Medication info

Ostock Soft Capsule 10 mg (Alitretinoin)

Prescription medicationSoft capsuleOralApproval withdrawn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Approval withdrawn

MFDS item code 201907198 · Approved 2019.10.14

This product's status changed to Approval withdrawn on 2025.01.22.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 that does not respond 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 depending on 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 effect. 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 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
Os Korea Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Chronic severe hand eczema
View approved original text

This medication is used when there is no response to potent topical corticosteroid treatment for at least 4 weeks in adults with 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 depending on 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 effect. 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 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 not be used by pregnant women or women who may become pregnant. It can cause serious congenital malformations in the fetus, so pregnancy status should be regularly checked before and during treatment. During treatment, two or more effective methods of contraception should be used continuously, and contraception should continue for a period after treatment. Patients with very high or uncontrolled triglyceride levels should use this medication with caution, as there is a risk of serious side effects such as acute pancreatitis, necessitating regular blood tests. Patients with a history of mental illness or depressive symptoms should closely monitor their mental health status while taking this medication, and seek professional treatment if necessary. This medication can cause various side effects such as dry skin, headache, flushing, and dry eyes; patients should consult a physician if symptoms are severe. Increased sensitivity to ultraviolet rays may occur, so excessive sun exposure should be avoided and sunscreen should be used. Intense physical activity should be avoided while taking this medication, and any discomfort in the eyes or vision abnormalities should be reported to a doctor immediately. There may be drug interactions, so all medications being taken must be disclosed to healthcare professionals, especially tetracycline-class medications which should not be taken together with this drug. This medication should be swallowed with water during or immediately after a meal and should not be chewed. Store in a container that does not allow light to enter since this medication is light-sensitive. Additionally, it is important to store it at room temperature between 1 degree and 30 degrees Celsius to maintain its efficacy.

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 thoughts
  • dizziness
  • benign increased intracranial pressure
  • conjunctivitis
  • dry eyes
  • eye irritation
  • blurred vision
  • cataract
  • reduced night vision
  • tinnitus
  • hypertension
  • vasculitis
  • nosebleed
  • nausea
  • dry mouth
  • vomiting
  • dyspepsia
  • inflammatory bowel disease
  • increased aminotransferases
  • dry skin and lips
  • cheilitis
  • eczema
  • dermatitis
  • hair loss
  • pruritus
  • rash
  • skin peeling
  • xerotic eczema
  • nail disorders
  • phototoxic reaction
  • hair texture abnormalities
  • arthralgia
  • myalgia
  • osteomalacia
  • ankylosing spondylitis
  • fatigue
  • peripheral edema
  • hypertriglyceridemia
  • decreased HDL
  • hypercholesterolemia
  • increased serum creatine phosphokinase
  • diabetes
  • color blindness
  • contact lens intolerance
  • premature closure of epiphyses
  • 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; therefore, it should be stored in a container that protects it from light. Furthermore, it is essential to keep it at room temperature between 1 degree and 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Brown oval soft capsule containing a yellow to yellow-green uniform 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.

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.