Description

Brand Name: OxyContin
Generic Name: Oxycodone Hydrochloride
Dosage Form and Strength: Extended-Release Oral Tablet, 60mg
Imprint/Identification: OP 60 on one side, ◊ on the other | Round, grayish-green, bi-convex tablet

1. What is OxyContin OP 60mg and what is it used for?

OxyContin OP 60mg is an extended-release (long-acting) formulation of the potent opioid analgesic oxycodone hydrochloride. The “OP” designation refers to a proprietary abuse-deterrent technology intended to make the tablet more difficult to manipulate for misuse and abuse.

It is indicated for the management of severe pain requiring daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Important Note: Because of the risks of addiction, abuse, and misuse, even at recommended doses, OxyContin should be reserved for pain that is not responsive to other pain medications.

2. Important Safety Information

BLACK BOX WARNING:
OxyContin carries several Black Box Warnings from the U.S. Food and Drug Administration (FDA):

• Addiction, Abuse, and Misuse: OxyContin exposes users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing.

• Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression (slow or ineffective breathing) can occur, especially during initiation or following a dose increase.

• Accidental Ingestion: Accidental ingestion of even one tablet, especially by a child, can result in a fatal overdose.

• Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome in the newborn, which may be life-threatening.

• Cytochrome P450 3A4 Interaction: Concomitant use with CYP3A4 inhibitors (e.g., certain macrolide antibiotics, antifungals) may increase oxycodone levels and cause fatal respiratory depression.

• Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use can result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative options.

3. Directions for Use

• Must be swallowed whole. Do not break, chew, crush, or dissolve the tablet. Doing so can cause rapid release and absorption of a potentially fatal dose of oxycodone.

• The OP formulation is designed to be abuse-deterrent. If the tablet is tampered with (e.g., crushed), it becomes a viscous hydrogel that is difficult to inject or snort.

• Taken every 12 hours, as directed by a physician.

• This is not an “as-needed” pain medication.

4. Contraindications and Precautions

Do not use OxyContin:

• In patients with significant respiratory depression.

• In patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.

• In patients with known or suspected gastrointestinal obstruction.

• In patients with a known hypersensitivity to oxycodone.

Use with extreme caution in patients with:

• Chronic pulmonary disease

• Head injury or increased intracranial pressure

• Seizure disorders

• Severe liver or kidney impairment

• A history of substance abuse or mental illness

5. Potential Side Effects

Common Side Effects:

• Constipation

• Nausea

• Somnolence (sleepiness)

• Dizziness

• Vomiting

• Pruritus (itching)

• Headache

Serious Side Effects (Seek Immediate Medical Attention):

• Respiratory Depression: Slow or shallow breathing, difficulty waking up.

• Circulatory Depression: Low blood pressure, shock.

• Severe Hypotension: Extreme dizziness or fainting.

• Adrenal Insufficiency: Nausea, vomiting, loss of appetite, fatigue, weakness, dizziness.

• Signs of an allergic reaction: Hives, difficulty breathing, swelling of the face or throat.

6. Storage and Disposal

• Store securely, at controlled room temperature.

• Keep in a locked container out of sight and reach of children and others. It is a prime target for theft and misuse.

• Dispose of unused tablets promptly through a FDA-approved drug take-back program. If none are available, follow specific FDA instructions for flushing. OxyContin is recommended for flushing to prevent accidental ingestion and misuse.

Disclaimer: This is a model product description for informational purposes only. It is not medical advice. OxyContin is a Schedule II controlled substance that carries significant risks and requires a prescription from a licensed healthcare professional. Always follow the guidance of your doctor and the official Medication Guide. Misuse of this drug is extremely dangerous and can lead to addiction, overdose, and death.