Description
Sotret® is manufactured by Sun Pharma. This is an oral treatment for recalcitrant nodular acne (also called nodulocystic or cystic acne), acne conglobata, and acne fulminans. Sotret® capsules should be used in patients who failed to respond to safer acne treatments, including oral antibiotics. The active substance comprised in Sotret® is Isotretinoin, a first-generation anti-acne retinoid, derivative of vitamin A.
Indications:
- severe acne vulgaris (cystic, nodulocystic or recalcitrant nodular acne), characterized by red painful bumps, cysts, nodules with a diameter of 5 mm or greater, and painful lesions beneath the skin. It occurs if skin produces too much sebum and pores get clogged, as the acne-causing bacteria P. acnes (Propionibacterium acnes) proliferate inside of a clogged pore.
- acne conglobata, characterized by abscesses and draining sinus tracts in addition to nodulocystic acne symptoms.
- acne fulminans, that develops after an unsuccessful treatment of acne conglobata and is much harder to treat due to its unresponsiveness to the variety of medications.
MOA (mechanism of action):
Isotretinoin has strong comedolytic, keratolityc, sebostatic, and anti-inflammatory properties. It cures acne by suppressing skin oil secretion and follicular hyperkeratinization (overabundance of the dead epithelial cells in the pores). Isotretinoin reduces the size of sebaceous glands (microscopic organs producing skin oil) and exfoliates the dead skin cells from the pores. By these actions Isotretinoin indirectly reduces the amount of P. acnes in the skin.
Dosage
Sotret® capsules are swallowed whole and taken with food.
The treatment duration is between 16-24 weeks depending on the severity of condition and tolerance.
The daily intake should be divided in two doses.
For adults and children over 12 years:
The recommended starting dose: 0,5-1,0 mg per kg of body weight a day. After a few weeks the dose should be adjusted by the doctor.
For patients with severe kidney problems: 10 mg a day. After a few weeks the dose should be adjusted by the doctor.
For severe skin condition: 2,0 mg per kg of body weight a day as tolerated.
Precautions
Never exceed the doctor’s recommended dose.
Do not adjust the dose without your doctor’s approval.
Do not take your daily dose of Sotret® at once.
If you notice any of the more serious side effects, stop taking Sotret® immediately and seek medical advice.
Women of child-bearing potential must not get pregnant 1 month before starting the Sotret® treatment course, during it, and 1 month after stopping the course.
Your acne may get worse during the first week of the Sotret® treatment course. This does not mean you should stop taking Sotret®. Your skin condition will most likely improve with continuous treatment.
If your acne has not improved after 4-6 weeks of the Sotret® treatment, seek medical advice.
Missing a dose
If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule. Do not apply a double dose.
Overdose
Do not exceed the doctor's recommended dose. The symptoms of Sotret® overdose may include vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. If any of these occurs and you are feeling unwell, you should seek emergency medical attention or contact your healthcare provider immediately.
Storage
Store at a room temperature from 20 and 25 degrees C (68 and 77 degrees F) away from moisture and heat. Throw away the tube after the expiration date. Keep away from children.
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