Manage the Triad of Depression, Anxiety & Chronic Pain
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For the Use of a Registered Medical Practitioner or a Hospital or a Laboratory Only Manage the Triad of Depression, Anxiety & Chronic Pain • Reduces anxiety & depressive symptoms from day 41 • Reduces pain reception by blocking NMDA receptors2 INDPRT173558 22 DEC 2017 Ref: 1. Ramakrishnan K, et al. Clinical experience with dothiepin in an Indian population. J Drug Dev 1991;4(3):151-159. 2. Huizinga M. Painful Diabetic Neuropathy: A Management-Centered Review. Clin Diabet 2007;25(1):6-25. Abbreviated Prescribing Information Dosulepin Tablets BP (Formerly Dothiepin tablets BP) PROTHIADENTM COMPOSITION Each film coated tablet contains Dosulepin Hydrochloride B.P. 25 mg Each film coated tablet contains Dosulepin Hydrochloride B.P. 75 mg INDICATION For the treatment of symptoms of depressive illness, especially where an anti-anxiety effect is required. For the treatment of chronic pain. DOSAGE AND ADMINISTRATION Depression: 25 to 50 mg three times daily or 75 to 150 mg as a single dose at night. Chronic Pain: 50 to 150mg once a day orally CONTRAINDICATIONS Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias, for the treatment of mania, for patients with severe liver disease, for patients with known hypersensitivity to Dosulepin hydrochloride or any of the excipients. WARNINGS & PRECAUTIONS Suicide/suicidal thoughts or clinical worsening, Avoid use in patients with a history of epilepsy, thyroid disease, mania or urinary retention and in those with narrow-angle glaucoma or symptoms suggestive of prostatic hypertrophy. PREGNANCY & LACTATION Safe use of Dosulepin Hydrochloride in pregnancy and lactation has not been adequately studied. ADVERSE REACTIONS The following adverse effects, although not necessarily all reported with Dosulepin, have occurred with other tricyclic antidepressants: Bone marrow depression, agranulocytosis, Hypersensitivity reactions, Inappropriate antidiuretic hormone (ADH) secretion, Hyponatremia, Psychotic manifestations, including mania and paranoid delusions, may be exacerbated during treatment with tricyclic antidepressants, Tremors, drowsiness, convulsions, movement disorders, Postural hypotension, dyspepsia, skin rashes, sweating Issued on: 16 Dec 2016 Source : Prepared based on full prescribing information (version -2 dated Oct 2015) TM Trademark of the Abbott India Limited For full prescribing information, please contact: Abbott India Limited, 16th Floor, Godrej BKC, Plot – C, “G” Block, Bandra-Kurla Complex, Bandra (East), Mumbai – 400 051 India Abbott India Limited 16th Floor, Godrej BKC, Plot C-68, “G” Block, BKC, Near MCA Club, Bandra (E), Mumbai, Maharashtra 400051, India For the Use of a Registered Medical Practitioner or a Hospital or a Laboratory Only PSYCHIATRY Dosulepin: Role in the Management of Depression, Manage the Triad of Depression, Anxiety and Chronic Pain Anxiety & Chronic Pain SAJJAN SINGH ABSTRACT Depression has high global prevalence and is associated with anxiety and chronic pain. Impairment of neurotransmitters such as serotonin and noradrenaline may lead to the triad (depression, anxiety and pain). Tricyclic antidepressants (TCAs) inhibit the reuptake of these neurotransmitters and are ideal for the treatment of the triad on account of high efficacy and low cost. Dosulepin or dothiepin hydrochloride, a TCA, is structurally a thio-analogue of amitriptyline and is considered better than other TCAs. Many clinical studies have reported dosulepin as an antidepressant, anxiolytic and analgesic. However, limited data are available to support the clinical use of dosulepin for the treatment of the triad. Even the available guidelines present debatable recommendations on the clinical use of dosulepin. Thus, the present review emphasizes on the role of dosulepin in the management of the triad along with description of guideline recommendations about dosulepin. Keywords: Analgesic, antidepressant, chronic pain, dosulepin • Reduces anxiety & depressive epression has a high prevalence worldwide Society and American College of Physicians guidelines 1 symptoms from day 4 with considerably increased rates of morbidity also support the use of TCAs in relieving low back and mortality. About 340 million people suffer pain.7 TCAs have demonstrated good clinical response D 1 from depression at any given time at a global level. in neuropathic pain, headaches, low back pain, • Reduces pain reception by In India, the prevalence of depression is 9%, whereas fibromyalgia and irritable bowel syndrome (IBS).8 2 2 the prevalence of major depressive episode is 36%. A systematic review by Mikocka-Walus et al also blocking NMDA receptors Depression is observed more frequently in urban concluded that