Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The following adverse reactions associated with the use of pentazocine and naltrexone were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular - Hypertension, hypotension, circulatory depression, tachycardia, syncope.
Respiratory - Rarely, respiratory depression.
Acute CNS Manifestations - Hallucinations (usually visual), disorientation, and confusion.
Other CNS Effects - Grand mal convulsions, increase in intracranial pressure, dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation;
infrequently weakness, disturbed dreams, insomnia, syncope, and depression;
and rarely tremor, irritability, excitement, tinnitus.
Autonomic - Sweating;
infrequently flushing;
WARNINGS Addiction, Abuse, and Misuse Pentazocine and Naloxone Tablets contain pentazocine, a Schedule IV controlled substance.
As an opioid, Pentazocine and Naloxone Tablets expose users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Pentazocine and Naloxone Tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Pentazocine and Naloxone Tablets, and monitor all patients receiving Pentazocine and Naloxone Tablets for the development of these behaviors and conditions.
Like all medications, Pentazocine And Naloxone can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: