Medication info

Ostok Soft Capsule 30 mg (Alitretinoin)

Prescription medicationSoft capsuleOralApproval withdrawn
Ingredient · strength
Alitretinoin›30mg / 1 capsule
Manufacturer / importer
Os Korea Pharmaceuticals Co., Ltd.
Appearance
Brown-red oval soft capsules containing a uniform yellow to yellow-green liquid
Packaging
30 capsules/box [10 capsules/PTP X 3]
Approval status
Approval withdrawn

MFDS item code 201906879 · Approved 2019.09.27

This product's status changed to Approval withdrawn on 2025.01.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic severe hand eczema in adults unresponsive 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 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
Os Korea Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of chronic severe hand eczema in adults unresponsive 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 treatment.

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 by women who are pregnant or may become pregnant due to the very high risk of causing serious birth defects. Women of childbearing potential must undergo pregnancy testing before, during, and after treatment and must use two effective forms of contraception. If a pregnancy occurs during treatment, immediate consultation with a physician is required. Severe elevations in triglyceride levels can lead to serious side effects like acute pancreatitis; therefore, regular blood tests to check lipid levels are necessary. If lipid levels are not controlled, the use of this medication should be discontinued. It is recommended that this medication be prescribed by a specialist experienced in systemic retinoid therapy. Patients with severely decreased liver or kidney function, uncontrolled hypothyroidism, hypervitaminosis A, and those allergic to this medication or similar components should not use it. Patients with a history of mental illness or symptoms of depression must be closely monitored for their mental health status while taking this medication; if symptoms worsen, treatment should be immediately discontinued, and a physician should be consulted. While taking this medication, excessive sun exposure or the use of UV lamps should be avoided, and sunscreen should be used if necessary. Additionally, it is advisable to refrain from vigorous exercise. Dry eyes or changes in vision may occur; therefore, if dryness of the eyes develops, supplementary treatment with artificial tears may help, and any visual disturbances should be reported to a physician immediately. This medication should not be shared with others, and any leftover medication after treatment should be returned to a pharmacist. Moreover, patients who are taking or have discontinued this medication within the last month should not donate blood. Care should be taken concerning drug interactions, especially not to use it with vitamin A or other retinoid preparations, or tetracycline antibiotics. Patients taking other medications must inform their physician or pharmacist. When taking this medication, it must be swallowed with water, with or immediately after meals, and care should be taken not to chew the capsules. Store this medication at room temperature between 1 to 30 degrees Celsius, in a place that is protected from light, and in a safe location out of the reach of children.

Side effects

  • Headache
  • erythema
  • flushing
  • increased triglycerides
  • increased cholesterol
  • decreased thyroxine-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 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 aminotransferases
  • dry skin and lips
  • cheilitis
  • eczema
  • dermatitis
  • hair loss
  • pruritus
  • rash
  • skin peeling
  • dry eczema
  • nail disorders
  • photosensitivity reaction
  • hair shaft abnormalities
  • arthralgia
  • myalgia
  • osteitis
  • 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 reaction
  • 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 is sensitive to light and should be stored in a specific container that does not allow light exposure. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius to maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Brown-red oval soft capsules 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.