Dipsotrex B

A pale yellow or yellow ointment.
Each gram contains: Calcipotriol monohydrate 50 mcg (as Calcipotriol anhydrous 52.2 mcg); Betamethasone 500 mcg (as dipropionate 0.643 mg).

For the topical treatment of psoriasis vulgaris.

Apply an adequate layer of Calcipotriol + Betamethasone (Dipsotrex B) Ointment to the affected area(s) once daily for up to 4 weeks. The maximum weekly dose should not exceed to 100 g. Treatment of more than 30% body surface area is not recommended. Calcipotriol + Betamethasone (Dipsotrex B) Ointment should be rubbed in gently and completely. Patients should wash their hands after applying Calcipotriol + Betamethasone (Dipsotrex B) Ointment. Calcipotriol + Betamethasone (Dipsotrex B) Ointment is not for oral, ophthalmic, or intravaginal use.

Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.
Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. In such cases, symptomatic treatment is indicated.
In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.

Hypersensitivity to the active substances or to any of the excipients.
Patients with known disorders of calcium metabolism.
Due to the content of corticosteroid, this drug is contraindicated in the following conditions: Viral (e.g. 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.
Patients with guttate, erythrodermic, exfoliative and pustular psoriasis.
Patients with severe renal insufficiency or severe hepatic disorders.
Infants.
Face or around the eyes.
Patients with itch in genitals or anus.

Adverse effects 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 under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.
Due to the content of calcipotriol, hypercalcemia may occur if the maximum weekly dose (100 g) is exceeded. Serum calcium is, however, quickly normalized when treatment is discontinued. The risk of hypercalcemia is minimal when the recommendations relevant to calcipotriol are followed.
Efficacy and safety of use of this product on areas other than the scalp have not been established. Treatment of more than 30% of the body surface should be avoided. Application on large areas of damaged skin or in mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Skin of the face and genitals are very sensitive to corticosteroids. These areas should only be treated with weaker corticosteroids. Uncommon local adverse reactions (such as eye irritation or irritation of facial skin) were observed, when the drug was accidentally administered in the area of face, or accidentally to the eyes or conjunctives. The patient must be instructed in correct use of the product to avoid application and accidental transfer to the face, mouth and eyes.
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.
When treating psoriasis with topical corticosteroids, there may be a risk of generalized pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
With long-term use there is an increased risk of local and systemic corticosteroid undesirable effects. The treatment should be discontinued in case of undesirable effects related to long-term use of corticosteroid.
There is no experience with concurrent use of other anti-psoriatic products administered systemically or with phototherapy.
During Calcipotriol + Betamethasone (Dipsotrex B) treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks.
Calcipotriol + Betamethasone (Dipsotrex B) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Use in the elderly: All other reported clinical experience has not identified any differences in response between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Pregnancy: There are no adequate data from the use of Calcipotriol + Betamethasone (Dipsotrex B) in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroid during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Calcipotriol + Betamethasone (Dipsotrex B) should only be used when the potential benefit justifies the potential risk.
Lactation: Betamethasone passes into breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk.
Caution should be exercised when prescribing Calcipotriol + Betamethasone (Dipsotrex B) to women who breast-feed.

Based on data from clinical trials, the only known common adverse drug reaction is pruritus. Uncommon adverse drug reactions are burning sensation of skin, skin pain or irritation, folliculitis, dermatitis, erythema, acne, dry skin, exacerbation of psoriasis, rash, pustular rash, and eye irritation. These adverse drug reactions were all non-serious local reactions.
Eye disorders (Uncommon): Eye irritation.
Skin and subcutaneous tissue disorders: Common: Pruritus.
Uncommon: Burning sensation of skin, skin pain or irritation, folliculitis, dermatitis, erythema, acne, dry skin, exacerbation of psoriasis, rash, pustular rash.
Adverse drug reactions observed for calcipotriol and betamethasone, respectively: Calcipotriol: Adverse drug reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial edema. Systemic effects after topical use may appear very rarely causing hypercalcemia or hypercalciuria.
Betamethasone (as dipropionate): 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 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 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.

As this drug contains a potent group III steroid, concurrent treatment with other steroids on the scalp must be avoided.
As salicylic acid may decrease the effect of calcipotriol, concurrent administration with salicylic acid must be avoided.
Concurrent administration with other psoriasis product and other forms of light treatment was not experienced.

Store at temperatures not exceeding 30°C. Protect from light.

Psoriasis, Seborrhea & Ichthyosis Preparations

D05AX52 - calcipotriol, combinations ; Belongs to the class of other antipsoriatics for topical use.

Rx