General Safety Information on Opioids

Indications and usage for different opioid analgesics vary and the Full Prescribing Information for the specific product should be consulted.

Overdose

Persons who are not prescribed an opioid analgesic can overdose by taking even one dose. Persons who have a prescription for an opioid analgesic can overdose by taking more than the amount prescribed.

Certain doses of specific opioid analgesics may cause fatal respiratory depression if taken by patients who have not developed tolerance to the respiratory depressive effects of opioids.

Manipulation by any means of any opioid analgesic dosage form poses a significant risk to the abuser that could result in overdose and death. The risk of fatal outcome is increased with concurrent use or abuse of alcohol or other CNS depressants.

Opioids should be kept in a secure place out of reach of children, and protected from theft or misuse. Accidental consumption especially in children may result in overdose or death.

Respiratory Depression

Respiratory depression is the chief hazard from all opioid agonists, which can result in death.

The risk of respiratory depression is increased in elderly or debilitated patients, usually following large initial doses in persons who have not developed any degree of tolerance to the respiratory depressive effects of opioid, or when opioids are given in conjunction with other agents that depress respiratory drive.

Addiction, Abuse and Diversion

There is a potential for drug addiction to develop following exposure to opioids even under appropriate medical use.

All patients treated with opioids require careful monitoring for signs of abuse and addiction. Opioid agonists have the potential for being abused and are subject to criminal diversion.

Physical Dependence and Tolerance

The development of physical dependence and/or tolerance is not unusual during chronic opioid therapy.

When a patient no longer requires therapy with an opioid, the daily dose should be tapered gradually to prevent signs and symptoms of withdrawal syndrome in the physically-dependent patient.

Contraindications

Opioids are contraindicated in any setting with a risk of significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), in patients who have acute or severe bronchial asthma, in patients who have or are suspected of having paralytic ileus, or in patients with known hypersensitivity to any of the opioid product’s constituents.

Serious Side Effects

Respiratory depression, apnea, respiratory arrest, and to a lesser degree, circulatory depression, hypotension, shock or cardiac arrest have all been associated with opioid use and abuse.

Common Side Effects

Nausea, vomiting, dizziness, drowsiness, constipation, itching, dry mouth, sweating, weakness, and headache are the most common non-serious side effects of opioid analgesics.

Opioid analgesics may cause drowsiness, dizziness, or lightheadedness and may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g. driving, operating machinery). Patients should be cautioned accordingly.