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Calcitrene
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Ointment
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Dosage (Posology) and method of administration
| Adults: | Calcitrene®* Ointment should be applied to the affected area once or twice daily. For maximum benefit use the ointment twice daily. Maximum weekly dose should not exceed 100 g. |
| Children over 12 years: | Calcitrene®* Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75 g. |
| Children aged 6 to 12 years: | Calcitrene®* Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50 g. |
Children under 6 years: | There is limited experience of the use of Calcitrene®* Ointment in this age group. A maximum safe dose has not been established. |
These dose recommendations are based on extensive experience in adults. In respect of children, clinical experience in children has shown Calcitrene®* to be safe and effective over eight weeks at a mean dose of 15 g per week but with wide variability in dose among patients. Individual dose requirement depends on the extent of psoriasis but should not exceed the above recommendations. There is no experience of use of Calcitrene®* in combination with other therapies in children.
Undesirable effects
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reactions during treatment are pruritus, skin irritation and erythema.
Systemic reactions (hypercalcaemia and hypercalciuria) have been reported. The risk of developing such reactions increases if the recommended total dose is exceeded.
Adverse reactions are listed by MedDRA SOC and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
| Very common Common Uncommon Rare Very rare | >1/10 >1/100 to <1/10 >1/1,000 to <1/100 >1/10,000 to <1/1,000 <1/10,000 |
Approximately 25% of the patients treated with Calcitrene®* Ointment could experience an adverse reaction. These reactions are usually mild.
| Infections and infestations | |
| Uncommon (>1/1,000 to <1/100) | Folliculitis |
| Immune system disorders | |
| Rare (>1/10,000 to <1/1,000) | Hypersensitivity |
| Metabolism and nutrition disorders | |
| Rare (>1/10,000 to <1/1,000) | Hypercalcaemia |
| Skin and subcutaneous tissue disorders | |
| Common (>1/100 to < 1/10) | Psoriasis aggravated Dermatitis Erythema Skin exfoliation Skin burning sensation Skin irritation Pruritus |
| Uncommon (>1/1,000 to <1/100) | Rash* Dry skin |
| Rare (>1/10,000 to <1/1,000) | Photosensitivity reaction Skin oedema Urticaria Seborrhoeic dermatitis |
| Renal and urinary disorders | |
| Rare (>1/10,000 to <1/1,000) | Hypercalciuria |
| General disorders and administration site conditions | |
| Common (>1/100 to <1/10) | Application site pain |
| Uncommon (>1/1,000 to <1/100) | Application site pigmentation changes |
* Various types of rash reactions such as rash erythematous, rash maculo-papular, rash morbilliform, rash papular and rash pustular have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.Overdose
Use above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcemia include polyuria, constipation, muscle weakness, confusion and coma.
Name of the medicinal product
Qualitative and quantitative composition
Pharmaceutical form
Therapeutic indications
Calcitrene®* Ointment is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris) amenable to topical therapy.
Contraindications
Due to the content of calcipotriol, Calcitrene®* is contraindicated in patients with known disorders of calcium metabolism.
Special warnings and precautions for use
Effects on calcium metabolism
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum weekly dose is exceeded. Care should be exercised in patients with other types of psoriasis, since hypercalcaemia has been reported in patients with generalised pustular or erythrodermic exfoliative psoriasis. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the dosage recommendations are followed. The maximum weekly dose in adults is 100 g of cream or ointment (equivalent to 5 mg of calcipotriol) or 60 ml of scalp solution (equivalent to 3 mg of calcipotriol). When cream, ointment or cutaneous solution are applied together, the total dose of calcipotriol should not exceed 5 mg per week.
Local adverse reactions
Calcitrene®* should not be applied to the face, as it may cause skin irritation
The patient must be instructed in correct use of the product to avoid accidental transfer to the face and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
UV exposure
During Calcitrene®* Ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Calcitrene®* should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks.
Unevaluated use
Due to lack of data, Calcitrene®* should be avoided in guttate, erythrodermic, exfoliative and pustular psoriasis.
Due to lack of data, Calcitrene®* should be avoided in patients with severe liver and kidney disease.
Adverse reactions to excipients
Calcitrene®* ointment contains propylene glycol as an excipient which may cause skin irritation.
Effects on ability to drive and use machines
Calcipotriol has no or negligible influence on the ability to drive and to use machines.
Pharmacodynamic properties
ATC Code: D05A X02
Pharmacotherapeutic group: Antipsoriatics for topical use
Calcipotriol is a vitamin D derivative. In vitro data suggest that calcipotriol induces differentiation and suppresses proliferation of keratinocytes. This is the proposed basis for its effect in psoriasis.
Pharmacokinetic properties
Data from a single study containing 5 evaluable patients with psoriasis treated with 0.3-1.7 g of a 50 micrograms/g tritium labelled calcipotriol ointment suggested that less than 1% of the dose was absorbed.
However, total recovery of the tritium label over a 96 hour period ranged from 6.7 to only 32.6%, figures maximised by uncorrected chemiluminescence. There were no data on 3H tissue distribution or excretion from the lungs.
Pharmacotherapeutic group
Incompatibilities
Should not be mixed with other medicinal products.
Special precautions for disposal and other handling
No special requirements.
Attention! Always consult to a doctor or pharmacist before using pills or medicines.
Medically reviewed by . Last updated on 5/22/2025
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