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Duloxetine Boehringer Ingelheim is a brand name for Duloxetine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of diabetic peripheral neuropathic pain in adults.
Verbatim from this product's EMA label. Tap a section to expand.
For oral use. Adults The starting and recommended maintenance dose is 60 mg daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
2). Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose. Response to treatment should be evaluated after 2 months. In patients with inadequate initial response, additional response after this time is unlikely.
1). Elderly No dosage adjustment is recommended for elderly patients solely on the basis of age. 2). 4). 2). Medicinal product no longer authorised3 Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
3).. Discontinuation of treatment Abrupt discontinuation should be avoided. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
8. Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). 2). Akathisia/psychomotor restlessness The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Medicinal products containing duloxetine Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive episodes as well as stress urinary incontinence).
The use of more than one of these products concomitantly should be avoided. 8). Most of them occurred during the first months of treatment. The pattern of liver damage was predominantly hepatocellular. Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Sucrose DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take this medicine.
5 Interaction with other medicinal products and other forms of interaction CNS medicinal products: the risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Mania and seizures DULOXETINE BOEHRINGER INGELHEIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures. Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing DULOXETINE BOEHRINGER INGELHEIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Blood pressure and heart rate Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients. This may be due to the noradrenergic effect of duloxetine. Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension.
Therefore,in patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment. Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.
5). 8). 3). Medicinal product no longer authorised4 Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min). 3. 2 for information on patients with mild or moderate renal dysfunction.
Use with antidepressants Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants. In particular the combination with selective reversible MAOIs is not recommended. St John’s wort Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John’s wort (Hypericum perforatum).
Depression, suicidal ideation and behaviour Although DULOXETINE BOEHRINGER INGELHEIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Hypersensitivity to the active substance or to any of the excipients. 5). 2). e. 5). 4). 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Duloxetine in European Union.
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g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines). Monoamine Oxidase Inhibitors (MAOIs): due to the risk of serotonin syndrome, DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with nonselective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an Medicinal product no longer authorised6 MAOI.
3). For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower. 4). g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products. Caution is advisable if DULOXETINE BOEHRINGER INGELHEIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Medicinal products metabolised by CYP2D6:
Duloxetine is a moderate inhibitor of CYP2D6. When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold. The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Caution is advised if DULOXETINE BOEHRINGER INGELHEIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Oral contraceptives and other steroidal agents: results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A. Specific in vivo drug interaction studies have not been performed.
Anticoagulants and antiplatelet agents:
Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction. Furthermore, increases in INR values have been reported when duloxetine was co-administered to patients treated with warfarin.
However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of duloxetine with aluminium- and magnesium- containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 […]
This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
8). Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time. If while on DULOXETINE BOEHRINGER INGELHEIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
2). Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations. DULOXETINE BOEHRINGER INGELHEIM should not be used in the treatment of children and adolescents under the age of 18 years.
Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Haemorrhage There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs).
Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function, and in patients with known bleeding tendencies. Medicinal product no longer authorised5 Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics. Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
8). In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with […]