Presentation

Planex ointment: Each gram ointment contains Calcipotriol BP 0.05 mg.

Description

In humans, natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin. Calcipotriol is a synthetic analog of vitamin D3. Calcipotriol regulates skin cell production and development, thereby modifying the abnormal growth and production of keratinocytes, responsible for the plaque psoriasis.

Indications

Calcipotriol ointment is indicated for the treatment of plaque psoriasis in adults.

Dosage & Administration

A thin layer of Calcipotriol ointment once or twice daily and rub in gently and completely. The maximum recommanded weekly dose of Calcipotriol ointment is 100 gm/week.

Pediatric use: Safety and effectiveness of Calcipotriol ointment in pediatric patients have not been established.

Side Effects

The most frequent adverse experiences reported for Calcipotriol 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.

Precautions

Use of Calcipotriol ointment may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, Calcipotriol ointment should be discontinued.

Transient, rapidly reversible elevation of serum calcium has occurred with use of Calcipotriol ointment. If elevation in serum calcium outside the normal range occurs, discontinue treatment until normal calcium levels are restored.

Use in Pregnancy & Lactation

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Therefore, Calcipotriol 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 Calcipotriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriol ointment is administered to a nursing woman.

Over Dose

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

Storage

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

Commercial Pack

Planex ointment: Tube containing 10 gram of Calcipotriol ointment.