COMPOSITION:

active substance: calcitriol (1.25- dihydroxycholecalciferol);

1 g of ointment contains 3 µg of calcitriol;

excipients:

white soft paraffin, propylene glycol, mineral oil light, alpha-Tocopherol.

INDICATIONS:

Plaque psoriasis of mild to moderate severity (local treatment of skin manifestations).

DOSAGE:

For external use only. Apply thin layer of the ointment to the affected areas of skin 2 times a day (in the morning and in the evening). Daily application of the ointment should not exceed 35% of the skin surface. Do not apply more than 30 g of ointment per day. The average duration of treatment is 6 weeks. On the recommendation of the physician a long-term treatment is possible.

ADVERSE REACTIONS:

Usually the drug is well tolerated. Some patients may develop side effects, which are usually localized at the application site and are characterized by mild to moderate flow, they disappear on their own. In case of severe irritation at the ointment application site or allergic reactions, contact dermatitis, the patient should consult a doctor and, if necessary, stop the treatment.

Skin and its appendages:

itching, discomfort, burning, skin irritation (can be expressed in the form of pustules, papules or vesicles), erythema (redness), dry skin, psoriasis (worsening), swelling of the skin, contact dermatitis. Dermatitis may occur on the face, particularly around the mouth, which usually resolves after discontinuation of the drug administration.

Metabolism:

hypercalcaemia.

Kidneys and the urinary system:

hypercalciuria, urolithiasis.

Drug interactions:

Synchronous usage of calcitriol with betamethasone has shown higher efficacy of this combination for local treatment of psoriasis, than separate usage of these drugs.

Prescription of Phorcal® ointment in combination with UV irradiation has a faster therapeutic effect.

Thiazide diuretics increase the risk of hypercalcaemia.

Caution should be exercised when using Phorcal® ointment synchronously with oral active metabolites of vitamin D (calcitriol, alfacalcidol), high doses of vitamin D and preparations of calcium because of possible potential action and increasing of risk of development of hypercalcaemia.

It is not recommended to apply Phorcal® ointment synchronously with salicylic acid and preparations containing salicylic acid.

As calcitriol ointment may cause light irritation, its synchronous use with peeling agents, astringent or irritating substances may increase the irritating effect.

Pregnancy and lactation:

It is not recommended to administer the drug during pregnancy due to the lack of sufficient data regarding the drug application in pregnant women.

There is no information if calcitriol is excreted into breast milk, so if it is necessary to use the Phorcal® ointment during lactation, one should decide on termination of breast-feeding.

Children:

Because of the absence of data regarding the application of calcitriol ointment to children, the drug is contraindicated in this age group of patients.

PRECAUTIONS:

Application on the face increases the risk of skin irritation. Avoid getting ointment into the eyes. After applying the ointment on the affected area, wash your hands. In case of accidental contact of the ointment with mucous membrane of the eyes, mouth or nose, wash it thoroughly with warm water.

Daily application of the ointment should not exceed 35% of the skin surface. Do not apply more than 30 g of ointment per day, as a certain amount of calcitriol penetrates through the skin, and excessive use of the ointment can cause systemic side effects associated with hypercalcaemia.

Do not add the substances that enhance the ointment penetration, or apply bandage on the skin coated with the drug.

In case of severe irritation at the application site or allergic reactions, patient should consult a doctor and if necessary stop treatment.

At long-term administration one should periodically monitor the level of calcium in the blood serum, because the systemic effect of the drug can occur.

The data obtained in animal tests have shown that the use of calcitriol ointment enhances the sensitivity of the skin to ultraviolet radiation (UVR). Therefore, patients who use the ointment Phorcal® should avoid excessive action of the sunlight (both natural and artificial) on the affected skin. Furthermore, we recommend to limit the use of phototherapy in patients receiving treatment with Phorcal® ointment.

There is no information on the use of calcitriol with other clinical implications of psoriasis (another than plaque psoriasis), including acute psoriasis guttata, pustular psoriasis, erythrodermic psoriasis, progressive plaque psoriasis.

Ability to influence reaction velocity while driving or operating any other mechanisms.

No effect.

Overdose:

In the local application at the recommended doses the drug overdose is unlikely, but long-term treatment and excessive application of ointment (over 100 g per week) may cause hypercalcaemia and hypercalciuria. In the case of hypercalcaemia and hypercalciuria it is necessary to stop drug administration until the calcium levels in serum and urine come back to normal. In case of accidental ingestion, anorexia, nausea, vomiting, constipation, hypotension, depression, sometimes drowsiness and coma may occur.

Treatment:

symptomatic therapy.

CONTRAINDICATIONS:

Hypersensitivity to the components of the drug. Hypercalcaemia and other pathological conditions characterized by calcium dysmetabolism; systemic therapy of calcium homeostasis, liver and kidney dysfunction.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics. Calcitriol acts on specific receptors of epidermal keratinocytes. This leads to normalization of mitosis rate in epithelial cells, slows down the process of proliferation in them and accelerates morphological differentiation of non-keratinizing epithelium. It reduces the adhesion and accelerates desquamation of keratinized cells. It inhibits the activity of interleukine-1, decreases the production of interleukine-2. It has antiproliferative effect on T-lymphocytes. Thus, calcitriol has effect on pathogenetic mechanisms of psoriasis.

Pharmacokinetics. When applying locally, the absorption of calcitriol is about 1%. Small amount of absorbed calcitriol is subject to rapid biotransformation in the liver with the formation of inactive metabolites excreted by the kidneys and the intestine.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties:

white or almost white uniform ointment.

Shelf-life:

3 years.

Storage:

Store in a dry, protected from light place at a temperature not more than 25° C.

Keep it out of reach of children.

Package:

30 g, 100 g in tubes, 1 tube in a carton box.

Conditions of supply:

By prescription.