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Amnesteem (Isotretinoin) - Summary

 
 



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 HIGHLIGHTS

Media Articles Related to Amnesteem (Isotretinoin)

Some acne products can cause serious allergic reactions, FDA warns
Source: Dermatology News From Medical News Today [2014.06.27]
Over the counter skin products for acne that contain benzoyl peroxide or salicylic acid can cause rare but serious and potentially life-threatening reactions, say FDA.

Some Acne Products Can Trigger Severe Allergic Reactions: FDA
Source: MedicineNet Acne Specialty [2014.06.26]
Title: Some Acne Products Can Trigger Severe Allergic Reactions: FDA
Category: Health News
Created: 6/25/2014 4:35:00 PM
Last Editorial Review: 6/26/2014 12:00:00 AM

New Approaches to Acne Treatment
Source: MedicineNet Acne Specialty [2014.06.10]
Title: New Approaches to Acne Treatment
Category: Health News
Created: 6/9/2014 12:35:00 PM
Last Editorial Review: 6/10/2014 12:00:00 AM

Clear Skin Pictures Slideshow: Helping Your Teen With Acne
Source: MedicineNet Boils Specialty [2013.11.07]
Title: Clear Skin Pictures Slideshow: Helping Your Teen With Acne
Category: Slideshows
Created: 1/20/2010 3:54:00 PM
Last Editorial Review: 11/7/2013 12:00:00 AM

Acne (Pimples)
Source: MedicineNet Boils Specialty [2013.08.13]
Title: Acne (Pimples)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/13/2013 12:00:00 AM

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Published Studies Related to Amnesteem (Isotretinoin)

A single blind randomized clinical study: the efficacy of isotretinoin plus narrow band ultraviolet B in the treatment of psoriasis vulgaris. [2011.06]
In this randomized clinical trial, 39 patients with psoriasis vulgaris were randomized in two groups. Intervention group received narrow band ultraviolet B (NBUVB)+isotretinoin (0.5 mg/kg/day), control group received NBUVB+placebo.

A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. [2010.11]
External beam radiation therapy (XRT) with concomitant temozolomide and 6 cycles of adjuvant temozolomide (5/28-day schedule) improves survival in patients with newly diagnosed glioblastoma compared with XRT alone...

Mortality in the randomized, controlled lung intergroup trial of isotretinoin. [2010.06]
In 2001, we reported that mortality may have been higher with isotretinoin (30 mg/d for 3 years) than with placebo in the subgroup of current smokers among the 1,166 patients with definitively resected early-stage non-small cell lung cancer who participated in the randomized, controlled Lung Intergroup Trial...

A randomized and controlled trial about the use of oral isotretinoin for photoaging. [2010.02]
Topical retinoids are used to treat photoaging; oral isotretinoin is gold standard for acne; "off label" indications, including photoaging, have been reported with insufficient evidence of efficacy. This is a randomized controlled phase II trial with clinical and histological assessment to evaluate efficacy and safety of oral isotretinoin for photoaging...

Dose response of retinol and isotretinoin in the prevention of nonmelanoma skin cancer recurrence. [2010]
Using data from a randomized, double blind, study of the efficacy of retinol or isotretinoin vs. placebo on recurrence of nonmelanoma skin cancer in high-risk subjects, a reanalysis of the original intent to treat analysis was performed in a dose-response format...

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Clinical Trials Related to Amnesteem (Isotretinoin)

Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea [Recruiting]
Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of reversible mucocutaneous side effects, as well as alterations in lipid profile and transaminases. The major problem is teratogenicity which demands pregnancy control from treatment beginning to one month after treatment end. Seborrhea and seborrheic dermatitis are chronic conditions characterized by oily skin, hair and scalp, erythema, desquamation and negative impact on quality of life. This will be an interventional, therapeutic and quality of life randomized, comparative (parallel groups), blinded evaluation clinical trial, comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin will be compared to topical anti-seborrheic products to evaluate the reduction of sebaceous secretion and colonization of affected areas by yeasts of Malassezia gender. Efficacy will be evaluated by clinical parameters, as well as by sebum secretion measure and application of quality of life questionnaires. Safety will be evaluated by skin hydration measure, side effects report and observation. For subjects using oral isotretinoin blood counting, transaminases, lipid profile and pregnancy test will be requested as selection criteria, on days 30 and 180. Data will be submitted to statistical analysis.

Aflac ST1001 Prolonged Isotretinoin [Recruiting]
Neuroblastoma is a cancer of the nervous system and accounts for 15% of cancer related deaths in children. With the advancement of treatment therapies, the long term survival rate has progressed to approximately 50%. The therapy used for treatment, however, is very toxic and associated with serious long-term side effects. Treatment for neuroblastoma typically includes chemotherapy, surgery, stem cell transplantation, radiation therapy, and immunotherapy. At the end of this treatment, children with neuroblastoma commonly take the drug isotretinoin for 6 months. Isotretinoin maintains the response to previous treatments and helps turn the remaining cancer cells into normal nerve cells.

Most patients often respond to this treatment at first but are at a high-risk for the cancer coming back. The majority of the children who relapse after treatment or develop recurrent disease do so in the first two years following the completion of therapy and there are no current treatments to cure those who relapse. This study will explore whether or not extending the therapy with isotretinoin from 6 months to 24 months will help prevent the cancer from coming back without causing severe side effects.

Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma [Recruiting]
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help cells that are involved in the body's immune response to work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given with isotretinoin in treating patients with recurrent malignant glioma.

Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma [Recruiting]
This phase I trial is studying the side effects and the best dose of vorinostat when given together with isotretinoin to see how well it works in treating patients with high-risk refractory or recurrent neuroblastoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat work better by making tumor cells more sensitive to the drug. Giving vorinostat together with isotretinoin may be an effective treatment for neuroblastoma

Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment [Recruiting]
The goal of this study is to enroll 250 participants that have joined the MURDOCK Study Horizon 1. 5 (Duke IRB Pro00011196) with a current or prior diagnosis of severe acne AND current or prior treatment with oral isotretinoin. All 250 participants will answer a 5-page questionnaire designed to collect information on the diagnosis of severe acne and response to oral isotretinoin treatment. The aim is to identify genetic predictors of severe acne vulgaris and the outcome of oral isotretinoin treatment.

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Reports of Suspected Amnesteem (Isotretinoin) Side Effects

Inflammatory Bowel Disease (271)Colitis Ulcerative (85)Depression (83)Arthralgia (77)Blood Triglycerides Increased (73)Crohn's Disease (58)Headache (55)LIP DRY (55)DRY Skin (54)Anxiety (54)more >>


Page last updated: 2014-06-27

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