12 HR Hydrocodone Bitartrate 30 MG Extended Release Oral Capsule
1 INDICATIONS AND USAGE Hydrocodone bitartrate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see Warnings and Precautions (5.1)] , reserve hydrocodone bitartrate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydrocodone bitartrate extended-release capsules are not indicated as an as-needed (prn) analgesic. Hydrocodone bitartrate extended-release capsules are an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve hydrocodone bitartrate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) Hydrocodone bitartrate extended-release capsules are not indicated as an as-needed (prn) analgesic. ( 1 )
alvogen inc.
CAPSULE YELLOW ALV 412
ALV 412 CAPSULE YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
HYDROCODONE BITARTRATE extended-release capsules are supplied in bottles with child-resistant closures as follows: Strength capsule Color(s) capsule Text NDC Number 10 mg Light blue cap and yellow body "ALV" printed on the cap and "409" printed on the body in grey ink 47781-409-60 60 Count Bottle 15 mg Light Lavender cap and yellow body "ALV" printed on the cap and "410" printed on the body in grey ink 47781-410-60 60 Count Bottle 20 mg white cap and yellow body "ALV" printed on the cap and "411" printed on the body in grey ink 47781-411-60 60 Count Bottle 30 mg Light pink cap and yellow body "ALV" printed on the cap and "412" printed on the body in grey ink 47781-412-60 60 Count Bottle 40 mg yellow cap and yellow body "ALV" printed on the cap and "413" printed on the body in grey ink 47781-413-60 60 Count Bottle 50 mg Light grey cap and yellow body "ALV" printed on the cap and "414" printed on the body in grey ink 47781-414-60 60 Count Bottle
HYDROCODONE BITARTRATE extended-release capsules contain
HYDROCODONE BITARTRATE which is a controlled substance and is controlled under Schedule II of the Controlled Substances Act. Hydrocodone, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to dispose of any
HYDROCODONE BITARTRATE extended-release capsules that are no longer needed.
HYDROCODONE BITARTRATE extended-release capsules may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product. Healthcare professionals should advise patients to store
HYDROCODONE BITARTRATE extended-release capsules in a secure place, preferably locked and out of the reach of children and other non-caregivers. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure. Advise patients to dispose of any unused capsules from a prescription as soon as they are no longer needed in accordance with local State guidelines and/or regulations [see Patient Counseling Information ( 17 )] .
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