Apadaz : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:
Apadaz (Benzhydrocodone and acetaminophen) can be habit-forming, especially with long-term use. Take Apadaz exactly as directed. Don’t take more, take it more often, or take it in a way other than that directed by your doctor. While taking Apadaz, talk with your healthcare provider about your pain management goals, the length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever had large amounts of alcohol, uses or has ever used illegal drugs, uses or has overused prescription drugs, or has or has ever had depression or other Mental illness. There is an increased risk that you will overuse Apadaz if you or someone in your close family has or has had any of these conditions. Speak with your healthcare provider immediately and seek guidance if you think 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.

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

Taking certain other medications during your treatment with Apadaz may increase the risk that you will experience breathing problems or other serious life-threatening breathing problems, sedation, or coma. Tell your doctor if you are taking, plan to take, or plan to stop taking any of the following medications: benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); carbamazepine (Carbatrol, Tegretol, others); erythromycin (Eryc, E.E, S., others); ketoconazole; other narcotic pain relievers; medications for mental illness; muscle relaxants including cyclobenzaprine (Amrix) and metaxalone (Skelaxin); phenytoin (Dilantin, Phenytek); rifampicin (Rimactane, in Rifamate, Rifater); ritonavir (Norvir, in Kaletra, Technivie, Viekira Pak); sedative sleeping pills; or tranquilizers. Your doctor may need to change the doses of your medications and will monitor you carefully. If you take Apadaz with any of these medications and experience any of the following symptoms, call your doctor immediately or seek emergency medical attention: unusual dizziness, lightheadedness, extreme drowsiness, slow or difficult breathing, or lack of response. Make sure your doctor or family members know what symptoms can be serious so they can call a doctor or emergency medical attention if you are unable to seek treatment on your own.

Taking too much acetaminophen (found in this combination preparation) can cause liver damage, sometimes severe enough to require a liver transplant or cause death. Keep in mind that you should not take more than 4000 mg of acetaminophen per day. You may accidentally take too much acetaminophen if you don’t follow prescription directions 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 to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist for help. Tell your doctor if you have or have ever had liver disease. Your doctor may tell you not to take benzhydrocodone or acetaminophen.

Drinking alcohol, taking prescription or over-the-counter medications that contain alcohol, or using illicit drugs during your treatment with Apadaz increases the risk that you will experience serious and life-threatening side effects. Do not drink alcohol, take prescription or over-the-counter medications that contain alcohol, or use illegal drugs during your treatment with Apadaz.

Do not let anyone else take your medicine. Apadaz can harm or kill others who take your medicine, especially children. Keep Apadaz in a safe place so that no one else can take them accidentally or on purpose. Take special care to keep Apadaz out of the reach of children. Keep track of how many tablets are left to see if any medications are missing. Flush tablets that are out of date or no longer needed down the toilet so that others will not take them.

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Tell your doctor if you are pregnant or plan to become pregnant. If you take Apadaz 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 sleepiness, high-pitched crying, uncontrollable shaking of a part of the body, vomiting, diarrhea, or lack of weight gain.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start treatment with Apadaz and each time you get a refill. 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 Apadaz.

Why is this medication prescribed?
Apadaz (Benzhydrocodone and acetaminophen) is used to relieve acute pain (pain that starts suddenly, has a specific cause, and is expected to go away when the cause of the pain is cured) that cannot be relieved by other non-opioid pain relievers. Benzhydrocodone is in a class of medications called opioid (narcotic) pain relievers. 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 perceives pain.

How should this medicine be used?
Apadaz (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 parts you do not understand. Take Apadaz exactly as directed.

Do not stop taking Apadaz without talking to your doctor. If you stop taking Apadaz suddenly, you may experience withdrawal symptoms such as restlessness, watery eyes, runny nose, yawning, sweating, chills, standing hair, muscle pain, dilated 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 likely reduce your dose gradually.

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

What special precautions should I follow?

