Roxicodone 20mg (RP20)

Product Overview

Generic Name: Oxycodone hydrochloride[citation:3]

Brand Name: Roxicodone®[citation:3][citation:8]

Manufacturer: SpecGx LLC (Mallinckrodt)[citation:8]

DEA Schedule: CII (Schedule II Controlled Substance)[citation:8]

Imprint Code: RP20

Strength: 20mg immediate-release tablet[citation:3][citation:10]

Initial FDA Approval: 1950[citation:8]

Roxicodone is an immediate-release formulation of oxycodone hydrochloride, a semi-synthetic opioid agonist derived from thebaine (an alkaloid found in the opium poppy). Unlike extended-release formulations (such as OxyContin or Xtampza ER), the immediate-release tablet provides rapid onset of analgesia and is typically dosed every 4-6 hours as needed for pain[citation:3][citation:8].

Imprint Code Information (RP20)

Property	Information
Imprint Code	RP20
Strength	20 mg
Dosage Form	Immediate-release tablet
Manufacturer	SpecGx LLC (Mallinckrodt)[citation:8]

Indications and Usage

Roxicodone is indicated for the management of pain severe enough to require opioid treatment and for which alternative treatment options (non-opioid analgesics or opioid combination products) are inadequate[citation:1][citation:8].

Important limitations:

• Immediate-release formulation is typically used for acute pain or breakthrough pain[citation:3]
• Should be taken at the lowest effective dose for the shortest possible duration[citation:1][citation:8]
• Roxicodone is NOT indicated for as-needed (prn) use without a prescription[citation:8]

Available Strengths (Immediate-Release Tablets)

Roxicodone immediate-release tablets are available in the following strengths[citation:3][citation:10]:

• 5 mg
• 10 mg
• 15 mg
• 20 mg (RP20)
• 30 mg

Dosage and Administration

Typical Dosing for Opioid-Naïve Patients:

• Starting dose: 5-15 mg every 4-6 hours as needed for pain[citation:4]
• Individualize dosing based on pain severity and patient response
• Use the lowest effective dose for the shortest duration[citation:1][citation:8]

Important Administration Instructions[citation:3][citation:8]:

• Take exactly as prescribed — do not change your dose
• Take every 4-6 hours as needed for pain
• If you miss a dose, take your next dose at the usual time (do not double up)
• Take with or without food — if nausea occurs, taking with food may help[citation:1]
• For acute (short-term) pain, you may only need to take Roxicodone for a few days[citation:3][citation:8]

Grapefruit Interaction Warning: Avoid eating grapefruit or drinking grapefruit juice while taking Roxicodone unless approved by your healthcare provider, as grapefruit can increase the chance of side effects[citation:1].

Mechanism of Action

Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor (MOR). By binding to and activating mu-opioid receptors in the central nervous system (CNS), oxycodone[citation:5]:

• Inhibits ascending pain pathways
• Alters pain perception in the brain
• Produces analgesia, sedation, and euphoria
• Has no ceiling effect for analgesia — higher doses produce increasing pain relief but also increasing risk of respiratory depression and death

Pharmacokinetics

Parameter	Information
Onset of action (immediate-release)	10-30 minutes
Peak effect	1-2 hours
Duration of action (immediate-release)	3-6 hours
Bioavailability (oral)	60-87% (high)
Elimination half-life	3-5 hours

BOXED WARNINGS (FDA)

Contraindications

Roxicodone is contraindicated in patients with[citation:8]:

• Severe asthma, trouble breathing, or other lung problems[citation:8]
• Bowel blockage or narrowing of the stomach or intestines[citation:8]
• Known hypersensitivity to oxycodone or any component of the formulation[citation:8]

Additional contraindications based on clinical guidelines:

• Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation
• Paralytic ileus

Warnings and Precautions

Warning/Precaution	Clinical Consideration
Respiratory Depression	Chief hazard of opioid agonists. Occurs most frequently in elderly or debilitated patients, following large initial doses in non-tolerant patients, or when given with other CNS depressants[citation:5]
COPD and Respiratory Conditions	Use with extreme caution in patients with COPD, cor pulmonale, or decreased respiratory reserve[citation:5]
Hypotensive Effect	May cause severe hypotension in hypovolemic patients or after concurrent administration with phenothiazines[citation:5]
Adrenal Insufficiency	Prolonged use may cause secondary adrenal insufficiency[citation:1]
Sleep Apnea	Opioids can cause central sleep apnea and worsen existing sleep-disordered breathing[citation:1]
Constipation	Opioids decrease propulsive peristaltic waves in the colon, leading to constipation[citation:5]

Adverse Reactions (Side Effects)

Most Common (≥5% and greater than placebo)[citation:1][citation:5]:

• Nausea and vomiting
• Constipation (very common — may require prophylactic laxatives)
• Lightheadedness, dizziness
• Drowsiness (somnolence)
• Headache
• Pruritus (itching)
• Dry mouth
• Sweating
• Weakness, fatigue

Serious Adverse Reactions (Seek immediate medical attention)[citation:1][citation:5]:

• Respiratory depression: Slow/shallow breathing, difficulty breathing, apnea
• Severe hypotension: Fainting, lightheadedness
• Seizures
• Serotonin syndrome: Agitation, confusion, muscle rigidity, hyperthermia (when combined with serotonergic drugs)
• Sleep apnea: Interrupted breathing during sleep[citation:1]
• Adrenal insufficiency: Loss of appetite, unusual tiredness, weight loss[citation:1]
• Severe allergic reaction: Rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing[citation:1]

Gastrointestinal Effects (Mechanism-Based)

Oxycodone produces opioid-related effects on the gastrointestinal tract[citation:5]:

• Nausea and vomiting caused by direct stimulation of the chemoreceptor trigger zone (CTZ) in the medulla — frequency and severity diminish with time
• Decreased gastric motility and increased tone of the antrum, stomach, and duodenum
• Delayed digestion and decreased propulsive contractions in the small intestine
• Decreased propulsive peristaltic waves in the colon, increased tone to the point of spasm — resulting in constipation
• Possible spasm of sphincter of Oddi and transient elevations in serum amylase

Cardiovascular Effects

At therapeutic doses, oxycodone produces[citation:5]:

• Peripheral vasodilatation (arteriolar and venous)
• Decreased peripheral resistance
• Inhibition of baroreceptor reflexes
• Orthostatic hypotension (especially in ambulatory patients)
• Manifestations of histamine release: pruritus, flushing, red eyes, sweating, orthostatic hypotension

Caution is required in hypovolemic patients (e.g., acute myocardial infarction) as opioids may cause or aggravate hypotension[citation:5].

Tolerance and Dependence

• Tolerance: Higher doses required over time to achieve same analgesic effect
• Physical dependence: Abrupt discontinuation causes withdrawal syndrome. Babies born to mothers who use opioids long-term may develop severe (possibly fatal) withdrawal symptoms[citation:1]
• Addiction (Opioid Use Disorder): Characterized by compulsive use, loss of control, and continued use despite harm

Withdrawal Symptoms: These include[citation:1]:

• Agitation, anxiety, insomnia
• Yawning, tearing, runny nose
• Sweating, chills, goosebumps
• Muscle aches, bone pain
• Nausea, vomiting, diarrhea
• Dilated pupils, tachycardia, hypertension
• In newborns: Crying that does not stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, difficulty gaining weight[citation:1]

Overdose Signs and Treatment

Overdose Signs[citation:1]:

• Pinpoint pupils (miosis)
• Respiratory depression (slow, shallow, or stopped breathing)
• Extreme somnolence or unresponsiveness — difficulty waking up
• Cold, clammy skin
• Bradycardia, hypotension
• Coma

Overdose Treatment (Emergency)[citation:1][citation:8]:

• Naloxone (Narcan) or nalmefene: Opioid antagonists — multiple doses may be required due to oxycodone’s duration of action
• Call 911 or local emergency services immediately
• Rescue breathing and CPR as needed
• Supportive care (airway management, oxygen, IV fluids)
• Ask your healthcare provider about having naloxone available to treat opioid overdose[citation:8]

