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Duloxetine Zentiva is a brand name for Duloxetine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Zentiva is indicated in adults. For further information see section 5.1. 3
Verbatim from this product's EMA label. Tap a section to expand.
Posology Major depressive disorder The starting and recommended maintenance dose is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations. Therapeutic response is usually seen after 2-4 weeks of treatment. After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse.
In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered. Generalised anxiety disorder The recommended starting dose in patients with generalised anxiety disorder is 30 mg once daily with or without food.
In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients. In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once daily (please see also dosing recommendation above).
Doses up to 120 mg per day have been shown to be efficacious and have been evaluated from a safety perspective in clinical trials. In patients with insufficient response to 60 mg, escalation up to 90 mg or 120 mg may therefore be considered.
Dose escalation should be based upon clinical response and tolerability. After consolidation of the response, it is recommended to continue treatment for several months, in order to avoid relapse. Diabetic peripheral neuropathic pain 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). Special populations Elderly No dosage adjustment is recommended for elderly patients solely on the basis of age.
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). Elderly Data on the use of duloxetine 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
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 disorder, generalised anxiety disorder and 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.
8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRIs. 8 Sucrose Duloxetine Zentiva gastro-resistant hard capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Mania and seizures Duloxetine should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures. 5 Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Duloxetine Zentiva 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). 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.
5). g. , nausea, vomiting, diarrhoea). Serotonin syndrome in its most severe form can resemble NMS, which includes hyperthermia, muscle rigidity, elevated serum creatine kinase levels, autonomic instability with possible rapid fluctuation of vital signs and mental status changes.
If concomitant treatment with duloxetine and other serotonergic/neuroleptic agents that may affect the serotonergic and/or dopaminergic neurotransmitter systems is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. St. John’s wort Adverse reactions may be more common during concomitant use of Duloxetine Zentiva and herbal preparations containing St.
1. 5). 2). e. 5). 4). 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2). 2). 4 Renal impairment No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). 3). 1). The safety and efficacy of duloxetine for the treatment of generalised anxiety disorder in paediatric patients aged 7-17 years have not been established.
2. The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied. No data are available. Discontinuation of treatment Abrupt discontinuation should be avoided. 8). 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. Method of administration For oral use.
5 Interaction with other medicinal products and other forms of interaction Monoamine oxidase inhibitors (MAOIs) Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
3). 4). 4). Inhibitors of CYP1A2 Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine. Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-t 6-fold.
3). 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. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Serotonergic agents In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents. Caution is advisable if duloxetine is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St.
4). 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 is co- administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, 9 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 […]
John’s wort (Hypericum perforatum). 6 Suicide Major Depressive Disorder and Generalised Anxiety Disorder Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide- related events). 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.
Other psychiatric conditions for which duloxetine is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
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 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). Close supervision of patients and in particular those at high risk should accompany medicinal product therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Diabetic Peripheral Neuropathic Pain As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Concerning risk factors for suicidality in depression, see above. Physicians should encourage patients to report any distressing thoughts or feelings at any time. Use in children and adolescents […]