Online OxyContin OC 20 mg +1-909-545-6717(Buy Online OxyContin OC 20 mg) is a prescription medicine used to treat moderate to severe pain. OxyContin OC 20 mg may be used alone or with other medications.
OxyContin OC 20 mg is an opioid pain medication.
It is not known if OxyContin OC 20 mg is safe and effective in children younger than 18 years of age.
OxyContin OC 20 mg may cause serious side effects including:
noisy breathing,
shallow breathing,
breathing that stops during sleep (sleep apnea),
slow heart rate or weak pulse,
light-headed feeling,
confusion,
unusual thoughts or behavior,
seizure,
nausea,
vomiting,
loss of appetite,
dizziness, and
worsening tiredness or weakness,
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of OxyContin OC 20 mg include:
drowsiness,
headache,
dizziness,
tiredness,
constipation,
stomach pain,
nausea, and
vomiting
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of OxyContin OC 20 mg. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
WARNING
ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
OxyContin OC 20 mg® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OxyContin OC 20 mg and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS AND PRECAUTIONS].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see WARNINGS AND PRECAUTIONS]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
complete a REMS-compliant education program,
counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
consider other tools to improve patient, household, and community safety.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with the use of OxyContin OC 20 mg. Monitor for respiratory depression, especially during initiation of OxyContin OC 20 mg or following a dose increase. Instruct patients to swallow OxyContin OC 20 mg tablets whole; crushing, chewing, or dissolving OxyContin OC 20 mg tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see WARNINGS AND PRECAUTIONS].
Accidental Ingestion
Accidental ingestion of even one dose of OxyContin OC 20 mg, especially by children, can result in a fatal overdose of oxycodone [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OxyContin OC 20 mg during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS].
Cytochrome P450 3A4 Interaction
The concomitant use of OxyContin OC 20 mg with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OxyContin OC 20 mg and any CYP3A4 inhibitor or inducer [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous systems (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].
Reserve concomitant prescribing of OxyContin OC 20 mg and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.
DESCRIPTION
OxyContin OC 20 mg® (oxycodone hydrochloride) extended-release tablets is an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:

C18 H21 NO4 • HCl MW 351.83
The chemical name is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol-water partition coefficient 0.7).
The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide.
The 10 mg tablets also contain hydroxypropyl cellulose.
The 15 mg tablets also contain black iron oxide, yellow iron oxide, and red iron oxide.
The 20 mg tablets also contain polysorbate 80 and red iron oxide.
The 30 mg tablets also contain polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide.
The 40 mg tablets also contain polysorbate 80 and yellow iron oxide.
The 60 mg tablets also contain polysorbate 80, red iron oxide, and black iron oxide.
The 80 mg tablets also contain hydroxypropyl cellulose, yellow iron oxide, and FD&C Blue #2/Indigo Carmine Aluminum Lake.
Indications
INDICATIONS
OxyContin OC 20 mg is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
Adults; and
Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.
Limitations Of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see WARNINGS AND PRECAUTIONS], reserve OxyContin OC 20 mg for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
OxyContin OC 20 mg is not indicated as an as-needed (PRN) analgesic.

QUESTION
Medically speaking, the term "myalgia" refers to what type of pain?
See Answer
Dosage
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
OxyContin OC 20 mg should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
OxyContin OC 20 mg 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Adult patients who are opioid-tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
Initiate the dosing regimen for each patient individually; taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS].
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with OxyContin OC 20 mg and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].
Instruct patients to swallow OxyContin OC 20 mg tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see PATIENT INFORMATION]. Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing it in the mouth [see WARNINGS AND PRECAUTIONS]. Cutting, breaking, crushing, chewing, or dissolving OxyContin OC 20 mg tablets will result in the uncontrolled delivery of oxycodone and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].
OxyContin OC 20 mg is administered orally every 12 hours.
Initial Dosage In Adults Who Are Not Opioid-Tolerant
The starting dosage for patients who are not opioid-tolerant is OxyContin OC 20 mg 10 mg orally every 12 hours.
Use of higher starting doses in patients who are not opioid-tolerant may cause fatal respiratory depression [see WARNINGS AND PRECAUTIONS].
Conversion From Opioids To OxyContin OC 20 mg In Adults
Conversion From Other Oral Oxycodone Formulations To OxyContin OC 20 mg
If switching from other oral oxycodone formulations to OxyContin OC 20 mg, administer one-half of the patient's total daily oral oxycodone dose as OxyContin OC 20 mg every 12 hours.
Conversion From Other Opioids To OxyContin OC 20 mg
Discontinue all other around-the-clock opioid drugs when OxyContin OC 20 mg therapy is initiated.
