HOVID DULOXETINE DELAYED RELEASE CAPSULE 60MG [SIN15282P]

Product Info

HOVID DULOXETINE DELAYED RELEASE CAPSULE 60MG

[SIN15282P]

INDICATIONS

• Treatment of major depressive disorder

• Management of neuropathic pain associated with diabetic peripheral neuropathy in adults

• Treatment of generalized anxiety disorder

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

DOSAGE AND ADMINISTRATION
For oral use, with or without food.

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: 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.

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).

Use in elderly: No dosage adjustment is necessary.

Use in renal impairment: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). Duloxetine must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min).

Use in hepatic impairment: Duloxetine must not be used in patients with liver disease resulting in hepatic impairment.

Use in paediatric population: Duloxetine 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.The safety and efficacy of Duloxetine for the treatment of generalised anxiety disorder in paediatric patients aged 7–17 years have not been established. The safety and efficacy of Duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied. No data are available.

CONTRAINDICATIONS
Duloxetine is contraindicated in patients with hypersensitivity to the active substance.

Concomitant use of Duloxetine with non-selective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated.

Liver disease resulting in hepatic impairment.

Duloxetine 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 Duloxetine.

Increased plasma concentrations of Duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min). Duloxetine must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min).

The initiation of treatment with Duloxetine is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis.