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Combunox (Generic Oxycodone)

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WARNING

Oxycodone may lead to addiction. Follow the prescription for oxycodone exactly. Do not take it in larger amounts, more frequently, or otherwise differently than prescribed by your doctor. Discuss your pain management options, treatment duration, and goals with your healthcare professional while using oxycodone. Inform your doctor if you or any family members regularly use significant amounts of alcohol, take street drugs, abuse prescription drugs excessively, experience overdosing, or currently suffer from depression or another mental disorder. If you currently have or have previously had any of these conditions, there is a higher chance that you may abuse oxycodone. If you believe you may have an opioid addiction, speak with your healthcare physician right away and ask for advice. You can also contact the SAMHSA National Helpline by calling 1-800-662-HELP.

During the first 24 to 72 hours of treatment and whenever your dose is increased, oxycodone might cause serious or life-threatening respiratory issues. Throughout your therapy, your doctor will keep a close eye on you. If you have asthma or slow breathing, let your doctor know. Most likely, your doctor will advise against taking oxycodone. A head injury, a brain tumour, or any condition that raises your blood pressure should also be disclosed to your doctor. Lung conditions including chronic obstructive pulmonary disease (COPD), a group of illnesses that affect the lungs and airways, should also be mentioned. The likelihood that you will experience breathing issues may be increased if you are an older adult, weak, or undernourished as a result of a sickness. Get emergency medical care if you encounter any of the following symptoms, or call your doctor right away: sluggish breathing, protracted breath gaps, or shortness of breath.

Using oxycodone with some other drugs may increase the risk of serious or life-threatening respiratory issues, sedation, or coma. If you are now taking or intend to take any of the following medications, please let your doctor and pharmacist know: a few antifungal drugs like itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); certain antibiotics like erythromycin (Erytab, Erythrocin) and clarithromycin (Biaxin, in PrevPac); benzodiazepines like alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin);sedatives, sleeping pills, tranquillizers, and certain HIV medications like indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra), as well as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, and Teril); medications for mental illness, nausea, or pain; muscle relaxants; phenytoin (Dilantin, Phen Your prescription doses may need to be adjusted, and your doctor will closely monitor you. If you take oxycodone together with any of these drugs and experience any of the following side effects, call your doctor right away or go to the hospital for emergency care: unusual dizziness, lightheadedness, extreme drowsiness, slowed or laboured breathing, or unresponsiveness. Make sure your carer or family members are aware of any symptoms that could be significant so they can contact an emergency room or a doctor if you are unable to do so on your own.

You run a higher chance of developing severe, potentially fatal adverse effects while receiving oxycodone treatment if you consume alcohol, use prescription or over-the-counter drugs that do, or use illicit substances. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.

Do not chew, break, divide, crush, or dissolve the oxycodone extended-release pills; instead, consume them whole. Never lick, soak, or otherwise wet the tablet before putting it in your mouth. After placing each tablet in your mouth, immediately swallow it. You risk taking too much oxycodone at once if you ingest extended-release pills that have been chewed, crushed, chewed, or dissolved. This could result in fatal overdoses and other severe issues.

Both a standard liquid solution of oxycodone and a concentrated solution, which contains more oxycodone per millilitre of solution, are available. Make sure you are aware of the dosage in millilitres and if your doctor has recommended the ordinary or concentrated solution. Measure the precise number of millilitres of solution that your doctor advised using the dosage cup, oral syringe, or dropper that came with your prescription. If you have any doubts about how to measure your dose or how much medication you should take, carefully read the instructions that came with your prescription and consult your doctor or pharmacist. If you use an oxycodone solution with a different concentration or if you use a different dosage than what your doctor has advised, you could encounter serious or even fatal adverse effects.

Do not share your medication with anybody else. Children in particular are particularly vulnerable to damage or death from oxycodone.

So that no one else can take it intentionally or accidently, store oxycodone in a secure location. Oxycodone should be kept out of children’s reach at all times. Keep track of how many tablets, capsules, or liquids are remaining so you can identify any missing medications. Follow the directions for disposing of unneeded capsules, tablets, extended-release tablets, capsules, and liquid. (See DISPOSAL and STORAGE.)

If you are pregnant or want to become pregnant, let your doctor know. Regular oxycodone use during pregnancy increases the risk of your unborn child developing potentially fatal withdrawal symptoms. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, diarrhoea, or failure to gain weight.

