Oxycontin

Oxycontin

Oxycontin Recall

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Questions & Answers

Side Effects & Adverse Reactions

OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

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.

Misuse, Abuse and Diversion of Opioids

Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

OxyContin has been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS and DRUG ABUSE AND ADDICTION).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.

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.

Interactions with Alcohol and Drugs of Abuse

Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

OxyContin is NOT intended for use as a prn analgesic.

Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for HealthCare Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society.

OxyContin is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OxyContin is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

History

There is currently no drug history available for this drug.

Other Information

OxyContin® (oxycodone hydrochloride controlled-release) Tablets are an opioid analgesic supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:

Oxycontin Structure

The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.

Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin.

The 10 mg tablets also contain: hydroxypropyl cellulose.

The 15 mg tablets also contain: black iron oxide, yellow iron oxide, and red iron oxide.

The 20 mg tablets also contain: polysorbate 80 and red iron oxide.

The 30 mg tablets also contain: polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide.

The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide.

The 60 mg tablets also contain: polysorbate 80 and FD&C Red No. 40 Aluminum Lake

The 80 mg tablets also contain: FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide.

The 160 mg tablets also contain: FD&C blue No. 2 and polysorbate 80.

OxyContin® 10 mg, 20 mg, 40 mg, and 80 mg Tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.

OxyContin® 15 mg, 30 mg, and 60 mg Tablets are not described in the USP but are tested using USP Dissolution Test 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.

Oxycontin Manufacturers


  • Blenheim Pharmacal, Inc.
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Blenheim Pharmacal, Inc.]
  • Stat Rx Usa Llc
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Stat Rx Usa Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • St Marys Medical Park Pharmacy
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [St Marys Medical Park Pharmacy]
  • Rebel Distributors Corp
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Rebel Distributors Corp]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycontin (Oxycodone Hydrochloride) Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Stat Rx Usa Llc
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Stat Rx Usa Llc]
  • Stat Rx Usa Llc
    Oxycontin (Oxycodone Hydrochloride) Tablet [Stat Rx Usa Llc]
  • Rebel Distributors Corp
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Rebel Distributors Corp]
  • Bryant Ranch Prepack
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Purdue Pharma Lp
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Purdue Pharma Lp]
  • Bryant Ranch Prepack
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Oxycontin (Oxycodone Hydrochloride) Tablet, Film Coated, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]

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