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Capital & Codeine (Generic Acetaminophen and Codeine)

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WARNING

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. Moreover, let your physician know if you now have or previously had a lung condition like chronic obstructive pulmonary disease (COPD), a group of illnesses that affect the lungs and airways, a head injury, a brain tumour, or any other condition that raises the pressure inside of your skull. If you are an older adult, frail, or undernourished as a result of a sickness, your risk of developing breathing issues may be higher. Call your doctor right away or seek emergency medical attention if you have any of the following symptoms: breathing slowly, holding their breath for a lengthy time, or having trouble breathing.

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 neuromuscular disease (a condition that affects the nerves that control voluntary muscles), lung disease, or obstructive sleep apnea (a condition in which the airway narrows or becomes blocked and breathing stops briefly during sleep) should not take acetaminophen or codeine as these conditions may increase their risk of 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. Get assistance from your physician or pharmacist.

While receiving therapy with acetaminophen and codeine, taking certain drugs may raise your chance of developing breathing issues or other serious, life-threatening breathing issues, drowsiness, or coma. Inform your physician if you are now taking or intend to take any of the following drugs: Benzodiazepines such alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); some antifungal drugs including itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); erythromycin (Erytab, Erythrocin), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), some anti-HIV drugs as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra), muscle relaxants, other pain relievers, phenytoin (Dilantin, Phenytek); rifampin, sedatives, tranquillizers, or sleeping pills (Rifadin, Rimactane, in Rifamate). Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away or go to the emergency room if any of the following symptoms occur when taking acetaminophen and codeine with any of these medications: Unusual lightheadedness, drowsiness, breathing that is sluggish or difficult, or inability to respond. 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?

Acetaminophen and codeine are combined to treat mild to moderate pain. Acetaminophen belongs to the group of drugs known as analgesics (painkillers) and antipyretics (fever reducers). It functions by cooling the body and altering how the body perceives pain. In addition to being an antitussive, codeine is a member of the opiate (narcotic) analgesic drug class. The way the brain and nervous system react to pain is altered when codeine is used to relieve pain. Codeine serves to lessen coughing by reducing activity in the area of the brain that triggers 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, inform your doctor and pharmacist right away. For a list of the ingredients, ask your doctor or pharmacist.
  • Inform your doctor or pharmacist if you are taking or receiving any of the following monoamine oxidase (MAO) inhibitors, or if you have stopped taking them within the previous two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). If you are currently taking one or more of these medications, or if you have recently taken them, your doctor may generally advise against taking acetaminophen and codeine.
  • 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 any of the following medications you are taking: Buprenorphine (Belbuca, Butrans, Probuphine), amiodarone (Nexterone, Pacerone), antihistamines (used in cold and allergy treatments); butorphanol, diuretics (often known as “water pills”), bupropion (Aplenzin, Wellbutrin, Zyban), eletriptans (Relpax), naratriptans (Amerge), rizatriptans (Maxalt), sumatriptans (Imitrex, in Treximet), and zolmitriptans (Zomig), as well as the antidepressants mirtazapine (Remeron); nalbuphine; pentazocine (Talwin); selective serotonin-reuptake inhibitors such fluoxetine (Prozac, Sarafem, in Symbyax), citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); tricyclic antidepressants, or “mood elevators,” include amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine. Serotonin and norepinephrine reuptake inhibitors include duloxe (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 suffer from or have ever suffered from kidney, pancreatic, gallbladder, or seizure disorders.
  • 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.
  • If you are breastfeeding, let your doctor know. While using acetaminophen and codeine, you shouldn’t breastfeed. Codeine can lead to irregular or noisy breathing, shallow breathing, disorientation, unusual tiredness, difficulties nursing, or 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 may be severe. Get emergency medical assistance or call your doctor right away if you encounter any of these signs or those listed in the IMPORTANT CAUTION section:

  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • 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
  • Blistering, peeling, or red skin
  • Rash
  • Hives
  • Itching
  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Hoarseness
  • Breathing or swallowing challenges
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal

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

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

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 Medications website at http://goo.gl/c4Rm4p for additional information.

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 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.

Even if there are no symptoms, get medical attention right away if someone takes more acetaminophen and codeine than is advised. The following are examples of overdose symptoms:

  • Nausea
  • Vomiting
  • Reduced appetite
  • Sweating
  • Uncommon bruising or bleeding
  • Stomach’s upper right corner hurts
  • Yellowing of the eyes or skin
  • Weak or sluggish breathing
  • Having trouble breathing
  • Sleepiness
  • Not able to speak or awaken
  • Decline in muscular tone
  • Expanded or narrowed pupils
  • Clammy, frigid 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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