Medication info
OurQ-Tan Soft Capsules (Isotretinoin)

OurQ-Tan Soft Capsules (Isotretinoin)

Prescription medicationSoft capsuleOral
Ingredient · strength
Isotretinoin›10mg / 1 capsule
Manufacturer / importer
Pharmgen Science Co., Ltd.
Appearance
Brown oval soft capsule containing a thick yellowish suspension.
Packaging
100 capsules/PTP (10 capsules/PTP package x 10EA)
Approval status
Active

MFDS item code 201508411 · Approved 2015.12.23 · Insurance code 670103910

Summary

Main use
Treatment of severe acne unresponsive to other treatments (such as nodular and cystic acne)
Who takes it
Adults
Adult dose
The therapeutic effect and adverse reactions of this drug are dose-dependent; therefore, adjust the dose appropriately according to the patient's symptoms and condition. ○ Initial dose Administer isotretinoin at 0.5 mg/kg of body weight per day while monitoring the response. ○ Maintenance dose Administer this drug at 0.5–1.0 mg/kg of body weight per day; the dose may be increased to 2.0 mg in patients with severe acne. Take the low dose once daily and the high dose in two divided doses per day, with meals. A cumulative dose of 120 mg/kg of body weight during each course of treatment improves the rate of symptom resolution and reduces the recurrence rate. The treatment period may vary depending on the daily dose, but usually takes 16–24 weeks, and symptoms may continue to improve after treatment is discontinued. If symptoms recur, repeat the above course of treatment, but do not resume treatment until at least an 8-week drug-free period has elapsed. ○ Patients with renal impairment Experience is very limited. If this drug is administered, start at 10 mg per day and adjust the dose. ○ Patients with intolerance Continue treatment at a low dose. In these cases, the treatment period is prolonged and the risk of recurrence is increased. In such patients, continue treatment at the maximum tolerated dose to achieve optimal efficacy.

Ingredients

Manufacturer
Pharmgen Science Co., Ltd.

Efficacy & effects

Treatment of severe acne unresponsive to other treatments (such as nodular and cystic acne)

  • Severe acne
  • nodular acne
  • cystic acne
  • pustular acne
  • cystic acne associated with trunk lesions
  • pustular acne associated with trunk lesions
View approved original text

This medication is used for severe acne that is ineffective to common treatments, especially nodular, cystic, and pustular acne. It is particularly effective for treating cystic and pustular acne that appears on the trunk, such as the chest or back. This drug helps to improve symptoms by alleviating skin inflammation and infection that trigger acne. It is suitable for treating complex acne lesions and overall improves skin condition. Continuous use helps restore skin health and reduce scarring caused by acne. Thus, it is effectively used for the treatment of severe acne.

How to take

Adult dose

The therapeutic effect and adverse reactions of this drug are dose-dependent; therefore, adjust the dose appropriately according to the patient's symptoms and condition. ○ Initial dose Administer isotretinoin at 0.5 mg/kg of body weight per day while monitoring the response. ○ Maintenance dose Administer this drug at 0.5–1.0 mg/kg of body weight per day; the dose may be increased to 2.0 mg in patients with severe acne. Take the low dose once daily and the high dose in two divided doses per day, with meals. A cumulative dose of 120 mg/kg of body weight during each course of treatment improves the rate of symptom resolution and reduces the recurrence rate. The treatment period may vary depending on the daily dose, but usually takes 16–24 weeks, and symptoms may continue to improve after treatment is discontinued. If symptoms recur, repeat the above course of treatment, but do not resume treatment until at least an 8-week drug-free period has elapsed. ○ Patients with renal impairment Experience is very limited. If this drug is administered, start at 10 mg per day and adjust the dose. ○ Patients with intolerance Continue treatment at a low dose. In these cases, the treatment period is prolonged and the risk of recurrence is increased. In such patients, continue treatment at the maximum tolerated dose to achieve optimal efficacy.

