Cymbalta api_july 2013_a4 portrait.pdf

CYMBALTA® (DULOXETINE)
ABBREVIATED PRESCRIBING should not take this medicine. Interactions Caution is advised when taken in
INFORMATION Presentation Hard gastro-resistant capsules, 30mg or 60mg of
combination with other centrally acting medicinal products or substances, duloxetine. Also contains sucrose. Uses Treatment of major depressive disorder.
including alcohol and sedative medicinal products; exercise caution when using in Treatment of generalised anxiety disorder. Treatment of diabetic peripheral combination with antidepressants. In rare cases, serotonin syndrome has been neuropathic pain (DPNP) in adults. Dosage and Administration Major Depressive
reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents. Disorder Starting and maintenance dose is 60mg once daily, with or without food. Caution is advisable if duloxetine is used concomitantly with serotonergic agents Dosages up to a maximum dose of 120mg per day have been evaluated from a like SSRIs/SNRIs, tricyclics, MAOIs like moclobemide and linezolid, St John’s safety perspective in clinical trials. However, there is no clinical evidence Wort, antipsychotics, triptans, tramadol, pethidine, and tryptophan. Undesirable suggesting that patients not responding to the initial recommended dose may effects may be more common during use with herbal preparations containing St benefit from dose up-titrations. Therapeutic response is usually seen after 2-4 John’s Wort. Effects on other drugs: Caution is advised if co-administered with weeks. After establishing response, it is recommended to continue treatment for products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic several months, in order to avoid relapse. In patients responding to duloxetine, antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine) and with a history of repeated episodes of major depression, further long-term particularly if they have a narrow therapeutic index (such as flecainide, treatment at 60 to 120mg/day could be considered. Generalised Anxiety Disorder propafenone, and metoprolol). Undesirable Effects The majority of common
The recommended starting dose in patients with generalised anxiety disorder is adverse reactions were mild to moderate, usually starting early in therapy, and 30mg once daily, with or without food. In patients with insufficient response the most tended to subside as therapy continued. Those observed from spontaneous dose should be increased to 60mg, which is the usual maintenance dose in most reporting and in placebo-controlled clinical trials in depression, generalised patients. In patients with co-morbid major depressive disorder, the starting and anxiety disorder, and diabetic neuropathic pain at a rate of ≥1/100, or where the maintenance dose is 60mg once daily. Doses up to 120mg per day have been event is clinically relevant, are: Very common (≥1/10): Headache, somnolence, shown to be efficacious and have been evaluated from a safety perspective in nausea, dry mouth. Common (≥1/100 and <1/10): Weight decrease, palpitations, clinical trials. In patients with insufficient response to 60mg, escalation up to dizziness, lethargy, tremor, paraesthesia, blurred vision, tinnitus, yawning, 90mg or 120mg may therefore be considered. After consolidation of the response, constipation, diarrhoea, abdominal pain, vomiting, dyspepsia, flatulence, sweating it is recommended to continue treatment for several months, in order to avoid increased, rash, musculoskeletal pain, muscle spasm, dysuria, urinary frequency, relapse. Diabetic Peripheral Neuropathic Pain Starting and maintenance dose is ejaculation disorder, ejaculation delayed, decreased appetite, blood pressure 60mg daily, with or without food. Doses above 60mg/day, up to a maximum dose increased, flushing, falls, fatigue, erectile dysfunction, insomnia, agitation, libido of 120mg/day in evenly divided doses, have been evaluated from a safety decreased, anxiety, orgasm abnormal, abnormal dreams. Clinical trial and perspective. Some patients that respond insufficiently to 60mg may benefit from spontaneous reports of anaphylactic reaction, hyperglycaemia (reported especially a higher dose. The medicinal response should be evaluated after 2 months in diabetic patients), mania, hyponatraemia, SIADH, hallucinations, dyskinesia, treatment. Additional response after this time is unlikely. The therapeutic benefit serotonin syndrome, extra-pyramidal symptoms, convulsions, akathisia, should regularly be reassessed. Abrupt discontinuation should be avoided. When psychomotor restlessness, glaucoma, mydriasis, syncope, tachycardia, supra- stopping treatment with Cymbalta the dose should be gradually reduced over at ventricular arrhythmia (mainly atrial fibrillation), hypertension, hypertensive least one to two weeks to reduce the risk of withdrawal reactions. If intolerable crisis, epistaxis, gastritis, haematochezia, gastro-intestinal haemorrhage, hepatic symptoms occur following a decrease in the dose or upon discontinuation of failure, hepatitis, acute liver injury, angioneurotic oedema, Stevens-Johnson treatment, then resuming the previously prescribed dose may be considered. syndrome, trismus, and gynaecological haemorrhage have been made. Cases of Subsequently, continue decreasing the dose, but at a more gradual rate. Contra-
suicidal ideation and suicidal behaviours have been reported during duloxetine indications Hypersensitivity to any of the components. Combination with
