Acetaminophen & Codeine Phosphate, USP

Product Overview

Acetaminophen & Codeine Phosphate is a combination medication used for the relief of moderate to moderately severe pain. It contains two active ingredients:

1. Acetaminophen - a non-opioid pain reliever that helps reduce pain and fever.
2. Codeine Phosphate - an opioid analgesic that acts on the central nervous system to relieve pain.

Indications

This medication is indicated for:

• Management of mild to moderate pain where treatment with an opioid is appropriate and other pain relief methods are not sufficient.

Dosage and Administration

• Dosage Form: Oral tablets or liquid solution
• Standard Strengths: Typically available in strengths such as 300 mg of Acetaminophen and 30 mg of Codeine Phosphate, though specific doses can vary.
• Administration: It is generally taken every 4 to 6 hours as needed for pain, with or without food. Dosage should be tailored to the individual’s needs, considering factors like pain severity, response to therapy, and the risk of dependency.

Mechanism of Action

• Acetaminophen: Works by inhibiting the synthesis of prostaglandins, which are chemicals in the body responsible for causing pain and fever.
• Codeine Phosphate: Binds to opioid receptors in the brain and spinal cord, altering the perception of and response to pain, which provides additional analgesic effects.

Pharmacokinetics

• Absorption: Rapidly absorbed through the gastrointestinal tract.
• Onset of Action: Typically within 30 to 60 minutes.
• Duration of Action: Usually lasts 4 to 6 hours.
• Metabolism: Primarily metabolized in the liver; Codeine is partially converted to morphine, which contributes to its analgesic effects.
• Excretion: Mostly eliminated through urine.

Safety and Precautions

• Contraindications: Hypersensitivity to Acetaminophen, Codeine, or other opioids. It is also contraindicated in patients with severe respiratory depression or acute or severe bronchial asthma.
• Warnings: Risk of addiction, abuse, and misuse due to the presence of Codeine. It may also cause drowsiness and dizziness; caution should be exercised while operating machinery or driving.
• Pregnancy and Lactation: Not recommended during pregnancy or breastfeeding due to potential risks to the fetus or infant.
• Drug Interactions: May interact with other CNS depressants, MAO inhibitors, and certain medications that affect liver enzymes.

Adverse Reactions

Common side effects may include:

• Nausea, vomiting, and constipation
• Drowsiness or dizziness
• Allergic reactions like rash or itching
• Respiratory depression (in higher doses)

Storage

• Store at room temperature, away from moisture and direct sunlight.
• Keep out of reach of children.

Regulatory Classification

• Controlled Substance: Codeine is classified as a Schedule III controlled substance in the United States, indicating moderate potential for abuse.
• Prescription-only Medicine: It requires a valid prescription from a licensed healthcare professional.