Acetaminophen / Caffeine / Dihydrocodeine Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pain

Moderate to moderately severe:
Acetaminophen/caffeine/dihydrocodeine 356.4 mg-30 mg-16 mg oral capsule: 2 capsules orally every 4 hours as needed
No more than 2 capsules should be taken in a 4-hour period. No more than 10 capsules should be taken in a 24-hour period.

Acetaminophen/caffeine/dihydrocodeine 712.8 mg-60 mg-32 mg oral tablet: 1 tablet orally every 4 hours as needed
No more than 1 tablet should be taken in a 4-hour period. No more than 5 tablets should be taken in a 24-hour period.

Renal Dose Adjustments

The manufacturer recommends caution and a reduced dosage when administering this drug to patients with renal dysfunction.

Liver Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with liver dysfunction.

Dose Adjustments

Dosage should be adjusted according to the severity of pain and response of the patient.

Precautions

Cases of acute liver failure (some resulting in liver transplant and death) have been reported with acetaminophen. Most cases of liver injury are associated with doses greater than 4 g per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients try to get more pain relief or unknowingly take other acetaminophen-containing products. Patients should be advised to check package labels for acetaminophen (or APAP) and not to use more than one product that contains acetaminophen. Patients should seek medical attention at once if more than 4 g of acetaminophen is taken per day, even if they feel well.

Acetaminophen/caffeine/dihydrocodeine should be used with caution in patients with hepatic impairment and in patients who ingest alcohol as the risk of acute liver failure is higher in such patients while taking acetaminophen.

Acetaminophen/caffeine/dihydrocodeine is contraindicated in patients in any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.

Hypersensitivity and anaphylaxis have been reported during postmarketing experience with acetaminophen. Infrequently, life-threatening anaphylaxis requiring emergency medical attention has been reported. Acetaminophen/caffeine/dihydrocodeine should be stopped at once and patients should seek medical care if symptoms (e.g., swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting) develop.

Acetaminophen/caffeine/dihydrocodeine should be used with caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or respiratory depression. Opioids should be administered under careful medical supervision at the lowest effective dose.

Acetaminophen/caffeine/dihydrocodeine should be used cautiously in the presence of head injury or increased intracranial pressure.

Acetaminophen/caffeine/dihydrocodeine should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Acetaminophen/caffeine/dihydrocodeine should be used with caution in the 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 opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered.

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.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

The FDA has asked manufacturers to limit the maximum amount of acetaminophen in prescription products to 325 mg per dosage unit. There are no data that indicate that taking more than 325 mg of acetaminophen per dosage unit provides more pain relief. The goal of the FDA is to reduce the risk of severe liver injury from acetaminophen overdose, which can lead to liver failure, liver transplant, and even death. The total number of units that may be prescribed and the time intervals for dosing will not change. Drug companies will have until January 14, 2014 to comply with FDA requirements.

Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused.

Dihydrocodeine may impair the mental and/or physical abilities required for the performance or potentially hazardous tasks such as driving a car or operating machinery.

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