therapy or early after treatment discontinuation. Cases of aggression and anger MAOIs. Liver disease resulting in hepatic impairment. Use with potent inhibitors have been reported, particularly early in treatment or after treatment of CYP1A2, eg, fluvoxamine, ciprofloxacin, enoxacin. Severe renal impairment discontinuation. Cases of convulsion and tinnitus have been reported after (creatinine clearance <30ml/min). Should be used in pregnancy only if the treatment discontinuation. Discontinuation of duloxetine (particularly abrupt) potential benefit justifies the potential risk to the foetus. Breast-feeding is not commonly leads to withdrawal symptoms. Dizziness, sensory disturbances recommended. Initiation in patients with uncontrolled hypertension that could (including paraesthesia), sleep disturbances (including insomnia and intense expose patients to a potential risk of hypertensive crisis. Precautions Do not use
dreams), fatigue, agitation or anxiety, nausea and/or vomiting, tremor, headache, in children and adolescents under the age of 18. No dosage adjustment is irritability, diarrhoea, hyperhydrosis, and vertigo are the most commonly reported recommended for elderly patients solely on the basis of age. However, as with any reactions. The heart rate-corrected QT interval in duloxetine-treated patients did medicine, caution should be exercised. Data on the use of Cymbalta in elderly not differ from that seen in placebo-treated patients. No clinically significant patients with generalised anxiety disorder are limited. Use with caution in patients differences were observed for QT, PR, QRS, or QTcB measurements between with a history of mania, bipolar disorder, or seizures. As with other serotonergic duloxetine-treated and placebo-treated patients. In clinical trials in patients with agents, serotonin syndrome, a potentially life-threatening condition, may occur DPNP, small but statistically significant increases in fasting blood glucose were with duloxetine treatment, particularly with concomitant use of other serotonergic observed in duloxetine-treated patients compared to placebo at 12 weeks. At 52 agents, as described under ‘Interactions’ (below). Caution in patients with weeks there was a small increase in fasting blood glucose and in total cholesterol increased intra-ocular pressure or those at risk of acute narrow-angle glaucoma. in duloxetine-treated patients compared with a slight decrease in the routine care Duloxetine has been associated with an increase in blood pressure and clinically group. There was also an increase in HbA1c in both groups, but the mean increase significant hypertension in some patients. In patients with known hypertension was 0.3% greater in the duloxetine-treated group. For full details of these and other and/or other cardiac disease, blood pressure monitoring is recommended as side-effects, please see the Summary of Product Characteristics, which is available at appropriate, especially during the first month of treatment. Use with caution in http://www.medicines.org.uk/emc/. Overdose Cases of overdoses, alone or in
patients whose conditions could be compromised by an increased heart rate or by combination with other drugs, with duloxetine doses of 5400mg have been an increase in blood pressure. For patients who experience a sustained increase in reported. Some fatalities have occurred, primarily with mixed overdoses, but also blood pressure while receiving duloxetine, consider either dose reduction or with duloxetine alone at a dose of approximately 1000mg. Signs and symptoms of gradual discontinuation. Caution in patients taking anticoagulants or products overdose (duloxetine alone or in combination with other medicinal products) known to affect platelet function, and those with bleeding tendencies. included somnolence, coma, serotonin syndrome, seizures, vomiting, and Hyponatraemia has been reported rarely, predominantly in the elderly. Caution is tachycardia. Legal Category POM Marketing Authorisation Numbers
required in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, EU/1/04/296/001, EU/1/04/296/002 Basic NHS Cost £22.40 per pack of 28 X
or dehydrated patients, or patients treated with diuretics. Hyponatraemia may be 30mg capsules. £27.72 per pack of 28 X 60mg capsules. Date of Preparation or
due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH). Last Review July 2013 Full Prescribing Information is Available From Eli Lilly
Adverse reactions may be more common during concomitant use of Cymbalta and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, and herbal preparations containing St John’s Wort. Monitor for suicidal thoughts, RG24 9NL Telephone: Basingstoke (01256) 315 000 E-mail: [email protected] especially during first weeks of therapy, dose changes, and in patients under 25 Website: www.lillypro.co.uk CYMBALTA® (duloxetine) is a registered trademark years old. Since treatment may be associated with sedation and dizziness, patients should be cautioned about their ability to drive a car or operate hazardous machinery. Cases of akathisia/psychomotor restlessness have been reported for duloxetine. Duloxetine is used under different trademarks in several indications (major depressive disorder, generalised anxiety disorder, stress urinary incontinence, and diabetic neuropathic pain). The use of more than one of these products concomitantly should be avoided. Cases of liver injury, including severe Adverse events should be reported. Reporting forms
elevations of liver enzymes (>10-times upper limit of normal), hepatitis, and and further information can be found at:
jaundice have been reported with duloxetine. Most of them occurred during the www.mhra.gov.uk/yellowcard.
first months of treatment. Duloxetine should be used with caution in patients with substantial alcohol use or with other drugs associated with hepatic injury. Adverse events and product complaints should also be
Capsules contain sucrose. Patients with rare hereditary problems of fructose reported to Lilly: please call Lilly UK on 01256 315 000.
intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency

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