The dangers of oxycodone use should be discussed with your doctor.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start your oxycodone therapy and each time you fill your prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets and extended-release capsules are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Oxycodone extended-release tablets and extended-release capsules should not be used to treat pain that can be controlled by medication that is taken as needed. Oxycodone extended-release tablets, extended-release capsules, and concentrated solution should only be used to treat people who are tolerant (used to the effects of the medication) to opioid medications because they have taken this type of medication for at least one week. Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Oxycodone is also available in combination with acetaminophen (Oxycet, Percocet, Roxicet, Xartemis XR, others); aspirin (Percodan); and ibuprofen. This monograph only includes information about the use of oxycodone alone. If you are taking an oxycodone combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.

How should this medicine be used?

Oxycodone comes as a solution (liquid), a concentrated solution, a tablet, a capsule, an extended-release (long-acting) tablet (Oxycontin) and an extended-release capsule (Xtampza ER) to take by mouth. The solution, concentrated solution, tablet, and capsule are taken usually with or without food every 4 to 6 hours, either as needed for pain or as regularly scheduled medications. The extended-release tablets (Oxycontin) are taken every 12 hours with or without food. The extended-release capsules (Xtampza ER) are taken every 12 hours with food; eat the same amount of food with each dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxycodone exactly as directed.

If you are taking Oxaydo brand tablets, swallow the tablets one at a time with plenty of water. Swallow the tablet or right after putting it in your mouth. Do not presoak, wet, or lick the tablets before you put them in your mouth. Do not chew or crush Oxaydo brand tablets. and do not give them through a nasogastric tube (NG tube; a tube threaded through the nose to deliver food and medication directly to the stomach).

If you have trouble swallowing extended-release capsules (Xtampza ER), you can carefully open the capsule and sprinkle the contents on soft foods such as applesauce, pudding, yogurt, ice cream, or jam, then consume the mixture immediately. Dispose of the empty capsule shells right away by flushing them down a toilet. Do not store the mixture for future use.

If you have a feeding tube, the extended-release capsule contents can be poured into the tube. Ask your doctor how you should take the medication and follow these directions carefully.

If you are taking the concentrated solution, your doctor may tell you to mix the medication in a small amount of juice or semisolid food such as pudding or applesauce. Follow these directions carefully. Swallow the mixture right away; do not store it for later use.

Your doctor will likely start you on a low dose of oxycodone and may increase this dose over time if your pain is not controlled. After you take oxycodone for a period of time, your body may become used to the medication. If this happens, your doctor may need to increase your dose to control your pain. Your doctor may decrease your dose if you experience side effects. Talk to your doctor about how you are feeling during your treatment with oxycodone.

Do not stop taking oxycodone without talking to your doctor. If you stop taking this medication suddenly, you may experience withdrawal symptoms such as restlessness, watery eyes, runny nose, sneezing, yawning, sweating, chills, muscle or joint aches or pains, weakness, irritability, anxiety, depression, difficulty falling asleep or staying asleep, cramps, nausea, vomiting, diarrhea, loss of appetite, fast heartbeat, and fast breathing. Your doctor will probably decrease your dose gradually.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking oxycodone,

  • If you have an allergy to oxycodone, any other medications, or any of the ingredients in the oxycodone product you intend to take, let your doctor and pharmacist know right away. Get a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention the drugs in the IMPORTANT CAUTION section as well as any of the following: diuretics (often known as “water pills”), antihistamines (used in cold and allergy treatments), buprenorphine (Butrans, Suboxone, Zubsolv, and other brands), and butorphanol; drugs for glaucoma, irritable bowel syndrome, and urinary issues; cyclobenzaprine (Amrix); dextromethorphan (present in many cough suppressants; in Nuedexta); Lithium (Lithobid); migraine drugs such sumatriptan (Imitrex, in Treximet), eletriptan (Relpax), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig), as well as mirtazapine (Remeron);   pentazocine (Talwin); 5-HT3 receptor antagonists like alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); nalbuphine; naloxone (Evzio, Narcan, and others); naloxone; fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft) are examples of selective serotonin-reuptake inhibitors. Tramadol (Conzip, Ultram, in Ultracet), trazodone (Oleptro); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); or tricyclic antidepressants (often known as “mood elevators”), including amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Additionally, let your doctor or pharmacist know if you’re receiving any of the following monoamine oxidase (MAO) inhibitors or if you’ve recently stopped taking them: methylene blue, isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Tell your doctor about all of your current medications, even any not on this list, as many other drugs may also interact with oxycodone. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor about the herbal supplements you are taking, especially if you take St. John’s wort or tryptophan.
  • Inform your doctor if you have or have ever had paralytic ileus or any of the disorders listed in the IMPORTANT WARNING section (condition in which digested food does not move through the intestines). Your physician might advise against taking oxycodone.
  • Also let your doctor know if you have or have ever had a blockage in your stomach or intestine, low blood pressure, seizures, Addison’s disease (a condition in which the adrenal gland does not produce enough hormone), urethral strictures, enlarged prostates (male reproductive glands), urination issues, or heart, kidney, liver, pancreas, thyroid, or gall bladder disease. Tell your doctor if you have or have ever had difficulty swallowing, diverticulitis (a condition in which small pouches form in the intestines and become swollen and infected), colon cancer (a cancer that starts in the large intestine), or esophageal cancer if you will be taking the extended-release tablets or extended-release capsules (cancer that begins in the tube that connects the mouth and stomach).
  • Describe to your doctor if you are nursing a baby.
  • You should be aware that this medicine may lower both male and female fertility. The dangers of oxycodone use should be discussed with your doctor.
  • Inform your doctor or dentist that you are taking oxycodone if you are having surgery, including dental surgery.
  • You should be aware that this medicine may cause you to feel sleepy. Drive a car, operate machinery, or engage in any other potentially risky activities until you have a better understanding of how this drug affects you.
  • You should be aware that oxycodone can make you feel weak, lightheaded, and dizzy if you get out of bed too quickly. Get out of bed gradually and rest your feet on the floor for a few minutes before standing up to help prevent this issue.
  • You ought to be aware that oxycodone might result in constipation. While using oxycodone, discuss with your doctor whether you should alter your diet or take other drugs to avoid or cure constipation.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Take the missing dose of oxycodone right away if you take it on a regular basis. Skip the missed dose and carry on with your regular dosing plan, nevertheless, if it is almost time for the subsequent dose. Never take two doses at once to make up for missing ones. The extended-release pills or tablets should not be taken more than once every 12 hours.

