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MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-30 Filed 03/24/2010 Page 1 Paofg 215e 1 of 215 DRUGDEX® Evaluations FLUOXETINE 0.0 Overview 1) Class a) This drug is a member of the following class(es): Antidepressant Central Nervous System Agent Serotonin Reuptake Inhibitor 2) Dosing Information a) Fluoxetine Hydrochloride 1) Adult a) Bulimia nervosa 1) 60 mg ORALLY once daily in the morning (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) b) Major depressive disorder 1) initial, 20 mg ORALLY once daily in the morning (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) 2) maintenance, may increase daily dose after several weeks if inadequate response (maximum dose 80 mg daily) OR 90 mg ORALLY once a week (weekly capsule), starting 7 days after after the last daily dose of 20 mg (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) c) Obsessive-compulsive disorder 1) initial, 20 mg ORALLY once daily in the morning (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) 2) maintenance, 20-60 mg ORALLY daily (single or divided doses) after several weeks if inadequate response; maximum dose 80 mg daily (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) d) Panic disorder 1) 10 mg ORALLY once daily for 1 week, then increase to 20 mg per day; dosage increases up to 60 mg daily may be considered after several weeks if there is no clinical response (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) e) Premenstrual dysphoric disorder 1) 20 mg ORALLY once daily continuously OR 20 mg ORALLY once daily intermittently (start 14 days prior to the anticipated onset of menstruation and continue daily through the first full day of menses); maximum dosage 80 mg daily (Prod Info SARAFEM(R) Oral Capsule, 2005) 2) Pediatric a) safety and effectiveness in pediatric patients younger than age 8 (major depressive disorder) and younger than age 7 (obsessive compulsive disorder) have not been established (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) 1) Major depressive disorder a) 8 years and older, 10-20 mg ORALLY once daily (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) 2) Obsessive-compulsive disorder a) adolescents and higher weight children 7 years and older, initiate at 10 mg ORALLY once daily; may increase to 20 mg ORALLY once daily after 2 weeks; recommended dose range, 20-60 mg daily (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) b) lower weight children 7 years and older, initiate at 10 mg ORALLY once daily; may increase dose after several weeks if inadequate response; recommended dose range, 20-30 mg daily (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005) 3) Contraindications a) Fluoxetine Hydrochloride 1) concomitant use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine (Prod Info PROZAC(R) delayed-release capsules, oral capsules, solution, 2009) 2) hypersensitivity to fluoxetine or any components of the product (Prod Info PROZAC(R) delayed-release capsules, oral capsules, solution, 2009) 3) use of MAOIs within 5 weeks after fluoxetine discontinuation (Prod Info PROZAC(R) delayed-release capsules, oral capsules, solution, 2009) 4) use of fluoxetine within 14 days of MAOI discontinuation (Prod Info PROZAC(R) delayed-release capsules, oral capsules, solution, 2009) 4) Serious Adverse Effects a) Fluoxetine Hydrochloride 1) Bleeding Exhibit E.22, page 1 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/1/2009 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-30 Filed 03/24/2010 Page 2 Paofg 215e 2 of 215 2) Depression, worsening 3) Hyponatremia 4) Mania 5) Prolonged QT interval 6) Seizure 7) Serotonin syndrome 8) Suicidal thoughts 5) Clinical Applications a) Fluoxetine Hydrochloride 1) FDA Approved Indications a) Bulimia nervosa b) Major depressive disorder c) Obsessive-compulsive disorder d) Panic disorder e) Premenstrual dysphoric disorder 1.0 Dosing Information Drug Properties Storage and Stability Adult Dosage Pediatric Dosage 1.1 Drug Properties A) Information on specific products and dosage forms can be obtained by referring to the Tradename List (Product Index) B) Synonyms Fluoxetine Fluoxetine HCl Fluoxetine Hydrochloride C) Orphan Drug Status 1) Fluoxetine Hydrochloride a) Fluoxetine has been designated an orphan product for use in the treatment of autism. D) Physicochemical Properties 1) Fluoxetine Hydrochloride a) Molecular Weight 1) Fluoxetine: 309.33 (Canada, 1997); Fluoxetine hydrochloride: 345.79 (Canada, 1997; Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008) b) pKa 1) 9.5 (Taddio et al, 1996) c) Solubility 1) Soluble at 14 mg per mL in water (Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008) 1.2 Storage and Stability A) Fluoxetine Hydrochloride 1) Oral route a) Capsule/Capsule, Delayed Release/Solution 1) Store at controlled room temperature, between 15 and 30 degrees Celsius (59 to 86 degrees Fahrenheit). Protect from light (Prod Info Sarafem(TM), 2002; Prod Info PROZAC(R) oral capsules, delayed-release capsules, solution, 2008). 1.3 Adult Dosage Normal Dosage Dosage in Renal Failure Dosage in Hepatic Insufficiency Exhibit E.22, page 2 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/1/2009 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-30 Filed 03/24/2010 Page 3 Paofg 215e 3 of 215 Dosage in Geriatric Patients Dosage Adjustment During Dialysis 1.3.1 Normal Dosage Important Note Fluoxetine Fluoxetine Hydrochloride 1.3.1.A Important Note At least 14 days should elapse between the discontinuation of a monoamine oxidase (MAO) inhibitor and the initiation of fluoxetine, and at least 5 weeks should elapse between discontinuation of fluoxetine and initiation of treatment with MAO inhibitors. Cases of serious, sometimes fatal reactions have been reported in patients receiving fluoxetine in combination with an MAO inhibitor, and in patients who have recently discontinued fluoxetine and are then started on an MAO inhibitor. Reactions have been characterized by hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitations progressing to delirium and coma. Some reports resembled cases of neuroleptic malignant syndrome (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005; Prod Info SARAFEM(R) Oral Capsule, 2005). 