What is Balacet (Acetaminophen Propoxyphene)?

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

Acetaminophen is a less potent pain reliever and a fever reducer that increases the effects of propoxyphene.

The combination of acetaminophen and propoxyphene is used to relieve mild to moderate pain with or without fever.

Acetaminophen and propoxyphene may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Balacet (Acetaminophen Propoxyphene)?

Avoid drinking alcohol while taking acetaminophen and propoxyphene. Alcohol may increase your risk of liver damage while taking acetaminophen.

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 use acetaminophen and propoxyphene if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use acetaminophen and propoxyphene before the MAO inhibitor has cleared from your body.

Do not take this medication in larger amounts, or use it for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

What should I discuss with my healthcare provider before taking Balacet (Acetaminophen Propoxyphene)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or propoxyphene.

Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Propoxyphene should never be shared with 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.

Do not use acetaminophen and propoxyphene if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use acetaminophen and propoxyphene before the MAO inhibitor has cleared from your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take acetaminophen and propoxyphene:

• asthma, COPD, sleep apnea, or other breathing disorders
• liver or kidney disease
• a history of head injury or brain tumor
• a gallbladder or pancreas disorder
• low blood pressure
• a stomach or intestinal disorder
• mental illness; or
• a history of drug or alcohol addiction

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

FDA pregnancy category C. It is not known whether acetaminophen and propoxyphene is harmful to an unborn baby, but it 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.

Acetaminophen and propoxyphene can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Balacet Side Effects

What are the possible side effects of Balacet (Acetaminophen Propoxyphene)?

Get emergency medical help if you have any of these signs of an allergic reaction: 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
• chest pain, feeling short of breath
• feeling like you might pass out
• confusion, unusual thoughts or behavior
• seizure (convulsions); or
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)

Less serious side effects include:

• feeling dizzy or drowsy
• mild nausea, vomiting, upset stomach, constipation
• headache
• blurred vision; or
• dry mouth

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.

Balacet Interactions

What other drugs affect Balacet (Acetaminophen Propoxyphene)?

Cold or allergy medicine, sleeping pills, muscle relaxers, antidepressants, or seizure medication can add to sleepiness caused by propoxyphene, or could slow your breathing. Tell your doctor if you regularly use any of these medicines, or any other narcotic medications.

Tell your doctor about all other medications you use, especially:

• aprepitant (Emend)
• aspirin or a blood thinner such as warfarin (Coumadin)
• birth control pills
• dexamethasone (Decadron, Hexadrol)
• a diuretic (water pill) such as furosemide (Lasix)
• probenecid (Benemid)
• St. John’s wort
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin)
• an antidepressant such as nefazodone
• antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend)
• a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton)
• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), propranolol (Inderal), verapamil (Calan, Covera, Isoptin, Verelan), and others
• HIV or AIDS medicine such as fosamprenavir (Lexiva), nelfinavir (Viracept), ritonavir (Norvir), zidovudine (Retrovir), and others; or
• seizure medication such as carbamazepine (Carbatrol, Tegretol), lamotrigine (Lamictal), phenytoin (Dilantin), and others

This list is not complete and there are many other drugs that can interact with acetaminophen and 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.

What should I avoid while taking Balacet (Acetaminophen Propoxyphene)?

This medication 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 use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Avoid drinking alcohol while taking acetaminophen and propoxyphene. Alcohol may increase your risk of liver damage while taking acetaminophen.

Balacet Dosage

How should I take Balacet (Acetaminophen Propoxyphene)?

Take this medication exactly as it was prescribed for you. Do not take it 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.

An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. One acetaminophen and propoxyphene tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take this medicine with a full glass of water.

Ask your doctor about ways to prevent constipation while you are taking acetaminophen and propoxyphene. Do not use a stool softener (laxative) without your doctor’s advice.

You may have withdrawal symptoms when you stop using acetaminophen and propoxyphene after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and propoxyphene.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and propoxyphene. You may need to stop using the medicine for a short time.

Store acetaminophen and 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.

What happens if I overdose on Balacet (Acetaminophen Propoxyphene)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen and propoxyphene can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, fainting, weak pulse, seizure (convulsions), coma, blue lips, shallow breathing, or no breathing.

What happens if I miss a dose of Balacet (Acetaminophen Propoxyphene)?

Since acetaminophen and 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.

Edited from everydayhealth.com