Composition and form of Accutane 20mg capsules
Capsules content: isotretinoin – 20 mg.
Excipients: soybean oil; beeswax yellow; soybean oil, hydrogenated; soybean oil, partially hydrogenated capsule shell: gelatin; glycerol; Karion 83 (hydrolyzed potato starch, mannitol, sorbitol); canthaxanthin; titanium dioxide; ink for the inscription on the capsule (shellac, iron dye, black oxide) in a blister 10 pcs.; in a pack of cardboard 3 or 10 blisters.
Indications for use
Accutane is a retinoid for the systemic treatment of acne. It is used for severe forms of cystic nodular acne; acne, not amenable to previous therapy, in particular, cystic and conglobatic acne, especially on the trunk.
Isotretinoin – the active substance of the drug Accutane – is a stereoisomer of all-trans retinoic acid (tretinoin). Accutane is produced in dosages of 10 and 20 mg.
Accutane is used to treat severe cystic nodular acne; acne, not amenable to previous therapy, in particular, cystic and conglobatic acne, especially on the trunk.
Contraindications for use
– hepatic and renal failure;
– hypervitaminosis A;
– severe hyperlipidemia;
– hypersensitivity to Accutane (isotretinoin).
Use during pregnancy and children
Accutane is a drug with a strong teratogenic effect, therefore it is contraindicated in women who are already pregnant or may become pregnant during treatment. Accutane is contraindicated in women of childbearing age.
Most side effects of Accutane are dose-dependent. As a rule, when the recommended doses are prescribed, the ratio of benefit and risk, given the severity of the disease, is acceptable for the patient.
Symptoms associated with hypervitaminosis A: most often – dry skin, mucous membranes of the lips, nasal cavity (bleeding), laryngopharynx (hoarseness), eyes (conjunctivitis, reversible corneal opacity, and contact lens intolerance).
Skin and its appendages: rash, itching, facial dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased growth of granulation tissue, persistent hair thinning, reversible hair loss, fulminant forms of acne, hirsutism, hyperpigmentation, photosensitization.
Musculoskeletal system: muscle pain, joint pain, hyperostosis and other bone changes, tendinitis. In one patient, the development of hyperostosis of the spine and calcification of the vertebral ligaments with subsequent compression of the spinal cord during prolonged (over several years) treatment with another drug of the retinoid group – Tigason (etretinate) – was described. Accutane is not intended for long-term use; however, you should remember the likelihood of this side effect if the drug is used incorrectly (too long).
The initial dose of Accutane is 0.5 mg/kg per day. Often, at the beginning of treatment, there is a short-term exacerbation of acne. The efficacy and side effects of Accutane differ in different patients, therefore, after about 4 weeks of therapy, it is necessary to make an individual adjustment of the Accutane maintenance dose in the range from 0.1 to 1.0 mg/kg per day. The highest daily dose of Accutane (1 mg/kg) should be administered only for a limited time. Usually, treatment with Accutane lasts 16 weeks. When evaluating its results, it should be remembered that often the improvement continues after the abolition of Accutane. Therefore, before prescribing a repeated course of Accutane, you should take a break of at least 8 weeks. A repeated course of treatment with Accutane is carried out in accordance with the above recommendations.
Accutane capsules are taken with meals, in small doses – once a day, higher doses – in one or more doses per day.
The drug is used for the simultaneous external treatment.
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