There are no established conversion ratios for conversion from other opioids to OxyContin OC 20 mg defined by clinical trials. Initiate dosing using OxyContin OC 20 mg 10 mg orally every 12 hours.
It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone dosage and manage an adverse reaction due to an overdose. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioids.
Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal and for signs of oversedation/toxicity after converting patients to OxyContin OC 20 mg.
Conversion From Methadone To OxyContin OC 20 mg
Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.
Conversion From Transdermal Fentanyl To OxyContin OC 20 mg
Treatment with OxyContin OC 20 mg can be initiated after the transdermal fentanyl patch has been removed for at least 18 hours. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of OxyContin OC 20 mg every 12 hours for each 25 mcg per hour fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OxyContin OC 20 mg, as there is limited documented experience with this conversion.
Initial Dosage In Pediatric Patients 11 Years And Older
The following dosing information is for use only in pediatric patients 11 years and older already receiving and tolerating opioids for at least five consecutive days. For the two days immediately preceding dosing with OxyContin OC 20 mg, patients must be taking a minimum of 20 mg per day of oxycodone or its equivalent. OxyContin OC 20 mg is not appropriate for use in pediatric patients requiring less than a 20 mg total daily dose. Table 1, based on clinical trial experience, displays the conversion factor when switching pediatric patients 11 years and older (under the conditions described above) from opioids to OxyContin OC 20 mg.
Discontinue all other around-the-clock opioid drugs when OxyContin OC 20 mg therapy is initiated.
There is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. Therefore, a conservative approach is advised when determining the total daily dosage of OxyContin OC 20 mg. It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements and manage an adverse reaction due to an overdose.
Consider the following when using the information in Table 1.
This is not a table of equianalgesic doses.
The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to OxyContin OC 20 mg.
The table cannot be used to convert from OxyContin OC 20 mg to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in a fatal overdose.
The formula for conversion from prior opioids, including oral oxycodone, to the daily dose of OxyContin OC 20 mg, is mg per day of prior opioid x-factor = mg per day of OxyContin OC 20 mg. Divide the calculated total daily dose by 2 to get the every-12-hour OxyContin OC 20 mg dose. If rounding is necessary, always round the dose down to the nearest OxyContin OC 20 mg tablet strength available.
Table 1: Conversion Factors When Switching Pediatric Patients 11 Years and Older to OxyContin OC 20 mg
Prior Opioid
Conversion Factor
Oral
Oral Parenteral*
Oxycodone
1
-
Hydrocodone
0.9
-
Hydromorphone
4
20
Morphine
0.5
3
Tramadol
0.17
0.2
*For patients receiving high-dose parenteral opioids, a more conservative conversion is warranted. For example, for high-dose parenteral morphine, use 1.5 instead of 3 as a multiplication factor.

Step #1
To calculate the estimated total OxyContin OC 20 mg daily dosage using Table 1:
For pediatric patients taking a single opioid, sum the current total daily dosage of the opioid and then multiply the total daily dosage by the approximate conversion factor to calculate the approximate OxyContin OC 20 mg daily dosage.
For pediatric patients on a regimen of more than one opioid, calculate the approximate oxycodone dose for each opioid and sum the totals to obtain the approximate OxyContin OC 20 mg daily dosage.
For pediatric patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion.
Step #2
If rounding is necessary, always round the dosage down to the nearest OxyContin OC 20 mg tablet strength available and initiate OxyContin OC 20 mg therapy with that dose. If the calculated OxyContin OC 20 mg total daily dosage is less than 20 mg, there is no safe strength for conversion, and do not initiate OxyContin OC 20 mg.
Example conversion from a single opioid (e.g., hydrocodone) to OxyContin OC 20 mg: Using the conversion factor of 0.9 for oral hydrocodone in Table 1, a total daily hydrocodone dosage of 50 mg is converted to 45 mg of oxycodone per day or 22.5 mg of OxyContin OC 20 mg every 12 hours. After rounding down to the nearest strength available, the recommended OxyContin OC 20 mg starting dosage is 20 mg every 12 hours.
Step #3
Close observation and titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of oversedation/ toxicity after converting patients to OxyContin OC 20 mg. [see Titration And Maintenance Of Therapy In Adults And Pediatric Patients 11 Years And Older] for important instructions on titration and maintenance of therapy.
There is limited experience with the conversion from transdermal fentanyl to OxyContin OC 20 mg in pediatric patients 11 years and older. If switching from transdermal fentanyl patch to OxyContin OC 20 mg, ensure that the patch has been removed for at least 18 hours prior to starting OxyContin OC 20 mg. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of OxyContin OC 20 mg every 12 hours for each 25 mcg per hour fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OxyContin OC 20 mg.
