Medication info
Unitok Soft Capsule 30mg (Alitretinoin)

Unitok Soft Capsule 30mg (Alitretinoin)

Prescription medicationSoft capsuleOral
Ingredient · strength
Alitretinoin›30mg / 1 capsule
Manufacturer / importer
Korea Union Pharmaceutical Co., Ltd.
Appearance
A dark reddish 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 201906880 · Approved 2019.09.27

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 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 to 10mg according to adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: The initial dose is 10mg; if necessary, it may be increased to 30mg according to tolerability and efficacy. Periodic monitoring of the blood lipid profile and blood glucose may be necessary during treatment with this medicine. Discontinue treatment as soon as the treatment goal of clear or almost clear hands is reached. 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 Union 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 to treat chronic severe hand eczema in adults that does not respond to potent topical steroid treatments for at least 4 weeks. Hand eczema is a chronic inflammatory skin disease that occurs on the hands, causing itching and skin damage. This drug helps reduce inflammation and improve symptoms, enhancing the quality of life for patients. Appropriate therapeutic effects can be expected according to expert evaluations. Therefore, it is effectively used for the treatment of chronic severe hand eczema.

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 to 10mg according to adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: The initial dose is 10mg; if necessary, it may be increased to 30mg according to tolerability and efficacy. Periodic monitoring of the blood lipid profile and blood glucose may be necessary during treatment with this medicine. Discontinue treatment as soon as the treatment goal of clear or almost clear hands is reached. 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, due to a very high risk of causing serious fetal malformations. Effective contraceptive measures must be taken during the treatment, before starting the medication, and for some time after stopping it. It is important to undergo regular pregnancy tests to confirm pregnancy status. If blood triglyceride levels are very high, acute pancreatitis can occur, so blood lipid levels should be checked periodically, and if abnormalities are found, the physician should be consulted immediately. This medication should be prescribed by a physician experienced in systemic retinoid therapy, and patients must fully understand the side effects and risks associated with this drug. Pregnant women, nursing mothers, patients with liver disorders, severe renal impairment, patients with uncontrolled thyroid function, and patients with hypervitaminosis A should not take this medication. Patients with a history of mental illness or those showing symptoms of depression need to be cautious during treatment and should have their mental state continuously monitored. If new psychiatric symptoms occur, they must inform the healthcare provider immediately. This medication increases sensitivity to ultraviolet light, so it is advisable to avoid sun exposure and use sunscreen. Dry eyes, visual disturbances, and skin dryness may occur; if symptoms are severe, consult a physician. The risk of side effects increases when this drug is taken with other vitamin A preparations or tetracycline antibiotics, so concomitant use should be avoided. The medication should be swallowed with water during or immediately after a meal, and should not be chewed or crushed. During the treatment, blood donation is prohibited and should not be done for a certain period afterward. Store in a cool place out of reach of children, away from direct sunlight, and do not use expired medications. In case of overdose, since there is no specific antidote, seek medical attention immediately for appropriate treatment and monitoring, and male patients should avoid sexual relations with women of childbearing potential or use condoms 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
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  • increased platelets
  • anaphylactic reaction
  • hypersensitivity reaction
  • depression
  • mood changes
  • suicidal thoughts
  • dizziness
  • benign intracranial hypertension
  • conjunctivitis
  • dry eyes
  • ocular irritation
  • blurred vision
  • cataracts
  • decreased night vision
  • tinnitus
  • flushing
  • 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
  • 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 opacity
  • keratitis
  • inflammatory bowel disease
  • skin allergy reaction
  • anaphylactic reaction
  • purpura
  • serious allergic vasculitis
  • polymorphic erythema
  • 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, so it should be stored in a tightly closed container that blocks light. Additionally, it is recommended to store the drug at room temperature between 1°C and 30°C. This storage condition helps maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

A dark reddish 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.

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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.