DermacinRx DPN Pak
Generic name: duloxetine, lidocaine and menthol
Dosage form: capsules, cream - kit
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Drug Abuse and Dependence
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
- Warnings
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)].
Duloxetine delayed-releaseis not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Indications and Usage for DermacinRx DPN Pak
Major Depressive Disorder
Duloxetine delayed-release capsules, USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day fo...
