DOCSLIB.ORG

Fluvoxamine: an Antidepressant for the Elderly?

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Fluvoxamine: an Antidepressant for the Elderly? Fluvoxamine: An Antidepressant for the Elderly? John M. Kellett Consultant Psychiatrist and Senior Lecturer, Department of Geriatric Medicine, St. George's Hospital & Medical School, London, England Though depression remains as common in the elderly as in Efficacy younger adults, it is more frequently accompanied and precipitated by physical illness (Murphy 1983). This Although it is becoming common practice to test efficacy combined with the normal changes of aging (eg. prostatic by comparison with an antidepressant of proven strength, hypertrophy, increased intraocular pressure, constipation, there is no substitute for a placebo-controlled study. Wakelin vertebrobasilar insufficiency and ischaemic heart disease) (1986) describes such a study in severely-depressed patients render this group especially susceptible to the side effects of over the age of 59. Following a 1-week placebo washout, 33 traditional tricyclic antidepressants (cholinergic blockade patients were given fluvoxamine at a mean dose of 161 mg, [Snyder and Yamamura 1977], postural hypotension [Muller and 14 patients were provided a placebo. By the second et al 1961], and cardiac arrhythmias [Moir et al 1972]), week, double blind assessment using the Hamilton particularly when taken in overdose. Though ECT is a safe Depression Scale, and a Clinical Global Improvement Scale, and effective remedy for this age group (Baldwin and Jolley indicated significantly greater (p<0.05) improvement in the 1986; Benbow 1989; Burvill et al 1991), the newer antide- active group, which remained throughout the trial of 4 weeks. pressants are often particularly suitable for this group. Double blind comparative trials of fluvoxamine have been The clinician will have a series of questions to be performed with imipramine (Wakelin 1986), mianserin (Keet answered before being prepared to add a new antidepressant et al 1989), and dothiepin (Ashford and Rahman 1990). The to a portfolio of therapeutics. trials are summarized in Table 2. Table 1 Comparison of fluvoxamine and placebo Hamilton & CGI scores (in parentheses) and % response at 4 weeks. N Pre Week 1 Week 2 Week 3 Week 4 Responders Fluvoxamine 33 24.7(4.8) 19.6(3.6) 15.6(2.8)* 12.4(2.4) 10.5(2.1)* 56.1* Placebo 14 25.4(4.7) 22.1(3.9) 21.9(3.5) 20.4(3.5) 19.4(3.1) 21.5 * difference from placebo significant at p<O.05 (Adapted from Wakelin 1986) Address reprint requests to: Dr. J.M. Kellett, St. George's Hospital Medical School, Cranmer Terrace, Tooting, London, SW17 ORE England J Psychiatr Neurosci, VoL 16, No. 2 (SuppL 1), 1991 July 1991 Fluvoxamine: An Antidepressantfor the Elderly? Z7 Table 2 Double blind comparative trials of fluvoxamine. Author Wakelin(1986) Keet et al(1989) Ashford and Rahman(1990) Fluvoxamine Imipramine Fluvoxamine Mianserin Fluvoxamine Dothiepin Number entered: 33 29 25 25 26 26 Number completed: 24 17 16 15 17 19 Ages (mean) 60-71(65) 60-70(66) (75.7) (76.7) 65-86(73) 61-85(75) Male Sex 9 6 10 6 6 6 Placebo washout: 1 week 1 week 1 week Mean dose 161mg 160mg 175mg 66mg Measures HAMD (CGI) MADRS (CGI) MADRS (CGI) Minimum Score 15 30 30 Score on entry 24.7 25.2 36 36 36 36 at week 1 19.6(3.6) 21.4(3.6) 31(3.4) 30(3.2) 29(3.6) 29(3.6) at week 2 15.6(2.8) 17.5(3.1) 28(2.8) 29(3.4) 25(3.2) 26(3.3) at week 3 12.4(2.4) 13.8(2.5) at week 4 10.5(2.1) 11.5(2.1) 25(2.7) 24(2.9) 15(2.2) 18(2.6) at week 5 23(2.8) 20(2.7) 13(1.8) 14(2.3) Although there are slight differences, such as the speed In a large, open study of 135 patients aged over 64, with with which the CGI (Clinical Global Improvement - lower a DSM III major depression and a MADRS score of at scores are