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)
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Category: Medications Second Source
Created: 3/2/2005 12:00:00 AM
Last Editorial Review: 9/21/2011 12:00:00 AM
Thyme's Time as an Acne Remedy May Be Coming Soon
Source: MedicineNet Acne Specialty [2012.04.13]
Title: Thyme's Time as an Acne Remedy May Be Coming Soon
Category: Health News
Created: 4/13/2012 11:00:00 AM
Last Editorial Review: 4/13/2012 12:00:00 AM
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Source: MedicineNet Rosacea Specialty [2012.03.30]
Title: Acne rosacea
Category: Medical Dictionary
Created: 1/14/1999 9:13:00 PM
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Source: MedicineNet Attention Deficit Hyperactivity Disorder (ADHD) Specialty [2012.03.23]
Title: Acne-ADHD Link?
Category: Health News
Created: 3/23/2012 11:01:00 AM
Last Editorial Review: 3/23/2012 12:00:00 AM
Acne vulgaris
Source: MedicineNet Keloid Specialty [2012.03.19]
Title: Acne vulgaris
Category: Medical Dictionary
Created: 11/2/1999 12:00:00 AM
Last Editorial Review: 3/19/2012 12:00:00 AM
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...
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, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM) [Recruiting]
Objectives:
Phase I
1. To determine the maximum tolerated dose (MTD) of vorinostat/isotretinoin (cRA),
temozolomide (TMZ)/cRA and vorinostat/cRA/TMZ combinations in adult patients with recurrent
glioblastoma multiforme (GBM) and anaplastic gliomas.
Phase II
Primary objective:
1. To determine the efficacy of vorinostat/cRA versus TMZ/cRA versus vorinostat/cRA/TMZ in
patients with recurrent GBM as determined by Progression Free Survival (PFS) using an
adaptive randomization phase II trial design.
Secondary objectives:
2. To determine the radiological response, progression free survival at 6 months, overall
survival and unexpected toxicity in the three treatment arms.
3. To obtain exploratory data regarding histone 3 and 4 acetylation and p21 levels in
tumor tissue and peripheral monocytes in a subset of surgical patients and in
non-surgical patients with available tissue from previous surgical procedures.
4. To evaluate the occurrence of symptoms and correlate to disease progression and
tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module
(MDASI-BT) self-reporting tool.
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.
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