DEPALTA

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). 1). The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain or generalized anxiety disorder have not been studied.

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 disorders 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.

Sucrose Duloxetine hard 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. 8).

There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI. 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.

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. Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Duloxetine 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 in clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

St John’s wort Adverse reactions may be more common during concomitant use of Duloxetine and herbal preparations containing St John’s wort (Hypericum perforatum).

5). 2). e. 5). 4). 8).