OXYCODONE HCl CONTROLLED-RELEASE TABLETS, 10 mg and 20 mg CII, 302389-0A

/OXYCODONE HCl CONTROLLED-RELEASE TABLETS, 10 mg and 20 mg CII, 302389-0A
OXYCODONE HCl CONTROLLED-RELEASE TABLETS, 10 mg and 20 mg CII, 302389-0A2018-09-06T09:12:40+00:00

Prescription Drug Name:

OXYCODONE HCl CONTROLLED-RELEASE TABLETS, 10 mg and 20 mg CII, 302389-0A

ID:

88603d5f-4ad0-46ab-999f-740312dc35dc

Code:

34391-3

WARNING


id: ea77febc-6659-4804-9487-8338ea7293d7
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Oxycodone HCl Controlled-Release Tablets are an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Oxycodone HCl Controlled-Release Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. OXYCODONE HCl CONTROLLED-RELEASE 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

DESCRIPTION


id: c40dc0bc-c7b0-43af-8c9c-0fc16b134d8e
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg and 20 mg tablet strengths 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 formula 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 tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin. The 10 mg tablets also contain: hydroxypropyl cellulose. The 20 mg tablets also contain: polysorbate 80 and red iron oxide. Oxycodone HCL controlled-release 10 mg and 20 mg tablets are tested using USP dissolution test 2 and meet the associated tolerances provided in acceptance table 2 of the oxycodone hydrochloride extended-release tablets USP monograph.

CLINICAL PHARMACOLOGY


id: a172a6a9-312d-4246-9a19-f9f84e4a5c1d
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, hydromorphone, fentanyl, codeine, and hydrocodone. Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, and cough suppression, as well as analgesia. Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.

PHARMACOKINETICS AND METABOLISM


id: 06513545-00af-4b42-8927-8bcb808a85d4
displayName: PHARMACOKINETICS SECTION
FDA Article Code: 43682-4

The activity of Oxycodone HCl Controlled-Release Tablets is primarily due to the parent drug oxycodone. Oxycodone HCl Controlled-Release Tablets are designed to provide controlled delivery of oxycodone over 12 hours. Breaking, chewing or crushing Oxycodone HCl Controlled-Release Tablets eliminates the controlled delivery mechanism and results in the rapid release and absorption of a potentially fatal dose of oxycodone. Oxycodone release from Oxycodone HCl Controlled-Release Tablets is pH independent. Oxycodone is well absorbed from Oxycodone HCl Controlled-Release Tablets with an oral bioavailability of 60% to 87%. The relative oral bioavailability of Oxycodone HCl Controlled-Release Tablets to immediate-release oral dosage forms is 100%. Upon repeated dosing in normal volunteers in pharmacokinetic studies, steady-state levels were achieved within 24-36 hours. Dose proportionality and/or bioavailability has been established for the 10 mg, 20 mg, 40 mg, 80 mg, and 160 mg tablet strengths for both peak plasma levels (Cmax) and extent of absorption (AUC). Oxycodone is extensively metabolized and eliminated primarily in the urine as both conjugated and unconjugated metabolites. The apparent elimination half-life of oxycodone following the administration of Oxycodone HCl Controlled-Release Tablets was 4.5 hours compared to 3.2 hours for immediate-release oxycodone.

CLINICAL TRIALS


id: a39b7bbd-1c80-4d71-8431-8592fb22dbee
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

A double-blind placebo-controlled, fixed-dose, parallel group, two-week study was conducted in 133 patients with chronic, moderate to severe pain, who were judged as having inadequate pain control with their current therapy. In this study, 20 mg Oxycodone HCl Controlled-Release Tablets q12h but not 10 mg Oxycodone HCl Controlled-Release Tablets q12h decreased pain compared with placebo, and this difference was statistically significant.

INDICATIONS AND USAGE


id: 7a85f023-3879-4a4d-bbc6-fbd55a542115
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

CONTRAINDICATIONS


id: f879433b-d79f-4fc6-bc52-4aebef004dc1
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Oxycodone HCl Controlled-Release Tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone HCl Controlled-Release Tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.

WARNINGS


id: 4c4e93b7-8afd-4f44-882c-da7867bc4f0d
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE. Oxycodone HCl Controlled-Release 80 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. PATIENTS SHOULD BE INSTRUCTED AGAINST USE BY INDIVIDUALS OTHER THAN THE PATIENT FOR WHOM IT WAS PRESCRIBED, AS SUCH INAPPROPRIATE USE MAY HAVE SEVERE MEDICAL CONSEQUENCES, INCLUDING DEATH.