What side effects can this medication cause?

Side effects from oxycodone are possible. If any of these symptoms persist or are severe, consult your doctor right away.

  • Mouth ache
  • Abdominal pain
  • Drowsiness
  • Flushing
  • Headache
  • Mood shifts

Certain adverse effects can be very harmful. Call your doctor right away or seek emergency medical assistance if you develop any of these signs or any of the ones listed in the IMPORTANT WARNING section:

  • Alterations in heartbeat
  • Agitation, hallucinations (hearing voices or seeing things that are not there), disorientation, fever, sweating, shivering, extremely stiff or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal
  • Chest ache
  • Hives
  • Itching
  • Rash
  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Hoarseness
  • Breathing or swallowing challenges
  • Seizures
  • Extreme somnolence
  • Feeling dizzy when shifting positions

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Other negative effects from oxycodone may occur. If you experience any strange issues while taking this drug, call your doctor right away.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from light, excessive heat, and moisture at room temperature (not in the bathroom). Any medication that has expired or is no longer needed must be disposed of right away via a medicine take-back programme. If there isn’t a take-back programme close by or one you can quickly get to, flush any obsolete or unnecessary prescription down the toilet to prevent others from using it. See your pharmacist for advice on how to properly dispose of your medications.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

You should speak with your doctor about keeping naloxone, a life-saving drug, on hand while taking oxycodone (e.g., home, office). Naloxone is used to undo an overdose’s potentially fatal consequences. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. If you live with young children or someone who has abused prescription or illicit drugs, your doctor could also advise you to get naloxone. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. You and your family members will be shown how to use the medication by your doctor or pharmacist. For the directions, speak to your pharmacist or go to the manufacturer’s website. A carer or family member should administer the first dosage of naloxone if overdose symptoms appear, dial 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. After receiving naloxone, your symptoms can come back a short while later. The person should administer you another dose of naloxone if your symptoms come back. If symptoms reappear before receiving medical attention, more doses may be given every 2 to 3 minutes.

Overdose signs could include the following:

  • Having trouble breathing
  • Breathing slowed or stopped
  • Extreme drowsiness
  • Weak or limp muscles
  • Pupil dilation or dilation of the pupils (dark circle in the eye)
  • Clammy, frigid skin
  • Not able to speak or awaken

What other information should I know?

Keep all of your doctor’s appointments. To monitor how your body reacts to oxycodone, your doctor might request specific lab tests.

Inform your doctor and the lab staff that you are taking oxycodone prior to any laboratory test (particularly one that uses methylene blue).

This medication cannot be renewed. Call your doctor if you experience discomfort even after you have finished the oxycodone.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Dazidox®
  • Endocodone®
  • ETH-Oxydose®
  • Oxaydo®
  • Oxecta®
  • Oxycontin®
  • Oxyfast®
  • OxyIR®
  • Percolone®
  • Roxicodone®
  • Xtampza® ER
  • Targiniq® ER (as a combination product containing naloxone, oxycodone)
  • Xartemis XR® (as a combination product containing Acetaminophen, Oxycodone)
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