Psoritop

Uses

Psoritop ointment is used for the treatment of plaque psoriasis in adults.

Psoritop is also used to associated treatment for these conditions: Plaque psoriasis of the scalp, Psoriasis Vulgaris (Plaque Psoriasis)

How Psoritop works

The precise mechanism of calcipotriol in remitting psoriasis is not well-understood, however, it has been shown to have comparable affinity with calcitriol for the Vitamin D receptor while being less than 1% the activity in regulating calcium metabolism. The Vitamin D receptor (VDR) belongs to the steroid/thyroid receptor superfamily, and is found on the cells of many different tissues including the thyroid, bone, kindney, and T cells of the immune system. T cells are known to play a role in psoriasis and are believed to undergo modulation of gene expression with binding of calcipotriol to the VDR. This modulation is thought to affect gene products related to cell differentiation and proliferation.

Dosage

Psoritop dosage

A thin layer of Psoritop ointment once or twice daily and rub in gently and completely. The maximum recommanded weekly dose of Psoritop ointment is 100 gm/week.Pediatric use: Safety and effectiveness of Psoritop ointment in pediatric patients have not been established.

Side Effects

The most frequent adverse experiences reported for Psoritop ointment were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis.

Toxicity

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of calcipotriene.

Precaution

Use of Psoritop ointment may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, Psoritop ointment should be discontinued.Transient, rapidly reversible elevation of serum calcium has occurred with use of Psoritop ointment. If elevation in serum calcium outside the normal range occurs, discontinue treatment until normal calcium levels are restored.

Food Interaction

Elimination Route

Clinical studies with radiolabeled ointment indicate that approximately 6% (+3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques or 5% (+2.6%, SO) when applied to normal skin.

Elimination Route

The active form of the vitamin, 1,25-dihydroxy vitamin D3 (calcitriol), is known to be recycled via the liver and excreted in the bile. There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk.

Pregnancy & Breastfeeding use

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Therefore, Psoritop ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Psoritop is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Psoritop ointment is administered to a nursing woman.

Contraindication

Psoritop cream & ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. It is also contraindicated in patients with known disorders of calcium metabolism.

Acute Overdose

Topically applied Psoritop can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical Psoritop. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored.

Storage Condition

Store at 15 °C -25 °C (59 °F -77 °F). Do not freeze.

Innovators Monograph

You find simplified version here Psoritop