AMNESTEEM SUMMARY
Isotretinoin, a retinoid, is available as Amnesteem in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin, with the following dye systems: 10 mg - red iron oxide paste and black ink; 20 mg - red iron oxide paste, yellow iron oxide paste, titanium dioxide and black ink; 40 mg - red iron oxide paste, yellow iron oxide paste, titanium dioxide, and black ink.
Amnesteem is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition2, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, Amnesteem should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Amnesteem is indicated only for those females who are not pregnant, because isotretinoin can cause severe birth defects (see boxed CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS:
Skeletal:
Bone Mineral Density,
Hyperostosis
and Premature Epiphyseal Closure).
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NEWS HIGHLIGHTSMedia Articles Related to Amnesteem (Isotretinoin)
Health Tip: Caring for Acne-Prone Skin (HealthDay)
Source: Y! Health Skin Conditions News [2010.01.21]
HealthDay - (HealthDay News) -- The exact cause of acne isn't understood,
but the American Academy of Dermatology says four factors are involved:
too much oil, clogged pores, bacteria, and inflammation.
Clear Skin Pictures Slideshow: Helping Your Teen With Acne
Source: MedicineNet Acne Specialty [2010.01.21]
Title: Clear Skin Pictures Slideshow: Helping Your Teen With Acne
Category: Slideshows
Created: 1/20/2010 3:54:00 PM
Last Editorial Review: 1/21/2010
Health Tip: Caring for Acne-Prone Skin
Source: MedicineNet Acne Specialty [2010.01.21]
Title: Health Tip: Caring for Acne-Prone Skin
Category: Health News
Created: 1/21/2010 8:10:00 AM
Last Editorial Review: 1/21/2010
Health Tip: What's Triggering My Acne?
Source: MedicineNet Acne Specialty [2009.06.24]
Title: Health Tip: What's Triggering My Acne?
Category: Health News
Created: 6/24/2009 7:00:00 AM
Last Editorial Review: 6/24/2009
FDA OKs New Acne Gel Epiduo
Source: MedicineNet adapalene Specialty [2009.01.07]
Title: FDA OKs New Acne Gel Epiduo
Category: Health News
Created: 1/7/2009
Last Editorial Review: 1/7/2009
Published Studies Related to Amnesteem (Isotretinoin)
Comparison of dose-related ocular side effects during systemic isotretinoin administration. [2009.03]
PURPOSE: To compare the effects of high- (Group 1) and low-dose (Group 2) isotretinoin treatments for acne vulgaris on lacrimal functions and other ocular complications... CONCLUSIONS: During systemic isotretinoin treatment, eye dryness was related to the dose used, at least during the period of treatment. Conversely, the rate of conjunctival S aureus colonization was unrelated to the dose of isotretinoin.
Oral isotretinoin in photoaging: clinical and histopathological evidence of efficacy of an off-label indication. [2009.02]
BACKGROUND: Despite evidences of the beneficial clinical effects of oral isotretinoin in the treatment of cutaneous photoaging, scientific evidences are still scarce, mainly supported by histopathological and morphometric studies. OBJECTIVES: To analyse possible clinical and morphological changes resulting from the treatment of photoaging with oral isotretinoin... CONCLUSION: Low dosages of oral isotretinoin seem to be an effective therapeutic option for cutaneous photoaging.
Oral isotretinoin is as effective as a combination of oral isotretinoin and topical anti-acne agents in nodulocystic acne. [2008.03]
BACKGROUND: Due to the late introduction of oral isotretinoin, there is only a single report of the use of this drug from India. AIMS: To evaluate the efficacy, acceptability and side effects of oral isotretinoin in Indian conditions and to compare the efficacy of oral isotretinoin monotherapy with that of a combination of oral isotretinoin and topical anti-acne agents... CONCLUSION: Isotretinoin produces gratifying results in patients of nodulocystic acne in Indian conditions. Addition of topical antiacne agents does not alter the final outcome. This addition is well tolerated but requires careful monitoring.
Beneficial effect of a moisturizing cream as adjunctive treatment to oral isotretinoin or topical tretinoin in the management of acne. [2006.11]
Despite their beneficial effects on the treatment of acne vulgaris, topical and oral retinoids may cause severe local irritation (retinoid dermatitis) due to their mechanism of action, thereby jeopardizing patient adherence, and thus compromising treatment efficacy...
Randomized phase III trial of low-dose isotretinoin for prevention of second primary tumors in stage I and II head and neck cancer patients. [2006.04.05]
BACKGROUND: Isotretinoin (13-cis-retinoic acid) is a synthetic vitamin A derivative, or retinoid, widely used in the treatment of cystic acne. Preclinical and clinical studies of high-dose isotretinoin in patients with head and neck squamous cell cancer (HNSCC) have produced encouraging results. We conducted a phase III randomized trial of low-dose isotretinoin versus placebo in early-stage HNSCC patients to assess its effect on second primary tumor incidence and survival... CONCLUSIONS: Low-dose isotretinoin was not effective in reducing the rate of second primary tumors or death or smoking-related disease. Smoking statistically significantly increased the rate of second primary tumors and death. Ongoing trials are testing higher doses of isotretinoin as part of combination bioadjuvant therapeutic methods for patients with locally advanced HNSCC.
Clinical Trials Related to Amnesteem (Isotretinoin)
Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer [Active, not recruiting]
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of isotretinoin may be an effective way to
prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy.
PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the
side effects of isotretinoin in former and current smokers who are receiving isotretinoin to
prevent lung cancer.
Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial [Completed]
A clinical and histological randomized controlled phase II trial to evaluate the efficacy and
safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or
sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A-
21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three
months; B- 11 women received only same moisturizer/sunscreen.
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies [Terminated]
The purpose of this study is to determine the response rate of patients with T-cell
malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin
(Accutane).
Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment of Sever Acne [Completed]
serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with
isotretinoin for sever acne
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors [Completed]
The purpose of this study is to see if it is safe and effective to give isotretinoin to
HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous.
Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected
women are at a greater risk, and often their tumors become cancerous more quickly than those
in HIV-negative women. Isotretinoin may be able to prevent this from happening. However,
since these tumors tend to disappear over time, many doctors are hesitant to give their
patients isotretinoin since this drug causes birth defects. This study looks at whether it is
better to treat cervical tumors in HIV-infected women or to wait and see if they will
disappear by themselves.
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