better) became significantly different from the least 25, Houillon and Douge (1989) attempted to separate control and imipramine groups (week 3 for imipramine vs. the effects of fluvoxamine on individual symptom clusters. week 2 for fluvoxamine), and the fluvoxamine group shows Both the MADRS and the Tyrer scale for anxiety showed significantly greater improvement at week 2 compared to significant improvement in the first week, though the mianserin, a reasonable view is that these drugs are of antidepressant effect was more marked in the second week. comparable efficacy, with the possibility that fluvoxamine Apparent sadness, expressed sadness, tension, reduction of works more quickly. In the Wakelin study, by dividing the sleep, difficulty with concentration, attitude, inability to Hamilton scale into 6 factors there was a suggestion that feel, suicidal ideation, internal tension, unjustified anxiety, fluvoxamine acted more quickly on retardation, anxiety, and and muscular tension were significantly improved by day somatisation than imipramine. 7, while a reduction in pessimistic thoughts, hypochondri- Table 3 Percentage of patients with side effects (studies with older patients). Drug Fluvoxamine Dothiepin Mianserin Imipramine Placebo Author Tebbs & Houillon & Ahford & Keet Ashford & Keet Martin+ Douge+ Rahman et al Wakelin Rahman et al Wakelin Wakelin Number of patients 1096 133 26 25 32 26 25 29 14 Side Effect Nausea 15 13 23 0 41 12 12 10 20 Vomiting 5 8 0 4 - 0 4 - - Constipation <1 5 8 0 25 8 4 21 7 Dry mouth 3 6 4 - 25 15 - 52 21 Dizziness 7 6 19 12 9 15 8 24 0 Confusion <1 - - 4 - - 4 14 0 Asthenia 4 12* 4 0 - 12 4 - - Somnolence 4 - 8 8 16 8 16 25 17 * fatique; + open trial 28 Journal ofPsychiatry & Neuroscience Supplement I Vol. 16, No. 2,1l99 Table 4 Effects on the autonomic system. Fluvoxamine Amitryptilene Doxepin Salivary flow - 0.1 - 0.8 - 0.75** (differences from placebo in g./2 minutes) Pupil diameter + 0.25 - 0.75** - 0.6** (differences from placebo in mm.) Pulse rate standing - 3.5 + 4.2 + 4.7 (differences from placebo in beats/min) Systolic blood pressure standing + 3.3 - 0.5 - 9.4* (differences from placebo in mm. Hg.) Diastolic blood pressure standing - 0.3 - 0.8 - 4.5* (differences from placebo in mm. Hg.) * p<O.Ol; ** p<O.OOl (Adapted from Wilson et al 1983) asis, phobias, neurovegetative problems and pain improved of 150 mg of fluvoxamine on patients with hypertension, significantly by day 14. There was also significant loss of arrhythmias, and ischaemia and found no differences from appetite by this time. placebo. Roos and Sharp (1984) came to the same conclusion when comparing the effect of fluvoxamine with Unwanted Effects tricyclic antidepressants. Apart from the studies mentioned above, Tebbs and Indications Martin (1987) reported on an open trial with 1,096 patients over the age of 59 in general practice which provides a Despite a suspicion that serotonergic drugs may be source of information on most of the side effects. indicated for different types of depression than noradrenergic Though there was considerable variation in the incidence drugs, no evidence in support of this came from these studies of side effects between studies, a fair conclusion is that in the elderly. Nevertheless, the appetite suppressant effect of nausea occurs in about 1 in 7 patients, and 118 out of 1312 these drugs may be of value in those whose depression is (11I%) withdrew because of vomiting, though 98 of these associated with weight gain. The effects of this group of were from the general practice study. There was however, a drugs on obsessional symptoms, may make them especially striking lack of anticholinergic effects (constipation, dry effective where these are also present. Recent evidence that mouth, and confusion) which