Medication info
Altitok Soft Capsule 10 mg (Alitretinoin)

Altitok Soft Capsule 10 mg (Alitretinoin)

Prescription medicationSoft capsuleOral
Ingredient · strength
Alitretinoin›10mg / 1 capsule
Manufacturer / importer
Medica Korea Co., Ltd.
Appearance
Brown oval soft capsule filled with a uniform yellow to yellow-green liquid
Packaging
30 capsules/box [(10 capsules/PTP x 3)]
Approval status
Active

MFDS item code 201907134 · Approved 2019.10.08 · Insurance code 646004870

Summary

Main use
Treatment of chronic severe hand eczema in adults unresponsive to 4 weeks of treatment with 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, which should be reduced to 10mg depending on adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: Administer an initial dose of 10mg, which may be increased to 30mg if needed 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
Medica Korea Co., Ltd.

Efficacy & effects

Treatment of chronic severe hand eczema in adults unresponsive to 4 weeks of treatment with 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 do not respond to potent topical steroid therapy for at least 4 weeks.

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, which should be reduced to 10mg depending on adverse reactions. Patients with diabetes, obesity, cardiovascular risk factors, or dyslipidemia: Administer an initial dose of 10mg, which may be increased to 30mg if needed 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 in women who are pregnant or may become pregnant. If pregnancy occurs while taking this medication, there is a very high risk of severe birth defects in the fetus, so effective two or more contraceptive methods must be used. Pregnancy tests must be conducted before starting this medication, and repeat pregnancy tests should be performed monthly during treatment. It is essential to strictly follow the physician's and pharmacist’s instructions regarding pregnancy prevention programs, and care should be taken to avoid becoming pregnant during treatment and for 1 month after stopping the medication. Blood triglyceride and cholesterol levels should be tested regularly, and immediate consultation with a doctor is required if any abnormalities occur. Care should be taken, especially if triglyceride levels rise significantly, as it may lead to serious problems such as acute pancreatitis. This medication can affect mental health, and if symptoms such as depression, mood changes, or suicidal thoughts occur, notify your doctor immediately. Patients with a history of mental illness should use this medication more cautiously, and their mental status should be consistently monitored during treatment. Excessive sun exposure or light treatments should be avoided, and sunscreen should be used if necessary to protect the skin. Vigorous exercise should also be avoided, and if dry eyes or visual problems occur, immediate consultation with medical personnel is necessary. This medication should not be used in patients with certain allergies, severe liver or kidney impairment, or uncontrolled hypothyroidism. Additionally, those with vitamin A toxicity or known hypersensitivity to this medication or similar medications should avoid taking it. If you are taking other medications, you must inform your doctor or pharmacist, and particularly, this medication should not be taken with tetracycline antibiotics. This medication should be taken with food or immediately after a meal, and it should not be chewed but swallowed whole with water. Store in a cool place out of direct sunlight, away from children, and do not take any expired medications. In case of overdose, symptoms such as severe headache, diarrhea, facial flushing, and increased triglycerides may occur, so if such symptoms arise, inform medical personnel immediately and receive appropriate treatment. For 30 days after an overdose, avoid sexual relations with women who may become pregnant or use condoms.

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 reactions
  • depression
  • mood changes
  • suicidal thoughts
  • dizziness
  • benign intracranial hypertension
  • conjunctivitis
  • dry eyes
  • eye irritation
  • blurred vision
  • cataract
  • decreased 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
  • dry eczema
  • nail disorders
  • photosensitivity reactions
  • abnormal hair texture
  • arthralgia
  • myalgia
  • osteomalacia
  • ankylosing spondylitis
  • fatigue
  • peripheral edema
  • hypertriglyceridemia
  • decreased HDL
  • hypercholesterolemia
  • increased serum creatine phosphokinase
  • diabetes mellitus
  • color blindness
  • contact lens intolerance
  • premature epiphyseal closure
  • hyperostosis
  • calcification of ligaments and tendons
  • corneal opacity
  • keratitis
  • skin allergic reactions
  • 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 container that does not allow light in. Additionally, it is best stored at room temperature, between 1 to 30 degrees Celsius, that is neither too hot nor too cold. This will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Brown oval soft capsule filled with 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.

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.