If using asymmetric dosing, instruct patients to take the higher dose in the morning and the lower dose in the evening.
Titration And Maintenance Of Therapy In Adults And Pediatric Patients 11 Years And Older
Individually titrate OxyContin OC 20 mg to a dosage that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OxyContin OC 20 mg to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and adverse reactions, as well as monitoring for the development of addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.
Patients who experience breakthrough pain may require a dosage adjustment of OxyContin OC 20 mg or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the OxyContin OC 20 mg dosage. Because steady-state plasma concentrations are approximated in 1 day, OxyContin OC 20 mg dosage may be adjusted every 1 to 2 days.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
There are no well-controlled clinical studies evaluating the safety and efficacy of dosing more frequently than every 12 hours. As a guideline for pediatric patients 11 years and older, the total daily oxycodone dosage usually can be increased by 25% of the current total daily dosage. As a guideline for adults, the total daily oxycodone dosage usually can be increased by 25% to 50% of the current total daily dosage, each time an increase is clinically indicated.
Dosage Modifications With Concomitant Use Of Central Nervous System Depressants
If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin OxyContin OC 20 mg, start with one-third to one-half the recommended starting dosage of OxyContin OC 20 mg, consider using a lower dosage of the concomitant CNS depressant, and monitor patients for signs of respiratory depression, sedation, and hypotension [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].
Dosage Modifications In Geriatric Patients Who Are Debilitated And Not Opioid- Tolerant
For geriatric patients who are debilitated and not opioid-tolerant, start dosing patients at one-third to one-half the recommended starting dosage and titrate the dosage cautiously [see Use In Specific Populations].
Dosage Modifications In Patients With Hepatic Impairment
For patients with hepatic impairment, start dosing patients at one-third to one-half the recommended starting dosage and titrate the dosage carefully. Monitor for signs of respiratory depression, sedation, and hypotension [see Use In Specific Populations, CLINICAL PHARMACOLOGY].
Discontinuation Of OxyContin OC 20 mg
When the patient no longer requires therapy with OxyContin OC 20 mg, taper the dosage gradually, by 25% to 50% every 2 to 4 days, while monitoring for signs and symptoms of withdrawal. If a patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue OxyContin OC 20 mg [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence].
HOW SUPPLIED
Dosage Forms And Strengths
Extended-release tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg.
10 mg film-coated extended-release tablets (round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other)
15 mg film-coated extended-release tablets (round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other)
20 mg film-coated extended-release tablets (round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other)
30 mg film-coated extended-release tablets (round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other)
40 mg film-coated extended-release tablets (round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other)
60 mg film-coated extended-release tablets (round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other)
80 mg film-coated extended-release tablets (round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other)
Storage And Handling
OxyContin OC 20 mg (oxycodone hydrochloride) extended-release tablets 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-410-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-410-20).
OxyContin OC 20 mg (oxycodone hydrochloride) extended-release tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-415-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-415-20).
OxyContin OC 20 mg (oxycodone hydrochloride) extended-release tablets 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-420-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-420-20).
OxyContin OC 20 mg (oxycodone hydrochloride) extended-release tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-430-10) and unit dose packaging with 20 individually numbered tablets per card; two cards per glue end carton (NDC 59011-430-20).
OxyContin OC 20 mg (oxycodone hydrochloride) extended-release tablets 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-440-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-440-20).
OxyContin OC 20 mg (oxycodone hydrochloride) extended-release tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-460-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-460-20).
OxyContin OC 20 mg (oxycodone hydrochloride) extended-release tablets 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-480-10) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-480-20).
Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container.
Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431. Revised: Sep 2018
Side Effects
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
Interactions With Benzodiazepines and Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
Severe Hypotension [see WARNINGS AND PRECAUTIONS]
Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
Seizures [see WARNINGS AND PRECAUTIONS]
Withdrawal [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Adult Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of OxyContin OC 20 mg was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OxyContin OC 20 mg in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.
OxyContin OC 20 mg may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see OVERDOSE].
