Benzhydrocodone and Acetaminophen

IMPORTANT WARNING:

Benzhydrocodone and acetaminophen may be habit forming, especially with prolonged use. Take benzhydrocodone and acetaminophen exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking benzhydrocodone and acetaminophen, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, uses or has overused prescription medications, or has had an overdose, or has or have ever had depression or other mental illness. There is a greater risk that you will overuse benzhydrocodone and acetaminophen if you or anyone in your close family has or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Benzhydrocodone and acetaminophen may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor may tell you not to take benzhydrocodone and acetaminophen. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), a head injury, brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weakened or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Do not allow anyone else to take your medication. Benzhydrocodone and acetaminophen may harm or cause death to other people who take your medication, especially children. Keep benzhydrocodone and acetaminophen in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep benzhydrocodone and acetaminophen out of the reach of children. Keep track of how many tablets are left so you will know if any medication is missing. Flush any tablets that are outdated or no longer needed down the toilet so that others will not take them.

Taking certain other medications during your treatment with benzhydrocodone and acetaminophen may increase the risk that you will experience breathing problems or other serious, life threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take benzhydrocodone and acetaminophen with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Taking too much acetaminophen (found in this combination preparation) can cause liver damage, sometimes serious enough to require liver transplantation or cause death. Be aware that you should not take more than 4,000 mg of acetaminophen per day. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen. If you need to take more than one product that contains acetaminophen, it may be difficult for you to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you. Tell your doctor if you have or have ever had liver disease. Your doctor may tell you not to take benzhydrocodone and acetaminophen.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with benzhydrocodone and acetaminophen increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment with benzhydrocodone and acetaminophen.

Tell your doctor if you are pregnant or plan to become pregnant. If you take benzhydrocodone and acetaminophen regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with benzhydrocodone and acetaminophen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) (or the manufacturer's website) to obtain the Medication Guide.

Talk to your doctor about the risks of taking benzhydrocodone and acetaminophen.

WHY is this medicine prescribed?

The combination of benzhydrocodone and acetaminophen is used to relieve severe, acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and whose pain cannot be relieved by other non-opioid pain medications. Benzhydrocodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). When acetaminophen is used in combination with benzhydrocodone to treat pain, it works by changing the way the body senses pain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of benzhydrocodone and acetaminophen comes as a tablet to take by mouth. It is usually taken with or without food every 4 to 6 hours as needed for pain for 2 weeks or less. You should not take more than 12 tablets in 24 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take benzhydrocodone and acetaminophen exactly as directed.

Your doctor may adjust your dose of benzhydrocodone and acetaminophen during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with benzhydrocodone and acetaminophen. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with benzhydrocodone and acetaminophen. Do not take more of it or take it more often than prescribed by your doctor.

Do not stop taking benzhydrocodone and acetaminophen without talking to your doctor. If you suddenly stop taking benzhydrocodone and acetaminophen, you may experience withdrawal symptoms such as restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle pain, widened pupils (black circles in the middle of the eyes), irritability, anxiety, back or joint pain, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast breathing, or fast heartbeat. Your doctor will probably decrease your dose gradually.

What SPECIAL PRECAUTIONS should I follow?

Before taking benzhydrocodone and acetaminophen,

• tell your doctor and pharmacist if you are allergic to benzhydrocodone, hydrocodone, acetaminophen, any other medications, or any of the ingredients in benzhydrocodone and acetaminophen tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).

• The following nonprescription or herbal products may interact with oxycodone: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking oxycodone. Do not start these medications while taking oxycodone without discussing it with your healthcare provider.

• The following nonprescription or herbal products may interact with benzhydrocodone and acetaminophen: St. John's wort.

• tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor will probably tell you not to take benzhydrocodone and acetaminophen.

• tell your doctor if you have or have ever had low blood pressure; seizures; difficulty urinating; diabetes; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions);or pancreas, gallbladder, thyroid, heart, or kidney disease.

• tell your doctor if you are breastfeeding. If you breastfeed while taking benzhydrocodone and acetaminophen, monitor the breastfed infant carefully for increased sleepiness, trouble breathing, or limpness. If you stop taking benzhydrocodone and acetaminophen, or if you stop breastfeeding the infant, monitor the infant carefully for signs of withdrawal such as restlessness, teary eyes, runny nose, yawning, sweating, chills, or dilated pupils. Call your doctor immediately if the breastfed infant has any of these symptoms.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking benzhydrocodone and acetaminophen.

• you should know that benzhydrocodone and acetaminophen may make you drowsy, dizzy, or lightheaded. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that benzhydrocodone and acetaminophen may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking benzhydrocodone and acetaminophen, or after a dose increase. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that benzhydrocodone and acetaminophen may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are taking benzhydrocodone and acetaminophen.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

This medication is usually taken as needed. If your doctor has told you to take benzhydrocodone and acetaminophen regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Benzhydrocodone and acetaminophen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• itching
• headache
• abdominal swelling or pain
• gas
• lack of energy
• feeling faint
• sudden feeling of warmth

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• peeling, blistering skin
• sores in your mouth
• swelling of the face, throat, tongue, lips, and eyes
• difficulty swallowing or breathing
• extreme drowsiness
• lightheadedness when changing positions
• agitation, fever, confusion, fast heartbeat, severe muscle stiffness or twitching, loss of coordination
• seizures
• experiencing more than one of the following symptoms, especially if taking benzhydrocodone and acetaminophone for one month or longer: nausea, vomiting, loss of appetite, extreme tiredness, weakness, dizziness, feeling faint

Benzhydrocodone and acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store it at room temperature and away from excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any medication that is outdated or no longer needed down the toilet so that others will not take it. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

While taking benzhydrocodone and acetaminophen, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include:

• slowed or shallow breathing
• difficulty breathing
• excessive sleepiness
• unable to respond or wake up
• limp or weak muscles
• cold, clammy skin
• narrowing or widening of the pupils (dark circle in the eye)
• slowed heartbeat
• unusual snoring
• nausea
• vomiting
• sweating
• feeling unwell

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking benzhydrocodone and acetaminophen.

This prescription is not refillable. If you continue to have pain after you finish the benzhydrocodone and acetaminophen, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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