Precautions

This medication can cause serious birth defects if taken during pregnancy; therefore, it should never be taken by women who are pregnant or may become pregnant. Before, during, and after treatment, effective contraception methods must be used, and regular pregnancy tests are required. If triglyceride levels in the blood are very high, serious side effects such as acute pancreatitis can occur, so lipid levels should be monitored and controlled frequently during treatment. This medication can cause various side effects such as dry skin, itching, cracked lips, dry eyes, and vision disturbances; if symptoms appear, consult with healthcare professionals. It may affect mental health, so if symptoms of depression or emotional changes occur, inform healthcare professionals immediately, and discontinuation of treatment may be necessary. This drug can impact liver and kidney function, so regular liver and kidney function tests are needed. Due to an increased risk of skin irritation, avoid exposure to ultraviolet light, and refrain from chemical peels, laser treatments, and waxing while on treatment. Extra caution is necessary for children and the elderly, and it is especially not recommended for children under 12 years old. When taking this medication, it must be taken with sufficient water during meals to prevent esophageal irritation. Co-administration with other vitamin A preparations, certain antibiotics, and hormonal contraceptives may increase side effects, so inform healthcare professionals of all medications being taken. There should be a prohibition on blood donation for a certain period after treatment, and male patients are advised to use condoms for 30 days to prevent pregnancy if excessively taken. This medication must be used under the prescription and supervision of a specialist, and any side effects should be immediately discussed with healthcare professionals.

Side effects

Mucosal dryness, skin dryness, skin damage, itching, nasal dryness, lip dryness, dry eyes, epistaxis, pharyngeal mucosal dryness, hoarseness, conjunctivitis, reversible corneal opacity, cheilitis, rashes, dermatitis, skin peeling, skin weakening, palmoplantar skin peeling, skin infections, increased sensitivity to sunburn, reversible alopecia, fulminant acne, persistent alopecia, hirsutism, paronychia, nail growth abnormalities with increased granulation tissue formation, photosensitivity, pyogenic granuloma, hyperpigmentation, sweating, hair abnormalities, pyogenic fungus infection, acne exacerbation, facial dermatitis, urticaria, papular xanthoma, nodular erythema, flushing, disseminated herpes simplex, hypopigmentation, phot allergic reactions, bruising, abnormal wound healing, myalgia, arthralgia, abdominal pain, rhabdomyolysis, hyperostosis, arthritis, calcification of ligaments and tendons, decreased bone density, premature epiphyseal closure, tendinitis, sacroiliitis, headache, depression, exacerbation of depression, aggressive behavior, emotional instability, behavioral disorders, suicidal thoughts, suicide attempts, suicide, psychosis, pseudotumor cerebri, seizures, drowsiness, lethargy, dizziness, insomnia, neuroexcitation, sensory abnormalities, weakness, stroke, syncope, blepharitis, ocular irritation, blurred vision, photophobia, cancer adaptation disorder, color discrimination disorder, cataract, keratitis, corneal opacity, difficulty wearing contact lenses, hearing impairment, vision impairment, optic neuritis, tinnitus, nonspecific gastrointestinal symptoms, nausea, hemorrhagic diarrhea, enteritis, inflammatory bowel disease, pancreatitis, gum bleeding and inflammation, esophagitis, esophageal ulcer, elevated liver transaminase levels, hepatitis, nasopharyngitis, bronchial spasms, respiratory infections, voice changes, nasal congestion, localized systemic infection, anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis, neutropenia, agranulocytosis, allergic reactions, decreased erythrocyte counts, nonspecific urogenital symptoms, glomerulonephritis, urethritis, menstrual irregularities, erectile dysfunction, decreased libido, gynecomastia, hypertriglyceridemia, decreased serum HDL, hypercholesterolemia, elevated blood glucose levels, increased serum CPK levels, diabetes, hyperuricemia, elevated ALP, AST, ALT, GGTP, LDH, vasculitis, palpitations, tachycardia, vascular thrombotic disease, stroke, transient chest pain, fatigue, systemic hypersensitivity reactions, anaphylactic reactions, lymphadenopathy, edema, weight loss, hematuria, proteinuria, increased granulation tissue formation, delayed recovery, lymphadenitis, increased prolactin, detection of leukocytes and erythrocytes in urine, headache, vomiting, facial flushing, abdominal pain, dizziness, drowsiness, hypersensitivity, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a closed container that does not allow light and is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness.

Appearance and packaging

Appearance

Brown oval soft capsule containing a thick yellowish suspension.

Package unit

100 capsules/PTP (10 capsules/PTP package x 10EA)

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.