Propoxyphene is in a group of drugs called narcotic pain relievers.

Propoxyphene is used to relieve mild to moderate pain.

Propoxyphene may also be used for purposes other than those listed in this medication guide.

Do not use propoxyphene if you have a history of suicidal thoughts or actions. Propoxyphene should never be taken together with a sedative (such as Valium or Xanax) or an antidepressant if you are also drinking large amounts of alcohol. Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking propoxyphene. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more than your prescribed dose of propoxyphene. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Propoxyphene can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using propoxyphene suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Take propoxyphene exactly as it was prescribed for you. Never take propoxyphene in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take each dose with a full glass of water. Take propoxyphene with food or milk if it upsets your stomach. Do not stop using propoxyphene suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store propoxyphene at room temperature away from moisture and heat.

Keep track of how many pills have been used from each new bottle of this medicine. Propoxyphene is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Usual Adult Dose for Pain:

65 mg (HCl) orally every 4 hours as needed or
100 mg (Napsylate) orally every 4 hours as needed.

Do not use propoxyphene if you have a history of suicidal thoughts or actions. Propoxyphene should never be taken together with a sedative (such as Valium or Xanax) or an antidepressant if you are also drinking large amounts of alcohol. Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Propoxyphene should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using propoxyphene, tell your doctor if you are allergic to any drugs, or if you have:

• asthma, COPD, sleep apnea, or other breathing disorders;

• liver or kidney disease;

• a history of head injury or brain tumor;

• mental illness; or

• a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use propoxyphene, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. propoxyphene may be harmful to an unborn baby, and could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Propoxyphene passes into breast milk and could harm a nursing baby. Do not use propoxyphene without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

Since propoxyphene is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of propoxyphene can be fatal, especially if you are also drinking alcohol or taking a sedative or antidepressant.

Overdose symptoms may include extreme drowsiness, pinpoint or dilated pupils, confusion, cold and clammy skin, blue lips, weak pulse, slow or uneven heart rate, shallow breathing, fainting, or breathing that stops.

Do not drink alcohol while you are taking propoxyphene. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol. propoxyphene can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Grapefruit and grapefruit juice may interact with propoxyphene and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction to propoxyphene: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heartbeat;

• feeling light-headed, fainting;

• confusion, hallucinations, unusual thoughts or behavior;

• seizure (convulsions); or

• jaundice (yellowing of the skin or eyes).

Less serious propoxyphene side effects include:

• feeling dizzy or drowsy;

• nausea, vomiting, stomach pain, constipation;

• headache, muscle pain;

• blurred vision; or

• mild skin rash.

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 take propoxyphene with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before taking propoxyphene, tell your doctor if you are using any of the following drugs:

• amiodarone (Cordarone, Pacerone);

• aprepitant (Emend);

• bosentan (Tracleer);

• conivaptan (Vaprisol);

• dexamethasone (Decadron, Hexadrol);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• St. John's wort;

• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifampin (Rifadin, Rifater, Rifamate), or telithromycin (Ketek);

• antifungal medication such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

• an antidepressant such as nefazodone;

• a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

• a blood thinner such as warfarin (Coumadin);

• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir);

• medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

• seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and there may be other drugs that can interact with propoxyphene. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.