Daivobet D.A.C. Uses

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Daivobet D.A.C. indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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This combination medication is used to treat certain skin conditions such as psoriasis. It combines a chemical related to vitamin D (Calcipotriol (Daivobet D.A.C.)) with a corticosteroid (Betamethasone (Daivobet D.A.C.)) that reduces swelling/inflammation and itching. This product is not recommended for use in children.

Daivobet D.A.C. description

Each gram of ointment contains Calcipotriol (Daivobet D.A.C.) 50 mcg and Betamethasone (Daivobet D.A.C.) dipropionate 0.5 mg.

Each gram of Daivobet D.A.C. gel contains Calcipotriol (Daivobet D.A.C.) monohydrate 50 mcg and Betamethasone (Daivobet D.A.C.) 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.

Daivobet D.A.C. dosage

Gel: Daivobet D.A.C. should be applied to the affected area once daily. The recommended treatment duration is 4 weeks. After this period, repeated treatment with Daivobet D.A.C. 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 D.A.C. 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 D.A.C. gel can be initiated under medical supervision.

All the affected scalp areas may be treated with Daivobet D.A.C. 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 (Daivobet D.A.C.) 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 (Daivobet D.A.C.) 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 Daivobet D.A.C. gel. Daivobet D.A.C. gel should remain on the skin during the night or during the day.

Daivobet D.A.C. interactions

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No interaction studies have been performed.

Incompatibilities: In the absence of compatibility studies, Daivobet D.A.C. gel must not be mixed with other medicinal products.

Daivobet D.A.C. side effects

The trial programme for Daivobet D.A.C. ointment has so far included >2500 patients for Daivobet D.A.C. ointment and >4,700 patients for Daivobet D.A.C. Gel and has shown that approximately 10% and 8% of patients can be expected to experience a non-serious undesirable effect for Daivobet D.A.C. 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 (Daivobet D.A.C.) and Betamethasone (Daivobet D.A.C.), respectively:

Calcipotriol (Daivobet D.A.C.): 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 (Daivobet D.A.C.) (as Dipropionate): Daivobet D.A.C. 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.

Daivobet D.A.C. contraindications

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Hypersensitivity to Calcipotriol (Daivobet D.A.C.) monohydrate or Betamethasone (Daivobet D.A.C.) dipropionate gel or to any of the excipients of Daivobet D.A.C..

Due to the content of Calcipotriol (Daivobet D.A.C.), Daivobet D.A.C. gel is contraindicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid, Daivobet D.A.C. 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 D.A.C. 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 D.A.C.:

Betamethasone/Calcipotriol in Iceland.


List of Daivobet D.A.C. substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Ointment; Topical; Betamethasone Dipropionate 0.05%; Calcipotriol Hydrate 0.005% (Win Medicare Pvt Ltd)
Daivobet Calcipotriol 50 mcg, Betamethasone 0.5 mg/1 g. OINT / 15g (Win Medicare Pvt Ltd)$ 12.91
Daivobet 15 g (Win Medicare Pvt Ltd)$ 22.24
Daivobet 15 g x 1's (Win Medicare Pvt Ltd)$ 23.93
Daivobet 30 g (Win Medicare Pvt Ltd)$ 38.37
Daivobet 1 tube 15 g (Win Medicare Pvt Ltd)
15g (Win Medicare Pvt Ltd)$ 12.91
Daivobet Skin 15 gm Ointment (Win Medicare Pvt Ltd)$ 0.82
Daivobet oint 15 g x 1's (Win Medicare Pvt Ltd)$ 22.91
Daivobet oint 30 g x 1's (Win Medicare Pvt Ltd)$ 41.18
Daivobet gel 15 g x 1's (Win Medicare Pvt Ltd)
Daivobet gel 30 g x 1's (Win Medicare Pvt Ltd)$ 41.98
Daivobet gel 60 g x 1's (Win Medicare Pvt Ltd)
DAIVOBET oint 15g (Win Medicare Pvt Ltd)$ 12.29
Gel; Topical; Betamethasone Dipropionate 0.5 mg; Calcipotriol Monohydrate 50 mcg / g (LEO Pharma)
Xamiol 30 g (LEO Pharma)$ 41.98
Xamiol 15 g x 1's (LEO Pharma)
Xamiol 15 g (LEO Pharma)
Xamiol topical gel 30 g x 1's (LEO Pharma)$ 41.98
Xamiol topical gel 15 g x 1's (LEO Pharma)

References

  1. 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... (accessed September 17, 2018).
  2. 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... (accessed September 17, 2018).
  3. PubChem. "betamethasone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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