Medication info
Aliderm Soft Capsule 30mg (Alitretinoin)

Aliderm Soft Capsule 30mg (Alitretinoin)

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

MFDS item code 201906947 · Approved 2019.09.30 · Insurance code 657806720

Summary

Main use
Treatment of chronic severe hand eczema in adults that does not respond to topical corticosteroids
Who takes it
Adults
Adult dose
Take 10~30mg once daily with 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 depending on adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: Start with an initial dose of 10mg and, if necessary, increase to 30mg depending on tolerability and effect. Periodic monitoring of blood lipid profile and blood glucose may be required during treatment with this medicine. Stop treatment as soon as the treatment goal of clear or almost clear hands is achieved. If hand eczema remains severe after the initial 12 weeks of treatment, discontinue treatment. Also discontinue treatment if the treatment goal has not been achieved by week 24.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Chronic severe hand eczema
View approved original text

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

How to take

Adult dose

Take 10~30mg once daily with 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 depending on adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: Start with an initial dose of 10mg and, if necessary, increase to 30mg depending on tolerability and effect. Periodic monitoring of blood lipid profile and blood glucose may be required during treatment with this medicine. Stop treatment as soon as the treatment goal of clear or almost clear hands is achieved. If hand eczema remains severe after the initial 12 weeks of treatment, discontinue treatment. Also discontinue treatment if the treatment goal has not been achieved by week 24.

Precautions

This medication should never be taken by women who are pregnant or may become pregnant, as it can cause serious birth defects. Pregnancy tests must be conducted before and during treatment, and effective contraception methods must be consistently used. Regular pregnancy tests should be conducted before, during, and after treatment. Severe adverse effects such as acute pancreatitis may occur if blood triglyceride levels are very high, hence blood lipid levels should be checked regularly, and discontinuation should occur if issues arise. Patients with mental health issues or a history of depression should be cautious while taking this medication, and mental status should be frequently monitored, receiving appropriate treatment if necessary. This medication should not be administered to patients with liver dysfunction, severe kidney dysfunction, hypothyroidism, hypervitaminosis A, and specific allergies. Sensitivity to UV light increases during treatment, so it is recommended to avoid excessive sun exposure and use sunscreen. It is advised to avoid vigorous physical activity, and the use of artificial tears or lubricating eye ointment may help with dryness of the eyes. If there are any changes in vision during the course of taking this medication, the doctor must be notified immediately, especially as decreased night vision may occur, necessitating caution when driving or operating machinery. This medication should not be shared with others, and any remaining medication after discontinuation should be returned to the pharmacist. Additionally, during treatment, blood cholesterol and triglyceride levels should be periodically checked for any abnormalities. In case of overdose, severe headache, diarrhea, facial flushing, and increased triglycerides may occur, so immediate consultation with healthcare providers is required if these symptoms arise. This medication should be taken with a meal or right after a meal, without chewing, and swallowed with water. Finally, this medication must be stored in a cool place out of reach of children, avoiding direct sunlight, and medications past their expiration date should not be taken.

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
  • pruritus
  • rash
  • skin peeling
  • dry eczema
  • nail disorders
  • photosensitivity reactions
  • 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
  • premature epiphyseal closure
  • hyperostosis
  • calcification of ligaments and tendons
  • corneal opacity
  • keratitis
  • inflammatory bowel disease
  • skin allergic reactions
  • anaphylactic reaction
  • purpura
  • 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 tightly sealed container that protects it from light, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's effectiveness for a prolonged period.

Appearance and packaging

Appearance

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

Package unit

30 capsules/box [10 capsules/PTP x 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.