are particularly devastating in stimulation of 5HT la receptors reduces irritability (Coccaro the elderly. This might have been predicted from the study et al 1990) may give these drugs a further indication, by Curran et al (1986), who showed that 100 mg of fluvox- especially in conditions like dementia. It has even been amine had no effect on the ability of 9 healthy volunteers to suggested that the reduction in 5HT and 5HIAA in the brains learn and recall new information. of Alzheimer's patients might enable fluvoxamine to improve their mental function. One trial by Olafsson et al Toxic Effects (1988) of fluvoxamine in demented subjects demonstrated an improvement in 4 who could be distinguished by their poor Wilson et al (1983) studied the effects of fluvoxamine, prolactin response to TRH. amitriptyline and doxepin on the autonomic systems of 17 healthy, young volunteers, in maximum doses of 100 mg, CONCLUSIONS 75 mg and 75 mg respectively, at 3 hours. The authors concluded that fluvoxamine has little effect Despite sharing the side effects of all the 5HT specific on the autonomic system versus the comparison drugs, drugs of nausea, and occasional vomiting (side effects which though the ability of doxepin and amitryptilene to constrict diminish over a week or two), fluvoxamine is likely to prove the pupil, rendered elucidation difficult. a valuable antidepressant for the elderly. Its relatively short More serious from the point of view of overdose is the half life makes its use easier to regulate than fluoxetine, effect on the heart. Prager et al (1986) examined the effect which is also more likely to excite epilepsy. Bearing in mind July 1991 Fluvoxamine: An Antidepressantfor the Elderly? 29 that there were 2551 fatal overdoses of antidepressants in 10 Moir OC, Cornwell WB, Dingwall-Fordyce I, Crooks J, years in the U.K. (Cassidy and Henry 1987), its safety in O'Malley K, Tumbull MJ (1972) Cardiotoxicity of overdose which it shares with mianserin and lofepramine, and amitriptyline.
Load more

Recommended publications
  • Meta-Analysis of the Dose-Response Relationship of SSRI in Obsessive
    Molecular Psychiatry (2010) 15, 850–855 & 2010 Macmillan Publishers Limited All rights reserved 1359-4184/10 www.nature.com/mp ORIGINAL ARTICLE Meta-analysis of the dose-response relationship of SSRI in obsessive-compulsive disorder MH Bloch1, J McGuire1, A Landeros-Weisenberger1, JF Leckman1 and C Pittenger2 1Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA and 2Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA We sought to determine differences in efficacy and tolerability between different doses of selective serotonin reuptake inhibitors in the treatment of obsessive-compulsive disorder (OCD) using meta-analysis. We identified 9 studies involving 2268 subjects that were randomized, double-blind placebo-controlled clinical trials that compared multiple, fixed- doses of selective serotonin reuptake inhibitors (SSRIs) to each other and to placebo in the treatment of adults with OCD. Change in Y-BOCS score, proportion of treatment responders, and dropouts (all-cause and due to side-effects) were determined for each included study. Weighted mean difference was used to examine mean change in Y-BOCS score. Pooled absolute risk difference was used to examine dichotomous outcomes. Meta-analysis was performed using a fixed effects model in RevMan 4.2.8. We found that compared with either low or medium doses, higher doses of SSRIs were associated with improved treatment efficacy, using either Y-BOCS score or proportion of treatment responders as an outcome. Dose of SSRIs was not associated with the number of all-cause dropouts. Higher doses of SSRIs were associated with significantly higher proportion of dropouts due to side-effects.
