CYMBALTA CAPSULE 60MG [SIN13190P]

Product Info

CYMBALTA CAPSULE 60MG

[SIN13190P]

4.1 Therapeutic indications

Treatment of major depressive disorder.
Treatment of generalised anxiety disorder.
Treatment of diabetic peripheral neuropathic pain. Management of pain associated with fibromyalgia.

Cymbalta is not indicated for use in children and adolescents below 18 years of age.

4.2 Posology and method of administration

For oral use, with or without food. Cymbalta should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating.

Major depressive disorder
The starting and recommended maintenance dose is 60 mg once daily. Dosages above 60 mg once daily, up to a maximum dose of 120 mg/day administered in evenly divided doses, 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
For most patients, the recommended starting dose for Cymbalta is 60 mg administered once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg once daily confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, dose increases should be in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated.

Diabetic peripheral neuropathic pain
The starting and recommended maintenance dose is 60 mg daily. While a dose up to 120mg/day was shown to be safe and effective, there is no evidence that doses higher than 60mg confer additional significant benefit, and the higher dose is clearly less well tolerated. For patients for whom tolerability is a concern, a lower starting dose may be considered. Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment. As the progression of diabetic peripheral neuropathy is highly variable and management of pain is empirical, the effectiveness of Cymbalta must be assessed individually. Efficacy beyond 12 weeks has not been systemically studied in placebo-controlled trials, but a 1-year open-label safety study was conducted.

Response to treatment should be evaluated after 2 months. In patients with inadequate initial response, additional response after this time is unlikely.

The therapeutic benefit should be reassessed regularly (at least every three months) (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Fibromyalgia
The recommended dose for Cymbalta is 60 mg once daily. Treatment may begin at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is limited evidence that doses greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions. The safety of doses above 120 mg once daily has not been evaluated in fibromyalgia. The efficacy of Cymbalta in the management of fibromyalgia has been demonstrated in placebo-controlled studies up to 3 months. The efficacy of Cymbalta was not demonstrated in longer studies; however, continued treatment should be based on individual patient response.

Elderly
No dosage adjustment is recommended for elderly patients solely on the basis of age. However, as with any medicine, caution should be exercised when treating the elderly, especially with Cymbalta 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
Cymbalta must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). See section 4.3 for patients with severe renal impairment.

Paediatric population
Cymbalta should not be used in children and adolescents under the age of 18 years for the treatment of major depressive disorder because of safety and efficacy concerns (see sections 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The safety and efficacy of Cymbalta for the treatment of diabetic peripheral neuropathic pain or generalised anxiety disorder have not been established.

Therefore, administration of Cymbalta to children and adolescents is not recommended.

Discontinuation of treatment
Abrupt discontinuation should be avoided. When stopping treatment with Cymbalta the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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.

4.3 Contraindications

Hypersensitivity to duloxetine or to any of the excipients.

Concomitant use of Cymbalta with non-selective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with pre-existing liver diseases, patients with substantial alcohol use or evidence of chronic liver disease (see sections 4.4 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Cymbalta should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of Cymbalta (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The initiation of treatment with Cymbalta is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).