Before taking Apadaz,

  • Tell your doctor and pharmacist if you are allergic to benzhydrocodone, hydrocodone, acetaminophen, any other medications, or any of the ingredients in Apadaz tablets. Ask your pharmacist or see the Medication Guide for a list of the ingredients.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antihistamines (found in cold and allergy medications); diuretics (‘water pills’); buprenorphine (Butrans, in Suboxone, in Zubsolv, others); butorphanol; medications for irritable bowel disease, Parkinson’s disease, and urinary problems; linezolid (Zyvox); medications for mental illness and nausea such as chlorpromazine, fluphenazine, prochlorperazine (Compra, Procomp), thioridazine, and trifluoperazine; Methylene blue; medications for migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); nalbuphine; pentazocine (Talwin); 5-HT3 receptor antagonists such as alosetron (Lotronex), granisetron (Sancuso, Sustol), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi, in Akynzeo); selective serotonin reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), levomilnacipran (Fetzima); milnacipran (Savella) and venlafaxine (Effexor); tramadol (Conzip, Ultram, in Ultracet); trazodone; or tricyclic antidepressants (‘mood elevators’) such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil, Surmontil), nortriptyline (Pamelor), protriptyline, and trimipramine (Surtilipramine). Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them in the last two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications can also interact with Apadaz, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • Tell your doctor what herbal products you are taking, especially 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 (a condition in which digested food does not move through the intestines). Your doctor will likely tell you not to take Apadaz.
  • Tell your doctor if you have or have ever had seizures, trouble urinating, or disease of the pancreas, gallbladder, thyroid, heart, or kidneys.
  • Tell your doctor if you are breastfeeding. If you breastfeed while taking Apadaz, carefully monitor your breastfed baby for increased drowsiness, shortness of breath, or sagging. If you stop taking Apadaz, or if you stop breastfeeding, watch your baby closely for signs of withdrawal such as restlessness, watery eyes, runny nose, yawning, sweating, chills, or dilated pupils. Call your doctor immediately if the breastfed infant exhibits any of these symptoms.
  • You should know that this medicine can decrease fertility in men and women. Talk to your doctor about the risks of taking Apadaz.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Apadaz.
  • You should know that Apadaz can make you drowsy, dizzy, or lightheaded. Do not drive a car or operate machinery until you know how this drug affects you.
  • You should know that Apadaz can cause dizziness, lightheadedness, and fainting when you get up too quickly from lying down. This is more common when you start taking Apadaz, 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 Apadaz can cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while taking Apadaz.
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What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?
This medication is usually taken as needed. If your doctor has told you to take Apadaz regularly, take the missed dose as soon as you remember. 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 the one you forgot.

What side effects can this medication cause?

Apadaz 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

Apadaz can cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (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 medicine in the container it came in, tightly closed, and out of the reach of children. Store at room temperature and away from excess heat and moisture (not in the bathroom). You should immediately dispose of any medications that are out of date or no longer needed through a drug take-back program. If you don’t have a take-back program nearby or one you can access right away, flush any medications that are out of date or no longer needed so that others won’t take them. Talk to your pharmacist about the correct way to dispose of your medicine.

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It is important to keep all medicines out of the sight and reach of children, since many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not child-resistant and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

In case of emergency/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 collapsed, had a seizure, is having trouble breathing, or cannot wake up, immediately call 911 for emergency services.

While taking Apadaz, you may be told to always have a rescue medicine called naloxone available (for example, at home, in the office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opioids to relieve dangerous symptoms caused by high levels of opioids in the blood. You probably won’t be able to treat yourself if you experience an opioid overdose. You need to make sure that your family members, caregivers, or people who spend time with you know how to know if you are experiencing 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 medicine. Ask your pharmacist for instructions or visit the manufacturer’s website for instructions. If someone sees that you are experiencing symptoms of an overdose, they should give you their first dose of naloxone, call 911 immediately, and stay with you and monitor you closely until emergency medical help arrives. Your symptoms may return within minutes after receiving naloxone. If their symptoms return, the person should give them another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms reappear before medical help arrives.

Symptoms of overdose may include:

  • slowed or stopped breathing
  • difficulty breathing
  • sleepiness
  • limp or weak muscles
  • cold, clammy skin
  • narrowing or widening of the pupils
  • slowed heartbeat
  • unusual snoring
  • nausea
  • vomiting
  • sweating
  • feeling unwell

What other information should I know?
Keep all your 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 Apadaz.

This recipe is not refillable. If you continue to have pain after you finish Apadaz, call your doctor.

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

Brand Names

  • Apadaz®

Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.

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