Medication info
Dermatox Soft Capsule 10mg (Alitretinoin)

Dermatox Soft Capsule 10mg (Alitretinoin)

Prescription medicationSoft capsuleOral
Ingredient · strength
Alitretinoin›10mg / 1 capsule
Manufacturer / importer
Korea Hutex Pharmaceutical Co., Ltd.
Appearance
Brownish black oval soft capsule containing a yellow to yellow-green uniform liquid
Packaging
30 capsules/box [(10 capsules/ptp*3)]
Approval status
Active

MFDS item code 201906968 · Approved 2019.09.30 · Insurance code 649104590

Summary

Main use
Treatment of chronic severe hand eczema in adults unresponsive to potent topical corticosteroids for 4 weeks or longer
Who takes it
Adults
Adult dose
Take 10~30mg once daily with a meal or immediately after a meal. It is preferable to take it at the same time each day. The initial dose is 30mg of alitretinoin; reduce the dose to 10mg according to adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: The initial dose is 10mg and may be increased to 30mg if necessary, depending on tolerability and efficacy. Periodic monitoring of the blood lipid profile and blood glucose may be needed during treatment with this medicine. Discontinue treatment as soon as the treatment goal of clear or almost clear hands is achieved. Discontinue treatment if hand eczema remains severe after the initial 12 weeks of treatment, and also discontinue if the treatment goal has not been achieved by 24 weeks of treatment.

Ingredients

Manufacturer
Korea Hutex Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic severe hand eczema in adults unresponsive to potent topical corticosteroids for 4 weeks or longer

  • Chronic severe hand eczema
View approved original text

This medication is used for the treatment of chronic severe hand eczema in adults that does not respond to strong topical steroid therapy for at least 4 weeks.

How to take

Adult dose

Take 10~30mg once daily with a meal or immediately after a meal. It is preferable to take it at the same time each day. The initial dose is 30mg of alitretinoin; reduce the dose to 10mg according to adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: The initial dose is 10mg and may be increased to 30mg if necessary, depending on tolerability and efficacy. Periodic monitoring of the blood lipid profile and blood glucose may be needed during treatment with this medicine. Discontinue treatment as soon as the treatment goal of clear or almost clear hands is achieved. Discontinue treatment if hand eczema remains severe after the initial 12 weeks of treatment, and also discontinue if the treatment goal has not been achieved by 24 weeks of treatment.

Precautions

This drug can cause severe birth defects and should never be taken by pregnant women or women who may become pregnant. Great caution is required if pregnancy occurs while taking the drug as it may pose significant risks to the fetus. Women of childbearing potential must use two or more effective methods of contraception before, during, and after treatment. A test to confirm pregnancy must be done before taking this medication, and monthly pregnancy tests should be conducted during treatment. Very high blood triglyceride levels can lead to serious side effects such as acute pancreatitis, so regular blood lipid level checks are necessary. Certain conditions such as liver impairment, severe kidney impairment, and uncontrolled hypothyroidism prohibit use of this drug. Patients with a history of mental illness require careful monitoring as psychiatric symptoms such as depression or mood changes may worsen. This drug may cause side effects like headaches, dry skin, chapped lips, increased triglycerides and cholesterol; any unusual symptoms should prompt consultation with a doctor. Avoid excessive sun exposure, use sunscreen, and refrain from vigorous exercise. If you experience dry eyes or changes in vision, appropriate measures should be taken and treatment may need to be discontinued if necessary. This drug may pose risks when taken with other vitamin A preparations or certain antibiotics, so it's crucial to inform the doctor of all medications being taken. Follow the doctor's and pharmacist's guidance strictly in accordance with the pregnancy prevention program, and maintain pregnancy prevention measures for a period after treatment ends. This medication is restricted for use in children and should not be taken by breastfeeding women. It should be taken with food or immediately after a meal, and should not be chewed. Store this medication in its original container in a cool place away from direct sunlight, and do not take expired medication.

Side effects

  • Headache
  • erythema
  • flushing
  • increased triglycerides
  • increased cholesterol
  • decreased thyroid-stimulating hormone
  • decreased free T4
  • anemia
  • increased iron-binding capacity
  • decreased monocytes
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  • increased platelets
  • anaphylactic reaction
  • hypersensitivity reaction
  • depression
  • mood changes
  • suicidal thoughts
  • dizziness
  • benign intracranial hypertension
  • conjunctivitis
  • dry eyes
  • eye irritation
  • blurred vision
  • cataracts
  • decreased night vision
  • tinnitus
  • hypertension
  • vasculitis
  • nosebleeds
  • nausea
  • dry mouth
  • vomiting
  • dyspepsia
  • inflammatory bowel disease
  • increased aminotransferases
  • dry skin and lips
  • cheilitis
  • eczema
  • dermatitis
  • hair loss
  • itching
  • rash
  • skin peeling
  • dry eczema
  • nail disorders
  • photosensitivity reaction
  • abnormal hair texture
  • arthralgia
  • myalgia
  • osteomalacia
  • ankylosing spondylitis
  • fatigue
  • peripheral edema
  • hypertriglyceridemia
  • decreased HDL
  • hypercholesterolemia
  • increased serum creatine phosphokinase
  • diabetes mellitus
  • color blindness
  • intolerance to contact lenses
  • premature epiphyseal closure
  • hyperostosis
  • calcification of ligaments and tendons
  • corneal opacity
  • keratitis
  • inflammatory bowel disease
  • skin allergic reaction
  • anaphylactic reaction
  • purpura
  • severe allergic vasculitis
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis

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

Storage

This drug is sensitive to light and should be stored in a container that blocks light. It is also important to store it in a well-sealed container that prevents air exposure. The storage temperature should be maintained between 1 to 30 degrees Celsius, avoiding excessively hot or cold environments.

Appearance and packaging

Appearance

Brownish black oval soft capsule containing a yellow to yellow-green uniform liquid

Package unit

30 capsules/box [(10 capsules/ptp*3)]

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.