codeine sulfate
Drug Details
- Generic Name
- codeine sulfate
- Brand Names
- Codeine sulfate
- Application Number
- NDA022402
- Sponsor
- Hikma Pharmaceuticals USA Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- CODEINE SULFATE
Indications and Usage
1 INDICATIONS AND USAGE Codeine sulfate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. L i m i t ations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including codeine sulfate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Codeine sulfate tablets are an opioid agonist, indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including codeine sulfate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 )