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Adverse Events – causality not establishedVery rare cases of the following adverse events have been reported in post-marketingexperience, but no causal link between these events and duloxetine has been established.Abnormal bleeding events e.g. intracerebral, gastrointestinal; blood dyscrasias; cardiacevents e.g., myocardial infarction and ventricular arrhythmias; pancreatitis; renalimpairment; rhabdomyolysis; skin reactions especially in regards to subcutaneous tissuedisorderDiscontinuation SymptomsThe most commonly reported symptoms following abrupt or tapered discontinuation ofduloxetine in clinical trials have included dizziness, nausea, headache, paraesthesia,fatigue vomiting, irritability, nightmares, insomnia, diarrhoea, anxiety, hyperhidrosis,vertigo, somnolence and myalgia. (see PRECAUTIONS).DOSAGE AND ADMINISTRATIONMajor Depressive DisorderCYMBALTA should be administered for the treatment of major depressive disorder at adose of 60 mg once daily, with or without food. There is no adequate evidencesuggesting that patients not responding to 60 mg once daily will benefit from having theirdose increased.Diabetic Peripheral Neuropathic PainThe starting and maintenance dose of CYMBALTA in diabetic peripheral neuropathicpain is 60 mg once daily. As the progression of diabetic neuropathy is highly variableand management of pain is empirical, effectiveness of CYMBALTA should be assessedon an individual basis.Generalised Anxiety DisorderThe recommended starting dose of CYMBALTA in patients with generalized anxietydisorder is 30 mg once daily with or without food. The daily dose should be increased in30 mg increments until the minimum effective dose is achieved. The maximum dose is120 mg per day, given as 120 mg once daily. Doses above 120 mg have not beensystematically evaluated.Initial TolerabilityFor patients in whom initial tolerability may be a concern, such as treatment-naïvepatients or those with a history of adverse events with other medications, use of a lowerstarting dose such as 30 mg once daily for one week before increasing the dose to 60 mgonce daily should be considered. A dose of 30 mg once daily should be used in patientswith end stage renal disease (see below). In addition, clinical studies have shown thattaking CYMBALTA with food may improve initial tolerability.Discontinuation of treatmentWhen discontinuing CYMBALTA after more than one week of therapy it is generallyCymbalta PI Nov 2012 v8.0 28
ecommended that the dose be tapered to minimise the risk of discontinuation symptoms.As a general recommendation, the dose of CYMBALTA should be reduced by half oradministered on alternate days during a period of not less than two weeks. The preciseregimen followed should take into account the individual circumstances of the patient,such as duration of treatment, dose at discontinuation, etc.Renal ImpairmentA lower dose of 30 mg once daily should be used in patients with end stage renal disease(creatinine clearance < 30 mL/min) (see Pharmacokinetics).Hepatic ImpairmentCYMBALTA is contraindicated in patients with liver disease resulting in hepaticimpairment (see Pharmacokinetics).Patients aged ≥ 65 yearsNo dosage adjustment is recommended for elderly patients on the basis of age (seePharmacokinetics).Children and adolescents aged < 18 yearsDuloxetine is not indicated for use in patients under 18 years of age (seePRECAUTIONS)OVERDOSAGEOn the available evidence there is a wide margin of safety in overdose. In premarketingclinical trials, cases of acute ingestions up to 1400 mg, alone or in combination with otherdrugs, have been reported and have not been fatal. However in post marketingexperience, fatal outcomes have been reported for acute overdoses, primarily with mixedoverdoses, but also with duloxetine only, at doses as low as approximately 1000 mg. ..Signs and symptoms of overdose (most with mixed drugs) included serotonin syndrome,somnolence, vomiting and seizures.In animal studies, the major signs of overdose toxicity are related to the CNS and gastrointestinalsystems. Signs of toxicity include CNS effects such as tremors, clonicconvulsions, ataxia, emesis, and decreased appetite.Management of Overdose - No specific antidote is known, but if serotonin syndromeensues, specific treatment (such as with cyproheptadine and/or temperature control) maybe considered. An airway should be established. Monitoring of cardiac and vital signs isrecommended, along with appropriate symptomatic and supportive measures. Activatedcharcoal may be useful in limiting absorption. Duloxetine has a large volume ofdistribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely tobe beneficial.Contact your local Poisons Information Centre for information on the management ofoverdose with duloxetine.Cymbalta PI Nov 2012 v8.0 29
Page 1 and 2: CYMBALTA ®(duloxetine hydrochlorid
Page 3 and 4: metabolites circulating in plasma a
Page 5 and 6: evaluation of efficacy of duloxetin
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Page 12 and 13: those receiving antidepressants. Th
Page 14 and 15: Activation of ManiaIn placebo-contr
Page 16 and 17: Orthostatic Hypotension and Syncope
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Page 20 and 21: famotidine had no significant effec
Page 22 and 23: Table 5: Treatment-Emergent Adverse
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Page 26 and 27: Renal and Urinary DisordersCommon:
Page 30: PRESENTATIONCapsules containing 30

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