Xamiol

Xamiol

betamethasone + calcipotriol

Manufacturer:

LEO Pharma

Distributor:

Getz Bros
Full Prescribing Info
Contents
Calcipotriol monohydrate, betamethasone dipropionate.
Description
Each gram of Xamiol gel contains calcipotriol (as monohydrate) 50 mcg and betamethasone (as dipropionate) 0.5 mg.
Action
Pharmacology: Pharmacodynamics: Calcipotriol is a vitamin D analogue. In vitro data suggest that calcipotriol induces differentiation and suppresses proliferation of keratinocytes. This is the proposed basis for its effect in psoriasis.
Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, however, without curing the underlying condition. Through occlusion the effect can be enhanced due to increased penetration of the stratum corneum, hence, the incidence of adverse events will increase. In general, the mechanism of the anti-inflammatory activity of the topical steroids is unclear.
Pharmacokinetics: The systemic exposure to calcipotriol and betamethasone dipropionate from topically applied Xamiol gel is comparable to Daivobet ointment in rats and minipigs. Clinical studies with radiolabeled ointment indicate that the systemic absorption of calcipotriol and betamethasone from Daivobet ointment formulation is <1% of the dose (2.5 g) when applied to normal skin (625 cm2) for 12 hrs. Application to psoriasis plaques and under occlusive dressings may increase the absorption of topical corticosteroids.
Following systemic exposure, both active ingredients, calcipotriol and betamethasone dipropionate, are rapidly and extensively metabolized. The main route of excretion of calcipotriol is via feces (rats and minipigs) and for betamethasone dipropionate it is via urine (rats and mice).
Calcipotriol and betamethasone dipropionate were below the lower limit of quantification in all blood samples of 34 patients treated for 4 or 8 weeks with both Xamiol gel and Daivobet ointment for extensive psoriasis involving the body and scalp. One metabolite of calcipotriol and 1 metabolite of betamethasone dipropionate were quantifiable in some of the patients.
Indications/Uses
Topical treatment of scalp psoriasis.
Dosage/Direction for Use
Xamiol gel should be applied to affected areas of the scalp once daily. The recommended treatment period is 4 weeks. After this period, repeated treatment with Xamiol gel can be initiated under medical supervision.
All the affected scalp areas may be treated with Xamiol gel. Usually an amount between 1 and 4 g/day is sufficient for treatment of the scalp (4 g corresponds to 1 teaspoon).
When using calcipotriol-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 treated with calcipotriol-containing products should not exceed 30%.
Shake the bottle before use. In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Xamiol gel. Xamiol gel should remain on the scalp during the night or during the day.
Overdosage
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.
It has been reported that due to misuse, 1 patient with extensive erythrodermic psoriasis treated with 240 g of Daivobet ointment weekly (maximum dose of 100 g weekly) for 5 months developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment.
Contraindications
Hypersensitivity to the active substances or to any of the excipients of Xamiol.
Due to the calcipotriol content, Xamiol gel is contraindicated in patients with known disorders of calcium metabolism.
Due to the corticosteroid content, Xamiol 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.
It is also contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis.
Patients with severe renal insufficiency or severe hepatic disorders.
Special Precautions
Xamiol gel contains a potent group III steroid and concurrent treatment with other steroids on the scalp must be avoided. Adverse effects found in connection with systemic corticosteroid treatment eg, 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.
In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Xamiol gel (scalp application) and high doses of Daivobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotrophic hormone (ACTH) challenge after 4 weeks of treatment.
Due to the calcipotriol content, 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 Xamiol use on areas other than the scalp have not been established. Treatment of >30% of the body surface should be avoided. Application on large areas of damaged skin or on 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 (eg, eye irritation or irritation of facial skin) were observed, when Xamiol was accidentally administered in the area of face or accidentally to the eyes or conjunctives. The patient must be instructed in the correct use of Xamiol to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
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 antipsoriatic products administered systemically or with phototherapy.
During Xamiol gel 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.
Xamiol gel contains butylated hydroxytoluene (E321), which may cause local skin reactions (eg, contact dermatitis), or irritation to the eyes and mucous membranes.
Use in pregnancy: There are no adequate data from the use of Xamiol gel 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 corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Xamiol gel should only be used when the potential benefit justifies the potential risk.
Use in lactation: Betamethasone passes into the 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 Xamiol gel to women who are breastfeeding.
Use in children: Xamiol gel is not recommended for use in children <18 years due to lack of data on safety and efficacy.
Use In Pregnancy & Lactation
Use in pregnancy: There are no adequate data from the use of Xamiol gel 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 corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Xamiol gel should only be used when the potential benefit justifies the potential risk.
Use in lactation: Betamethasone passes into the 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 Xamiol gel to women who are breastfeeding.
Adverse Reactions
The clinical trial program for Xamiol gel has so far included >4,400 patients of whom more than 1,900 were treated with Xamiol gel.
Approximately 8% of patients treated with Xamiol gel experienced a nonserious adverse drug reaction.
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 nonserious local reactions.
The adverse drug reactions are listed by MedDRA System Organ Class, and the individual adverse drug reactions are listed starting with the most frequently reported.
Eye Disorders: Uncommon (≥1/1,000 and <1/100): Eye irritation.
Skin and Subcutaneous Tissue Disorders: Common (≥1/100 and <1/10): Pruritus. Uncommon (≥1/1,000 and <1/100): 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, aggravated psoriasis, 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.
Drug Interactions
No interaction studies have been performed.
Incompatibilities: In the absence of compatibility studies, Xamiol gel must not be mixed with other medicinal products.
Storage
Store at temperatures not exceeding 30°C. Do not refrigerate. Protect from light.
Discard 3 months after opening.
ATC Classification
D05AX52 - calcipotriol, combinations ; Belongs to the class of other antipsoriatics for topical use.
Presentation/Packing
Topical gel (clear, colorless to slightly off-white) 30 g.
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