln 50 mcg/mL 30 mL x 1’s (Croslands (Ranbaxy Laboratories Ltd)$ 30.44 Daivonex cream 50 mcg/g 30 g x 1’s (Croslands (Ranbaxy Laboratories Ltd)$ 29.58 DAIVONEX oint 0.005 % w/w x 15g (Croslands (Ranbaxy Laboratories Ltd)$ 10.37 DAIVONEX oint 0.005 % w/w x 30g (Croslands (Ranbaxy Laboratories Ltd)$ 16.95 DAIVONEX scalp soln 0.005 % w/v x 30ml (Croslands (Ranbaxy Laboratories Ltd)$ 16.95 Daivonex 0.005% (Egypt) Daivonex 50μg/g (Germany) Daivonex 50μg/ml (Germany) Daivonex D.A.C. (Iceland) Daivonex Scalp Solution Solution; Topical; Calcipotriol Hydrate 0.005% Darederm (India) Darederm Betamethasone valerate 0.61mg, Gentamycin sulphate 1 mg, Tolnaftate 10 mg, Iodochlorhydroxyquinoline 10mg/1 g. TUBE / 5g (Mount Mettur Pharmaceuticals Ltd)$ 0.17 5g (Mount Mettur Pharmaceuticals Ltd)$ 0.17 Darederm Skin 5 gm Cream (Mount Mettur Pharmaceuticals Ltd)$ 0.17 DAREDERM cream 5g (Mount Mettur Pharmaceuticals Ltd)$ 0.17 See 2688 substitutes for Daivobet
- DailyMed. “CALCIPOTRIENE HYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).”. https://dailymed.nlm.nih.gov/dailyme…
- DailyMed. “BETAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).”. https://dailymed.nlm.nih.gov/dailyme…
- PubChem. “betamethasone”. https://pubchem.ncbi.nlm.nih.gov/com…
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