Dovonex Ointment (Calcipotriene)




Topical Nonsteroidal Antipsoriatic

Action And Clinical Pharmacology: Calcipotriol is a nonsteroidal antipsoriatic agent, derived from the naturally occurring vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25 (OH)2D3 receptor. Calcipotriol is as potent as 1,25 (OH)2D3, the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25 (OH)2D3 in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with calcipotriol is thus a normalization of epidermal growth.

Calcipotriol cream and ointment, applied topically, were found to be efficacious and well-tolerated in the treatment of psoriasis vulgaris. Calcipotriol ointment was used for the treatment of 686 patients with plaque-type psoriasis vulgaris participating in 5 clinical trials lasting from 6 to 8 weeks. The majority of patients had a marked improvement at the end of the treatment. Thickness, erythema and scaling were markedly improved. Only about 1% of the patients were withdrawn because of insufficient therapeutic response. It is characteristic that the improvement occurs rapidly. This data has been repeated in 3 long-term trials involving 334 patients with plaque-type psoriasis vulgaris treated for up to 12 months with calcipotriol ointment. Combination of topical calcipotriol with UVB phototherapy improved the therapeutic response, although to a statistically insignificant degree. Calcipotriol cream was used for the treatment of 159 patients with plaque type psoriasis vulgaris participating in a pivotal clinical trial lasting 8 weeks with efficacy similar to that of calcipotriol ointment.

The safety, efficacy and tolerability of calcipotriol ointment in children (ages 2 to 14 years) has been demonstrated by an 8-week open-label trial as well as an 8-week double-blind vehicle controlled trial. Calcipotriol was significantly more effective than vehicle in reducing the symptoms of redness, thickness and scaliness, and in the overall assessment of efficacy. No significant effects on hematology, serum and urine biochemistry parameters (including calcium levels) and parameters of bone formation or resorption were observed after 8 weeks of treatment (maximum dose 50 g/week/mbody surface area).

Three pivotal trials to evaluate the safety and efficacy of calcipotriol scalp solution in 284 patients with scalp psoriasis were conducted. There was a statistically significant improvement in the scalp psoriasis with a positive effect on total sign score, redness, thickness, scaliness and extent of scalp psoriasis.

Pharmacokinetics: A pharmacokinetic study of calcipotriol ointment has demonstrated that the apparent systemic absorption of the applied dose of calcipotriol over 12 hours is approximately 5.5% of the dose in normal subjects and in psoriatic patients.

Indications And Clinical Uses: Cream and Ointment: For the topical treatment of mild to moderate psoriasis.

Solution: For the topical treatment of scalp psoriasis.

Contra-Indications: Hypersensitivity to any constituent of calcipotriol cream, ointment or scalp solution. Not for ophthalmic use. tag_WarningWarnings

Manufacturers’ Warnings In Clinical States: Calcipotriol cream, ointment and scalp solution are not generally recommended for severe extensive psoriasis, in view of the risk of hypercalcemia secondary to excessive absorption of calcipotriol when there is extensive skin involvement. If calcipotriol is used for severe extensive psoriasis it is important to monitor the serum calcium levels at regular intervals. If the serum calcium level becomes elevated in such patients, calcipotriol therapy should be discontinued and the serum calcium level monitored in these patients until it returns to normal.

Topical calcipotriol is not recommended for use on the face since this may give rise to itching and erythema of the facial skin. Patients should be instructed to wash their hands after using calcipotriol to avoid inadvertent transfer to the face from other body parts. Should facial dermatitis develop in spite of these precautions, calcipotriol therapy should be discontinued (see Information for the Patient).

Pregnancy and Lactation: Safety for use during pregnancy has not yet been established, although studies in experimental animals have not shown teratogenic effects. It is not known whether calcipotriol could be excreted in breast milk. Calcipotriol should be used in women during pregnancy or breast-feeding only if the anticipated benefit clearly outweighs the potential risk.

Infants: There is inadequate experience with the use of calcipotriol in infants under 2 years of age to recommend use in this age group. Use beneath diapers has not been investigated and should be avoided as diapers may be occlusive.

Children: Administration to children should be supervised by a responsible individual to ensure proper administration and dosage.

Precautions: Calcipotriol should be used cautiously in skin folds, where the natural occlusion may give rise to an increase of the irritant effect of calcipotriol.

