DRIZALMA SPRINKLE

Duloxetine hydrochloride pharmacokinetics are dose proportional over the therapeutic range. Steady-state plasma concentrations are typically achieved after 3 days of dosing.

AbsorptionAfter oral duloxetine delayed-release capsules administration, duloxetine hydrochloride is well absorbed. Peak plasma concentration of duloxetine is attained at 5 hours following administration of duloxetine delayed-release capsules. There is a 3 hour delay in absorption and a one- third increase in apparent clear...

The efficacy of duloxetine delayed-release capsules has been established in the following populations in adequate and well-controlled trials: Major Depressive Disorder (MDD): 4 short-term and 1 maintenance trial in adults [see Clinical Studies (14.1)] . Generalized Anxiety Disorder (GAD): 3 short-term trials in adults, 1 maintenance trial in adults, and 1 short-term trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)] . Diabetic Peripheral Neuropathic Pain (DPNP): Two 12 week trials in adults [see Clinical Studies (14.3)] . Fibromyalgia (FM): Two trials in adults (one...

The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3)] Serotonin Syndrome [see Warnings and Precautions (5.4)] Increased Risk of Bleeding [see Warnings and Precautions (5.5)] Severe Skin Reactions [see Warnin...

The use of MAOIs intended to treat psychiatric disorders with DRIZALMA SPRINKLE, or within 5 days of stopping treatment with DRIZALMA SPRINKLE, are contraindicated because of an increased risk of serotonin syndrome. The use of DRIZALMA SPRINKLE within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.10), Warnings and Precautio...

Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue DRIZALMA SPRINKLE in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease (5.2) Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur (5.3) S ero t on in Syndrome : I...

7 DRUG INTERACTIONS

• Potent CYP1A2 Inhibitors: Avoid concomitant use (2.6, 7)
• CYP2D6 Substrates: Consider dose reduction with concomitant use (7) 7.1 Drugs Having Clinically Important Interactions with DRIZALMA SPRINKLE

Table 7Clinically Important Drug Interactions Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs and SNRIs including duloxetine with MAOIs increases...