This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Precautions See also Warning section. Before taking this product, tell your doctor or pharmacist if you are allergic to acetaminophen or codeine; or to other opioid pain medications such as morphine ; or if you have any other allergies.
This product may contain inactive ingredients such as metabisulfite , which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication , tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Liquid products may contain sugar and alcohol. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs , nonprescription drugs, and herbal products. See also Warning section. During pregnancy , this medication should be used only when clearly needed. To make sure this medicine is safe for you, tell your doctor if you have ever had: If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born.
Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Safe dosage of acetaminophen and codeine phosphate oral solution has not been established in pediatric patients below the age of 3 years.
These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, and agranulocytosis.
At higher doses codeine has most of the disadvantages of morphine including respiratory depression. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.
Toxicity from codeine poisoning includes the opioid triad of: Early symptoms following a potentially hepatotoxic overdose may include: Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
A single or multiple drug overdose with acetaminophen and codeine is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.
Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.
Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine NAC to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading.
Fosaprepitant mg IV as a single dose increased the AUC of midazolam given on days 1 and 4 by approximately 1. Less than a 2-fold increase in the midazolam AUC is not considered clinically important. Moderate Lumefantrine is an inhibitor and codeine is a substrate of the CYP2D6 isoenzyme; therefore, coadministration may lead to increased codeine concentrations.
Concomitant use warrants caution due to the potential for increased side effects. Moderate Drugs that can cause CNS depression, if used concomitantly with asenapine, may increase both the frequency and the intensity of adverse effects such as drowsiness, sedation, and dizziness.
Caution should be used when asenapine is given in combination with other centrally-acting medications including opiate agonists. Major Concomitant use of opiate agonists with skeletal muscle relaxants may cause respiratory depression, hypotension, profound sedation, and death. Limit the use of opiate pain medications with skeletal muscle relaxants to only patients for whom alternative treatment options are inadequate.
If an opiate agonist is initiated in a patient taking a skeletal muscle relaxant, use a lower initial dose of the opiate and titrate to clinical response. If a skeletal muscle relaxant is prescribed for a patient taking an opiate agonist, use a lower initial dose of the skeletal muscle relaxant and titrate to clinical response.
Avoid prescribing opiate cough medications in patients taking skeletal muscle relaxants. The pharmacological activity of codeine is due to its conversion to morphine via the cytochrome CYP2D6 hepatic isoenzyme.
The CYP3A4 pathway is also an important metabolic clearance route for codeine. Moderate Concomitant use of codeine with other CNS depressants, such as neuromuscular blockers, can potentiate the effects of alfentanil on respiration, alertness, and blood pressure. A dose reduction of one or both drugs may be warranted. Severe Codeine use is contraindicated in patients who are receiving or who have received monoamine oxidase inhibitors MAOIs within the previous 14 days. Methylene blue is a reversible inhibitor of MAO.
Concomitant use of codeine with other serotonergic drugs such as MAOIs may result in serious adverse effects including serotonin syndrome. MAOIs may cause additive CNS depression, respiratory depression, drowsiness, dizziness, or hypotension when used with opiate agonists such as codeine. Use caution during coadministration. Reduced GI motility when combined with opiate agonists may increase the risk of serious GI related adverse events.
Atropine; Hyoscyamine; Phenobarbital; Scopolamine: The CYP3A4 pathway is an important metabolic clearance route for codeine, and inhibition of this metabolic pathway by CYP3A4 inhibitors, such as azole antifungals, may lead to elevated codeine concentrations that are available for conversion to morphine by CYP2D6.
Monitor patients for increased opiate-related side effects and adjust the dose of codeine as necessary. Belladonna Alkaloids; Ergotamine; Phenobarbital: Moderate The vagal effects and respiratory depression induced by opiate agonists may be increased by the use of benzonatate.
Moderate Bethanechol facilitates intestinal and bladder function via parasympathomimetic actions. Opiate agonists impair the peristaltic activity of the intestine. Thus, these drugs can antagonize the beneficial actions of bethanechol on GI motility. Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: Moderate Additive constipation may be seen with concurrent use of opiate agonists and antidiarrheals.
Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Bismuth Subsalicylate; Metronidazole; Tetracycline: Moderate Close clinical monitoring is advised when administering acetaminophen with boceprevir due to an increased potential for acetaminophen-related adverse events.
If acetaminophen dose adjustments are made, re-adjust the dose upon completion of boceprevir treatment. Although this interaction has not been studied, predictions about the interaction can be made based on the metabolic pathway of acetaminophen.
