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(Generic versions may still be available.)
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
PROPOXYPHENE NAPSYLATE/ACETAMINOPHEN - ORAL
COMMON BRAND NAME(S): Darvocet A500, Darvocet-N
WARNING: Propoxyphene has caused overdose (even death) when taken in large doses, either alone or with alcohol/drugs that can cause drowsiness (such as antidepressants, sedatives, muscle relaxants). Do not take this medication more often or use a larger dose than prescribed. Avoid alcoholic beverages.
Other medications can affect the removal of propoxyphene from your body, which may affect how propoxyphene works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), nefazodone, HIV protease inhibitors (such as ritonavir), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as phenytoin), among others. Before taking this medication, tell your doctor or pharmacist of all the medications you may use.
One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.
Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.
USES: FDA and Health Canada have requested that manufacturers voluntarily withdraw propoxyphene-containing medications from the US and Canadian markets due to several problems with safety, and its limited effectiveness.
This combination medication is used to help relieve mild to moderate pain. It contains a narcotic pain reliever (propoxyphene) and a non-narcotic pain reliever (acetaminophen). Propoxyphene works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.
HOW TO USE: See also Warning section.
Read the Medication Guide provided by your pharmacist before you start taking propoxyphene napsylate/acetaminophen and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask 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 increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. Do not exceed the maximum daily dose of propoxyphene napsylate (600 milligrams per day).
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting narcotic medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other non-narcotic pain relievers (such as naproxen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist if you have any questions about using this product safely with other drugs.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask 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, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
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.
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