Medication info
Altinon Soft Capsule 10mg (Alitretinoin)

Altinon Soft Capsule 10mg (Alitretinoin)

Prescription medicationSoft capsuleOral
Ingredient · strength
Alitretinoin›10mg
Manufacturer / importer
Genupharm Co., Ltd.
Appearance
Brown oval soft gelatin capsule containing yellow oily contents
Packaging
30 capsules/PTP [10 capsules/PTP × 3]
Approval status
Active

MFDS item code 202005981 · Approved 2020.08.24

Summary

Main use
Treatment of chronic severe hand eczema in adults unresponsive to potent topical steroids
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: Administer an initial dose of 10mg and, if needed, increase to 30mg depending on tolerability and efficacy. Periodic monitoring of the blood lipid profile and blood glucose may be necessary during treatment with this drug. - 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 24 weeks of treatment.

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

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

  • 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 at least 4 weeks of potent topical steroid therapy. Hand eczema is an inflammatory skin disease that occurs on the hands and often has severe and long-lasting symptoms, necessitating appropriate treatment. This drug is effective in improving symptoms for patients who do not respond to existing treatments. Treatment effectiveness can be monitored according to the physician's assessment (PGA), providing safe and effective therapy. Therefore, it is a suitable treatment option for adults suffering from 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: Administer an initial dose of 10mg and, if needed, increase to 30mg depending on tolerability and efficacy. Periodic monitoring of the blood lipid profile and blood glucose may be necessary during treatment with this drug. - 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 24 weeks of treatment.

Precautions

This medication poses a very high risk of causing serious birth defects if taken during pregnancy; therefore, women who are pregnant or may become pregnant must not take it under any circumstances. During the treatment, effective contraception methods must be used for at least one month before and after treatment. Pregnancy tests should be conducted every month during treatment to confirm pregnancy status; if pregnancy is confirmed, the medication should be immediately discontinued, and medical consultation should be sought. High levels of triglycerides in the blood may lead to serious side effects, such as acute pancreatitis; thus, blood lipid levels should be regularly monitored, and treatment should be stopped if abnormalities are detected. This medication should not be administered to individuals with certain conditions, such as liver disease, severe kidney disease, or uncontrolled hypothyroidism. Patients with a history of mental illness should be carefully monitored for worsening psychiatric symptoms such as depression or mood changes before and after taking the medication. This medication may cause various side effects such as dry skin, headache, flushing, and changes in thyroid function; any unusual symptoms should be promptly discussed with healthcare professionals. Increased sensitivity to ultraviolet radiation occurs, so caution is needed to avoid excessive exposure to sunlight or artificial light sources, and the use of sunscreen is recommended. Exercise should avoid strenuous activities, and in case of dry eye symptoms, artificial tears or lubricating eye ointments may help. This medication should not be taken in combination with other retinoid products or vitamin A due to an increased risk of side effects. Additionally, concurrent use of the specific antibiotic tetracycline is contraindicated as it may cause serious side effects. During the use of this medication, strict adherence to the pregnancy prevention program is necessary, and it should never be shared with others. Excessive dosages may lead to severe headaches, diarrhea, and facial flushing; thus, the prescribed dose must be strictly followed, and in the case of men, sexual relations with women who may become pregnant should be avoided or condoms used for 30 days following overdose. This medication should be taken with food or immediately after a meal, and stored in a cool place out of reach of children, avoiding direct sunlight.

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
  • anaphylaxis
  • hypersensitivity reactions
  • depression
  • mood changes
  • suicidal thoughts
  • 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 reactions
  • hair texture abnormalities
  • arthralgia
  • myalgia
  • osteomalacia
  • ankylosing spondylitis
  • fatigue
  • peripheral edema
  • hypertriglyceridemia
  • decreased HDL
  • hypercholesterolemia
  • increased serum creatine phosphokinase
  • diabetes
  • color blindness
  • intolerance to contact lenses
  • premature epiphyseal closure
  • hyperostosis
  • calcification of ligaments and tendons
  • corneal opacity
  • keratitis
  • inflammatory bowel disease
  • skin allergic reactions
  • anaphylaxis
  • 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 dark container that prevents light exposure. It is also important to store it at a cool temperature below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Brown oval soft gelatin capsule containing yellow oily contents

Package unit

30 capsules/PTP [10 capsules/PTP × 3]

Same-ingredient medicines

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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.