Drug Interactions

Drug Class	Interaction	Risk Level
Benzodiazepines	Additive CNS depression, increased overdose risk[citation:8]	High
Gabapentinoids (gabapentin, pregabalin)	Increased sedation and respiratory depression[citation:8]	High
Alcohol	Profound sedation, respiratory depression, death[citation:1][citation:8]	High
Other opioids	Additive effects, overdose risk	High
MAO inhibitors	Potentially fatal reaction	Life-threatening
Serotonergic drugs (SSRIs, SNRIs, triptans)	Serotonin syndrome risk	Moderate to High
CYP3A4 inhibitors (grapefruit juice, erythromycin, ketoconazole)	Increased oxycodone levels, increased toxicity[citation:1]	Moderate to High

Use in Specific Populations

Population	Consideration
Pregnancy	May slightly increase risk of birth defects if used during first two months. Prolonged use near delivery may cause neonatal withdrawal syndrome (NOWS)[citation:1][citation:8].
Breastfeeding	Oxycodone passes into breast milk — discuss risks and benefits with healthcare provider
Geriatric (≥65 years)	Increased sensitivity to side effects (dizziness, sedation, constipation, respiratory depression). Lower starting doses recommended[citation:5]
Renal impairment	Dose adjustment recommended — use lower starting doses
Hepatic impairment	Significant dose reduction required (33-50% of usual dose) — monitor carefully[citation:6]
Pediatric	Safety and efficacy not established in pediatric patients

Storage and Disposal

• Storage: Store securely in a locked cabinet out of sight and reach of children, and in a location not accessible by others (including visitors to the home)[citation:1][citation:8]. Store between 59°F and 86°F (15°C-30°C)[citation:4].
• Disposal: The FDA recommends flushing unused oxycodone down the toilet when it is no longer needed if a drug take-back option is not readily available (immediate risk from accidental exposure)[citation:7][citation:8]. Alternatively, use authorized DEA drug take-back program or DEA-registered collector.

Never give your Roxicodone to anyone else — they could die from taking it. Selling or giving away Roxicodone is against the law[citation:8].

Product Identification Summary

Property	Description
Imprint Code	RP20
Strength	20 mg
Dosage Form	Immediate-release tablet
Brand Name	Roxicodone
Generic Name	Oxycodone hydrochloride
Manufacturer	SpecGx LLC (Mallinckrodt)[citation:8]

Legal Status (United States)

Roxicodone (oxycodone) is a Schedule II (CII) controlled substance under the Controlled Substances Act[citation:8]. Key restrictions:

• Prescription required — no refills permitted without a new prescription[citation:8]
• DEA registration required for prescribing and dispensing
• Records must be maintained separately from non-controlled prescriptions
• Illegal to possess without a valid prescription
• Penalties for illegal possession: up to 1 year imprisonment + fines (first offense)
• Selling or giving away Roxicodone is against the law and can result in criminal prosecution[citation:8]

Diversion and Counterfeit Warning (Educational)

Oxycodone (Roxicodone, OxyContin) has been subject to significant diversion and abuse. Counterfeit tablets, including those imprinted with “RP20,” have been found in the illicit market containing fentanyl or other dangerous adulterants. Patients should only obtain Roxicodone from licensed pharmacies with a valid prescription.

Educational Summary

Roxicodone 20mg (RP20) is an immediate-release oxycodone tablet indicated for moderate to severe pain. It is a Schedule II controlled substance with multiple boxed warnings for addiction, respiratory depression, and fatal interactions with CNS depressants. The medication should be taken exactly as prescribed at the lowest effective dose for the shortest duration. Roxicodone is for opioid-naïve and opioid-tolerant patients but requires careful dosing and monitoring. Naloxone should be available for overdose reversal. Store securely, dispose of unused medication via flushing or take-back programs, and never share with others. Illegal possession is a criminal offense[citation:8].

Note: This information is for educational and awareness purposes only. Roxicodone (oxycodone) is a Schedule II controlled substance with high potential for abuse, addiction, overdose, and death. It is illegal to possess, sell, or distribute without a valid prescription. Nothing here is medical advice or an endorsement of use. If you or someone you know is experiencing a medical emergency, call 911 immediately. If you need help for substance use, contact SAMHSA at 1-800-662-4357.