The 230 yellow round pill is a prescription combination tablet containing Oxycodone Hydrochloride (10 mg) and Acetaminophen (325 mg), distributed for Alvogen (and manufactured by Norwich Pharmaceuticals / Packaging Coordinators). It is a high-potency semi-synthetic opioid analgesic and non-opioid antipyretic combination classified as a Schedule II controlled substance in the United States due to significant risks of misuse, addiction, dependence, and overdose.
Pill Identification & Physical Characteristics
Property – Description
- Active Ingredients – Oxycodone Hydrochloride (10 mg) & Acetaminophen (325 mg)
- Imprint –
230debossed on one side; Alvogen logo (stylized dual-triangle/hourglass) on the reverse - Shape & Color – Round; Yellow
- Size – Approximately 11 mm in diameter
- Drug Class – Opioid Agonist / Non-Opioid Analgesic Combination
- Distributor / Manufacturer – Alvogen / Norwich Pharmaceuticals
Mechanism of Action
The tablet delivers dual-action analgesia via distinct central nervous system (CNS) pathways:
- Oxycodone Component (Opioid Agonist): Binds selectively to central nervous system opioid receptors. This binding inhibits presynaptic neurotransmitter release (such as substance P and glutamate) from nociceptive fibers, blocks ascending pain signals through the spinal cord, and stimulates descending inhibitory pathways, altering both the physical sensation and emotional perception of pain.
- Acetaminophen Component (APAP): Works primarily in the CNS by inhibiting central prostaglandin synthesis (via central cyclooxygenase pathways) and modulating descending serotonergic inhibitory pathways. It provides antipyretic (fever-reducing) and complementary analgesic effects without peripheral anti-inflammatory action or platelet impairment.
Indications & Dosage
Approved Indications
- Indicated for the management of acute, moderate-to-severe pain where non-opioid options (e.g., NSAIDs, acetaminophen alone) have failed, are contraindicated, or provide inadequate pain control.
General Adult Dosing
- Standard Dosing: 1 tablet orally every 4 to 6 hours as needed for pain.
- Maximum Daily Thresholds:
- Acetaminophen Limit: Total daily intake from all prescription and OTC sources must not exceed 4,000 mg in 24 hours (clinical practice often targets a safer ceiling of 3,000 day to reduce hepatic injury risk.)
- Oxycodone Titration: Should always be prescribed at the lowest effective dose for the shortest duration necessary (typically 3 to 7 days for acute, non-traumatic pain).
- Administration: Swallow whole with water. May be taken with food or milk to minimize gastrointestinal upset.
Side Effects
Common Adverse Reactions
- Drowsiness, dizziness, lightheadedness, and sedation
- Nausea, vomiting, and dyspepsia
- Constipation (often requires a prophylactic bowel regimen)
- Dry mouth, sweating (diaphoresis), and pruritus (itching)
Severe & Life-Threatening Reactions
- Fatal Respiratory Depression: Abnormally slow, shallow, or irregular breathing, leading to hypoxemia and hypercapnia.
- Acute Hepatotoxicity: Severe liver damage or acute liver failure, primarily associated with acetaminophen toxicity or concurrent alcohol consumption.
- Orthostatic Hypotension & Syncope: Significant drop in blood pressure upon standing.
- Serotonin Syndrome: When combined with serotonergic drugs (tremor, hyperreflexia, agitation, hyperthermia).
- Severe Skin Reactions: Rare, severe cutaneous reactions from acetaminophen, such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
Precautions & Drug Interactions
- CNS Depressants and Benzodiazepines: Concurrent use with sedatives, tranquilizers, muscle relaxants, hypnotics, or alcohol causes additive CNS depression, exponentially increasing the risk of profound sedation, coma, and fatal respiratory failure.
- Acetaminophen Overlap: Concomitant use with any over-the-counter or prescription product containing acetaminophen (e.g., cold/flu medications, sinus pills) can easily lead to inadvertent hepatotoxic overdose.
- CYP3A4 and CYP2D6 Enzymes: Co-administration with CYP3A4 inhibitors (e.g., erythromycin, ketoconazole) increases oxycodone plasma levels, worsening overdose risk. CYP3A4 inducers (e.g., rifampin, St. John’s Wort) decrease efficacy.
- Pre-existing Respiratory Conditions: Contraindicated in significant respiratory depression, acute/severe bronchial asthma in unmonitored settings, and known or suspected gastrointestinal obstruction, including paralytic ileus.
- Pregnancy & Lactation: Prolonged maternal use during pregnancy can result in Neonatal Opioid Withdrawal Syndrome (NOWS).
Black Box Warnings
- Critical Safety Warnings:
- Addiction, Abuse, and Misuse: Carries high vulnerability to substance use disorder, misuse, and life-threatening overdose even at prescribed doses.
- Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression can occur, especially at initiation or following dose escalation.
- Hepatotoxicity: Acetaminophen intake in excess of daily limits is a leading cause of acute liver failure, potentially requiring transplantation or resulting in death.
- Concomitant Use with Benzodiazepines or Alcohol: Concurrent use can result in profound sedation, respiratory depression, coma, and death.
- Accidental Ingestion: Ingestion of even a single dose, particularly by children, can cause fatal opioid toxicity.
- Emergency Naloxone Access: Co-prescription and patient education regarding naloxone for rapid opioid overdose reversal is strongly recommended. >