Acetaminophen Codeine
- Acetaminophen Codeine
- No Brand Name
- Tablet
- -
- Blister
- 100 Tablets
Each Tablet Contains:
• Acetaminophen 300mg
• Codeine Phosphate 20mg
• Acetaminophen 300mg
• Codeine Phosphate 20mg
• Moderate to Severe Pain
Mechanism of Action
Codeine blocks pain impulse generation and inhibits ascending pain pathways, thus altering the perception and response to pain. Acetaminophen may work peripherally to block pain impulse generation.
Pharmacokinetics
Bioavailability: Codeine (53%); acetaminophen (100%)
Onset: 0.5-1 hr
Duration: 4-6 hr
Excretion: Urine (90-100%)
Contraindications
• Children <12 years
• Post-operative management in children <18 years
• Patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within last 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to codeine, acetaminophen, or ingredients
• Hepatitis or severe hepatic/renal impairment
Adverse Reactions
Constipation, Drowsiness, Hypotension, Tachycardia or bradycardia, Dizziness, Restlessness, Urticaria, Nausea, Vomiting, Xerostomia, Ureteral spasm, Decreased urination, Increased LFTs, Blurred vision, Dyspnea, Histamine release, Laryngeal edema, Angioedema, Anaphylactoid reaction, Hepatotoxicity
Major Drug Interactions
Alvimopan – Mavorixafor - Olanzapine/Samidorphan
Warnings
• Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day
• Addiction, abuse and misuse is possible
• Life-Threatening Respiratory Depression may occur
• Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome
• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
Recommendations for patient
• Avoid self-medicating by this medicine.
Pregnancy Considerations
Category C
Breastfeeding Considerations
Maternal use of oral opioids during breastfeeding can cause infant drowsiness, which may progress to rare but severe central nervous system depression.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: Maybe acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Codeine blocks pain impulse generation and inhibits ascending pain pathways, thus altering the perception and response to pain. Acetaminophen may work peripherally to block pain impulse generation.
Pharmacokinetics
Bioavailability: Codeine (53%); acetaminophen (100%)
Onset: 0.5-1 hr
Duration: 4-6 hr
Excretion: Urine (90-100%)
Contraindications
• Children <12 years
• Post-operative management in children <18 years
• Patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within last 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to codeine, acetaminophen, or ingredients
• Hepatitis or severe hepatic/renal impairment
Adverse Reactions
Constipation, Drowsiness, Hypotension, Tachycardia or bradycardia, Dizziness, Restlessness, Urticaria, Nausea, Vomiting, Xerostomia, Ureteral spasm, Decreased urination, Increased LFTs, Blurred vision, Dyspnea, Histamine release, Laryngeal edema, Angioedema, Anaphylactoid reaction, Hepatotoxicity
Major Drug Interactions
Alvimopan – Mavorixafor - Olanzapine/Samidorphan
Warnings
• Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day
• Addiction, abuse and misuse is possible
• Life-Threatening Respiratory Depression may occur
• Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome
• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
Recommendations for patient
• Avoid self-medicating by this medicine.
Pregnancy Considerations
Category C
Breastfeeding Considerations
Maternal use of oral opioids during breastfeeding can cause infant drowsiness, which may progress to rare but severe central nervous system depression.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: Maybe acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
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