Treatment with calcipotriol in the recommended amounts (see Dosage) does not generally result in changes in laboratory values. However, it is recommended that base line serum calcium levels be obtained in all patients before starting treatment with calcipotriol, with subsequent monitoring of these serum calcium levels at suitable intervals. The monitoring of serum calcium levels is particularly important if the total dose of calcipotriol exceeds the recommended amount or if calcipotriol is used for severe psoriasis with extensive skin involvement. If the serum calcium becomes elevated, calcipotriol treatment should be discontinued, and the levels of serum calcium should be measured once weekly until the serum calcium levels return to normal values. Patients with marginally elevated serum calcium may be treated with calcipotriol, provided that the serum calcium is monitored at suitable intervals.

Drug Interactions: There is no experience of concomitant therapy with other antipsoriatic drugs applied to the same skin area.

Adverse Reactions: In clinical trials reported to-date, the most common adverse reactions have been related to lesional and perilesional irritation. Some patients develop face and scalp irritation which is likely related to the inadvertent transfer of calcipotriol cream or ointment from other body parts. Facial irritation may also occur with the use of calcipotriol scalp solution from inadvertent transfer of the scalp solution to the face. One unconfirmed case of Koebner phenomenon has been reported and 3 unconfirmed cases of hypersensitivity reaction to calcipotriol. Occasionally hypercalcemia has been reported usually related to excessive (greater than the recommended weekly amount – see Dosage) use of the topical calcipotriol or when excessive absorption of calcipotriol has occurred when used for severe psoriasis with extensive skin involvement (see Warnings).

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Hypercalcemia does not occur at the usual dose of calcipotriol (see Dosage). Excessive use, (i.e., more than the recommended weekly amount) may cause elevated serum calcium, which rapidly subsides when treatment is discontinued; in such cases the monitoring of serum calcium levels once weekly until the serum calcium returns to normal levels is recommended.

Dosage And Administration: Calcipotriol is available in an ointment or a cream formulation at a concentration of 50 g/g for use on the body and scalp solution at a concentration of 50 µg/mL for hairy areas. Calcipotriol is indicated for topical use only and not for ophthalmic use.

Adults: Calcipotriol should be applied topically to the affected area twice daily (i.e., in the morning and in the evening). Less frequent application may be indicated for maintenance treatment. After satisfactory improvement has occurred, the drug can be discontinued. If recurrence takes place after discontinuation, the treatment may be reinstituted.

The maximum weekly dose of calcipotriol cream and/or ointment for children is based on the adult dose of 100 g/week adjusted for body surface area (maximum 50 g/week/m. The dosage regimen is based on the following expected body surface area: 2 to 5 years: 0.5 m(25% of adult); 6 to 10 years: 1.0 m(50% of adult); 11 to 14 years: 1.5 m(75% of adult).

The maximum recommended adult weekly dose of calcipotriol scalp solution is 60 mL. There is no clinical trial experience with use of calcipotriol scalp solution in children. When cream, ointment or scalp solution are used together, the total dose of calcipotriol should not exceed the recommended weekly amount for each age group (i.e., 2 to 5 years: 1.25 mg; 6 to 10 years: 2.5 mg; 11 to 14 years: 3.75 mg; adults: 5 mg in any week).

Treatment with calcipotriol can be combined with UVB phototherapy. Treated patients are allowed to expose the skin to sunlight. In such cases, the calcipotriol should be applied after the exposure to UV light.

Availability And Storage: Cream: Each g of white cream contains: calcipotriol 50 g. Nonmedicinal ingredients: cetomacrogol 1 000, cetostearyl alcohol, chlorallylhexaminium chloride (dowicil 200), disodium edetate, disodium phosphate dihydrate, glycerol 85%, liquid paraffin, purified water and white soft paraffin. Lacquered aluminum tubes (equipped with an aluminum membrane) of 60 and 120 g. Store between 15 and 30°C.

Ointment: Each g of faintly translucent white to yellowish ointment contains: calcipotriol 50 g. Nonmedicinal ingredients: disodium edetate, disodium phosphate dihydrate, DL-tocopherol, liquid paraffin, polyoxyethylene-(2)-stearyl ether, propylene glycol, purified water and white soft paraffin. Lacquered aluminum tubes (equipped with an aluminum membrane) of 60 and 120 g. Store at room temperature between 15 and 25°C.

Scalp Solution: Each mL of colorless, slightly viscous solution contains: calcipotriol 50 g. Nonmedicinal ingredients: hydroxypropyl cellulose, isopropanol, levomenthol, propylene glycol, purified water and sodium citrate. Polyethylene bottles of 30 and 60 mL. Store below 25°C.

DOVONEX® Leo Calcipotriol Topical Nonsteroidal Antipsoriatic

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