Hydrocodone Bitartrate and Homatropine Methylbromide

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) are indicated for the symptomatic relief of cough in adult patients 18 years of age and older. 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 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) 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.

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) 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 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) 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.

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is contraindicated for: All pediatric patients younger than 6 years of age [ see Warnings and Precautions ( 5.2 , 5.3 ), Use in Specific Populations ( 8.4 ) ]. Significant respiratory depression [see Warnings and Precautions ( 5.2 )]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.4 )].

Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.9 )]. Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) [ see Adverse Reactions ( 6 ) ]. Children younger than 6 years of age. ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.