Active substanceCalcipotriolCalcipotriol
Dosage form: & nbspointment for external use
Composition:

In 100 g of ointment contains:

Active ingredient: calcipotriol (anhydrous) 0.005 g;

auxiliary components: sodium hydrogen phosphate dihydrate 0.026 g, disodium edetate 0.0065 g, paraffin liquid 5.0 g, water purified 2.60 g, propylene glycol 10.0 g, alpha-tocopherol 0.002 g, macrogol stearate 5.0 g, paraffin soft white 77,3605

Description:

Homogeneous ointment of white color.

Pharmacotherapeutic group:Psoriasis treatment
ATX: & nbsp

D.05.A.X.02   Calcipotriol

D.05.A.X   Other preparations for the treatment of psoriasis for external use

Pharmacodynamics:

Calcipotriol is an analogue of the active metabolite of natural vitamin D3. Causes a dose-dependent inhibition of the proliferation of keratinocytes and accelerates their morphological differentiation. Has an insignificant effect on the exchange of Ca2+ in the body (according to experimental data, 100-200 times less compared with calcitriol). The effect develops within 1-3 weeks.

Pharmacokinetics:

When ointment is applied to the systemic blood flow, up to 6% (± 3%) of the dose administered is administered to patients with psoriasis. From the surface of intact skin absorbed no more than 5% (± 2,6%). The affinity of calcipotriene for plasma proteins in vitro 30 times less than calcitriol. Metabolized in the liver with the formation of two inactive metabolites. It is inactivated within 24 hours. With urine and feces, less than 1% is output.

Indications:

Psoriasis vulgar (including the scalp) in a stationary and regressing stage.

Contraindications:
  • Hypersensitivity to calcipotriol and / or other components of the drug;
  • Psoriasis of the scalp in the acute stage;
  • Pregnancy;
  • Lactation period.
Carefully:

Hypercalcemia, hypercalciuria (including predisposition), vitamin hypervitaminosis-D, nephrourolythiasis in the anamnesis, elderly age (over 65 years).

Pregnancy and lactation:

Contraindicated in the use.

Dosing and Administration:

Adults

Apply a thin layer on the affected skin 2 times a day. The maximum daily dose should not exceed 15 g, and the maximum dose per week is not more than 100 g.

Therapeutic effect is usually observed after 1-2 weeks from the beginning of treatment. The duration of treatment is no more than 6-8 weeks.

Children

At the age of over 12 years: apply a thin layer on the affected skin areas 2 times a day, the maximum dose per week should not exceed 75 g.

At the age of 6 to 12 years: apply a thin layer on the affected skin 2 times a day. The maximum dose for a week is not more than 50 g.

Side effects:

Dermatitis (skin itching, swelling and skin flushing), skin rash, transient burning, skin irritation, itching, dryness and flaky skin, erythema, exacerbation of psoriasis (including on the face and scalp), skin atrophy, folliculitis , hyperpigmentation, systemic effects (usually asymptomatic, passing on their own).

Overdose:

Symptoms (more than 100 g of ointment): hypercalcemia, abdominal pain, constipation, depression, unusual fatigue, increased blood pressure, loss of appetite, weight loss, thirst, nausea, vomiting, hypercalciuria.

Treatment: stopping the use of the drug, the appointment of intensive hydration (oral and parenteral) of the organism and forced diuresis (against furosemide to increase the rate of excretion), potassium chloride (to prevent hypokalemia), glucocorticosteroids, hemodialysis (in renal failure); monitoring of electrolytes, monitoring diurnal diuresis.

Interaction:It is not recommended to apply simultaneously with salicylic acid and preparations containing it.
Special instructions:

If it becomes necessary to use on extensive skin surfaces or with severe chronic psoriasis, careful concentration of calcium ions in blood and urine is required (due to increased absorption and increased risk of hypercalcemia). After applying to the area of ​​lesions, you should thoroughly wash your hands to avoid getting the drug on your face, mucous membranes or healthy skin areas. Before treatment and regularly during therapy, it is recommended to monitor the concentration of calcium ions in the blood. With continued long-term use of large doses, the risk of developing hypercalcemia and focal calcifications in the kidneys can not be completely ruled out.

Form release / dosage:Ointment for external use 0,005%.
Packaging:

For 30 g or 60 g in aluminum tubes, latex painted, with a polypropylene lid. One tube together with the instruction for use is placed in a cardboard pack.

Storage conditions:

Store at temperatures between 2 ° C and 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:LP-000974
Date of registration:18.10.2011
Expiration Date:18.10.2016
The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India
Manufacturer: & nbsp
Representation: & nbspGLENMARK PHARMACEUTICALS LTD. GLENMARK PHARMACEUTICALS LTD. India
Information update date: & nbsp26.04.2017
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