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Other challenges have included reports of potential associations with depression, suicidal ideation, and inflammatory bowel disease.1,2,6-18 However, continued pharmacovigilance has demonstrated that these alleged risks have not been definitively associated with ISO as the causative factor and are not common enough to take away the accessability of ISO to the millions of patients with severe acne who have experienced major improvements in their quality of life after ISO treatment

즉, 부작용이 많이 보고되었지만, ISO의 장점과 비교했을때는 전혀 문제될게 없으며 그리고 저 부작용들이 ISO 때문에 되었다는 건 아니다 (definitive causative factor 아님)

Commonly recommended starting dose. Although a dosage range is published for ISO, the optimal recommended starting daily dose of ISO is 0.5mg/kg/day, which is increased to lmg/kg/day, as tolerated, usually after four weeks.2,24,25,27,29,65,84 A typical course might involve one month at 0.5mg/kg/day, increased to lmg/kg/day, which is maintained over the ensuing treatment course unless adverse clinical effects or laboratory changes warrant adjustment of therapy.2,65,84 This daily dosing approach of 0.5mg/kg/day for one month followed by lmg/kg/day for four months applies to Acc-ISO, AB-ISOs, and Lidose-ISO and achieves the target cumulative dose of >120 to 150mg/kg if ISO is administered over the maximum duration of treatment (20 weeks [5 months]) indicated in the FDA-approved package inserts for all ISO products.2,25,40,54,60,65,69-71 The observation that some patients experience marked initial inflammatory acne flares after starting ISO led to the recommendation of starting with a lower dose (i.e., 0.5mg/kg/day) to avert such flares in the first month of treatment, with the subsequent daily dose increased to lmg/kg/day as long as this dose escalation is well tolerated.2,24


최적의 효과를 보기 위해서는 0.5mg/kg/day 다. 예를들어 72kg면 하루에 38.5 즉 40mg 을 먹어야 한다 그리고 4주후 가능하면 1.0mg/kg/day 까지 올려라 (부작용 없으면). 왜 이렇게 했냐면 0.5 부터 시작 안하는 경우 심한 여드름이 올라왔기 때문에 안하는 것이다. 하지만 이렇게 올릴 경우 충분히 견딜만 하면 계속 해라.


Dosing frequency. The FDA-recommended dosing frequency has remained as twice daily, with no additional PK studies completed that have changed this recommendation and with no studies adequately assessing BID versus daily dosing with regard to efficacy and safety

FDA는 하루에 2번 먹는 것을 권장 (아침 20mg 저녁 20mg ) 함. 

Recommended course of therapy. The recommended dosage regimen of ISO incorporates the suggested daily dose and also the target cumulative dose achieved over the treatment course.2,29-36,39-41,79,81,82Based on both research and clinical practice with ISO, it is recommended that ISO be given at a dose of 0.5 to lmg/kg/day, administered BID, over a duration that achieves a cumulative dose of 120 to 150mg/kg.2,40The latter component on duration of therapy to be administered over the initial course of ISO is based on analyses that show that achieving this target cumulative dose maximizes the likelihood of obtaining long-term remission without the need for retreatment of acne. In patients who experience nuisance side effects that they have difficulty tolerating (i.e., dry skin, dry eyes, severe cracking of lips, muscle aches), a lower daily dose can be administered over a longer duration until the cumulative dose of 120 tol50mg/kg is reached; however, it is optimal to administer the complete course of therapy within 20 weeks if possible without sacrificing the target cumulative dose

120 에서 150mg /kg 까지 먹을 때까지 하고 20주 ~ 24주 만 해라 (즉 최대 6개월을 보고) . 

예시) 72kg 면 8640mg 을 최소 먹어야 효과가 있다. 
20주의 경우 매일 60~70mg을 먹어야 하고 24주면 51mg 즉 60mg까지 먹는다. 
여기서 더 기간을 늘려도 상관없지만 최적이며 절대로 target cumulative dose (총 복용량) (8640mg) 을 무시하면 안된다. 즉 반드시 채우는 게 중요 그게 6개월이 아니라도 (그래서 그 이상 먹는건 몸에 좋지 않음.

다른 권장하는 방법 엄청나게 빨리 많이 먹기도 있다고 한다.

Alternative dosing approach: High-dose isotretinoin. It has been suggested that using higher daily doses of ISO than what is typically prescribed (> lmg/kg/day) and achieving a higher total cumulative dose of ISO than what is generally recommended (>150mg/kg) produces a lower risk of acne relapse, although well-controlled comparative studies or data analyses have not been completed. In addition, the use of these higher doses of ISO did not compress the duration of therapy with the goal of achieving a cumulative total dose of 120 to 150mg/kg over a shorter duration; instead they achieved cumulative total doses of ISO that were substantially higher without shortening of the duration of therapy.

1mg/kg 이상 하루에 먹으면 (부작용이 없으면)  RISK OF ACNE RELAPSE (재발율) 을 현저하게 낮출 수 있다. 즉, 영구적으로 당연히 여드름을 없앨 수 있다.


만약 오래먹으면..!


 The use of a lower daily dose with a longer duration of therapy (in order to reach the threshold cumulative total dose) exposes the patient to a more prolonged time period in which idiosyncratic adverse events may emerge, and in women of child-bearing potential, a greater period of time in which pregnancy exposures can occur.


적게 먹고 오랫동안 먹는 경우 idiosyncratic adverse events들이 나옴 (부작용이 오히려 더 커짐) 예를들어 임신 관련등.




결론

ISO remains a highly effective agent for treating acne. Experience with ISO for more than three decades has more clearly defined efficacy and safety profiles. Over time, suggested dosage regimens have emerged and multiple reports have led to the observation that reaching a target cumulative dose (120mg-150mg/kg) over the initial course of ISO therapy markedly reduces the rate of acne recurrence and the need for retreatment of acne, including additional courses of ISO therapy. Several formulations of ISO are available. 

너무 좋은 약이며 안정성과 효과는 이미 30년의 경험을 통해 입증되었으며, 그리고 복용량을 채울 경우, 여드름 재발의 rate을 낮추며, 그리고 다시 여드름을 관리할 (retreatment) 를 없앤다.




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