MHM Magazine

S5 VOXRA XL 150/300 extended-release tablets (Reg. No. 41/1.2/0373 & 0374 respectively). Each tablet contains 150 mg/300 mg of bupropion hydrochloride respectively. INDICATIONS: Treatment of depression as defined by DSM IV Criteria. CONTRA-INDICATIONS: Patients under 18 years; hypersensitivity to any component of the preparation; in patients with a seizure disorder; should not be administered with any other preparation containing bupropion; abrupt discontinuation of alcohol or sedatives; current or previous diagnosis of bulimia or anorexia nervosa; concomitant administration with MAOIs; liver disease (Child-Pugh grades B and C, range 7-13). WARNINGS AND SPECIAL PRECAUTIONS: Recommended dose should not be exceeded. Should not administer to patients with one or more conditions predisposing to a lowered seizure threshold, including history of head trauma, CNS tumour, history of seizures, concomitant administration of medications known to lower the seizure threshold, excessive use of alcohol or sedatives, diabetes treated with hypoglycaemics or insulin & use of stimulants or anorectic products. Caution should be used in circumstances associated with an increased risk of seizures. Should be discontinued & not recommenced in patients who experience a seizure while on treatment. Observe patients closely for clinical worsening & suicidality, especially at the beginning of therapy, or at the time of dose changes, either increases or decreases. Symptoms reported in patients treated with antidepressants: anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia, hypomania & mania. Consideration should be given to changing the therapeutic regimen, including possible discontinuation, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Neuropsychiatric symptoms, in particular, psychotic and manic symptomatology has been observed, mainly in patients with a history of psychiatric illness. Aggression, rage and violent behaviour may occur. Prior to initiating treatment, patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Safety & efficacy in patients under 18 years not established. Discontinue treatment promptly if patients experience hypersensitivity reactions during treatment. Symptoms may persist after discontinuation & clinical management should be provided accordingly.Treatment in renal impairment should be initiated at reduced dosage. Should be used with caution in patients with mild hepatic impairment and reduced frequency of dosing should be considered. Closely monitor patient for possible adverse effects that could indicate elevated blood & tissue levels of drug & metabolites.A reduced frequencyofdosingmayberequired in theelderly.Cautionshouldbeexercised inpatientswithcardiovasculardisease.Exercisecautionbeforedrivingoruseofmachineryuntilcertainofeffects. INTERACTIONS: Concomitant therapy with certain betablockers, anti-arrhythmics, SSRIs, TCAs, antipsychotics & medication metabolised by CYP2D6 should be initiated at the lower end of the dose range of the concomitant medication. Citalopram. Coadministration of drugs known to induce metabolism (e.g. carbamazepine, phenobarbitone, phenytoin) or inhibit metabolism may affect its clinical activity. Ritonavir reduces bupropion exposure. Consumption of alcohol should be minimised/ avoided. Concurrent treatment with either levodopa or amantadine should be with caution. Concomitant use with Nicotine Transdermal System (NTS) may result in elevations of blood pressure. PREGNANCY & LACTATION: Safety not established. Epidemiological studies following maternal exposure in the first trimester have reported an association with increased risk of some congenital cardiovascular malformations, including ventricular septal defects and left ventricular outflow tract defects. Mothers should be advised not to breastfeed. DOSAGE AND DIRECTIONS FOR USE: The initial dose is 150 mg taken as a single daily dose in the morning. Patients not responding to this dose may be increased to 300 mg/day, given once daily. Tablets should be swallowed whole and not cut, crushed or chewed. When switching patients from SR tablets to XL tablets, give the same total daily dose when possible. A reduced frequency of dosing should be considered