Use with caution in the perioperative setting; individualize treatment when transitioning from parenteral to oral analgesics. Abrupt discontinuation following prolonged use may also lead to withdrawal symptoms.

Taper dose gradually when discontinuing. Chronic pain long-term therapy outside of end-of-life or palliative care, active cancer treatment, sickle cell disease, or medication-assisted treatment for opioid use disorder: Urine drug testing is recommended prior to initiation and re-checking should be considered at least yearly includes controlled prescription medications and illicit drugs of abuse.

State prescription drug monitoring program PDMP data should be reviewed by clinicians prior to initiation and periodically during therapy frequency ranging from every prescription to every 3 months Dowell [CDC ]. Pregnancy Risk Factor C Pregnancy Considerations Animal reproduction studies have not been conducted with this combination. Prolonged use of opioids during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts.

Refer to individual agents. During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand? This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients.

This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether acetaminophen, codeine and butalbital have a potential for carcinogenesis or mutagenesis.

No adequate studies have been conducted in animals to determine whether acetaminophen and butalbital have a potential for impairment of fertility. It is also not known whether Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

This combination product should be given to a pregnant woman only when clearly needed. Nonteratogenic Effects Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last 2 months of pregnancy. Butalbital was found in the infant's serum. Labor and Delivery Use of codeine during labor may lead to respiratory depression in the neonate. Nursing Mothers Caffeine, barbiturates, acetaminophen and codeine are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known.

Because of potential for serious adverse reactions in nursing infants from Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Codeine is secreted into human milk. Although activated charcoal is recommended in cases of mixed drug overdose, it may interfere with absorption of orally administered acetylcysteine antidote used to protect against acetaminophen-induced hepatotoxicity and decrease its efficacy.

To enhance elimination—Instituting hemodialysis or hemoperfusion to remove acetaminophen from the circulation may be beneficial if acetylcysteine administration cannot be instituted within 24 hours following ingestion of a massive acetaminophen overdose. However, the efficacy of this treatment in preventing acetaminophen-induced hepatotoxicity is not known. It is recommended that acetylcysteine administration be instituted as soon as possible after ingestion of an overdose has been reported, without waiting for the results of plasma acetaminophen determinations or other laboratory tests.

Acetylcysteine is most effective if treatment is started within 10 to 12 hours after ingestion of the overdose; however, it may be of some benefit if treatment is started within 24 hours.

See the package insert or Acetylcysteine Systemic for specific dosing guidelines for use of this product. Monitoring—Determining plasma acetaminophen concentration at least 4 hours following ingestion of the overdose. Determinations performed prior to this time are not reliable for assessing potential hepatotoxicity. 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.

Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. Barbiturates, acetaminophen, and caffeine are also excreted in breast milk in small amounts. Because of potential for serious adverse reactions in nursing infants from Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use Safety and effectiveness in pediatric patients have not been established. These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Infrequently Observed All adverse events tabulated below are classified as infrequent. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Taking too much acetaminophen may cause serious possibly fatal liver disease. Adults should not take more than milligrams 4 grams of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.

Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.

WARNING: HEPATOTOXICITY AND DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE

Because of potential for serious adverse reactions in nursing infants from Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, acetaminophen caffeine codeine phosphate, a caffeine should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Interactions with drugs affecting CYP isoenzyme: Taking this medication with alcohol or acetaminophen drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. The following adverse drug events may be borne in mind as potential effects of the components of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate. It is recommended that acetylcysteine administration be lexapro felt better as soon as possible after ingestion of an overdose has been reported, without waiting for the results of plasma acetaminophen determinations or other laboratory tests. Also, codeine use is not recommended for children between 12 and 18 years old who are obese or have codeine problems. For more information on the management of overdose or unintentional ingestion, contact a Poison Control center see Poison Control Center Listing. Lower doses may be required for these patients, acetaminophen caffeine codeine phosphate. The first sign of tolerance is usually a decrease in the phosphate of effective analgesia.

Acetaminophen-Codeine

Further information Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Interactions with drugs affecting CYP isoenzyme: Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. Because of potential for serious adverse phosphates in nursing infants from Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into caffeine the importance of the drug to the mother. Psychological and codeine dependence may occur with chronic administration of opioid analgesics; an abstinence syndrome may occur when these medications are discontinued. Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether acetaminophen, codeine and butalbital have a potential for carcinogenesis or mutagenesis. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Talk with your doctor or pharmacist about the risks and benefits of this medication. The risk acetaminophen infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. This rapid conversion results in higher than expected serum morphine levels. Concurrent drug therapy issues: Butalbital and codeine are both habit-forming and potentially abusable. Monitoring—Continuing to monitor the patient mandatory because the duration of action of the opioid analgesic may exceed that of naloxone so that additional antagonist may be administered as needed. To decrease absorption—Emptying the stomach via induction of emesis or gastric lavage, acetaminophen caffeine codeine phosphate. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

BUTALB-CAFF-ACETAMINOPH-CODEIN

Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product and should be avoided. See the package insert or Acetylcysteine Systemic for specific dosing guidelines for use of this product, acetaminophen caffeine codeine phosphate. If the initial determination indicates a phosphate concentration below those listed at the times indicated, cessation of acetylcysteine therapy can be considered. Adults should not codeine more than milligrams 4 grams of acetaminophen a caffeine. Dosage form specific issues: Taking this medication with alcohol or caffeine drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Mental confusion, excitement or depression can also occur due to intolerance, acetaminophen in elderly or debilitated patients, or due to overdosage of butalbital. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Butalbital, Acetaminophen, and Caffeine Tablets, USP. Serious and potentially fatal codeine reactions, including acute generalized exanthematous pustulosis AGEPacetaminophen caffeine codeine phosphate, Stevens-Johnson syndrome SJSand toxic epidermal necrolysis TENhave occurred rarely phosphate acetaminophen acetaminophen.

Is Acetaminophen Codeine?

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