DESCRIPTION
id: 42766668-11d2-418e-9fb6-be8b27eaa271
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:
C18N21NO4 •HCl 351.82
The tablets contain the following inactive ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycolate; colloidal silicon dioxide; corn starch; stearic acid; FD&C Yellow No. 6 (15 mg tablet).
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.
INDICATIONS AND USAGE
id: d594d02e-b3b4-4a86-be22-fc67c719c99e
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Oxycodone hydrochloride tablets, USP 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: cded28d4-7847-4603-9156-54c834ff617e
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: 1f9f2a04-8004-4bc9-8c64-0558e8b5da36
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
DOSAGE AND ADMINISTRATION
id: c91e507f-f706-4817-9b59-28e365cc9fc2
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 4-6 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.
HOW SUPPLIED
id: f00be901-cd64-4b04-bbbb-2e98a9375301
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Oxycodone hydrochloride tablets, USP are supplied as follows:
The 5 mg tablets are white, round, standard convex, scored tablets debossed with 112 above the score on one side of the tablet and blank on the other side. They are available as follows:
NDC 0378-6112-01
bottles of 100 tablets
The 15 mg tablets are peach, round, standard convex, scored tablets debossed with 113 above the score on one side of the tablet and blank on the other side. They are available as follows:
NDC 0378-6113-01
bottles of 100 tablets
The 30 mg tablets are white, round, standard convex, scored tablets debossed with 114 above the score on one side of the tablet and blank on the other side. They are available as follows:
NDC 0378-6114-01
bottles of 100 tablets
PRINCIPAL DISPLAY PANEL – 5 mg Tablet Bottle Label
id: 63312c67-11dd-40ca-98a1-bf92a5ac9511
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0378-6112-01
MYLAN®
CII
OXYCODONE
HYDROCHLORIDE
TABLETS, USP
5 mg
100 TABLETS
Rx
only
PRINCIPAL DISPLAY PANEL – 15 mg Tablet Bottle Label
id: 626c6a57-8635-496f-8a87-355a9ccdb7b8
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0378-6113-01
MYLAN®
CII
OXYCODONE
HYDROCHLORIDE
TABLETS, USP
15 mg
100 TABLETS
Rx
only
PRINCIPAL DISPLAY PANEL – 30 mg Tablet Bottle Label
id: 34c6f09a-b689-45ae-b7a0-e8d1491b4320
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 0378-6114-01
MYLAN®
CII
OXYCODONE
HYDROCHLORIDE
TABLETS, USP
30 mg
100 TABLETS
Rx
only
