Medication info
Dermatox Soft Capsule 30mg (Alitretinoin)

Dermatox Soft Capsule 30mg (Alitretinoin)

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

MFDS item code 201906960 · Approved 2019.09.30 · Insurance code 649104580

Summary

Main use
Treatment of chronic severe hand eczema in adults that does not respond to potent topical corticosteroids
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
HanKook HyuTex Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic severe hand eczema in adults that does not respond to potent topical corticosteroids

  • Chronic severe hand dermatitis
View approved original text

This medicine is used to improve chronic severe hand dermatitis in adults that does not respond to at least 4 weeks of potent topical steroid treatment.

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 medication should not be used by women who are pregnant or may become pregnant, as it can cause severe birth defects. Effective contraception must be ensured during treatment, before starting treatment, and for a certain period after discontinuation. It is recommended to use two or more contraceptive methods. Pregnancy tests must be performed regularly before and during treatment, and the drug can only be taken after confirming a negative test result. This medicine can increase blood triglyceride levels, so cholesterol and triglyceride levels should be periodically monitored through blood tests. If triglyceride levels are too high or symptoms of pancreatitis develop, the drug must be discontinued immediately. This medication can affect mental health, so patients with depression or mood changes should be cautious, and their mental state should be continuously monitored during treatment. Avoid excessive sun exposure, use sunscreen if necessary, and refrain from vigorous exercise. Because dry eyes or vision problems may occur, if there are symptoms of dry eyes, use artificial tears, and if there are any changes in vision, consult a doctor immediately. This medication may interact with certain drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. It should not be administered to specific patient groups such as pregnant or nursing women, patients with liver dysfunction, severe kidney dysfunction, or uncontrolled hypothyroidism. This medication should be taken with food or immediately after eating, and the capsules should be swallowed whole with water, not chewed. Store this medication out of reach of children, in a cool place below 30 degrees Celsius, avoiding direct sunlight. Additionally, it should be kept tightly closed in its original container.

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 ideation
  • dizziness
  • benign intracranial hypertension
  • conjunctivitis
  • dry eyes
  • eye irritation
  • blurred vision
  • cataract
  • 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
  • xerotic eczema
  • nail disorders
  • phototoxic reactions
  • hair texture abnormalities
  • arthralgia
  • myalgia
  • osteitis
  • ankylosing spondylitis
  • fatigue
  • peripheral edema
  • hypertriglyceridemia
  • decreased HDL
  • hypercholesterolemia
  • increased serum creatine phosphokinase
  • diabetes
  • color blindness
  • intolerance to contact lenses
  • premature epiphyseal closure
  • hyperostosis
  • calcification of ligaments and tendons
  • corneal opacification
  • keratitis
  • inflammatory bowel disease
  • skin allergic reactions
  • 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 medication should be stored in a special container to prevent exposure to light and air, and at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its efficacy and safety.

Appearance and packaging

Appearance

Brownish red oval soft capsules containing a uniform yellow to yellow-green 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.

Questions about this medicine

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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.