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Acetaminophen and Codeine

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Acetaminophen plus codeine may lead to addiction, especially if used frequently. Take codeine and acetaminophen precisely as prescribed. Do not take it in larger amounts, more frequently, or otherwise differently than prescribed by your doctor. Talk to your doctor about your pain management options, the length of your treatment, and your treatment goals while taking acetaminophen and codeine. 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 ever had any of these illnesses, you are more likely to misuse acetaminophen and codeine. If you suspect that you may have an opioid addiction, speak with your doctor right away and ask for advice, or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Acute or potentially fatal breathing issues can result with taking acetaminophen and codeine together, especially in the first 24 to 72 hours of treatment and if your dose is raised. 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 using acetaminophen and codeine. Additionally, let your doctor know if you now have or previously had a lung condition such chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a brain tumour, a head injury, or any other condition that raises the pressure inside your head. 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.

The use of codeine-containing medications in children has been linked to serious and fatal breathing issues, including deaths and slow or difficult breathing. Acetaminophen with codeine should never be used to children under the age of 12 for the treatment of pain or cough, or to children under the age of 18 for the relief of pain following surgery to remove the tonsils and/or adenoids. Children aged 12 to 18 who are obese, have a neuromuscular disorder (a condition that affects the nerves that control voluntary muscles), a lung problem, or have obstructive sleep apnea should not use acetaminophen or codeine (condition in which the airway becomes blocked or narrow and breathing stops for short periods during sleep) as these abnormalities could make them more susceptible to breathing issues.

The combination medication’s active ingredient, acetaminophen, when used in excess can harm the liver, sometimes seriously enough to necessitate liver transplantation or even result in death. If you don’t carefully read the instructions on the prescription or package label, or if you use multiple acetaminophen-containing products, you risk mistakenly taking too much of the medication. Be advised that you shouldn’t take more acetaminophen than 4,000 mg per day. If you have liver illness now or ever had it, let your doctor know. It could be challenging for you to figure out how much acetaminophen you are taking overall if you need to use multiple acetaminophen-containing products. Obtain assistance from your physician or pharmacist.

You run a higher risk of developing breathing issues or other severe, life-threatening breathing issues, drowsiness, or coma if you take certain drugs while receiving treatment with acetaminophen and codeine. Inform your doctor if you are currently taking or intend to take any of the following medicines: alprazolam, itraconazole, ketoconazole, and voriconazole (Vfend); some antifungal drugs such itraconazole (Onmel, Sporanox); and ketoconazole (Xanax), benzodiazepines such as diazepam (Valium, Diastat), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); erythromycin (Erytab, Erythrocin); some anti-HIV drugs such indinavir (Crixivan), sedatives, tranquillizers, phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane), muscle relaxants, other pain relievers, or sleeping drugs. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. If you take any of these drugs along with acetaminophen and codeine and experience any of the following symptoms, call your doctor right away. When you have unusual dizziness, lightheadedness, extreme tiredness, slowed or trouble breathing, or become unconscious, call your doctor right away or go to the hospital for emergency care. If you are unable to seek treatment on your own, make sure your carer or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

You have a higher risk of developing severe, perhaps fatal adverse effects while receiving acetaminophen and codeine treatment if you consume alcohol, use prescription or over-the-counter treatments that include alcohol, or use illicit substances. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.

If you are pregnant or want to become pregnant, let your doctor know. Regular use of acetaminophen and codeine during pregnancy increases the risk that your unborn child could develop 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.

When you start treatment with acetaminophen and codeine as well as each time your prescription is filled, your doctor or pharmacist will provide you the manufacturer’s patient information sheet (Medication Guide). 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?

To treat mild to severe pain, acetaminophen and codeine are combined. A class of drugs known as analgesics (pain relievers) and antipyretics includes acetaminophen (fever reducers). It functions by altering how the body perceives pain and by cooling the body. In addition to being an antitussive, codeine is part of the group of drugs known as opiate (narcotic) analgesics. When codeine is used to relieve pain, it alters how the nervous system and brain react to pain. Codeine works by reducing activity in the area of the brain that triggers coughing when used to treat coughing.

How should this medicine be used?

The oral dosage forms for the acetaminophen and codeine mixture are tablets, capsules, and liquids. As needed, it is typically taken every four hours. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take codeine and acetaminophen precisely as prescribed.

Do not discontinue taking acetaminophen and codeine without consulting your doctor if you have been taking it for several weeks or longer. Your dose could be gradually reduced by your doctor. Acetaminophen and codeine withdrawal symptoms may include agitation, teary eyes, widened pupils (black circles in the centre of the eyes), irritability, anxiety, runny nose, trouble falling or staying asleep, yawning, sweating, rapid breathing, rapid heartbeat, chills, nausea, loss of appetite, vomiting, diarrhoea, stomach cramps, or muscle aches if you suddenly stop taking them.