    [Show full text]
  • A Synbiotic Mixture Augmented the Efficacy of Doxepin, Venlafaxine
    A synbiotic mixture augmented the efficacy of doxepin, venlafaxine, and fluvoxamine in mice model of depression Azadeh Mesripour1, Andiya Meshkati1, Valiolah Hajhashemi2 1Department of Pharmacology and Toxicology, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, IRAN. 2‐ Isfahan Pharmaceutical Sciences Research Center, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, IRAN. ABSTRACT Objective: Currently available antidepressant drugs have notable downsides; in addition to their side effects and slow onset of action their moderate efficacy in some individuals, may influence compliance. Previous literature has shown that probiotics may have antidepressant effects. Introducing complementary medicineproof in order to augment the efficacy of therapeutic doses of antidepressant drugs seems to be very important. Therefore the effect of adding a synbiotic cocktail in drinking water was assessed in mice model of despair following administrating three antidepressant drugs belonging to different classes. Methods: The marble burring test (MBT), and forced swimming test (FST) were used as animal model of obsessive behavior and despair. The synbiotic cocktail was administered in mice drinking water (6.25×106 CFU) for 14 days and the tests were performed on the days 7 and 14 thirty minutes after injecting the lowest dose of doxepin (1 mg/kg), venlafaxine (15 mg/kg), and fluvoxamine (15 mg/kg). Results: After 7 days of the synbiotic ingestion immobility time decreased in FST for doxepin (92 sec ± 5.5) and venlafaxine (17.3 sec ± 2.5) compared to their control group (drinking water) but fluvoxamine could decrease immobility time after 14 days of ingesting the synbiotic (70 sec ± 7.5).
    [Show full text]
  • Doxepin Exacerbates Renal Damage, Glucose Intolerance, Nonalcoholic Fatty Liver Disease, and Urinary Chromium Loss in Obese Mice
    pharmaceuticals Article Doxepin Exacerbates Renal Damage, Glucose Intolerance, Nonalcoholic Fatty Liver Disease, and Urinary Chromium Loss in Obese Mice Geng-Ruei Chang 1,* , Po-Hsun Hou 2,3, Wei-Cheng Yang 4, Chao-Min Wang 1 , Pei-Shan Fan 1, Huei-Jyuan Liao 1 and To-Pang Chen 5,* 1 Department of Veterinary Medicine, National Chiayi University, 580 Xinmin Road, Chiayi 60054, Taiwan; [email protected] (C.-M.W.); [email protected] (P.-S.F.); [email protected] (H.-J.L.) 2 Department of Psychiatry, Taichung Veterans General Hospital, 1650 Taiwan Boulevard (Section 4), Taichung 40705, Taiwan; [email protected] 3 Faculty of Medicine, National Yang-Ming University, 155 Linong Street (Section 2), Taipei 11221, Taiwan 4 School of Veterinary Medicine, National Taiwan University, 1 Roosevelt Road (Section 4), Taipei 10617, Taiwan; [email protected] 5 Division of Endocrinology and Metabolism, Show Chwan Memorial Hospital, 542 Chung-Shan Road (Section 1), Changhua 50008, Taiwan * Correspondence: [email protected] (G.-R.C.); [email protected] (T.-P.C.); Tel.: +886-5-2732946 (G.-R.C.); +886-4-7256166 (T.-P.C.) Abstract: Doxepin is commonly prescribed for depression and anxiety treatment. Doxepin-related disruptions to metabolism and renal/hepatic adverse effects remain unclear; thus, the underlying mechanism of action warrants further research. Here, we investigated how doxepin affects lipid Citation: Chang, G.-R.; Hou, P.-H.; change, glucose homeostasis, chromium (Cr) distribution, renal impairment, liver damage, and fatty Yang, W.-C.; Wang, C.-M.; Fan, P.-S.; liver scores in C57BL6/J mice subjected to a high-fat diet and 5 mg/kg/day doxepin treatment for Liao, H.-J.; Chen, T.-P.
