Roaccutane 20 mg 30 capsules

Roaccutane 20 mg 30 capsules

Composition:

Each capsule contains Isoretinoin — 20 mg.
The excipients are soybean oil, yellow beeswax, hydrogenated soybean oil, and partially hydrogenated soybean oil.

Product Description:

Roaccutane is a systemic retinoid used for acne therapy, acting as a stereoisomer of all-trans retinoic acid (tretinoin).
The drug suppresses sebaceous gland activity, histologically reduces their size, and exerts a pronounced anti-inflammatory effect on the skin.
By restoring the normal process of cell differentiation and inhibiting sebocyte proliferation, it reduces sebum production, preventing duct clogging with keratin and suppressing colonization by Propionibacterium acnes.

Indications for Use:

The medication is indicated for severe forms of acne (nodulocystic, acne conglobata, or acne with a risk of scarring) as well as acne recalcitrant to other therapies.

Method of Administration and Dosage:

The drug is taken orally with food once or twice daily.
The initial dosage is 0.5 mg/kg of body weight per day, with most patients requiring a daily dose between 0.5 and 1.0 mg/kg/day (up to 2.0 mg/kg/day for severe forms or trunk acne).
Dosage is individually adjusted, and a treatment course of 16–24 weeks is usually sufficient to achieve full remission.

Contraindications:

• Hepatic impairment.
• Hypervitaminosis A.
• Marked hyperlipidemia.
• Concomitant tetracycline therapy.
• Pregnancy and lactation.
• Age under 12 years.
• Hypersensitivity to isotretinoin or any of the excipients of the drug.

Precautions:

• Isotretinoin is a potent teratogen, making pregnancy an absolute contraindication for treatment.
• If pregnancy occurs during therapy or within one month after discontinuation, there is an extremely high risk of severe fetal malformations. 
• The medication should only be prescribed by physicians (preferably dermatologists) experienced in systemic retinoids, and informational leaflets must be provided to patients.
• To prevent accidental exposure of other people to the drug, blood donation is strictly prohibited during treatment and for 1 month following the last dose.

Adverse Reactions / Side Effects:

• Symptoms of Hypervitaminosis A: dry skin and mucous membranes.
• Skin and Subcutaneous Tissue Disorders: very common — cheilitis, dermatitis, dry skin, localized peeling, pruritus, erythematous rash; acne exacerbation may occur at the start of treatment and persist for several weeks.
• Musculoskeletal Disorders: very common — arthralgia, back pain, myalgia with or without elevated serum CPK levels.
• Nervous System and Psychiatric Disorders: common — headache.
• Special Senses Disorders: very common — blepharitis, conjunctivitis, dry eye mucosa, eye irritation.
• Respiratory Disorders: common — epistaxis, dry nasal mucosa, nasopharyngitis.
• Blood and Lymphatic System Disorders: very common — anemia, increased ESR, increased or decreased platelet count; common — neutropenia.
• Investigations / Laboratory Data: very common — hypertriglyceridemia, decreased HDL levels; common — hypercholesterolemia, hyperglycemia, hematuria, proteinuria.

Pregnancy and Lactation:

The use of this drug during pregnancy and breastfeeding is strictly contraindicated.
The medication possesses strong teratogenic and embryotoxic properties.

Storage Conditions:

Store at a temperature not exceeding 30 °C.
Keep out of reach of children.

Packaging:

The cardboard box contains 30 capsules and a medical instruction insert.