DRUG ABUSE AND ADDICTION


id: 895f4da2-04d1-4fe1-bc52-b8e2b0141633
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

Oxycodone HCl Controlled-Release Tablets contain Oxycodone which is a full mu-agonist opiod with an abuse liability similar to morphine and is a schedule II controlled substance. Oxycodone, like morphine and other opiods used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. There is a potential for drug addiction to develop following exposure to opioids, including oxycodone. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. “Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxycodone HCl Controlled-Release Tablets, like other opioids, have been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Oxycodone HCl Controlled-Release Tablets consist of a dual-polymer matrix, intended for oral use only. Abuse of the crushed tablet poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. With parenteral abuse, the tablet excipients, especially talc, can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

ADVERSE REACTIONS


id: bdba5430-a30c-4f8f-a3f1-ae1861abe654
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The safety of Oxycodone HCl Controlled-Release Tablets 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 Oxycodone HCl Controlled-Release Tablets in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day. Serious adverse reactions which may be associated with Oxycodone HCl Controlled-Release Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock (see OVERDOSAGE). The non-serious adverse events seen on initiation of therapy with Oxycodone HCl Controlled-Release Tablets are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia. In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid. Many of these adverse events will cease or decrease in intensity as Oxycodone HCl Controlled-Release Tablet therapy is continued and some degree of tolerance is developed. Clinical trials comparing Oxycodone HCl Controlled-Release Tablets with immediate-release oxycodone and placebo revealed a similar adverse event profile between Oxycodone HCl Controlled-Release Tablets and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were:

TABLE 3
Oxycodone HCl Controlled- Release Tablets
(n=227)
(%)
Immediate-Release
(n=225)
(%)
Placebo
(n=45)
(%)
Constipation (23) (26) (7)
Nausea (23) (27) (11)
Somnolence (23) (24) (4)
Dizziness (13) (16) (9)
Pruritus (13) (12) (2)
Vomiting (12) (14) (7)
Headache (7) (8) (7)
Dry Mouth (6) (7) (2)
Asthenia (6) (7)
Sweating (5) (6) (2)
The following adverse experiences were reported in Oxycodone HCl Controlled-Release Tablets-treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups. The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience. Blood and lymphatic system disorders: lymphadenopathy Cardiac disorders: palpitations (in the context of withdrawal) Ear and labyrinth disorders: tinnitus Endocrine disorders: syndrome of inappropriate antidiuretic hormone secretion (SIADH) Eye disorders: abnormal vision Gastrointestinal disorders: dysphagia, eructation, flatulence, gastrointestinal disorder, ileus, increased appetite, stomatitis General disorders and administration site conditions: chest pain, edema, facial edema, malaise, pain, peripheral edema, thirst, withdrawal syndrome (with and without seizures) Immune system disorders: anaphylactic or anaphylactoid reaction (symptoms of) Infections and infestations: pharyngitis Injury, poisoning and procedural complications: accidental injury Investigations: hyponatremia, increased hepatic enzymes, ST depression Metabolism and nutrition disorders: dehydration Musculoskeletal and connective tissue disorders: neck pain Nervous system disorders: abnormal gait, amnesia, hyperkinesia, hypertonia (muscular), hypesthesia, hypotonia, migraine, paresthesia, seizures, speech disorder, stupor, syncope, taste perversion, tremor, vertigo Psychiatric disorders: agitation, depersonalization, depression, emotional lability, hallucination Renal and urinary disorders: dysuria, hematuria, polyuria, urinary retention, urination impaired Reproductive system and breast disorders: amenorrhea, decreased libido, impotence Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis, urticaria Vascular disorders: vasodilation

OVERDOSAGE


id: f66d3249-8674-4330-a45b-a584a38c0769
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, and death. Deaths due to overdose have been reported with abuse and misuse of Oxycodone HCl Controlled-Release Tablets, by ingesting, inhaling, or injecting the crushed tablets. Review of case reports has indicated that the risk of fatal overdose is further increased when Oxycodone HCl Controlled-Release Tablets are abused concurrently with alcohol or other CNS depressants, including other opioids. In the treatment of oxycodone overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. The pure opioid antagonists such as naloxone or nalmefene are specific antidotes against respiratory depression from opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. In patients who are physically dependent on any opioid agonist including Oxycodone HCl Controlled-Release Tablets, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.

SAFETY AND HANDLING


id: 6648f790-fc05-4082-b517-f26d0d1881a9
displayName: SAFE HANDLING WARNING SECTION
FDA Article Code: 50741-8

Oxycodone HCl Controlled-Release Tablets are solid dosage forms that contain oxycodone, which is a controlled substance. Like morphine, oxycodone is controlled under Schedule II of the Controlled Substances Act. Oxycodone HCl Controlled-Release Tablets have been targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

HOW SUPPLIED


id: acf308b9-3f7c-45d2-aaed-9f35b133086a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Oxycodone HCl Controlled-Release Tablets 10 mg are round, unscored, white-colored, convex tablets imprinted with OC on one side and 10 on the other. They are supplied as follows: NDC 63304-400-01: child-resistant closure, opaque plastic bottles of 100 Oxycodone HCl Controlled-Release Tablets 20 mg are round, unscored, pink-colored, convex tablets imprinted with OC on one side and 20 on the other. They are supplied as follows: NDC 63304-401-01: child-resistant closure, opaque plastic bottles of 100 Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in tight, light-resistant container. CAUTION DEA Order Form Required. Distributed by: Ranbaxy Pharmaceuticals Inc Jacksonville, FL 32257 USA U.S. Patent Numbers 5,508,042 and 7,129,248 302389-0A

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL


id: 83c3a8af-a15e-48c3-a4c7-2b5dc3a363a3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Container Label 10 mg


Container Label 20 mg