Acetaminophen is partially metabolized by the hepatic isoenzyme CYP3A4; boceprevir inhibits this isoenzyme. Coadministration may result in elevated acetaminophen plasma concentrations. Moderate Due to the CNS effects of brexpiprazole, caution is advisable when brexpiprazole is given in combination with other centrally-acting medications including opiate agonists. Moderate Monitor for decreased efficacy of codeine, including signs and symptoms of opioid withdrawal in patients who are physically dependent on codeine, if coadministration with brigatinib is necessary.
Moderate Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of opiate agonists. Moderate Drowsiness has been reported during administration of carbetapentane.
An enhanced CNS depressant effect may occur when carbetapentane is combined with other CNS depressants including morphine. In some cases of acute pain, trauma, or during surgical management, opiate-dependent patients receiving buprenorphine maintenance therapy may require concurrent treatment with opiate agonists, such as codeine. In these cases, health care professionals must exercise caution in opiate agonist dose selection, as higher doses of an opiate agonist may be required to compete with buprenorphine at the mu-receptor.
Management strategies may include adding a short-acting opiate agonist to achieve analgesia in the presence of buprenorphine, discontinuation of buprenorphine and use of an opiate agonist to avoid withdrawal and achieve analgesia, or conversion of buprenorphine to methadone while using additional opiate agonists if needed. Closely monitor patients for CNS or respiratory depression. When buprenorphine is used for analgesia, avoid co-use with opiate agonists.
Buprenorphine may cause withdrawal symptoms in patients receiving chronic opiate agonists as well as possibly potentiate CNS, respiratory, and hypotensive effects. Major Naloxone can antagonize the therapeutic efficacy of codeine in addition to precipitating withdrawal symptoms in patients who are physically dependent on opiate drugs including codeine.
Moderate Patients receiving inhibitors of the CYP2D6 isoenzyme, like bupropion, will have a reduction in the metabolic conversion of codeine to morphine and therefore may not experience an adequate analgesic response to codeine.
Major When naltrexone is used as adjuvant treatment of opiate or alcohol dependence, use is contraindicated in patients currently receiving opiate agonists.
Naltrexone will antagonize the therapeutic benefits of opiate agonists and will induce a withdrawal reaction in patients with physical dependence to opioids. An opiate antagonist should only be administered to a patient taking codeine with clinically significant respiratory or cardiovascular depression. Also, patients should be opiate-free for at least days prior to initiating naltrexone therapy. If a patient receives naltrexone, and an opiate agonist is needed for an emergency situation, large doses of opiate agonists may ultimately overwhelm naltrexone antagonism of opiate receptors.
Immediately following administration of exogenous opiate agonists, the opiate plasma concentration may be sufficient to overcome naltrexone competitive blockade, but the patient may experience deeper and more prolonged respiratory depression and thus, may be in danger of respiratory arrest and circulatory collapse.
Non-receptor mediated actions like facial swelling, itching, generalized erythema, or bronchoconstriction may occur presumably due to histamine release. A rapidly acting opiate agonist is preferred as the duration of respiratory depression will be shorter. Patients receiving naltrexone may also experience opiate side effects with low doses of opiate agonists.
If the opiate agonist is taken in such a way that high concentrations remain in the body beyond the time naltrexone exerts its therapeutic effects, serious side effects may occur.
Moderate Concomitant use of CNS depressants, such as buspirone, can potentiate the effects of codeine, which may potentially lead to respiratory depression, CNS depression, sedation, or hypotensive responses. If concurrent use of codeine and buspirone is imperative, reduce the dose of one or both drugs.
Moderate Use busulfan and acetaminophen together with caution; concomitant use may result in increased busulfan levels and increased busulfan toxicity.
Separating the administration of these drugs may mitigate this interaction; avoid giving acetaminophen within 72 hours prior to or concurrently with busulfan. Busulfan is metabolized in the liver through conjugation with glutathione; acetaminophen decreases glutathione levels in the blood and tissues and may reduce the clearance of busulfan.
Major Avoid the concomitant use of butorphanol and opiate agonists, such as codeine. Butorphanol may cause withdrawal symptoms in patients receiving chronic opiate agonists. Concurrent use of butorphanol with other opiate agonists can cause additive CNS, respiratory, and hypotensive effects. Moderate Inducers of CYP3A4 such as carbamazepine may induce the hepatic metabolism of opiate agonists, which may lead to opiate withdrawal or inadequate pain control.
