Medication info

Dermagel (Calcitriol Monohydrate, Betamethasone Dipropionate)

Prescription medicationApproval withdrawn
Ingredient · strength
Calcipotriol Monohydrate›52.2μg / 1gBetamethasone Dipropionate›0.643mg / 1g
Manufacturer / importer
이연제약(주)
Appearance
Colorless or whitish, nearly transparent gel
Packaging
60g/bottle
Approval status
Approval withdrawn

MFDS item code 201502614 · Approved 2015.04.30

This product's status changed to Approval withdrawn on 2024.01.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Local treatment of moderate to severe scalp psoriasis and plaque psoriasis
Who uses it
Adults · Children
Adult dosage
This medication is applied once daily to the affected area. It is recommended for use for 4 weeks on the scalp, and 8 weeks on areas outside the scalp. The daily dosage should not exceed 15 g and the maximum weekly dosage should not exceed 100 g in adults. The body surface area treated with calcitriol should not exceed 30%. For the scalp, a daily amount of between 1 g and 4 g is sufficient. (4 g corresponds to 1 teaspoon).
Children's dosage
The daily dosage should not exceed 15 g and the maximum weekly dosage should not exceed 60 g in adolescents.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Local treatment of moderate to severe scalp psoriasis and plaque psoriasis

  • Moderate to severe scalp psoriasis
  • plaque psoriasis outside the scalp
View approved original text

This medication is used for moderate to severe scalp psoriasis and plaque psoriasis outside the scalp in adolescents aged 12 years and older and adults. It is effective in improving psoriasis symptoms on the skin and helps alleviate inflammation and itching. Therefore, it is recommended to use it continuously for improving skin conditions.

Dosage and Administration

Adult dosage

This medication is applied once daily to the affected area. It is recommended for use for 4 weeks on the scalp, and 8 weeks on areas outside the scalp. The daily dosage should not exceed 15 g and the maximum weekly dosage should not exceed 100 g in adults. The body surface area treated with calcitriol should not exceed 30%. For the scalp, a daily amount of between 1 g and 4 g is sufficient. (4 g corresponds to 1 teaspoon).

Children's dosage

The daily dosage should not exceed 15 g and the maximum weekly dosage should not exceed 60 g in adolescents.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication or its components, patients with calcium metabolism issues, certain types of psoriasis patients, patients with severe kidney or liver diseases, children, and use on the face, around the eyes, or genital areas is prohibited. Additionally, it should not be used on skin infections caused by bacteria, fungi, viruses, or parasites, nor on wounds, ulcers, or burn areas, and caution is necessary in cases of perioral dermatitis, acne, or specific skin disorders. Women who are pregnant or breastfeeding, the elderly, and patients with liver dysfunction or diabetes should use this medication cautiously, as it may affect blood sugar levels. While using it, side effects such as skin irritation, itching, rash may occur, and rarely skin infections, allergic reactions, or eye irritation may occur. Caution is necessary as systemic side effects may occur with prolonged or excessive use over large areas. This medication must be used strictly according to the prescribed method and dosage and should not be applied to sensitive areas such as the face, around the eyes, mouth, or genital skin. After use, hands should be washed thoroughly, and if symptoms worsen or do not improve, usage should be stopped and consulted with a doctor. While using this medication, excessive exposure to natural light or artificial light should be avoided, and especially when combined with light therapy, medical guidance should be followed. In case of overdose, elevated blood calcium levels may occur, and there may be systemic adrenal suppression, so caution is advised. Pregnant or breastfeeding women should consult their physician before using this medication and are advised to use it for a short period on a small area of the skin whenever possible. Children are at a higher risk of systemic side effects compared to adults, and therefore its use is not recommended for children under 12 years old. Elderly patients are at a higher risk of adverse reactions, so particular caution is required for high doses or long-term use. It is advisable not to use this medication in conjunction with other corticosteroid preparations, and when combined with salicylic acid, its effectiveness may be decreased. The medication should be stored out of the reach of children and used within 6 months after opening, and it should not be stored in the refrigerator. Additionally, it must be protected from light during storage.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions, angioedema, facial swelling, sensitization symptoms (itching, redness, swelling, papules, vesicles, etc.), hypercalcemia (excessive calcium levels), severe edema, Cushing's syndrome, serious adrenal dysfunction, cataracts, glaucoma, central serous chorioretinopathy, exacerbation of secondary infections, severe skin adverse reactions (rash, blisters, skin peeling, mucosal pain), severe allergic reactions

Mild side effects

  • Itching
  • skin infections
  • folliculitis
  • eye irritation
  • worsening of psoriasis
  • dermatitis
  • erythema
  • rash
  • acne
  • burning sensation of the skin
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  • skin irritation
  • dry skin
  • skin peeling
  • pain at the application site
  • rebound effect
  • bumps
  • pain
  • fever
  • redness
  • allergic contact dermatitis
  • heat rash
  • wound worsening
  • pressure sores
  • pustulosis
  • decreased blood cortisol
  • decreased blood calcium
  • increased parathyroid hormone
  • decreased urinary calcium
  • headache
  • acneiform skin

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a container that does not allow light to penetrate. Additionally, it is recommended to store the medication in a cool room temperature, between 9 to 30 degrees Celsius, to maintain its efficacy.

Appearance and packaging

Appearance

Colorless or whitish, nearly transparent gel

Package unit

60g/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.