What is the generic name?

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

What is the Trade Name for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE?

Hycodan

What are the Indications for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE?

• 1 INDICATIONS AND USAGE HYCODAN is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. HYCODAN is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in adult patients 18 years of age and older. ( 1 ) Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve HYCODAN for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Limitations of Use: Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ] . Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4) ] . Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve HYCODAN for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

References: https://open.fda.gov/