    [Show full text]
  • A Synbiotic Mixture Augmented the Efficacy of Doxepin, Venlafaxine
    Turk J Pharm Sci 2020;17(3):293-298 DOI: 10.4274/tjps.galenos.2019.94210 ORIGINAL ARTICLE A Synbiotic Mixture Augmented the Efficacy of Doxepin, Venlafaxine, and Fluvoxamine in a Mouse Model of Depression Sinbiyotik Karışım, Fare Depresyon Modelinde Doksepin, Venlafaksin ve Fluvoksaminin Etkinliğini Artırdı Azadeh MESRIPOUR1*, Andiya MESHKATI1, Valiollah HAJHASHEMI2 1Isfahan University of Medical Sciences, School of Pharmacy and Pharmaceutical Sciences, Department of Pharmacology and Toxicology, Isfahan, Iran 2Isfahan University of Medical Sciences, School of Pharmacy and Pharmaceutical Sciences, Isfahan Pharmaceutical Sciences Research Center, Isfahan, Iran ABSTRACT Objectives: Currently available antidepressant drugs have notable downsides; in addition to their side effects and slow onset of action their moderate efficacy in some individuals may influence compliance. Previous literature has shown that probiotics may have antidepressant effects. Introducing complementary medicine in order to augment the efficacy of therapeutic doses of antidepressant drugs appears to be very important. Therefore, the effect of adding a synbiotic mixture to drinking water was assessed in a mouse model of depression following the administration of three antidepressant drugs belonging to different classes. Materials and Methods: The marble burying test (MBT) and forced swimming test (FST) were used as animal models of obsessive behavior and despair. The synbiotic mixture was administered to the mice’s drinking water (6.25x106 CFU) for 14 days and the tests were performed 30 min after the injection of the lowest dose of doxepin (1 mg/kg), venlafaxine (15 mg/kg), and fluvoxamine (15 mg/kg) on days 7 and 14. Results: After 7 days of ingestion of the synbiotic mixture, immobility time decreased in the FST for doxepin (92±5.5 s) and venlafaxine (17.3±2.5 s) compared to the control group (drinking water), but fluvoxamine decreased immobility time after 14 days of ingestion of the synbiotic mixture (70±7.5 s).
    [Show full text]
  • Impact of Citalopram and Fluvoxamine on Platelet Response To
    S24_5 Impact of Citalopram and Fluvoxamine on Platelet Response to Clopidogrel, a Randomized, Double-blind, Crossover Trial Bruria Hirsh Racch1, Galia Spectre2, Ella Shai2, Amit Ritter3, David Varon2, Ronny Alcalai3 1School of Pharmacy, Hadassah Hebrew University Medical Center, Israel 2Coagulation Unit, Hematology, Hadassah Hebrew University Medical Center, Israel 3Heart Institute, Hadassah Hebrew University Medical Center, Israel Background: Selective serotonin reuptake inhibitors (SSRI) are widely used antidepressant agents. Studies have shown that use of SSRI in combination with aspirin or warfarin is associated with an increased risk bleeding, while little information is known about the interaction of SSRIs and clopidogrel. Fluvoxamine and citalopram are both SSRIs and while fluvoxamine is an inhibitor of CYP2C19 and thus might reduce the efficacy of clopidogrel, the effect of citalopram on liver metabolism is unknown. Aim: The aim was to assess the effect these two different SSRIs on platelet aggregation and on the laboratory response to clopidogrel. Methods: A randomized, double-blind, crossover study in 15 healthy volunteers comparing the antiplatelet effect of clopidogrel with and without fluvoxamine or citalopram .The response to clopidogrel was assessed by Light Transmittance Aggregometry with10µmol/L ADP and by vasodilator-stimulated phosphoprotein (VASP) phosphorylation, a measure of P2Y12 receptor reactivity. Results: Mean baseline platelet aggregation was 80.1%±3.4 and reduced to 23.5% after treatment with clopidogrel. Both fluvoxamine and citalopram had modest effect on platelet reactivity (65.8%±6.4, p=0.06 vs. baseline and 67.3%±6.3, p=0.07 vs. baseline respectively). Laboratory response to clopidogrel was significantly better in the presence of citalopram as compared to fluvoxamine both in aggregometry (23.4%±3 vs.
