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Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
Overview
What is PANLOR?
PANLOR
(acetaminophen, caffeine, and dihydrocodeine bitartrate) Tablets are supplied in tablets form for oral administration.
Each tablet contains:
Acetaminophen .................... 325 mg
Caffeine ................................ 30 mg
Dihydrocodeine bitartrate ........ 16 mg
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder or white glistening needles, is a central nervous system stimulant. It has the following structural formula:
Dihydrocodeine Bitartrate (4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:
What does PANLOR look like?
What are the available doses of PANLOR?
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What should I talk to my health care provider before I take PANLOR?
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How should I use PANLOR?
PANLOR
Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Important Dosage and Administration Instructions
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see
].
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with PANLOR
Tablets and adjust the dosage accordingly [see
]
Initial Dosage
Initiating treatment with PANLOR
Tablets
The usual adult dosage is two (2) PANLOR
Tablets orally every four (4) hours, as needed. No more than five (5) doses, or ten (10) tablets should be taken in a 24-hour period.
Conversion from Other Opioids to PANLOR
Tablets
Titration and Maintenance of Therapy
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the PANLOR
Tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of PANLOR
Tablets
What interacts with PANLOR?
- PANLOR Tablets are contraindicated for:
- PANLOR Tablets are also contraindicated in patients with:
What are the warnings of PANLOR?
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Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed PANLOR
Tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing PANLOR
Tablets, and monitor all patients receiving PANLOR
Tablets for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as PANLOR
Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of PANLOR
Tablets along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing PANLOR
Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see
]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
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While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of PANLOR
Tablets, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of PANLOR
Tablets.
To reduce the risk of respiratory depression, proper dosing and titration of PANLOR
Tablets are essential [see
]. Overestimating the PANLOR
Tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.
Accidental ingestion of PANLOR
Tablets, especially by children, can result in respiratory depression and death due to an overdose of dihydrocodeine bitartrate.
- PANLOR Tablets are contraindicated for all children younger than 12 years of age [see ].
- PANLOR Tablets are contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [see ].
- Avoid the use of PANLOR Tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.
- As with adults, when prescribing codeine for adolescents, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose [see ].
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening Respiratory Depression in Children
Nursing Mothers
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CYP2D6 Genetic Variability: Ultra-rapid metabolizer
These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see ]. Therefore, individuals who are ultra-rapid metabolizers should not use codeine.
Neonatal Opioid Withdrawal Syndrome
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Cytochrome P450 3A4 Interaction
- Cytochrome P450 3A4 Interaction
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Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors
- Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The concomitant use of PANLOR Tablets with all cytochrome P450 3A4 inducers or discontinuation of a cytochrome P450 3A4 inhibitor may result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels. This may be associated with a decrease in efficacy, and in some patients, may result in signs and symptoms of opioid withdrawal.
Follow patients receiving PANLOR Tablets and any CYP3A4 inhibitor or inducer for signs and symptoms that may reflect opioid toxicity and opioid withdrawal when PANLOR Tablets are used in conjunction with inhibitors and inducers of CYP3A4.
If concomitant use of a CYP3A4 inhibitor is necessary or if a CYP3A4 inducer is discontinued, consider dosage reduction of PANLOR Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
If concomitant use of a CYP3A4 inducer is necessary or if a CYP3A4 inhibitor is discontinued, consider increasing the PANLOR Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal [see ].
The concomitant use of PANLOR Tablets with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in active metabolite morphine plasma concentration which could result in an analgesic efficacy reduction or symptoms of opioid withdrawal.
Discontinuation of a concomitantly used cytochrome P450 2D6 inhibitor may result in a decrease in codeine plasma concentration and an increase in active metabolite morphine plasma concentration which could which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
Follow patients receiving PANLOR Tablets and any CYP2D6 inhibitor for signs and symptoms that may reflect opioid toxicity and opioid withdrawal when PANLOR Tablets are used in conjunction with inhibitors of CYP2D6.
If concomitant use with a CYP2D6 inhibitor is necessary, follow the patient for signs of reduced efficacy or opioid withdrawal and consider increasing the PANLOR Tablets dosage. After stopping use of a CYP2D6 inhibitor, consider reducing the PANLOR Tablets dosage and follow the patient for signs and symptoms of respiratory depression or sedation [see ].
