Medication info
Alison Soft Capsules 10mg (Alitretinoin)

Alison Soft Capsules 10mg (Alitretinoin)

Prescription medicationSoft capsuleOral
Ingredient · strength
Alitretinoin›10mg / 1 capsule
Manufacturer / importer
Kolon Pharmaceutical Co., Ltd.
Appearance
Brown 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 201906965 · Approved 2019.09.30 · Insurance code 670304370

Summary

Main use
Treatment of chronic severe hand eczema in adults unresponsive 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
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic severe hand eczema in adults unresponsive to potent topical corticosteroids

  • 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 treatment for at least 4 weeks. Chronic severe hand eczema is a skin condition characterized by severe inflammation and itching on the hands, often unresponsive to existing treatments. This drug effectively controls inflammation to alleviate symptoms and improve skin condition. In particular, disease severity can be assessed based on the PGA evaluation criteria, thus allowing for the expectation of appropriate therapeutic effects. Therefore, this medication is a suitable option for patients with chronic hand eczema for whom rapid and sustained treatment is difficult.

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 by women who are pregnant or may become pregnant. It can cause serious fetal malformations, so pregnancy status must be verified before and during treatment, and effective methods of contraception must be used concurrently. Women who may become pregnant must avoid pregnancy during the use of this drug and for at least 1 month after treatment ends. If blood triglyceride levels are very high, there is a risk of acute pancreatitis, so regular tests for cholesterol and triglyceride levels are necessary, and dosing should be stopped if abnormalities are found. This drug should be prescribed by physicians experienced with systemic retinoid treatment, and patients with a history of mental illness should be closely monitored for depression or mood changes. This medication can cause dryness of the skin and lips, so moisturizers should be used, and excessive sun exposure should be avoided. If symptoms of dry eyes or changes in vision occur, consult a physician immediately. There is a risk of impaired night vision when driving or operating machinery, so caution is advised. Due to interactions with other drugs, inform your doctor or pharmacist of any medications you are taking. This medication should be taken with water with meals or immediately after meals and should not be chewed. Store in a cool place out of reach of children, avoiding direct sunlight. All related guidelines in accordance with the pregnancy prevention program must be adhered to by the doctor, pharmacist, and patient, and the medication must not be shared with others.

Side effects

  • Headache
  • erythema
  • flushing
  • increased triglycerides
  • elevated 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
  • cataracts
  • decreased night vision
  • tinnitus
  • hypertension
  • vasculitis
  • nosebleeds
  • nausea
  • dry mouth
  • vomiting
  • dyspepsia
  • inflammatory bowel disease
  • increased amino transferase
  • dry skin and lips
  • cheilitis
  • eczema
  • dermatitis
  • hair loss
  • pruritus
  • rash
  • skin peeling
  • dry eczema
  • nail disorders
  • phototoxic reactions
  • hair texture abnormalities
  • arthralgia
  • myalgia
  • exostosis
  • ankylosing spondylitis
  • fatigue
  • peripheral edema
  • hypertriglyceridemia
  • decreased HDL
  • hypercholesterolemia
  • increased serum creatine phosphokinase
  • diabetes
  • color blindness
  • contact lens intolerance
  • premature epiphyseal closure
  • hyperostosis
  • calcification of ligaments and tendons
  • corneal opacity
  • keratitis
  • inflammatory bowel disease
  • skin allergic reactions
  • anaphylactic reactions
  • purpura
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis

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

Storage

This medication is sensitive to light and should be stored in an opaque, tightly sealed container. It is also important to store it at room temperature, between 1 and 30 degrees Celsius, to prevent damage.

Appearance and packaging

Appearance

Brown 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.

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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.