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.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it.

Using opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Follow the directions on your prescription label and read all medication guides. Never use naloxone and pentazocine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Naloxone and pentazocine is usually taken as 1 or 2 tablets every 3 to 4 hours. Follow your doctor's instructions. Do not take more than 12 tablets in a 24-hour period.

If you are using any other narcotic pain medicine, the pain-relieving effects of the narcotic may be reversed while you are also taking naloxone and pentazocine.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

You should not stop using this medicine suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

You should not use naloxone and pentazocine 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.

Since naloxone and pentazocine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Do not take more than 12 tablets in a 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get a non-combination form of naloxone to reverse an opioid overdose and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

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

Avoid driving or operating machinery until you know how naloxone and pentazocine 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.

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.

Naloxone and pentazocine may cause serious side effects. 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 of naloxone and pentazocine 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.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• sleep medicine, muscle relaxers, or other drugs that make you drowsy; or

• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Many drugs may affect naloxone and pentazocine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.