xtampza er oxycodone capsule extended release
1 INDICATIONS AND USAGE XTAMPZA ER is 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. XTAMPZA ER is 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 ( 1 ) 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 XTAMPZA ER 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. XTAMPZA ER is not indicated as an as-needed (prn) analgesic. 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 XTAMPZA ER 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. XTAMPZA ER is not indicated as an as-needed (prn) analgesic.
collegium pharmaceutical, inc.
CAPSULE YELLOW Xtampza er 18 mg
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Collegium Pharmaceutical, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING XTAMPZA ER capsules are supplied in 100-count bottles with a child-resistant closure and as a hospital unit dose package with 10 individually blistered capsules per card; two cards per carton as follows: Table 8: Summary of XTAMPZA ER capsule Strengths and Packaging Configurations Strength capsule Description NDC Number (100-count Bottles with a child-resistant closure) NDC Number (20-count Hospital Unit Dose Blister Cartons) 9 mg (equivalent to 10 mg
OXYCODONE HCl) Size 3, ivory cap printed with "XTAMPZA ER" and white body printed with "9 mg" NDC 24510-110-10 NDC 24510-110-20 13.5 mg (equivalent to 15 mg
OXYCODONE HCl) Size 2, Swedish orange cap printed with "XTAMPZA ER" and white body printed with "13.5 mg" NDC 24510-115-10 NDC 24510-115-20 18 mg (equivalent to 20 mg
OXYCODONE HCl) Size 1, rich yellow cap printed with "XTAMPZA ER" and white body printed with "18 mg" NDC 24510-120-10 NDC 24510-120-20 27 mg (equivalent to 30 mg
OXYCODONE HCl) Size 0, light gray cap printed with "XTAMPZA ER" and white body printed with "27 mg" NDC 24510-130-10 NDC 24510-130-20 36 mg (equivalent to 40 mg
OXYCODONE HCl) Size 00, Flesh color cap printed with "XTAMPZA ER" and white body printed with "36 mg" NDC 24510-140-10 NDC 24510-140-20 Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container, with child-resistant closure. Store XTAMPZA ER securely and dispose of properly [see Patient Counseling Information (17) ] .
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