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Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, except for the increase from 10 mg to 20 mg q12h, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase. If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control. During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/ family. Special Instructions for OxyContin 80 mg and 160 mg Tablets (For use in opioid-tolerant patients only.) OxyContin 80 mg and 160 mg Tablets are for use only in opioid-tolerant patients requiring daily oxycodone equivalent dosages of 160 mg or more for the 80 mg tablet and 320 mg or more for the 160 mg tablet. Care should be taken in the prescribing of these tablet strengths. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death. Text Continues Below
One OxyContin ® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets. Supplemental Analgesia Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain). Maintenance of Therapy The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control. During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e. g., every 6 to 12 months) as appropriate. Cessation of Therapy When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient. Conversion from OxyContin to Parenteral Opioids To avoid overdose, conservative dose conversion ratios should be followed.
SAFETY AND HANDLING
OxyContin Tablets are solid dosage forms that contain oxycodone which is a controlled substance. Like morphine, oxycodone is controlled under Schedule II of the Controlled Substances Act. OxyContin has been targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. HOW SUPPLIED OxyContin ® (oxycodone hydrochloride controlled-release) Tablets 10 mg are round, unscored, white-colored, convex tablets imprinted with OC on one side and 10 on the other.
They are supplied as follows: NDC 59011-100-10: child-resistant closure, opaque plastic bottles of 100 NDC 59011-100-25: unit dose packaging with 25 individually numbered tablets per card; one card per glue end carton OxyContin ® (oxycodone hydrochloride controlled-release) Tablets 20 mg are round, unscored, pink-colored, convex tablets imprinted with OC on one side and 20 on the other. They are supplied as follows: NDC 59011-103-10: child-resistant closure, opaque plastic bottles of 100 NDC 59011-103-25: unit dose packaging with 25 individually numbered tablets per card; one card per glue end carton OxyContin ® (oxycodone hydrochloride controlled-release) Tablets 40 mg are round, unscored, yellow-colored, convex tablets imprinted with OC on one side and 40 on the other. They are supplied as follows: NDC 59011-105-10: child-resistant closure, opaque plastic bottles of 100 NDC 59011-105-25: unit dose packaging with 25 individually numbered tablets per card; one card per glue end carton OxyContin ® (oxycodone hydrochloride controlled-release) Tablets 80 mg are round, unscored, green-colored, convex tablets imprinted with OC on one side and 80 on the other. They are supplied as follows: NDC 59011-107-10: child-resistant closure, opaque plastic bottles of 100 NDC 59011-107-25: unit dose packaging with 25 individually numbered tablets per card; one card per glue end carton OxyContin ® (oxycodone hydrochloride controlled-release) Tablets 160 mg are caplet-shaped, unscored, blue-colored, convex tablets imprinted with OC on one side and 160 on the other. They are supplied as follows: NDC 59011-109-10: child-resistant closure, opaque plastic bottles of 100 NDC 59011-109-25: unit dose packaging with 25 individually numbered tablets per card; one card per glue end carton Store at 25° C (77° F); excursions permitted between 15°-30° C (59°-86° F). Dispense in tight, light-resistant container. Healthcare professionals can telephone Purdue Pharma's Medical Services Department (1-888-726-7535) for information on this product.
CAUTION DEA Order Form Required. ©2002, 2003, Purdue Pharma L. P. Purdue Pharma L. P. Stamford, CT 06901-3431 U. S. Patent Numbers 4,861,598; 4,970,075; 5,266,331; 5,508,042; 5,549,912; and 5,656,295 July 30, 2003
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