OXYCODONE HYDROCHLORIDE TABLETS, USP, CII, 82418401/1217, R x Only

/OXYCODONE HYDROCHLORIDE TABLETS, USP, CII, 82418401/1217, R x Only
OXYCODONE HYDROCHLORIDE TABLETS, USP, CII, 82418401/1217, R x Only2018-09-06T09:12:40+00:00

Prescription Drug Name:

OXYCODONE HYDROCHLORIDE TABLETS, USP, CII, 82418401/1217, R x Only

ID:

62d7ea73-6ad8-cb27-e053-2a91aa0ac0d4

Code:

34391-3

DESCRIPTION


id: 62d7ea73-6ad9-cb27-e053-2a91aa0ac0d4
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Oxycodone hydrochloride tablet, USP is an opioid analgesic. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula: The tablets contain the following inactive ingredients common to all strengths: Corn starch, lactose monohydrate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, and stearic acid. The 15 mg tablet also contains D&C Yellow #10 Aluminum Lake and FD&C Blue #2 Aluminum Lake. The 30 mg tablet also contains FD&C Blue #2 Aluminum Lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27.0 mg, respectively, of oxycodone free base.

CLINICAL PHARMACOLOGY


id: 62d7ea73-6ada-cb27-e053-2a91aa0ac0d4
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Pharmacology:

The analgesic ingredient, oxycodone, is a semi-synthetic narcotic with multiple actions qualitatively similar to those of morphine; the most prominent of these involves the central nervous system and organs composed of smooth muscle. Oxycodone, as the hydrochloride salt, is a pure agonist opioid whose principal therapeutic action is analgesia and has been in clinical use since 1917. Like all pure opioid agonists, there is no ceiling effect to analgesia, such as is seen with partial agonists or non-opioid analgesics. Based upon a single-dose, relative-potency study conducted in humans with cancer pain, 10 to l5 mg of oxycodone given intramuscularly produced an analgesic effect similar to 10 mg of morphine given intramuscularly. Both drugs have a 3 to 4 hour duration of action. Oxycodone retains approximately one-half of its analgesic activity when administered orally. Effects on Central Nervous System: The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug. A significant feature of opioid-induced analgesia is that it occurs without loss of consciousness. The relief of pain by morphine-like opioids is relatively selective, in that other sensory modalities, (e.g., touch, vibrations, vision, hearing, etc.) are not obtunded. Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation. Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia. Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on Gastrointestinal Tract and Other Smooth Muscle: Oxycodone, like other opioid analgesics, produces some degree of nausea and vomiting which is caused by direct stimulation of the chemoreceptor trigger zone (CTZ) located in the medulla. The frequency and severity of emesis gradually diminishes with time. Oxycodone may cause a decrease in the secretion of hydrochloric acid in the stomach that reduces motility while increasing the tone of the antrum, stomach, and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on Cardiovascular System: Oxycodone, in therapeutic doses, produces peripheral vasodilatation (arteriolar and venous), decreased peripheral resistance, and inhibits baroreceptor reflexes. Manifestations of histamine release and/or peripheral vasodilatation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Caution should be used in hypovolemic patients, such as those suffering acute myocardial infarction; because oxycodone may cause or further aggravate their hypotension. Caution should also be used in patients with cor pulmonale who have received therapeutic doses of opioids.

INDICATIONS AND USAGE


id: 62d7ea73-6add-cb27-e053-2a91aa0ac0d4
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

CONTRAINDICATIONS


id: 62d7ea73-6ade-cb27-e053-2a91aa0ac0d4
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Oxycodone hydrochloride 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 hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.

ADVERSE REACTIONS


id: 62d7ea73-6af2-cb27-e053-2a91aa0ac0d4
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Oxycodone hydrochloride tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. Oxycodone hydrochloride tablets are associated with adverse experiences similar to those seen with other opioids. Serious adverse reactions that may be associated with oxycodone hydrochloride tablet therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock (see
OVERDOSE, WARNINGS ).
The less severe adverse events seen on initiation of therapy with oxycodone hydrochloride tablets are also typical opioid side effects. These events are dose dependent, and their frequency depends on 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 of these include nausea, constipation, vomiting, headache, and pruritus. In many cases the frequency of adverse events during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse events will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy. In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving oxycodone hydrochloride tablets, the following adverse events were recorded in oxycodone hydrochloride tablet treated patients with an incidence
> 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The following adverse experiences occurred in less than 3% of patients involved in clinical trials with oxycodone: Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis. Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia. Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting. Hemic and Lymphatic: anemia and leukopenia. Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema. Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture. Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation. Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis. Skin and Appendages: herpes simplex, rash, sweating, and urticaria. Special Senses: amblyopia. Urogenital: urinary tract infection To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or
http://www.fda.gov/
for voluntary reporting of adverse reactions.