The most common adverse reactions (>5%) reported by patients in clinical trials comparing OxyContin OC 20 mg with placebo are shown in Table 2 below:
TABLE 2: Common Adverse Reactions (>5%)
Adverse Reaction
OxyContin OC 20 mg
(n=227)
Placebo
(n=45)
(%)
(%)
Constipation
(23)
(7)
Nausea
(23)
(11)
Somnolence
(23)
(4)
Dizziness
(13)
(9)
Pruritus
(13)
(2)
Vomiting
(12)
(7)
Headache
(7)
(7)
Dry Mouth
(6)
(2)
Asthenia
(6)
-
Sweating
(5)
(2)

In clinical trials, the following adverse reactions were reported in patients treated with OxyContin OC 20 mg with an incidence between 1% and 5%:
Gastrointestinal disorders: abdominal pain, diarrhea, dyspepsia, gastritis
General disorders and administration site conditions: chills, fever
Metabolism and nutrition disorders: anorexia
Musculoskeletal and connective tissue disorders: twitching
Psychiatric disorders: abnormal dreams, anxiety, confusion, dysphoria, euphoria, insomnia, nervousness, thought abnormalities
Respiratory, thoracic and mediastinal disorders: dyspnea, hiccups
Skin and subcutaneous tissue disorders: rash
Vascular disorders: postural hypotension
The following adverse reactions occurred in less than 1% of patients involved in clinical trials:
Blood and lymphatic system disorders: lymphadenopathy
Ear and labyrinth disorders: tinnitus
Eye disorders: abnormal vision
Gastrointestinal disorders: dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, stomatitis
General disorders and administration site conditions: withdrawal syndrome (with and without seizures), edema, peripheral edema, thirst, malaise, chest pain, facial edema
Injury, poisoning and procedural complications: accidental injury
Investigations: ST depression
Metabolism and nutrition disorders: dehydration
Nervous system disorders: syncope, migraine, abnormal gait, amnesia, hyperkinesia, hypoesthesia, hypotonia, paresthesia, speech disorder, stupor, tremor, vertigo, taste perversion
Psychiatric disorders: depression, agitation, depersonalization, emotional lability, hallucination
Renal and urinary disorders: dysuria, hematuria, polyuria, urinary retention
Reproductive system and breast disorders: impotence
Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration
Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis
Clinical Trial Experience In Pediatric Patients 11 Years And Older
The safety of OxyContin OC 20 mg has been evaluated in one clinical trial with 140 patients 11 to 16 years of age. The median duration of treatment was approximately three weeks. The most frequently reported adverse events were vomiting, nausea, headache, pyrexia, and constipation.
Table 3 includes a summary of the incidence of treatment emergent adverse events reported in ≥5% of patients.
Table 3: Incidence of Adverse Reactions Reported in ≥ 5.0% Patients 11 to 16 Years
System Organ Class
Preferred Term
11 to 16 Years
(N=140)
n (%)
Any Adverse Event >= 5%
71 (51)
GASTROINTESTINAL DISORDERS
56 (40)
Vomiting
30 (21)
Nausea
21 (15)
Constipation
13 (9)
Diarrhea
8 (6)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
32 (23)
Pyrexia
15 (11)
METABOLISM AND NUTRITION DISORDERS
9 (6)
Decreased appetite
7 (5)
NERVOUS SYSTEM DISORDERS
37 (26)
Headache
20 (14)
Dizziness
12 (9)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
23 (16)
Pruritus
8 (6)

The following adverse reactions occurred in a clinical trial of OxyContin OC 20 mg in patients 11 to 16 years of age with an incidence between ≥1.0% and < 5.0%. Events are listed within each System/Organ Class.
Blood and lymphatic system disorders: febrile neutropenia, neutropenia
Cardiac disorders: tachycardia
Gastrointestinal disorders: abdominal pain, gastroesophageal reflux disease
General disorders and administration site conditions: fatigue, pain, chills, asthenia
Injury, poisoning, and procedural complications: procedural pain, seroma
Investigations: oxygen saturation decreased, alanine aminotransferase increased, hemoglobin decreased, platelet count decreased, neutrophil count decreased, red blood cell count decreased, weight decreased
Metabolic and nutrition disorders: hypochloremia, hyponatremia
Musculoskeletal and connective tissue disorders: pain in extremity, musculoskeletal pain
Nervous system disorders: somnolence, hypoesthesia, lethargy, paresthesia
Psychiatric disorders: insomnia, anxiety, depression, agitation
Renal and urinary disorders: dysuria, urinary retention
Respiratory, thoracic, and mediastinal disorders: oropharyngeal pain
Skin and subcutaneous tissue disorders: hyperhidrosis, rash
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of extended-release oxycodone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Abuse, addiction, aggression, amenorrhea, cholestasis, completed suicide, death, dental caries, increased hepatic enzymes, hyperalgesia, hypogonadism, hyponatremia, ileus, intentional overdose, mood altered, muscular hypertonia, overdose, palpitations (in the context of withdrawal), seizures, suicidal attempt, suicidal ideation, syndrome of inappropriate antidiuretic hormone secretion, and urticaria.
In addition to the events listed above, the following have also been reported, potentially due to the swelling and hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat, and difficulty swallowing the tablet.
Serotonin Syndrome
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal Insufficiency
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.