Generic Name of Product | Brand Name | Dosage Form | Strength | Pharmacologic Group | Therapeutic Group | Unit Per Pack |
Acetaminophen Codeine | - | Tablet | 300 mg + 20 mg | Compound analgesic preparations | Analgesics | 100 |
Indications And Usage | Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. |
Administration | Dosage should be adjusted according to severity of pain and response of the patient. Take 1 – 2 tablets orally every 6-8 hours as needed. 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. |
Contraindications | Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. |
Precautions | Acetaminophen and codeine phosphate tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy. |
Adverse Reactions | 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. |
Pregnancy and lactation | C |
Renal and liver Impairment | - |
Laboratory Tests | In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. |