1.3.1.B Fluoxetine 1.3.1.B.1 Cataplexy - Narcolepsy See Drug Consult reference: NARCOLEPSY AND CATAPLEXY - DRUG THERAPY 1.3.1.C Fluoxetine Hydrochloride Oral route Tinnitus 1.3.1.C.1 Oral route Bulimia nervosa Major depressive disorder Obsessive-compulsive disorder Panic disorder Premenstrual dysphoric disorder 1.3.1.C.1.a Bulimia nervosa 1) The recommended dose for bulimia nervosa is 60 milligrams (mg) once daily, administered in the morning. For some patients, it may be appropriate to titrate up to 60 mg over several days. Studies in which lower doses (ie, 20 mg daily) were used did not demonstrate efficacy. Patients who have responded to fluoxetine 60 mg daily in an 8-week acute treatment phase continued to show benefit for up to 52 weeks in clinical trials. Patients should be periodically reassessed to determine the need for maintenance treatment (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005). 2) Continued fluoxetine treatment (60 milligrams/day), relative to placebo treatment, was associated with a significant reduction of relapse in patients who had responded acutely to treatment with fluoxetine for bulimia nervosa. The fluoxetine group had fewer relapses in the first 3 Exhibit E.22, page 3 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/1/2009 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-30 Filed 03/24/2010 Page 4 Paofg 215e 4 of 215 months (p less than 0.04). Thereafter, the difference between the groups remained at 14% to 18% but was not statistically significant due to high attrition rates. By the end of 52 weeks, 33% of the fluoxetine group and 51% of the placebo group had relapsed (Romano et al, 2002). 1.3.1.C.1.b Major depressive disorder 1) The recommended starting dose of fluoxetine in patients with major depressive disorder is 20 milligrams (mg) orally once daily, administered in the morning. Studies suggest that doses of 20 mg daily may be sufficient to obtain a satisfactory antidepressant response. If no clinical improvement is observed after several weeks, the dosage can be increased at intervals of several weeks, not to exceed a maximum dose of 80 mg daily. The full effect may be delayed until 4 weeks of treatment or longer. Efficacy has been maintained up to 38 weeks following 12 weeks of treatment with fluoxetine 20 mg daily in clinical trials. Due to the long elimination half lives of both parent drug and metabolites, the full effect of a dosage change may not be observed for several weeks. Doses greater than 20 mg daily may be administered once or twice daily (morning and noon) (Prod Info PROZAC(R) oral pulvule, oral solution, oral tablet, oral delayed-release capsule, 2005). 2) Once weekly dosing of 90 milligrams (mg) enteric-coated capsules was shown to be safe, effective, and well tolerated for the long-term treatment of depression. After responding to 20 mg daily for acute treatment of depression, patients were successfully treated with the once weekly formulation for up to 25 weeks.
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    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/006004 Al 9 January 2014 (09.01.2014) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/20 (2006.01) A61K 31/485 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/EP2013/06385 1 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, 1 July 20 13 (01 .07.2013) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (25) Filing Language: English OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, (26) Publication Language: English SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: PA 2012 70405 6 July 2012 (06.07.2012) DK (84) Designated States (unless otherwise indicated, for every 61/668,741 6 July 2012 (06.07.2012) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (71) Applicant: EGALET LTD.
  • Extrapyramidal Symptoms Often Arise During Psychiatric Therapy with Neuroleptics

    Extrapyramidal Symptoms Often Arise During Psychiatric Therapy with Neuroleptics

    DIFFERENTIAL ANTAGONISM OF ANTIAVOIDANCE, CATALEPTIC AND PTOTIC EFFECTS OF NEUROLEPTICS BY BIPERIDEN Makoto OKA, Kiyoko YAMADA, Chiaki KAMEI, Kouichi YOSHIDA and Masanao SHIMIZU Department of Pharmacology, Research Laboratories, Dainippon Pharmaceutical Co., Ltd., Suita-shi, Osaka 564, Japan Accepted January 11, 1979 Abstract-The interaction between neuroleptics and an anticholinergic, biperiden, in the antiavoidance, catalepsy and ptosis tests was investigated in mice for the purpose of predicting the extrapyramidal side-effects of neuroleptics. The cataleptic effect of most neuroleptics used was antagonized to some extent by biperiden, while the ptotic effect was hardly influenced. The antiavoidance effect of neuroleptics was differen tially antagonized by biperiden. The antiavoidance effect of haloperidol, trifluperidol and perphenazine was markedly antagonized and that of chlorpromazine moderately. However, the effect of thioridazine, chlorprothixene, levomepromazine and clozapine was little antagonized. In neuropharmacological tests, haloperidol, trifluperidol and perphenazine exhibited a selective antidopaminergic activity, while chlorprothixene, levomepromazine and clozapine showed antidopaminergic, antiadrenergic and also anticholinergic activities when similar doses were given. These results indicate that biperiden antagonism may be marked in the tests related to the extrapyramidal symp toms and in drugs liable to induce extrapyramidal side-effects, however, there would be little or no antagonism in drugs possessing the anticholinergic