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 acetaminophen and codeine,

  • If you have any allergies, including to acetaminophen, codeine, sulfite, other drugs, or any of the substances in acetaminophen and codeine products, tell your doctor and pharmacist right away. For a list of the ingredients, ask your doctor or pharmacist.
  • Any of the following monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine, should be disclosed to your doctor or pharmacist if you are taking them or receiving them (Parnate). If you are currently taking one or more of these medications, or if you have recently taken them, your doctor probably won’t advise you to take acetaminophen plus codeine.
  • Inform your physician and pharmacist of any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mentioning the following medications is important: Antihistamines, which are present in cold and allergy treatments, amiodarone (Nexterone, Pacerone); butorphanol, diuretics (‘water pills,’ drugs for migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig), mirtazapine (Remeron); serotonin and norepinephrine reuptake inhibitors like duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); tramadol (Conzip), trazodone (Oleptro); and selective serotonin-reuptake inhibitors like citalopram (Celexa), or tricyclic antidepressants (often known as “mood elevators”), including amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Acetaminophen and codeine may also interact with many other drugs, so be sure to inform your doctor of all the drugs you are taking, even if they do not appear on this list. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Inform your doctor if you have paralytic ileus, a blockage or constriction of your stomach or intestines, or any of the disorders listed in the IMPORTANT WARNING section (condition in which digested food does not move through the intestines). If you suffer from any of these problems, your doctor might advise against taking acetaminophen and codeine.
  • Inform your doctor if you currently have or previously had kidney, pancreatic, or gallbladder illness, as well as any trouble urinating.
  • You should be aware that this medicine may lower both male and female fertility. Discuss the dangers of taking acetaminophen and codeine with your doctor.
    Inform your doctor if you are nursing a child. While using codeine and acetaminophen, you shouldn’t breastfeed.
  • Codeine can result in shallow breathing, noisy breathing, disorientation, excessive drowsiness, nursing difficulties, and limpness in breastfed newborns.
  • Inform the surgeon or dentist that you are taking acetaminophen and codeine if you are having surgery, including dental surgery.
  • You should be aware that this medicine may cause you to feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that acetaminophen and codeine may result in fainting if you stand up suddenly from a laying posture. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.

What should I do if I forget a dose?

Typically, this drug is given as needed. Take the missing dose as soon as you remember it if your doctor has instructed you to take acetaminophen and codeine on a regular basis. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Codeine with acetaminophen could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • Having trouble urinating

Some 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:

  • Nausea, vomiting, appetite loss, exhaustion, or lightheadedness
  • Hallucinations (seeing or hearing objects or voices that aren’t there), agitation, sweating excessively, confusion, rapid heartbeat, shivering, extremely rigid or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Blistering, peeling, or red skin
  • Rash
  • Hives
  • Itching
  • Swelling of the lower legs, hands, feet, ankles, or face, neck, tongue, lips, eyes, or mouth
  • Hoarseness
  • Breathing or swallowing challenges
  • Failure to achieve or maintain erection
  • Abnormal menstruation
  • Reduced sexual arousal

Other adverse effects could be brought on by acetaminophen and codeine. If you have any strange side effects while taking this medicine, contact your doctor right once.

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).

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. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As 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.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at 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 a rescue drug called naloxone on hand while taking acetaminophen and codeine (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. If you start to experience overdose symptoms, a friend or family member should administer the first dose of naloxone, contact 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.

Get medical assistance right away if someone takes more acetaminophen and codeine than is advised, even if they are symptom-free. Overdose signs could include the following:

  • Nausea
  • Vomiting
  • Reduced appetite
  • Sweating
  • Uncommon bruising or bleeding
  • Yellowing of the skin or eyes
  • Pain in the upper right portion of the stomach
  • Shallow or sluggish breathing
  • Having trouble breathing
  • Sleepiness
  • Unable to wake up or speak
  • Muscle tone loss
  • Reduced vision or enlarged pupils
  • Tempest-like skin
  • Fainting
  • Sluggish heartbeat

What other information should I know?

Keep all of your doctor’s appointments. To determine how well your body responds to acetaminophen and codeine, your doctor may request specific lab tests.

Inform your doctor and the lab staff that you are taking acetaminophen and codeine prior to any laboratory test (particularly those that use methylene blue).

No one else should take your medication. Codeine and acetaminophen are considered restricted substances. Only a limited amount of refills are permitted for prescriptions; if you have any doubts, speak with your pharmacist.

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

  • Capital® & Codeine
  • Codrix®
  • Empracet® (#3, #4)
  • Papa-deine® (#3, #4)
  • Phenaphen® with Codeine (#2, #3, #4)
  • Proval® #3
  • Tylenol® with Codeine (#3, #4)
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