Duloxetinedosage

Do not initiate treatment with Duloxetine Delayed-Release Capsules. Use another duloxetine delayed-release capsule product for initial dosage, titration, and doses below 80 mg per day. Administer Duloxetine Delayed-Release Capsules once daily on an empty stomach at least one hour before or two hours after a meal. Swallow whole, do not open, chew or crush. Do not sprinkle the capsule contents on food or mix with liquids.

MDD: Administer Duloxetine Delayed-Release Capsules in doses of 80 mg, 90 mg, or 120 mg. Periodically reassess for appropriate dosing.

GAD: Administer Duloxetine Delayed-Release Capsules in doses of 90 mg or 120 mg. Periodically reassess for appropriate dosing. The maximum dosage is 120 mg once daily When discontinuing treatment, reduce dose gradually whenever possible to avoid discontinuation symptoms. Gradual dosage reduction will require use of another duloxetine delayed-release capsule product.

2.1 Important

Administration Instructions Do not initiate treatment with Duloxetine Delayed-Release Capsules 80 mg, 90 mg, and 120 mg. Use another duloxetine delayed-release capsule product for initial dosage, titration, and doses below 80 mg per day. Refer to the Prescribing Information of other duloxetine delayed-release capsule products for the recommended dosage of those products. Administer Duloxetine Delayed-Release Capsules orally once daily on an empty stomach at least one hour before or two hours after a meal. Swallow whole and do not chew or crush. Do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. If a dose of Duloxetine Delayed-Release Capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Duloxetine Delayed-Release Capsules at the same time.

2.2 Dosage for

Treatment of Major Depressive Disorder Administer Duloxetine Delayed-Release Capsules in adults with MDD receiving at least 60 mg per day of another duloxetine delayed-release capsule product for one week. While duloxetine at a 120 mg per day dose was shown to be effective, there is no evidence that doses greater than 60 mg per day confer any additional benefits. Administer Duloxetine Delayed-Release Capsules once daily in doses of 80 mg, 90 mg, or 120 mg, titrating dose as tolerated when appropriate. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily.

2.3 Dosage for

Treatment of Generalized Anxiety Disorder Adults Less than 65 Years of Age with GAD Administer Duloxetine Delayed-Release Capsules in adults less than 65 years of age with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for one week. While duloxetine at a 120 mg once daily dosage was shown to be effective, there is no evidence that doses greater than 60 mg per day confer additional benefit. Nevertheless, if a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Administer Duloxetine Delayed-Release Capsules once daily in doses of 90 mg or 120 mg. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily. Geriatric Patients with GAD Administer Duloxetine Delayed-Release Capsules in geriatric patients with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for two weeks. Patients may benefit from duloxetine dosages above 60 mg once daily. If a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Administer Duloxetine Delayed-Release Capsules once daily in doses of 90 mg or 120 mg. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily. Pediatric Patients 7 to 17 years of Age with GAD Administer Duloxetine Delayed-Release Capsules in pediatric patients 7 to 17 years of age with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for two weeks. Some patients may benefit from duloxetine dosages above 60 mg once daily. If a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Administer Duloxetine Delayed-Release Capsules once daily in doses of 90 mg or 120 mg. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily.

2.4 Dosage in

Patients with Hepatic Impairment or Severe Renal Impairment Avoid use in patients with chronic liver disease or cirrhosis. Recommended dosage in patients with mild to moderate renal impairment (estimated creatinine clearance (CrCl) 30-80 mL/min; CrCl was estimated using Cockcroft-Gault method) is similar to that in patients with normal renal function. Avoid use in patients with severe renal impairment, estimated CrCl < 30 mL/minute.

2.5 Screen for

Bipolar Disorder Prior to Starting Duloxetine Delayed-Release Capsules Prior to initiating treatment with Duloxetine Delayed-Release Capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

2.6 Discontinuing

Duloxetine Delayed-Release Capsules Adverse reactions may occur upon discontinuation of Duloxetine Delayed-Release Capsules. Adverse reactions after discontinuation of Duloxetine Delayed-Release Capsules, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in the dose, rather than abrupt cessation, is recommended whenever possible. Given that Duloxetine Delayed-Release Capsules are not available in strengths below 80 mg, gradual dosage reduction will require the use of another duloxetine delayed-release capsule product.

2.7 Switching a

Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with another duloxetine delayed-release capsule product. Duloxetine Delayed-Release Capsules may be initiated after titration with another duloxetine delayed-release product. Conversely, at least 5 days should be allowed after stopping Duloxetine Delayed-Release Capsules (or another duloxetine delayed-release capsule) before starting an MAOI intended to treat psychiatric disorders.

2.8 Use of Duloxetine

Delayed-Release Capsules with Other MAOIs such as Linezolid or Methylene Blue Do not start Duloxetine Delayed-Release Capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered. In some cases, a patient already receiving Duloxetine Delayed-Release Capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Duloxetine Delayed-Release Capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Duloxetine Delayed-Release Capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Duloxetine Delayed-Release Capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.