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Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. 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, agranulocytosis.
At higher doses codeine has most of the disadvantages of morphine including respiratory depression.
Dosage should be adjusted according to severity of pain and response of the patient.
The usual adult dosage is:
Single Doses (range)
Maximum 24 Hour Dose
15 mg to 60 mg
300 mg to 1000 mg
The usual dose of codeine phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
ACETAMINOPHEN AND CODEINE PHOSPHATE
TRIACIN-C (Triprolidine HCl, Pseudoephedrine HCl, and Codeine Phosphate Syrup)
PSEUDODINE™ C COUGH SYRUP (Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride & Codeine Phosphate)
The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codein...
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