    [Show full text]
  • Fluvoxamine Maleate Tablets Safely and Effectively
    Highlights Of Prescribing Information hypotension or seizures (5.7). Methadone: Coadministration may produce These highlights do not include all the information needed to use opioid intoxication. Discontinuation of fluvoxamine may produce opioid Fluvoxamine Maleate Tablets safely and effectively. See full prescribing withdrawal (5.7). Mexiletine: Monitor serum mexiletine levels (5.7). information for Fluvoxamine Maleate Tablets. Ramelteon: Should not be used in combination with fluvoxamine (5.7). Theophylline: Clearance decreased; reduce theophylline dose by one-third Fluvoxamine Maleate Tablets for oral administration (5.7). Warfarin: Plasma concentrations increased and prothrombin times Initial U.S. Approval: 1994 prolonged; monitor prothrombin time and adjust warfarin dose accordingly Warning: Suicidality and Antidepressants (5.7). Other Drugs Affecting Hemostasis: Increased risk of bleeding with See full prescribing information for complete boxed warning. concomitant use of NSAIDs, aspirin, or other drugs affecting coagulation (5.7, Increased risk of suicidal thinking and behavior in children, adolescents, and 5.9). See Contraindications (4). Discontinuation: Symptoms associated with young adults taking antidepressants for major depressive disorder and other discontinuation have been reported (5.8). Abrupt discontinuation not psychiatric disorders. Fluvoxamine Maleate Tablets are not approved for use in recommended. See Dosage And Administration (2.8). pediatric patients except those with obsessive compulsive disorder (5.1). Activation
    [Show full text]
  • Luvox and Luvox CR (Fluvoxamine)
    23 Luvox and Luvox CR (fluvoxamine) Generic name: Fluvoxamine Available strengths: 25 mg, 50 mg, 100 mg tablets; 100 mg, 150 mg sustained-release capsules (Luvox CR) Available in generic: Yes Drug class: Selective serotonin reuptake inhibitor antidepressant General Information Luvox (fluvoxamine) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder (OCD) and social aniety disorder, but not depression. The use of a medication for its approved indications is called its labeled use. In clinical practice, however, physicians often prescribe medications for unlabeled (“off-label”) uses when published clinical studies, case reports, or their own clinical experiences support the efficacy and safety of those treatments. Physicians may use Luvox for treatment of major depression, panic disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, nocturnal enuresis (incontinence of urine) in children, and bulimia nervosa. Luvox is a serotonin-specific medication that works by blocking the reuptake of the neurotransmitter se- rotonin back into brain cells, thereby increasing its levels in the brain. OCD, depression, and other mental disorders may be caused by abnormally low levels of serotonin. This abnormality may in turn produce changes in affected areas of the brain, resulting in psychiatric symptoms such as depression or anxiety. The presumed action of Luvox and other selective serotonin reuptake inhibitors (SSRIs) is to increase serotonin levels, which may help to restore those areas of the brain to normal functioning. OCD may also be successfully treated with other SSRIs as well as the tricyclic antidepressant (TCA) Anafranil (clomipramine). Dosing Information The recommended starting dose of Luvox is 50 mg as a single bedtime dose.