This interaction is most significant if the enzyme-inducing agent is added after opiate therapy has begun in patients who are opiate tolerant. Clinicians should be alert to changes in the effect of the opioid agonist. Opiate doses may need to be increased if carbamazepine is added.
Conversely, doses may need to be decreased if carbamazepine is discontinued. Minor Carbamazepine may potentially accelerate the hepatic metabolism of acetaminophen. In addition, due to enzyme induction, carbamazepine may increase the risk for acetaminophen-induced hepatotoxicity via generation of a greater percentage of acetaminophen's hepatotoxic metabolite, NAPQI.
Clinicians should be alert to decreased effect of acetaminophen. Moderate Concomitant use of opiate agonists with other central nervous system CNS depressants such as COMT inhibitors can potentiate the effects of the opiate and may lead to additive CNS or respiratory depression, profound sedation, or coma. Prior to concurrent use of an opiate in patients taking a CNS depressant, assess the level of tolerance to CNS depression that has developed, the duration of use, and the patient's overall response to treatment.
Carefully monitor the patient for hypotension, CNS depression, and respiratory depression. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. Moderate Due to the CNS effects of cariprazine, caution is advisable when cariprazine is given in combination with other centrally-acting medications including opiate agonists.
Major Consider reducing the dose of codeine if coadministration with cobimetinib is necessary; monitor frequently for sedation and respiratory depression. Coadministration with inhibitors of CYP3A4 may increase codeine plasma concentrations with subsequently greater metabolism by CYP2D6, resulting in greater morphine levels.
Moderate Additive drowsiness may occur if cetirizine or levocetirizine is administered with other drugs that depress the CNS, including opiate agonists. Minor Activated charcoal binds many drugs within the gut. Administering charcoal dietary supplements at the same time as a routine acetaminophen dosage would be expected to interfere with the analgesic and antipyretic efficacy of acetaminophen. Charcoal is mostly used in the setting of acetaminophen overdose; however, patients should never try to treat an acetaminophen overdose with charcoal dietary supplements.
Advise patients to get immediate medical attention for an acetaminophen overdose. Minor Due to the CNS depression potential of all local anesthetics, they should be used with caution with other agents that can cause respiratory depression, such as opiate agonists.
Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine: Moderate Phenothiazines can potentiate the CNS depressant action of other drugs such as opiate agonists. Experts have recommended that cholestyramine not be given within 1 hour of acetaminophen if analgesic or antipyretic effect is to be achieved. If this happens to a nursing mother, the baby is a risk of receiving a morphine overdose through the breast milk.
If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. The safety and effectiveness of using this medication have not been established for children under 12 years of age.
Seniors who take this medication may be more likely to experience side effects or worsening of preexisting medical conditions. What other drugs could interact with this medication? There may be an interaction between acetaminophen - codeine - caffeine and any of the following: This can cause life-threatening withdrawal symptoms in the baby after it is born.
Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not breast-feed while taking this medicine. How should I take acetaminophen and codeine?
Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Codeine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.
Selling or giving away this medicine is against the law.
Because of the acetaminophen content 120mg Tylenol 3, I decided to supplement the pills acetaminophen a codeine codeine syrup I had left over from a respiratory codeine. The closer to delivery and 120mg larger 12mg dose used, acetaminophen codeine 120mg 12mg, the greater the possibility of respiratory depression in the newborn. Do not drink alcohol. Consequently, the extended use of this acetaminophen is not 120mg. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes, acetaminophen codeine 120mg 12mg. Acetaminophen to other opioids[ edit ] Codeine has been used in the codeine as the starting material and prototype of 12mg large class of mainly mild to acetaminophen strong opioids; such 12mg hydrocodone in Germanyoxycodone in Germanydihydrocodeine in Germanyacetaminophen codeine 120mg 12mg, and its derivatives such 120mg nicocodeine in Austria. They didn't question me any further, so I lucked out, because 12mg was a nervous wreck lying to them. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including 12mg codeine more than codeinedifficulty breastfeeding, breathing difficulties, or limpness. Acetaminophen and codeine are supplied in liquid form for oral administration. These higher levels of morphine in breast milk may lead to lifethreatening or fatal side effects in nursing babies. What is acetaminophen and codeine? Skip the missed dose if acetaminophen is almost time for your next scheduled dose. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical 120mg may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed, acetaminophen codeine 120mg 12mg. Ask your doctor before making any changes in how or when you take your medications.
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