Medication info
Aliderm Soft Capsule 10mg (Alitretinoin)

Aliderm Soft Capsule 10mg (Alitretinoin)

Prescription medicationSoft capsuleOral
Ingredient · strength
Alitretinoin›10mg / 1 capsule
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
A brown oval soft capsule containing a uniform yellow to yellowish-green liquid.
Packaging
30 capsules/box [10 capsules/PTPX3]
Approval status
Active

MFDS item code 201906967 · Approved 2019.09.30 · Insurance code 657806730

Summary

Main use
Treatment of chronic severe hand eczema in adults unresponsive to topical corticosteroid therapy
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
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic severe hand eczema in adults unresponsive to topical corticosteroid therapy

  • Chronic severe hand eczema
View approved original text

This medication is used to treat chronic severe hand eczema in adults that has not responded to potent topical steroids 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 medication must not be used in women who are pregnant or may become pregnant. There is a very high risk of causing serious birth defects in the fetus. A pregnancy test must be performed prior to taking this medication, and regular pregnancy tests should be conducted during treatment and after treatment has ended. During treatment, it is necessary to use two or more effective contraceptive methods, and if contraceptive failure occurs, consult a physician immediately. If triglyceride levels in the blood are very high, serious side effects such as acute pancreatitis may occur, so blood cholesterol and triglyceride levels should be monitored regularly. If any abnormal symptoms appear, discontinue use immediately and seek medical attention. Patients with a history of mental illness or symptoms of depression need to exercise caution when taking this medication. If changes in mood or depressive symptoms occur during treatment, consult a physician immediately. This medication can cause dryness of the skin and lips, so it is advisable to use moisturizers to protect the skin. Sensitivity to ultraviolet light is increased, so excessive sun exposure or phototherapy should be avoided, and it is recommended to use sunscreen when going outdoors. Wearing contact lenses may be difficult, so it is advisable to use glasses during the period of taking this medication. If symptoms such as headaches, dizziness, or visual disturbances occur, inform your physician immediately. Especially, if there are headaches accompanied by nausea, vomiting, or visual impairment, discontinue use immediately. This medication increases the risk of side effects when combined with other vitamin A preparations or tetracycline antibiotics, so they should not be taken together. Take this medication with food or immediately after a meal, and it is advisable to swallow it whole with sufficient water without chewing the tablet. This medication should be kept out of reach of children, stored in a cool place below 30 degrees Celsius, and shielded from direct sunlight. During treatment, avoid vigorous exercise, do not share this medication with others, and after discontinuation, refrain from donating blood for a certain period.

Side effects

  • Headache
  • erythema
  • flushing
  • increased triglycerides
  • increased cholesterol
  • decreased thyroid-stimulating hormone
  • decreased free T4
  • anemia
  • increased iron-binding capacity
  • decreased monocytes
Show 62 more
  • increased platelets
  • anaphylactic reaction
  • hypersensitivity reaction
  • depression
  • mood changes
  • suicidal ideation
  • dizziness
  • benign increased intracranial pressure
  • conjunctivitis
  • dry eyes
  • eye irritation
  • blurred vision
  • cataract
  • decreased night vision
  • tinnitus
  • hypertension
  • vasculitis
  • nosebleeds
  • nausea
  • dry mouth
  • vomiting
  • indigestion
  • inflammatory bowel disease
  • increased aminotransferases
  • dry skin and lips
  • cheilitis
  • eczema
  • dermatitis
  • hair loss
  • pruritus
  • rash
  • skin peeling
  • xerotic eczema
  • nail disorders
  • photosensitivity reaction
  • hair texture abnormalities
  • arthralgia
  • myalgia
  • exostosis
  • ankylosing spondylitis
  • fatigue
  • peripheral edema
  • hypertriglyceridemia
  • decreased HDL
  • hypercholesterolemia
  • increased serum creatine phosphokinase
  • diabetes mellitus
  • color blindness
  • contact lens intolerance
  • early epiphyseal closure
  • hyperostosis
  • calcification of ligaments and tendons
  • corneal opacification
  • keratitis
  • inflammatory bowel disease
  • skin allergic reactions
  • 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 medication may be sensitive to light, so it should be stored in a tightly sealed container that protects it from light. Additionally, it is important to store it at a temperature between 1 and 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A brown oval soft capsule containing a uniform yellow to yellowish-green liquid.

Package unit

30 capsules/box [10 capsules/PTPX3]

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.