Daivobet 50 µg/g + 0,5 mg/g Uses

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Daivobet 50 µg/g + 0,5 mg/g indications

infoAn 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 50 µg/g + 0,5 mg/g)) with a corticosteroid (Betamethasone (Daivobet 50 µg/g + 0,5 mg/g)) that reduces swelling/inflammation and itching. This product is not recommended for use in children.

Daivobet 50 µg/g + 0,5 mg/g description

Each gram of ointment contains Calcipotriol (Daivobet 50 µg/g + 0,5 mg/g) 50 mcg and Betamethasone (Daivobet 50 µg/g + 0,5 mg/g) dipropionate 0.5 mg.

Each gram of Daivobet 50 µg/g + 0,5 mg/g gel contains Calcipotriol (Daivobet 50 µg/g + 0,5 mg/g) monohydrate 50 mcg and Betamethasone (Daivobet 50 µg/g + 0,5 mg/g) 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 50 µg/g + 0,5 mg/g dosage

Gel: Daivobet 50 µg/g + 0,5 mg/g should be applied to the affected area once daily. The recommended treatment duration is 4 weeks. After this period, repeated treatment with Daivobet 50 µg/g + 0,5 mg/g 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 50 µg/g + 0,5 mg/g 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 50 µg/g + 0,5 mg/g gel can be initiated under medical supervision.

All the affected scalp areas may be treated with Daivobet 50 µg/g + 0,5 mg/g 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 50 µg/g + 0,5 mg/g) 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 50 µg/g + 0,5 mg/g) 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 50 µg/g + 0,5 mg/g gel. Daivobet 50 µg/g + 0,5 mg/g gel should remain on the skin during the night or during the day.

Daivobet 50 µg/g + 0,5 mg/g interactions

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No interaction studies have been performed.

Incompatibilities: In the absence of compatibility studies, Daivobet 50 µg/g + 0,5 mg/g gel must not be mixed with other medicinal products.

Daivobet 50 µg/g + 0,5 mg/g side effects

The trial programme for Daivobet 50 µg/g + 0,5 mg/g ointment has so far included >2500 patients for Daivobet 50 µg/g + 0,5 mg/g ointment and >4,700 patients for Daivobet 50 µg/g + 0,5 mg/g Gel and has shown that approximately 10% and 8% of patients can be expected to experience a non-serious undesirable effect for Daivobet 50 µg/g + 0,5 mg/g 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 50 µg/g + 0,5 mg/g) and Betamethasone (Daivobet 50 µg/g + 0,5 mg/g), respectively:

Calcipotriol (Daivobet 50 µg/g + 0,5 mg/g): 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 50 µg/g + 0,5 mg/g) (as Dipropionate): Daivobet 50 µg/g + 0,5 mg/g 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 50 µg/g + 0,5 mg/g contraindications

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Hypersensitivity to Calcipotriol (Daivobet 50 µg/g + 0,5 mg/g) monohydrate or Betamethasone (Daivobet 50 µg/g + 0,5 mg/g) dipropionate gel or to any of the excipients of Daivobet 50 µg/g + 0,5 mg/g.

Due to the content of Calcipotriol (Daivobet 50 µg/g + 0,5 mg/g), Daivobet 50 µg/g + 0,5 mg/g gel is contraindicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid, Daivobet 50 µg/g + 0,5 mg/g 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 50 µg/g + 0,5 mg/g 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 50 µg/g + 0,5 mg/g:

Betamethasone/Calcipotriol in Austria, Germany.


List of Daivobet 50 µg/g + 0,5 mg/g 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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