Accutane – it’s a brand name of active substance Isotretinoin, which is an anti-inflammatory and anti-acne drug, prescribed for the treatment of acne in children and adults.
The drug for the treatment of chronic inflammatory diseases of sebaceous glands (acne) – Accutane came on market for the first time in 1982. The manufacturer of Accutane drug is the Swiss pharmaceutical company Hoffmann la Roche. During long time, Hoffmann la Roche was the only company producing Accutane drug and supplying it on the pharmaceutical market not just within the USA, but all over the world.
In year 2002, the patent on production of the active substance Isotretinoin had expired, therefore Hofmann la Roche lost the exclusive rights to sell the anti-acne drug Accutane.
In 2009, Hoffman la Roche informed the FDA about revocation of Accutane (Isotretinoin) from the U.S. Pharmaceutical market. Hoffmann la Roche explained this revocation of Accutane drug by serious competition with pharmaceutical manufacturers of cheaper generics of Accutane.
Up to date, 4 pharmaceutical companies carry out the production and sale of generics Accutane within the USA, such as: Mylan Pharmaceuticals; Barr Pharmaceuticals; Douglas Pharmaceuticals and Ranbaxy Laboratories Limited.
- You can buy generic Accutane (Mylan manufacturer) under the trademark Amnesteem.
- Barr pharmaceutical company sells generic Accutane under the name of Claravis.
- New Zealand pharmaceutical company Douglas Pharmaceuticals carries out the production of generic Accutane under the trademark – Myorisan.
- One of the greatest Indian manufacturers of generic drugs – is Ranbaxy Laboratories, and it provides the retail sale of generic Accutane under the name Sotret with in the USA.
All these medications are pharmacological analogues of Accutane drug, since they all contain equal amount of the active ingredient Isotretinoin.
Accutane is prescribed for the treatment of severe forms of acne, including:
- nodular-cystic acne;
- acne conglobata (confluent acne);
- acne with risk of scars;
- acne not susceptible to other forms of therapy
Pharmacokinetics of Accutane (Isotretinoin)
- Isotretinoin binds with proteins of blood plasma and metabolizes in liver.
- Maximum concentration of the active ingredient Isotretinoin in the blood plasma is reached in 1-4 hours after use of Accutane capsules.
- The active substance Isotretinoin is well digested in the body and rapidly absorbed from the gastrointestinal tract.
- The absorption rate of Isotretinoin may increase with food intake.
- Isotretinoin is excreted from the body within 10-20 hours after the oral intake.
- Most of Accutane drug is excreted with feces, unchanged as a rule, minimum in urine.
The application mode of Accutane (Isotretinoin)
- Accutane medication is taken orally with food, two times a day.
- The initial daily dosage of Accutane is 0,5mg per 1 kg of body mass (person with 80 kg, for instance, must take 1 capsule of Accutane 20mg two times a day).
- The average daily dose of Accutane is 1mg / 1kg of body mass (person with 80 kg has to take one capsule of Accutane 40mg – two times a day).
- Patients with severe forms of body acne, are prescribed the maximum daily dose of Accutane drug – 2mg per 1kg of body weight (patients whose body weight is 80kg, must take two capsules of Accutane 40mg, once – two times a day).
- Maximum recommended duration of treatment course with anti-acne drug Accutane – is 20 weeks (4,5 months).
- In case one achieved the regress of sebaceous glands inflammation on the body and (or) the face earlier than 20 weeks after the first intake of Accutane capsules, the treatment course can be stopped.
Pregnancy is an absolute contraindication to the Accutane drug. Women, who take Accutane capsules, should observe adequate precautionary measures, in order to avoid pregnancy.
A woman should use effective contraception means throughout use of Accutane drug, even in case she was diagnosed infertility or amenorrhea.
Still, if a woman became pregnant during the treatment with Accutane, she must stop using Accutane drug and tell the doctor about her pregnancy.
In case of need to use Accutane capsules during breastfeeding, one should stop breastfeeding. Since Isotretinoin has a high lipophilicity (fat-solubility), it penetrates into breast milk, which may lead to different pathologies of the fetus.
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