    [Show full text]
  • A Meta-Analysis
    who had smoked for more than 30 years. Moreover, Key messages breast cancer will occur eight years earlier in smokers than in non-smokers. This finding could support the * Breast cancer is the commonest cancer in women throughout the world, hypothesis ofa direct carcinogenic effect oftobacco. and its incidence is increasing * It has been suggested that smoking protects against breast cancer because This study was financially supported by the Niels Jensen of an antioestrogenic effect Foundation and Hj0rring District Hospital. * This study shows, however, that women who have smoked for more than 1 MacMahon B, Trichopoules D, Cole P, Brown J. Cigarette smoking and 30 years have an increased risk ofdeveloping breast cancer urinary estrogens. NEnglJMed 1982;307:1062-5. 2 Baron JA, LaVecchia C, Levi F. The antiestrogenic effect of cigarette smoking * Moreover, smokers with breast cancer were eight years younger than in women. Amy Obstet Gynecol 1990;162:502-14. non-smokers with breast cancer 3 Petrakis NL, Maack CA, Lee RE, Jyon M. Mutagenic activity in nipple aspirates ofhuman breast fluid. Cancer Res 1980;40:188-9. 4 Hiatt RA, Fireman BH. Smoking, menopause, and breast cancer. J Natl Cancer Inst 1986;76:833-8. than those in 5 Palmer JR, Rosenberg L. Cigarette smoking and the risk of breast cancer. included our model-for example, EpidemiolRev 1993;5:145-56. alcohol, diet, body size, and use of oral contraception 6 Hosmer DW, Lemeshow S. Applied logistic regression. New York: John Wiley, -have been studied extensively.' 02 The associations 1989. 7 Osler M. Danskernes rygevaner [Smoking habits of Danes].
    [Show full text]
  • ROZEREM Safely and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Reproductive effects: Include decreased testosterone and increased These highlights do not include all the information needed to use prolactin levels. Effect on reproductive axis in developing humans is ROZEREM safely and effectively. See full prescribing information for unknown. (5.5) ROZEREM. • Patients with severe sleep apnea: ROZEREM is not recommended for use in this population. (5.6) ROZEREM (ramelteon) tablets, for oral use Initial U.S. Approval: 2005 --------------------------------ADVERSE REACTIONS------------------------------ Most common adverse reactions (≥3% and more common than with --------------------------INDICATIONS AND USAGE------------------------------- placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated ROZEREM is indicated for the treatment of insomnia characterized by insomnia. (6.1) difficulty with sleep onset. (1) To report SUSPECTED ADVERSE REACTIONS, contact Takeda -----------------------DOSAGE AND ADMINISTRATION------------------------ Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1- • Adult dose: 8 mg taken within 30 minutes of going to bed. (2.1) 800-FDA-1088 or www.fda.gov/medwatch. • Should not be taken with or immediately after a high-fat meal. (2.1) • Total daily dose should not exceed 8 mg. (2.1) --------------------------------DRUG INTERACTIONS-------------------------------- • Rifampin (strong CYP enzyme inducer): Decreases exposure to and ----------------------DOSAGE FORMS AND STRENGTHS---------------------- effects of ramelteon.
    [Show full text]
  • Escitalopram Oxalate
    HIGHLIGHTS OF PRESCRIBING INFORMATION --------------WARNINGS AND PRECAUTIONS------------­ These highlights do not include all the information Clinical Worsening/Suicide Risk: Monitor for clinical needed to use Lexapro® safely and effectively. See full worsening, suicidality and unusual change in behavior, prescribing information for Lexapro®. especially, during the initial few months of therapy or at times of dose changes (5.1). Lexapro® (escitalopram oxalate) Tablets Serotonin Syndrome: Serotonin syndrome has been Lexapro® (escitalopram oxalate) Oral Solution reported with SSRIs and SNRIs, including Lexapro, both Initial U.S. Approval: 2002 when taken alone, but especially when co-administered WARNING: Suicidality and Antidepressant Drugs with other serotonergic agents (including triptans, See full prescribing information for complete boxed tricyclic antidepressants, fentanyl, lithium, tramadol, warning. tryptophan, buspirone, amphetamines, and St. John’s Increased risk of suicidal thinking and behavior in Wort). If such symptoms occur, discontinue Lexapro and children, adolescents and young adults taking initiate supportive treatment. If concomitant use of antidepressants for major depressive disorder (MDD) Lexapro with other serotonergic drugs is clinically and other psychiatric disorders. Lexapro is not warranted, patients should be made aware of a potential approved for use in pediatric patients less than 12 increased risk for serotonin syndrome, particularly during years of age (5.1). treatment initiation and dose increases (5.2). Discontinuation of Treatment with Lexapro: A gradual reduction in dose rather than abrupt cessation is -------------------RECENT MAJOR CHANGES---------------- recommended whenever possible (5.3). Warnings and Precautions (5.2) 1/2017 Seizures: Prescribe with care in patients with a history of seizure (5.4). --------------INDICATIONS AND USAGE------------------- Activation of Mania/Hypomania: Use cautiously in Lexapro® is a selective serotonin reuptake inhibitor (SSRI) patients with a history of mania (5.5).