DOSAGE AND ADMINISTRATION


id: 62d7ea73-6afa-cb27-e053-2a91aa0ac0d4
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Oxycodone hydrochloride tablets are intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required. Patients who have not been receiving opioid analgesics should be started on oxycodone hydrochloride tablets in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their initial dose of oxycodone hydrochloride tablets. Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient. For control of severe chronic pain, oxycodone hydrochloride tablets should be administered on a regularly scheduled basis, every 4 to 6 hours, at the lowest dosage level that will achieve adequate analgesia. As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of oxycodone hydrochloride tablets, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences. Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs:

When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of oxycodone hydrochloride tablets in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose of oxycodone hydrochloride tablets should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia. Patients Currently on Opioid Therapy:

If a patient has been receiving opioid-containing medications prior to taking oxycodone hydrochloride tablets, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone. In converting patients from other opioids to oxycodone hydrochloride tablets close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride tablets is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of oxycodone hydrochloride tablets may be necessary, especially in patients who have disease states that are changing rapidly. Maintenance of Therapy:

Continual reevaluation of the patient receiving oxycodone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be reassessed as appropriate. Cessation of Therapy:

When a patient no longer requires therapy with oxycodone hydrochloride tablets or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see
Drug Abuse and Dependence section for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of oxycodone hydrochloride tablets that treatment may be discontinued without risk of the opioid abstinence syndrome.

HOW SUPPLIED


id: 62d7ea73-6afb-cb27-e053-2a91aa0ac0d4
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Oxycodone hydrochloride tablets, USP 15 mg are available as green colored, round tablets, debossed “A214” on the bisected side. Tablets are supplied in unit dose packages of 100 (10 x 10) NDC 68084-184-01. Oxycodone hydrochloride tablets, USP 30 mg are available as blue colored, round tablets, debossed “A215” on the bisected side. Tablets are supplied in unit dose packages of 100 (10 x 10) NDC 68084-185-01. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

PROTECT FROM MOISTURE. FOR YOUR PROTECTION: Do not use if blister is torn or broken. DEA Order Form Required.

PACKAGING INFORMATION


id: 62d7ea73-6afc-cb27-e053-2a91aa0ac0d4
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Actavis Pharma, Inc. as follows:

(15 mg / 100 UD) NDC 68084-184-01 packaged from NDC 0228-2878

(30 mg / 100 UD) NDC 68084-185-01 packaged from NDC 0228-2879 Distributed by:

American Health Packaging

Columbus, OH 43217 8218401/1217

Package/Label Display Panel – Carton – 15 mg


id: 62d7ea73-6afd-cb27-e053-2a91aa0ac0d4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 68084-184-01 Oxycodone

Hydrochloride

Tablets, USP          
CII 15 mg 100 Tablets (10 x 10) Each Tablet Contains:

Oxycodone Hydrochloride, USP ………………………………………. 15 mg Usual Dosage: See package insert for full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between

15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

PROTECT FROM MOISTURE. Keep this and all drugs out of reach of children. DEA Order Form Required FOR YOUR PROTECTION: Do not use if blister is torn or broken. Rx Only The drug product contained in this package is from

NDC # 0228-2878, Actavis Pharma, Inc. Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217 085104

0218401/1217

Package/Label Display Panel – Blister – 15 mg


id: 62d7ea73-6afe-cb27-e053-2a91aa0ac0d4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Oxycodone Hydrochloride

Tablet, USP                 
CII 15 mg

Package/Label Display Panel – Carton – 30 mg


id: 62d7ea73-6aff-cb27-e053-2a91aa0ac0d4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 68084-185-01 Oxycodone

Hydrochloride

Tablets, USP          
CII 30 mg 100 Tablets (10 x 10) Each Tablet Contains:

Oxycodone Hydrochloride, USP………………………………………. 30 mg Usual Dosage: See package insert for full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between

15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

PROTECT FROM MOISTURE. Keep this and all drugs out of reach of children. DEA Order Form Required FOR YOUR PROTECTION: Do not use if blister is torn or broken. Rx Only The drug product contained in this package is from

NDC # 0228-2879, Actavis Pharma, Inc. Packaged and Distributed by:

American Health Packaging

Columbus, Ohio 43217 090524

0218501/1217

Package/Label Display Panel – Blister – 30 mg


id: 62d7ea73-6b00-cb27-e053-2a91aa0ac0d4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Oxycodone

Hydrochloride

Tablet, USP     
30 mg     
CII