Homatropine Methylbromide
Homatropine Methylbromide is listed in the FDA National Drug Code directory with 5 NDC codes. Available dosage form: powder.
Drug Details
- Generic Name
- Homatropine Methylbromide
- Brand Names
- N/A
- Application Number
- Sponsor
- C-SQUARED PHARMA LIMITED
- NDC Codes
- 5
- Dosage Forms
- POWDER
- Routes
- N/A
- Active Ingredients
- HOMATROPINE METHYLBROMIDE
Indications and Usage
1 INDICATIONS AND USAGE 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.