Oxycodone and Acetaminophen Capsules

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, skin rash and pruritus. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.

Drug Abuse And Dependence

TYLOX (oxycodone and acetaminophen capsules) capsules are a Schedule II controlled substance.

Oxycodone can produce drug dependence and has the potential for being abused. (See WARNINGS)

Since acetaminophen and oxycodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Each Oxycodone and Acetaminophen Capsule USP 5 mg/500 mg contains:

                  Oxycodone Hydrochloride USP.........................    5 mg*
                  Acetaminophen USP...................................... 500 mg

*5 mg Oxycodone Hydrochloride USP is equivalent to 4.4815 mg oxycodone.

In addition, each capsule contains the following inactive ingredients: gelatin, magnesium stearate, silicon dioxide, sodium lauryl sulfate, pregelatinized starch, stearic acid, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, and titanium dioxide.

The oxycodone component is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride, a white, odorless, crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine. Oxycodone hydrochloride may be represented by the structural formula shown below:

Acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder with a slightly bitter taste. It has the following structural formula:

The principal ingredient, oxycodone, is a semisynthetic narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in this product are analgesia and sedation.

Oxycodone is similar to codeine and methadone in that it retains at least one-half of its analgesic activity when administered orally.

Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic.

Oxycodone and Acetaminophen Capsules are indicated for the relief of moderate to moderately severe pain.

Safety and effectiveness in pediatric patients have not been established.

A single or multiple drug overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.