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1 Tablet of Oxycontin (Oxycodone Hydrochloride) 40mg

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$5.00
Weight:
3.33 Grams
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Product Description

PRESCRIBING INFORMATION:

OxyContin® (oxycodone hydrochloride controlled-release) Tablets, for oral use, CII

INDICATIONS AND USAGE:

OxyContin is an opioid agonist product indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use:

OxyContin is not for use:

As an as-needed (prn) analgesic.

For pain that is mild or not expected to persist for an extended period of time.

For acute pain.

In the immediate postoperative period.

For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to bemoderate to severe and persist for an extended period of time.

OxyContin 60 mg and 80 mg tablets are only for patients in whom tolerance to an opioid of comparable potency is established.

DOSAGE AND ADMINISTRATION:

Individualize dosing based on patient’s prior analgesic treatment experience, and titrate as needed to provide adequate analgesia and minimize adverse reactions.

Do not abruptly discontinue OxyContin in a physically dependent patient.

Tablets must be swallowed intact and are not to be cut, broken, chewed, crushed, or dissolved (risk of potentially fatal dose).

OxyContin tablets should be taken one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth.

DOSAGE FORMS AND STRENGTHS:

Tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg (3)

CONTRAINDICATIONS:

Significant respiratory depression.

Acute or severe bronchial asthma.

Known or suspected paralytic ileus and GI obstruction.

Hypersensitivity to oxycodone.

WARNINGS AND PRECAUTIONS:

Elderly, cachectic, and debilitated patients, and patients with chronic pulmonary disease: Monitor closely because of increased risk of respiratory depression.

Interaction with CNS depressants: Consider dose reduction of one or both drugs because of additive effects.

Hypotensive effects: Monitor during dose initiation and titration.

Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression. Avoid use of OxyContin in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention.

Use with caution in patients who have difficulty swallowing or have underlying GI disorders that may predispose them to obstruction.

Concomitant use of CYP3A4 inhibitors may increase opioid effects.

ADVERSE REACTIONS:

Most common adverse reactions (>5%) are constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

Muscle relaxants: Avoid use with OxyContin because of increased risk of respiratory depression.

The CYP3A4 isoenzyme plays a major role in the metabolism of OxyContin. Drugs that inhibit CYP3A4 activity may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations.

Mixed agonist/antagonist opioid analgesics: Avoid use with OxyContin because they may reduce analgesic effect of OxyContin or precipitate withdrawal symptoms.

USE IN SPECIFIC POPULATIONS:


Nursing mothers: Oxycodone has been detected in human milk. Closely monitor infants of nursing women receiving OxyContin.

Geriatrics: The initial dose may need to be reduced to 1/3 to 1/2 of the usual doses.

Hepatic impairment: Initiate therapy at 1/3 to 1/2 the usual doses and titrate carefully.

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