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Roaccutane is produced by the pharmaceutical company “Hoffmann-La Roche” (Switzerland), and Accutane is produced by the company “Jadran” (Croatia). The drugs contain isotretinoin and are practically equivalent to each other, but the production of Accutane involves the Lidose technology, which allows reducing the daily and course doses of isotretinoin, and therefore the risk of side effects during treatment. Lidose technology is a development of the Belgian company “SMB Laboratories SA”.

Indications for use:

  • severe forms of acne (nodular, conglobate, fulminant),
  • forms of acne with the risk of scarring,
  • acne that cannot be treated with drugs for external use, as well as oral antibiotics.

The exact mechanism of action of Roaccutane has not yet been clarified, but it has been established that the improvement of the clinical picture of severe forms of acne is associated with the suppression of the activity of the sebaceous glands and a histologically confirmed decrease in their size. The anti-inflammatory effect of isotretinoin on the skin has been proven. The therapeutic efficacy of Roaccutane and its side effects depend on the dose, which may differ in different patients. Therefore, it is important to individually select doses during treatment.

Method and dosage

Treatment with Roaccutane should begin with a dose of 0.5 mg/kg per day. In most patients, the dose ranges from 0.5 to 1.0 mg/kg of body weight per day. Patients with very severe forms of the disease or with acne of the trunk may require higher daily doses – up to 2.0 mg/kg.

It is proved that the best results of treatment and prevention of relapses are achieved at a cumulative dose of 120 mg/kg (per course of treatment). Therefore, the duration of therapy in each patient depends on the daily dose. Complete remission of acne is often achieved in 16-24 weeks of treatment. Patients who poorly tolerate the recommended dose, should continue treatment at a lower daily dose, but it should be carried out longer.

In most patients, acne completely disappears after a single course of treatment. In case of an obvious relapse, a repeated course of treatment is indicated in the same daily and cumulative dose of Roaccutane as the first one. Since the improvement can last up to 8 weeks after discontinuation of the drug, the second course should be prescribed no earlier than after the end of this period.

Capsules are taken with meals, once or twice a day.

Side effects

Most of the side effects of Roaccutane depend on the dose. As a rule, when prescribing the recommended doses, the ratio of benefit and risk, taking into account the severity of the disease, is acceptable for the patient.

  • dry skin, rash, itching, erythema of the face, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased growth of granulation tissue, persistent thinning of hair, reversible hair loss, fulminant forms of acne, hirsutism, hyperpigmentation, photosensitization, photo allergy, light skin injury

At the beginning of treatment, an exacerbation of acne may occur, which persists for several weeks.

Contraindications

  • hypersensitivity to the drug or its components
  • concomitant therapy with tetracyclines
  • liver failure
  • hypervitaminosis A
  • severe hyperlipidemia
  • children and adolescents under 18 years of age
  • pregnancy, lactation period

Drug interactions

Due to the possible increase in the symptoms of hypervitaminosis A, the simultaneous administration of Roaccutane and preparations containing vitamin A should be avoided.

Since tetracyclines can also cause an increase in intracranial pressure, their use in combination with Roaccutane is contraindicated.

Roaccutane can weaken the effectiveness of progesterone drugs, so you should not take contraceptives containing small doses of progesterone.

Special instructions

Roaccutane should be prescribed only by doctors, preferably dermatologists who have experience in the use of systemic retinoids and are aware of the risk of teratogenicity of the drug. Both female and male patients should be given a copy of the brochure with information for the patient.

If patients have taken Roaccutane shortly before (1 month), they cannot give donor blood in order to avoid accidental exposure of the drug to the body of other people.

It is recommended to monitor liver function before treatment, 1 month after its start, and then every 3 months. If the level of hepatic transaminases exceeds the norm, it is necessary to reduce the dose of the drug or cancel it.

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