Duloxetine (Cymbalta) is a hard gastro-resistant capsule formulation for oral use.
The starting and recommended maintenance dose of Duloxetine hydrochloride (Cymbalta) 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 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.
Hepatic impairment: Duloxetine should not be used in patients with liver disease resulting in hepatic impairment (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Renal insufficiency: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 mL/min). See Contraindications for severe renal impairment.
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 (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Children and adolescents: Duloxetine is not intended for use in children. The safety and efficacy in patients under the age of 18 years have not been established.
Discontinuation of treatment: Abrupt discontinuation should be avoided. When discontinuing duloxetine, it is generally recommended that the dose be tapered of at least one to two weeks before discontinuation in an effort to decrease the risk of discontinuation symptoms. As a general recommendation, the dose should be reduced by half or administered on alternate days during this period. The precise regimen followed should however take into account the individual circumstances of the patient, such as duration of treatment, dose at discontinuation, etc.