Taking pentazocine/naloxone with other medications that may also cause drowsiness or breathing problems may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of pentazocine/naloxone that works, and take it for the shortest possible time. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.Who should not take Pentazocine-naloxone HCL?
This product is used to treat moderate to severe pain. It contains 2 medications, pentazocine and naloxone. Pentazocine is an opioid (narcotic) pain reliever. It acts on certain centers in the brain to give you pain relief. Naloxone helps to prevent misuse of this product. It blocks the effect of pentazocine and may cause withdrawal reactions if this product is dissolved and injected. Naloxone does not have any effect when taken by mouth.
Take this medication by mouth with or without food, usually every 3 to 4 hours or as directed by your doctor. If you have nausea, it may help to take this drug with food. Consult your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).
The dosage is based on your medical condition and response to treatment. Do not take more than 600 milligrams of pentazocine in a 24-hour period. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.
If you have been regularly using other opioid pain medications (for example, morphine, methadone), withdrawal reactions (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur when you start this product. Consult with your doctor or pharmacist for more details.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
See also Warning section.
Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, headache, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes, fast heartbeat, stomach/abdominal pain, signs of infection (such as sore throat that doesn't go away, fever), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this product, tell your doctor or pharmacist if you are allergic to pentazocine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as seizures, head injury, tumor), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), gallbladder disease, heart problems (such as irregular heartbeat, recent heart attack), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), disease of the pancreas (pancreatitis), difficulty urinating (such as due to enlarged prostate), certain blood disorder (porphyria).
Before having surgery, tell your doctor or dentist that you are using this medication.
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that isn't normal or doesn't stop, slow/shallow breathing, irritability, vomiting, or diarrhea.
This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
See also Warning and How to Use sections.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness, severe dizziness, pinpoint pupils, coma.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
If you take this product regularly and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised September 2016. Copyright(c) 2016 First Databank, Inc.
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