Naloxone blocks certain effects of opioid medication, including feelings of well-being that can lead to opioid abuse. Pentazocine is an opioid pain medication.

Naloxone and pentazocine is a combination medicine used to treat moderate to severe pain in adults and children at least 12 years old. Naloxone is included in this medication to prevent the misuse of the opioid ingredient.

Naloxone and pentazocine may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to naloxone or pentazocine, or if you have:

• severe asthma or other breathing problems; or
• a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have ever had:

• breathing problems, sleep apnea (breathing stops during sleep);
• a head injury, brain tumor, or seizures;
• urination problems;
• liver or kidney disease;
• problems with your gallbladder, pancreas, or thyroid;
• alcoholism or drug addiction; or
• if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Naloxone and pentazocine is not approved for use by anyone younger than 12 years old.

Use Talwin NX (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• severe constipation;
• confusion, hallucinations, unusual thoughts or behavior;
• a seizure;
• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

• dizziness, drowsiness;
• constipation;
• stomach pain, nausea, vomiting; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Avoid smoking, which can make this medication less effective in relieving your pain.