    [Show full text]
  • Escitalopram
    Application for Inclusion to the 21st Expert Committee on the Selection and Use of Essential Medicines: ESCITALOPRAM December 7, 2018 Submitted by: Iona K. Machado, M.D., Csilla Lippert, M.D.,Ph.D.., Ricardo Lozano, M.D., Michael J. Ostacher, M.D., MPH, MMSc Primary Contact: Iona K. Machado, M.D., +1-650-721-4421, [email protected] 1 TABLE OF CONTENTS Page 3 1. Summary Statement Page 4 2. Focal Point Person in WHO Page 5 3. Name of the Submitting Organization Page 6 4. International Proprietary Name Page 7 5. Formulation Proposed for Inclusion & Current Availability Page 10 6. Listing Requested Page 11 7. Treatment Details Page 16 8. Public Health Relevance Page 19 9. Comparative Efficacy Page 23 10. Comparative Safety Page 43 11. Comparative Cost-Effectiveness Page 50 12. Regulatory Status Page 51 13. Pharmacoepial Standards Page 52 14. References Page 61 APPENDIX: Letters of Support 2 1. Summary statement of the proposal for inclusion of escitalopram This is a proposal to include escitalopram on the core WHO Model List of Essential Medications (EML) to treat adults age 18+ with major depressive disorder. The latest EML includes a member of the tricyclic antidepressant (TCA) class, amitriptyline, and one member of the selective serotonin reuptake inhibitor (SSRI) class, fluoxetine. We provide a review of evidence on efficacy, safety, availability, and cost-effectiveness of escitalopram, another member of the SSRI class, for the treatment of depression in adults. Escitalopram was first introduced to market in 2002 in the United States and has become a generically available product as of 2012.
    [Show full text]
  • Antidepressants: Mechanism of Action, Toxicity and Possible Amelioration
    Journal of Applied Biotechnology & Bioengineering Research Article Open Access Antidepressants: mechanism of action, toxicity and possible amelioration Abstract Volume 3 Issue 5 - 2017 Depression being a state of sadness may be defined as a psychoneurotic disorder Khushboo, Sharma B characterised by mental and functional activity, sadness, reduction in activity, Department of Biochemistry, University of Allahabad, India difficulty in thinking, loss of concentration, perturbations in appetite, sleeping, and feelings of dejection, hopelessness and generation of suicidal tendencies. It Correspondence: B Sharma, Department of Biochemistry, is a common and recurrent disorder causing significant morbidity and mortality University of Allahabad, Allahabad 211002, UP, India, worldwide. The antidepressant compounds used against depression are reported to Email [email protected] be used also for treating pain, anxiety syndromes etc. They have been grouped in five different categories such as Received: June 29, 2017 | Published: September 01, 2017 i. Tricyclic antidepressants (TCAs) ii. Selective serotonin-reuptake inhibitors (SSRIs) iii. Monoamine oxidase inhibitors (MAOIs) iv. Serotonin-norepinephrine reuptake inhibitor (SNRI) and v. Non-TCA antidepressants based on their mode of action. Most of the antidepressants have been reported to possess adverse effects on the health of users. The present review article focuses on an updated current of antidepressants, their mechanism of actions, pathophysiology of these compounds, their side effects and
    [Show full text]