Advise caregivers of children receiving codeine-containing products for other reasons to monitor for signs of respiratory depression. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers.
These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness more than usual , difficulty breastfeeding, breathing difficulties, or limpness.
Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call or local emergency services. Drug Interactions: This drug may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals to determine whether acetaminophen and codeine have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility.
Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and Micronucleus test on mouse bone marrow. There are no adequate and well-controlled studies in pregnant women.
Acetaminophen and codeine phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy.
Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life. Labor and delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn.
Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required. The effect of codeine, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known.
Because of the potential for serious adverse reactions in nursing infants from acetaminophen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Codeine is secreted into human milk. In women with normal codeine metabolism normal CYP2D6 activity , the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine.
These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby.
Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect.
Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby.
Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. It is also important information to carry with you in case of emergencies. Generic alternatives may be available. Acetaminophen and Codeine pronounced as a set a mee' noe fen koe' deen. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow?
What should I do if I forget a dose? What side effects can this medication cause? What should I know about storage and disposal of this medication?
Brand names Brand names of combination products Other names. Other uses for this medicine. What special precautions should I follow? Before taking acetaminophen and codeine, tell your doctor and pharmacist if you are allergic to acetaminophen, codeine, sulfite, any other medications, or any of the ingredients in acetaminophen and codeine products.
Ask your doctor or pharmacist for a list of the ingredients. Your doctor will probably tell you not to take acetaminophen and codeine if you are taking one or more of these medications, or have taken them within the past two weeks. Many other medications may also interact with acetaminophen and codeine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Your doctor may tell you not to take acetaminophen and codeine if you have any of these conditions. Talk to your doctor about the risks of taking acetaminophen and codeine. You should not breastfeed while taking acetaminophen and codeine. Codeine can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants in breastfed infants.
Do not drive a car or operate machinery until you know how this medication affects you. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Acetaminophen and codeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: constipation difficulty urinating Some side effects can be serious.
If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical help: nausea, vomiting, loss of appetite, weakness, or dizziness agitation, hallucinations seeing things or hearing voices that do not exist , fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea red, peeling or blistering skin rash hives itching swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs hoarseness difficulty breathing or swallowing inability to get or keep an erection irregular menstruation decreased sexual desire Acetaminophen and codeine may cause other side effects.
If someone takes more than the recommended dose of acetaminophen and codeine, get medical help immediately, even if the person does not have any symptoms. Symptoms of overdose may include the following: nausea vomiting loss of appetite sweating unusual bleeding or bruising pain in upper right part of the stomach yellowing of skin or eyes slow or shallow breathing difficulty breathing sleepiness unable to respond or wake up loss of muscle tone narrowed or widened pupils cold and clammy skin fainting slow heartbeat.
An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen sometimes abbreviated as APAP. Taking certain medications together can lead to a fatal overdose. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Opioid medicine can slow or stop your breathing, and death may occur.
A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated. Long-term use of opioid medication may affect fertility ability to have children in men or women. It is not known whether opioid effects on fertility are permanent.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines.
Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C. Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:. This list is not complete. Other drugs may affect acetaminophen and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products.
Not all possible interactions are listed here. Selling or giving away opioid medicine is against the law. If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using this medicine.
Do not stop using acetaminophen and codeine suddenly after long-term use , or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine. Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription. Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly.
Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet. Since this medicine is used for pain, you are not likely to miss a dose.
Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time. Seek emergency medical attention or call the Poison Help line at An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription.
Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing. Your doctor may recommend you get naloxone a medicine to reverse an opioid overdose and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR cardiopulmonary resuscitation on you while waiting for help to arrive.
Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen sometimes abbreviated as APAP.
Taking certain medications together can lead to a fatal overdose.
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