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Accutane: profile and news
Doxil® in the VAD Regimen for Myeloma Confirmed Less Toxic Than ... Feb 28, 2006 Gate City cancer patient shocked by $3,780 copay for medication Feb 18, 2006 Drug Rehab Feb 16, 2006 Author: Home prices set to fall Feb 19, 2006 Drug Rehab Feb 14, 2006 Fund manager searches for bright biotech stars Feb 15, 2006 Drug Rehab 09 Feb 2006 Thalomid Fuels Celgene's Rise Jan 9, 2006 Thalomid slows multiple myeloma, trial halted: Celgene Jan 9, 2006 Thalomid Slows Blood Cancer Jan 9, 2006 Celgene finishes Thalomid cancer study Jan 9, 2006 Celgene gives Thalomid to all patients in trial Jan 9, 2006 Celgene: Thalomid slows progression of multiple myeloma Jan 10, 2006 Thalomid Trial for Multiple Myeloma Achieves Primary Endpoint Jan 10, 2006 Addition of Thalomid® to Dexamethasone Improves Progression-Free ... Jan 9, 2006 Thalomid gives hope for blood cancer sufferers Jan 9, 2006 THALOMID(R) Pivotal Phase III Multiple Myeloma Trial Reaches Pre ... Jan 9, 2006 Celgene Corporation Reports Record Operating Performance for 2005 Jan 26, 2006 Celgene Corporation Reports Record Operating Performance for 2005 Jan 26, 2006 Celgene 4Q Profit Slumps on Drug Costs Jan 26, 2006 Celgene halts trial after drug proves effective Jan 9, 2006 Celgene 4th-qtr profit falls on drug launch costs Jan 26, 2006 Pharmion Provides EU Registration Strategy Update for Thalidomide Jan 10, 2006 Revenue Rises at Celgene Jan 26, 2006 NCCN Announces Important Updates to Several Clinical Practice ... Jan 30, 2006 Celgene Corporation Reviews Recent Highlights and Outlines 2006 ... Jan 9, 2006 (PRN) - Consolidated Graphics to Present at CJS Securities ... Jan 9, 2006 Analysts' Stock Picks: Part 1 Jan 23, 2006 Celgene Corporation Reviews Recent Highlights and Outlines 2006 ... Jan 9, 2006 Celgene Thalomid 'Approvable' for Cancer Nov 15, 2005 FDA Sends Second Approvable Letter For Celgene's Thalomid Nov 15, 2005 Celgene Receives Approvable Letter From FDA for THALOMID(R) in ... Nov 15, 2005 Celgene Receives Approvable Letter From FDA for THALOMID(R) in ... Nov 15, 2005 FDA Mails “Approvable Letterâ€? for Celgene’s Thalomid Nov 15, 2005 The International Myeloma Foundation Advocates Formal Approval of ... Nov 15, 2005 107 Abstracts on Clinical Data Evaluating REVLIMID(R) and ... Dec 8, 2005 The International Myeloma Foundation Advocates Formal Approval of ... Nov 15, 2005 107 Abstracts on Clinical Data Evaluating REVLIMID(R) and ... Dec 8, 2005 UPDATE 2-FDA requests more information on cancer drug Nov 15, 2005 FDA Wants More Data From Celgene Nov 15, 2005 NJ business briefs Nov 16, 2005 Celgene gets approvable letter for myeloma drug Nov 15, 2005 UPDATE 1-Celgene gets approvable letter for myeloma drug Nov 15, 2005 Are safety labeling and safety warnings enough? Nov 23, 2005 (PRN) - Eclipsys to Present at Credit Suisse First Boston ... Nov 15, 2005 (PRN) - Media Alert: Ultimate Software Presents Free Webcast ... ... Nov 15, 2005 Other information Indication For the treatment of severe recalcitrant nodular acne Pharmacology Isotretinoin, a retinoid, is indicated in 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 definition, means "many" as opposed to "few or several" nodules. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with Accutane, and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation. Mechanism Of Action Isotretinoin noticeably reduces the production of sebum and shrinks the sebaceous glands. It stabilises keratinization and prevents comedones from forming. The exact mechanism of action is unknown, however it is known that it alters DNA transcription. Drug Category Anti-acne Agents; Skin and Mucous Membrane Agents (84:92.00); ATC:D10AD04; ATC:D10BA01 Brand Names/Synonyms Accutane; Accutane Roche; Amnesteem; Avita; Claravis; Isotretinoin; Lsotretinoin; Renova; Retin-A; Retin-a Micro; Retinoic Acid; Retinoic Acid, All Trans Isomer; Sotret; Tretinoin; Vesanoid; Vitamin a Acid Dosage Forms CAPSULE Absorption Not Available Interactions -->Interactions for Isotretinoin: · Vitamin A: Because of the relationship of Accutane to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects. · Tetracyclines: Concomitant treatment with Accutane and tetracyclines should be avoided because Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. · Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations ("minipills" that do not contain an estrogen) may be an inadequate method of contraception during Accutane therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from women who have used combined oral contraceptives, as well as topical/injectable/implantable/insertable hormonal birth control products. These reports are more frequent for women who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Accutane. Therefore, it is critically important for women of childbearing potential to select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy. · Phenytoin: Accutane has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Accutane. Therefore, caution should be exercised when using these drugs together. · Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between systemic corticosteroids and Accutane. Therefore, caution should be exercised when using these drugs together. Prescribers are advised to consult the package insert of medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. Accutane use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. Johnís Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's Wort. Laboratory Tests Pregnancy Test Female patients of childbearing potential must have negative results from 2 urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Accutane prescription. The first test is obtained by the prescriber when the decision is made to pursue qualification of the patient for Accutane (a screening test). The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of Accutane therapy. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse (without using 2 effective forms of contraception). Each month of therapy, the patient must have a negative result from a urine or serum pregnancy test. A pregnancy test must be repeated each month prior to the female patient receiving each prescription. · Lipids: Pretreatment and follow-up blood lipids should be obtained under fasting conditions. After consumption of alcohol, at least 36 hours should elapse before these determinations are made. It is recommended that these tests be performed at weekly or biweekly intervals until the lipid response to Accutane is established. The incidence of hypertriglyceridemia is 1 patient in 4 on Accutane therapy. · Liver Function Tests: Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to Accutane has been established. · Glucose: Some patients receiving Accutane have experienced problems in the control of their blood sugar. In addition, new cases of diabetes have been diagnosed during Accutane therapy, although no causal relationship has been established. · CPK: Some patients undergoing vigorous physical activity while on Accutane therapy have experienced elevated CPK levels; however, the clinical significance is unknown. There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity. In a clinical trial of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, transient elevations in CPK were observed in 12% of patients, including those undergoing strenuous physical activity in association with reported musculoskeletal adverse events such as back pain, arthralgia, limb injury, or muscle sprain. In these patients, approximately half of the CPK elevations returned to normal within 2 weeks and half returned to normal within 4 weeks. No cases of rhabdomyolysis were reported in this trial. Chemical IUPAC Name 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)-nona-2,4,6,8-tetraenoicacid Chemical Formula C20H28O2 Half Life 17-50 hours Drug Type Approved Drug # Accession No APRD00140 CAS Registry Number 4759-48-2 |
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