in patients with mild hepatic impairment. Children and Adolescents: Contraindicated in children or adolescents aged less than 18 years. Elderly: A reduced frequency and/ or dose may be required. Renal Impairment: Treatment should be initiated at a reduced frequency and/or dose. Liver Impairment: Use with caution in patients with mild liver impairment - a reduced frequency of dosing should be considered. Contra-indicated in patients with moderate to severe hepatic cirrhosis. SIDE EFFECTS: Very common: weight loss, insomnia, headache. Common: hypersensitivity reactions such as urticaria, anorexia, agitation, anxiety, tremor, dizziness, taste disorders, visual disturbance, tinnitus, increased blood pressure (sometimes severe), flushing, dry mouth, gastrointestinal disturbance including nausea and vomiting, abdominal pain, constipation, rash, pruritus, sweating, fever, asthenia, chest pain. Uncommon: confusion, depression, concentration disturbance, tachycardia. Other: more severe hypersensitivity reactions including angioedema, dyspnoea/bronchospasm and anaphylactic shock. Arthralgia, myalgia and fever have also been reported in association with rash and other symptoms suggestive of delayed hypersensitivity; blood glucose disturbances; aggression, hostility, irritability, restlessness, hallucinations, abnormal dreams, depersonalisation, delusions, paranoid ideation; seizures, dystonia, ataxia, parkinsonism, incoordination, memory impairment, paraesthesia, syncope; palpitations; vasodilation, postural hypotension; elevated liver enzymes, jaundice,hepatitis; errythema multiforme and Stevens Johnson syndrome; twitching; urinary frequency and/or retention. MANAGEMENT OF OVERDOSAGE: Hospitalisation is advised. ECG and vital signs should be monitored. Ensure an adequate airway, oxygenation & ventilation. Gastric lavage may be indicated if performed soon after ingestion.The use of activated charcoal is also recommended. No specific antidote is known. For full prescribing information refer to the professional information approved by the medicines regulatory authority (03/2013). Trade marks are owned by or licenced to the GSK group of companies. © 2022 Aspen Group of companies or its licensor. All rights reserved. HCR: GlaxoSmithKline South Africa (Pty) Ltd. (Co. reg. no. 1948/030135/07), 39 Hawkins Ave, Epping Industria 1, 7460. Marketed by Aspen Pharmacare. Healthcare Park, Woodlands Drive, Woodmead, 2191. ZAR-BUR-02-22-00001 03/2022 MEVOX2432 REFERENCES: 1. IMS TPM Data, January 2020. 2. Hewett K, Chrzanowski W, Jokinen R, et al. Double-blind, placebo-controlled evaluation of extended-release bupropion in elderly patients with major depressive disorder. J Psychopharmacol 2009; OnlineFirst, published on January 22, 2009 as doi:10.1177/0269881108100254. 3. Clayton AH, Croft HA, Horrigan JP, et al . Bupropion Extended Release Compared With Escitalopram: Effects on Sexual Functioning and Antidepressant Efficacy in 2 Randomized, Double-Blind, Placebo-Controlled Studies. J Clin Psych 2006; 67(5):736-746. 4. Cooper JA, Tucker VL, Papakostas GI. Resolution of sleepiness and fatigue: A comparison of bupropion and selective serotonin reuptake inhibitors in subjects with major depressive disorder achieving remission at doses approved in the European Union. J Psychopharmacol 2014; 28(2) 118–124. 5. Fava M, Rush AJ,Thase ME, et al . 15 Years of Clinical Experience With Bupropion HCl: From Bupropion to Bupropion SR to Bupropion XL . Prim Care Companion J Clin Psych 2005; 7(3):106-113. 6. Stahl SM, Pradko JF, Haight BR, et al. A Review of the Neuropharmacology of Bupropion, a Dual Norepinephrine and Dopamine Reuptake Inhibitor. Prim Care Companion J Clin Psych 2004; 6(4):159-166. All adverse events should be reported by calling the Aspen Medical Hotline number or directly to GlaxoSmithKline on +27 10 300-1000. Offering a distinctive pharmacological profile aimed at dopamine and noradrenaline neurotransmitter systems 5,6 “Yesterday is not ours to recover, but tomorrow is ours to win or lose’’ Lyndon B. Johnson Aligned for a targeted victory in depression * 1,2,3,4 S5 The 1st and only WELLBUTRIN XL clone 1 V O X R A X L W E L L B U T R I N X L * as defined by DSM IV Criteria