Hepatotoxicity
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see ].
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.
Advise both patients and caregivers about the risks of respiratory depression and sedation when PANLOR Tablets are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see and ].
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
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Monitor such patients closely, particularly when initiating and titrating PANLOR Tablets and when PANLOR Tablets are given concomitantly with other drugs that depress respiration [see ]. Alternatively, consider the use of non-opioid analgesics in these patients.
Adrenal Insufficiency
Serious Skin Reactions
Usage in Ambulatory Patients
Respiratory Depression
Head Injury
Hypersensitivity/Anaphylaxis
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Hypotensive Effect
Drug Dependence
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What are the precautions of PANLOR?
General
Selection of patients for treatment with Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets should be governed by the same principles that apply to the use of similar opioid/non-opioid fixed combination analgesics. As with any such opioid analgesic, the dosing regimen should be adjusted for each patient [see
]. This combination product should be used with caution in elderly or debilitated patients or those with any of the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; head injury; hypotension; increased intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis. The benefits and risks of using opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered. The administration of an analgesic containing an opioid may obscure the diagnosis or clinical course in patients with acute abdominal conditions. This combination product may aggravate convulsions in patients with convulsive disorders and, like all opioids, may induce or aggravate seizures in some clinical settings.
Acetaminophen is relatively non-toxic at therapeutic doses, but should be used with caution in patients with severe renal or hepatic disease. Care should be observed when using large doses of acetaminophen in malnourished patients or those with a history of chronic alcohol abuse because they may be more susceptible to hepatic damage similar to that observed with toxic overdosage. Caffeine in high doses may produce central nervous system and cardiovascular stimulation and gastrointestinal irritation.
Information for Patients/Caregivers
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Serotonin Syndrome
Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications [see
]
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Patients receiving PANLOR
Tablets should be given the following information:
Advise caregivers of children receiving dihydrocodeine-containing products for other reasons to monitor for signs of respiratory depression.
Drug Interactions
CYP2D6 Inhibitors
After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the dihydrocodeine plasma concentration will decrease but the active metabolite dihydromorphine plasma concentration will increase, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
If concomitant use with a CYP2D6 inhibitor is necessary or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of PANLOR
Tablets and monitor patients closely at frequent intervals.
If concomitant use with CYP2D6 inhibitors is necessary, follow the patient for reduced efficacy or signs and symptoms of opioid withdrawal and consider increasing the PANLOR
Tablets as needed.
After stopping use of a CYP2D6 inhibitor, consider reducing the PANLOR
Tablets and monitor the patient for signs and symptoms of respiratory depression or sedation.
CYP3A4 Inhibitors
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower dihydrocodeine plasma levels, greater dihydronorcodeine levels, and less metabolism via 2D6 with resultant lower dihydromorphine levels, resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to dihydrocodeine.
If concomitant use with CYP3A4 inhibitor is necessary, consider dosage reduction of PANLOR
Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
If a CYP3A4 inhibitor is discontinued, consider increasing the PANLOR
Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
CYP3A4 Inducers
After stopping a CYP3A4 inducer, as the effects of the inhibitor decline, the dihydrocodeine plasma concentration may increase with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater dihyromorphine levels, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use with CYP3A4 inducer is necessary, follow the patient for reduced efficacy and signs of opioid withdrawal and consider increasing the PANLOR
Tablets dosage as needed.
If a CYP3A4 inducer is discontinued, consider PANLOR
Tablets dosage reduction and monitor for signs of respiratory depression and sedation at frequent intervals.
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see
].
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If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue PANLOR
Tablets immediately if serotonin syndrome is suspected.
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Carcinogenesis, Mutagenesis, Impairment of Fertility
Infertility
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Pregnancy:
Teratogenic Effects – Pregnancy Category C
Fetal/Neonatal Adverse Reactions
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see
].
Labor and Delivery
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. PANLOR
Tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including PANLOR
Tablets, and can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.
Nursing Mothers
Dihydrocodeine bitartrate and its active metabolite, morphine, are present in human milk. There are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk. Women who are ultra-rapid metabolizers of dihydrocodeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants. In women with normal dihydrocodeine metabolism (normal CYP2D6 activity), the amount of dihydrocodeine secreted into human milk is low and dose-dependent.
There is no information on the effects of the dihydrocodeine on milk production. Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with PANLOR
Tablets [see
].
