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Pronunciation |
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(a
seet a MIN oh fen & KOE
deen) |

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U.S. Brand
Names |
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Capital® and Codeine; Phenaphen®
With Codeine; Tylenol® With
Codeine |

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Generic
Available |
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Yes |

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Canadian Brand
Names |
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Atasol® 8, 15, 30 With Caffeine;
Empracet® 30, 60; Emtec-30®; Lenoltec No 1, 2, 3, 4;
Novo-Gesic-C8; Novo-Gesic-C15; Novo-Gesic-C30 |

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Synonyms |
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Codeine and Acetaminophen |

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Pharmacological Index |
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Analgesic, Narcotic |

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Use |
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Dental: Treatment of postoperative pain
Medical: Relief of mild to moderate pain |

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Restrictions |
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C-III; C-V |

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Pregnancy Risk
Factor |
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C |

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Contraindications |
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Hypersensitivity to acetaminophen, codeine phosphate, or similar
compounds |

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Warnings/Precautions |
|
Use with caution in patients with hypersensitivity reactions to other
phenanthrene derivative opioid agonists (morphine, hydrocodone, hydromorphone,
levorphanol, oxycodone, oxymorphone); tablets contain metabisulfite which may
cause allergic reactions |

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Adverse
Reactions |
|
>10%:
Central nervous system: Lightheadedness, dizziness, sedation
Gastrointestinal: Nausea, vomiting
Respiratory: Shortness of breath
1% to 10%:
Central nervous system: Euphoria, dysphoria
Dermatologic: Pruritus
Gastrointestinal: Constipation, abdominal pain
Miscellaneous: Histamine release
<1%: Palpitations, hypotension, bradycardia, peripheral vasodilation,
increased intracranial pressure, antidiuretic hormone release, biliary tract
spasm, urinary retention, miosis, respiratory depression, physical and
psychological dependence |

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Overdosage/Toxicology |
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Refer to the Acetaminophen Toxicity Nomogram in the Appendix
Acetylcysteine 140 mg/kg orally (loading) followed by 70 mg/kg every 4 hours
for 17 doses; therapy should be initiated based upon laboratory analysis
suggesting high probability of hepatotoxic potential
Naloxone 2 mg I.V. (0.01 mg/kg for children) with repeat administration as
necessary up to a total of 10 mg; can also be used to reverse the toxic effects
of the opiate. Activated charcoal is effective at binding certain chemicals, and
this is especially true for acetaminophen. |

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Drug
Interactions |
|
Increased toxicity: CNS depressants, phenothiazines, tricyclic
antidepressants, guanabenz, MAO inhibitors (may also decrease blood pressure);
effect of warfarin may be enhanced |

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Mechanism of
Action |
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Inhibits the synthesis of prostaglandins in the central nervous system and
peripherally blocks pain impulse generation; produces antipyresis from
inhibition of hypothalamic heat-regulating center; binds to opiate receptors in
the CNS, causing inhibition of ascending pain pathways, altering the perception
of and response to pain; causes cough supression by direct central action in the
medulla; produces generalized CNS depression |

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Pharmacodynamics/Kinetics |
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Acetaminophen:
Onset: 1-3 hours
Duration: 3-4 hours
Serum half-life: 1-4 hours
Time to peak serum concentration: 0.5-2 hours
Codeine:
Onset (analgesia): Oral: 30-45 minutes
Duration: 4-6 hours
Serum half-life: 2.5-3.5 hours
Time to peak serum concentration: 1-2 hours |

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Usual Dosage |
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Doses should be adjusted according to severity of pain and response of the
patient. Adult doses greater than or equal to 60 mg codeine fail to give
commensurate relief of pain but merely prolong analgesia and are associated with
an appreciably increased incidence of side effects. Oral:
Codeine: 0.5-1 mg codeine/kg/dose every 4-6 hours
Acetaminophen: 10-15 mg/kg/dose every 4 hours up to a maximum of 2.6 g/24
hours for children <12 years
3-6 years: 5 mL 3-4 times/day as needed of elixir
7-12 years: 10 mL 3-4 times/day as needed of elixir
>12 years: 15 mL every 4 hours as needed of elixir
Adults:
Antitussive: Based on codeine (15-30 mg/dose) every 4-6 hours
Analgesic: Based on codeine (30-60 mg/dose) every 4-6 hours
1-2 tablets every 4 hours to a maximum of 12 tablets/24 hours
Dosing adjustment in renal impairment: Refer to individual monographs
for Acetaminophen and Codeine |

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Dietary
Considerations |
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May be taken with food |

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Monitoring
Parameters |
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Relief of pain, respiratory and mental status, blood pressure, bowel
function |

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Mental Health: Effects
on Mental Status |
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Sedation is common; less commonly, codeine may produce euphoria or
dysphoria |

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Mental Health:
Effects on Psychiatric
Treatment |
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Codeine may produce physical and psychological dependence. Antipsychotics,
tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates,
benzodiazepines, and anticonvulsants may increase the toxicity of codeine.
Barbiturates and carbamazepine may increase the hepatotoxic potential of
acetaminophen. Diminution of pain relief may occur with the
SSRIs. |

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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |

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Dental Health:
Effects on Dental Treatment |
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<1% of patients may experience dry mouth |

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Patient
Information |
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See individual agents |

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Nursing
Implications |
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Observe patient for excessive sedation, respiratory depression,
constipation |

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Dosage Forms |
|
Capsule:
#2: Acetaminophen 325 mg and codeine phosphate 15 mg (C-III)
#3: Acetaminophen 325 mg and codeine phosphate 30 mg (C-III)
#4: Acetaminophen 325 mg and codeine phosphate 60 mg (C-III)
Elixir: Acetaminophen 120 mg and codeine phosphate 12 mg per 5 mL with
alcohol 7% (C-V)
Suspension, oral, alcohol free: Acetaminophen 120 mg and codeine phosphate 12
mg per 5 mL (C-V)
Tablet: Acetaminophen 500 mg and codeine phosphate 30 mg (C-III);
acetaminophen 650 mg and codeine phosphate 30 mg (C-III)
Tablet:
#1: Acetaminophen 300 mg and codeine phosphate 7.5 mg (C-III)
#2: Acetaminophen 300 mg and codeine phosphate 15 mg (C-III)
#3: Acetaminophen 300 mg and codeine phosphate 30 mg (C-III)
#4: Acetaminophen 300 mg and codeine phosphate 60 mg (C-III)
|

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References |
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Dionne RA, "New Approaches to Preventing and Treating Postoperative Pain,"
J Am Dent Assoc, 1992, 123(6):26-34.
Dionne RA, Campbell RA, Cooper SA, et al,
"Suppression of Postoperative Pain by Preoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen, and Acetaminophen Plus Codeine,"
J Clin Pharmacol, 1983, 23(1):37-43.
Forbes JA, Butterworth GA, Burchfield WH, et al,
"Evaluation of Ketorolac, Aspirin, and an Acetaminophen-Codeine Combination in Postoperative Oral Surgery Pain,"
Pharmacotherapy, 1990, 10(6 Pt 2):77S-93S.
Gobetti JP, "Controlling Dental Pain," J Am Dent Assoc, 1992,
123(6):47-52. |

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