Description
Isotroin® is manufactured by Cipla. This is a medication for severe forms of acne, such as recalcitrant nodular acne, acne conglobata, and acne fulminans. Isotroin® should be used in patients who failed to cure acne with milder treatments, including systemic antibiotics. The active ingredient of Isotroin® is Isotretinoin. This is a first-generation retinoid and 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 is a strong comedolytic, sebostatic, keratolytic, and anti-inflammatory agent. It destructs acne pathogenesis by normalizing keratinization and reducing sebaceous glands in size, thereby decreasing sebum (skin oil) secretion. When skin gets less oily and the dead skin cells residue peels off the pores, P. acnes bacteria loose the positive environment to proliferate in.
Dosage
Isotroin® capsules are swallowed whole and taken with food.
The treatment duration is between 15-20 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 Isotroin® at once.
If you notice any of the more serious side effects, stop taking Isotroin® immediately and seek medical advice.
Women of child-bearing potential must not get pregnant 1 month before starting the Isotroin® treatment course, during it, and 1 month after stopping the course.
Your acne may get worse during the first week of the Isotroin® treatment course. This does not mean you should stop taking Isotroin®. Your skin condition will most likely improve with continuous treatment.
If your acne has not improved after 4-6 weeks of the Isotroin® treatment course, 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 Isotroin® 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.