Clinical Considerations
Acetaminophen and caffeine are also excreted in breast milk in small amounts. Because of the potential for serious adverse reactions in nursing infants from this combination product, 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
- PANLOR Tablets are contraindicated for all children younger than 12 years of age [see ].
- PANLOR Tablets are contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [see ].
- Avoid the use of PANLOR Tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression [see ].
Safety and effectiveness of PANLOR Tablets in pediatric patients have not been established.
Life-threatening respiratory depression and death have occurred in children who received codeine [see ]. In most of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of codeine.
Because of the risk of life-threatening respiratory depression and death:
Geriatric Use
Elderly patients (aged 65 years or older) may have increased sensitivity to PANLOR Tablets. In general, use caution when selecting a dosage for an elderly patient, 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.
Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of PANLOR Tablets slowly in geriatric patients and monitor closely for signs of central nervous system and central nervous system depression [see ].
Hepatic Impairment
PANLOR Tablets should be given with caution to patients with hepatic insufficiency. Since dihydrocodeine is metabolized by the liver and since acetaminophen potentially causes hepatotoxicity, the effects of this combination product should be monitored closely in such patients.
Renal Impairment
PANLOR Tablets should be used with caution and at reduced dosage in the presence of impaired renal function.
Pancreatic/Biliary Tract Disease
Opioids may cause spasms of the sphincter of Oddi and should be used with caution in patients with biliary tract disease including pancreatitis.
What are the side effects of PANLOR?
Dihydrocodeine:
Acetaminophen:
Caffeine:
Postmarketing Experience:
Serotonin syndrome:
Adrenal insufficiency:
Anaphylaxis:
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What should I look out for while using PANLOR?
PANLOR
Tablets are contraindicated for:
PANLOR
Tablets are also contraindicated in patients with:
What might happen if I take too much PANLOR?
Following an acute overdosage with PANLOR
Tablets, toxicity may result from the dihydrocodeine or the acetaminophen. Toxicity due to the caffeine is less likely, due to the relatively small amounts in this formulation.
Clinical Presentation
Signs and Symptoms
Because overdose information on this combination product is limited, it is unclear which of the signs and symptoms of toxicity would manifest in any particular overdose situation.
Treatment of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to PANLOR
Tablets overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to PANLOR
Tablets overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of dihydrocodeine bitartrate in PANLOR
Tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
For respiratory depression due to unusual sensitivity to dihydrocodeine, 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. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
How should I store and handle PANLOR?
PANLOR Tablets, containing acetaminophen 325 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg , are supplied in bottles of 30 tablets (NDC 70362-720-30). Tablets are white, capsule-shaped tablets debossed “LL 720” on one side and plain on the other side.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
PANLOR
Tablets contain dihydrocodeine which is a semi-synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia.
This combination product also contains acetaminophen, a non-opiate, non-salicylate analgesic and antipyretic. This combination product contains caffeine as an analgesic adjuvant. Caffeine is also a central nervous system and cardiovascular stimulant.
Effects on the Endocrine System
Non-Clinical Toxicology
PANLOR Tablets are contraindicated for:PANLOR Tablets are also contraindicated in patients with:
Selection of patients for treatment with Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets should be governed by the same principles that apply to the use of similar opioid/non-opioid fixed combination analgesics. As with any such opioid analgesic, the dosing regimen should be adjusted for each patient [see ]. This combination product should be used with caution in elderly or debilitated patients or those with any of the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; head injury; hypotension; increased intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis. The benefits and risks of using opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered. The administration of an analgesic containing an opioid may obscure the diagnosis or clinical course in patients with acute abdominal conditions. This combination product may aggravate convulsions in patients with convulsive disorders and, like all opioids, may induce or aggravate seizures in some clinical settings.
Acetaminophen is relatively non-toxic at therapeutic doses, but should be used with caution in patients with severe renal or hepatic disease. Care should be observed when using large doses of acetaminophen in malnourished patients or those with a history of chronic alcohol abuse because they may be more susceptible to hepatic damage similar to that observed with toxic overdosage. Caffeine in high doses may produce central nervous system and cardiovascular stimulation and gastrointestinal irritation.
Dihydrocodeine:
Acetaminophen:
Caffeine:
Postmarketing Experience:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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