TCAs decreased pain, gut irritability females between 40 and 49 years of age, as compared and urgency of defecation successfully.9 to males. However, elevated rates (3.5%) of depression Dosulepin (International Nonproprietary Name; are also reported among the elderly.3 Approximately INN and British Approved Name; BAN) also known 85% of patients with depression also experience as dothiepin hydrochloride (United States Adopted symptoms of anxiety, whereas 70% of patients with Names; USAN), is one of the first-generation TCAs depression and anxiety also experience the ill effects which exhibits antidepressant and anxiolytic action. It is of chronic pain, as depression is an indicator of one of the most commonly used drugs for chronic pain persevering pain. Disabled functioning, brought about too.10-13 The present review article emphasizes on the by pain, may prompt social seclusion, which may role of dosulepin in the triad of depression, anxiety and ultimately lead to a negative impact on depression. chronic pain along with description of the guideline The psychological and physical distress of persistent 4-6 recommendations about dosulepin. INDPRT173558 22 DEC 2017 pain may also cause an episode of major depression. Ref: 1. Ramakrishnan K, et al. Clinical experience with dothiepin in an Indian population. J Drug Dev 1991;4(3):151-159. 2. Huizinga M. Painful Diabetic Neuropathy: A Management-Centered Review. Clin Tricyclic antidepressants (TCAs), on account of their INTERRELATIONSHIP BETWEEN DEPRESSION, ANXIETY Diabet 2007;25(1):6-25. high efficacy and low cost, are preferred for the AND CHRONIC PAIN Abbreviated Prescribing Information treatment of pain and depression. The American Pain Dosulepin Tablets BP (Formerly Dothiepin tablets BP) PROTHIADENTM The pathophysiological pathways for depression and COMPOSITION Each film coated tablet contains Dosulepin Hydrochloride B.P. 25 mg Each film coated tablet contains Dosulepin Hydrochloride B.P. 75 mg INDICATION For the treatment of symptoms of depressive illness, especially where an anti-anxiety effect is required. For the treatment of chronic pain. DOSAGE AND ADMINISTRATION Depression: 25 to 50 mg three times daily or 75 to 150 mg as a single anxiety disorders are similar to those causing pain. dose at night. Chronic Pain: 50 to 150mg once a day orally CONTRAINDICATIONS Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias, for the treatment of mania, for patients Various brain areas such as periaqueductal gray, with severe liver disease, for patients with known hypersensitivity to Dosulepin hydrochloride or any of the excipients. WARNINGS & PRECAUTIONS Suicide/suicidal thoughts or clinical worsening, Avoid use in amygdala and hypothalamus play a major role in patients with a history of epilepsy, thyroid disease, mania or urinary retention and in those with narrow-angle glaucoma or symptoms suggestive of prostatic hypertrophy. PREGNANCY & LACTATION Safe use Practising Psychiatrist of Dosulepin Hydrochloride in pregnancy and lactation has not been adequately studied. ADVERSE REACTIONS The following adverse effects, although not necessarily all reported with Dosulepin, have depression, anxiety and pain. Stress increases the occurred with other tricyclic antidepressants: Bone marrow depression, agranulocytosis, Hypersensitivity reactions, Inappropriate antidiuretic hormone (ADH) secretion, Hyponatremia, Psychotic Burnpur IISCO Hospital, Burnpur, Asansol, West Bengal manifestations, including mania and paranoid delusions, may be exacerbated during treatment with tricyclic antidepressants, Tremors, drowsiness, convulsions, movement disorders, Postural hypotension, Address for correspondence release of corticotropin-releasing hormone (CRH) dyspepsia, skin rashes, sweating Issued on: 16 Dec 2016 Source : Prepared based on full prescribing information (version -2 dated Oct 2015) TM Trademark of the Abbott India Limited For full prescribing Dr Sajjan Singh information, please contact: Burnpur IISCO Hospital, Burnpur, Asansol, West Bengal - 713 325 which prompts overproduction of adrenocorticotropic Abbott India Limited, 16th Floor, Godrej BKC, Plot – C, “G” Block, Bandra-Kurla Complex, Bandra (East), Mumbai – 400 051 India E-mail: [email protected], [email protected] hormone (ACTH) and glucocorticoids (GC). Prolonged Abbott India Limited 16th Floor, Godrej BKC, Plot C-68, “G” Block, BKC, Near MCA Club, Bandra (E), Mumbai, Maharashtra 400051, India 955 Indian Journal of Clinical Practice, Vol. 28, No. 10, March 2018 release of GC brings about more considerable Table 1. Pharmacokinetic Properties of Dosulepin hippocampal harm by causing neuron death, gliosis Molecular formula C H NS and atrophied perikaryal and decreases the release 19 21 IUPAC* name (3Z)-3-(6H-benzo[c][1]benzothiepin-