Oxycodone and Acetaminophen (Page 7 of 8)

DOSAGE AND ADMINISTRATION

Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings].
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].
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Oxycodone Hydrochloride and Acetaminophen Tablets and adjust the dosage accordingly [see WARNINGS].

Initial Dosage

Initiating Treatment with Oxycodone and Acetaminophen Tablets

Oxycodone and Acetaminophen Tablets, USP 2.5 mg/325 mg

The usual adult dosage is one or two tablets every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Oxycodone and Acetaminophen Tablets, USP 5 mg/325 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Oxycodone and Acetaminophen Tablets, USP 7.5 mg/325 mg; Oxycodone and Acetaminophen Tablets, USP 10 mg/325 mg
The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Strength Maximal Daily Dose
Oxycodone and Acetaminophen Tablets, USP 2.5 mg/325 mg 12 Tablets
Oxycodone and Acetaminophen Tablets, USP 5 mg/325 mg 12 Tablets
Oxycodone and Acetaminophen Tablets, USP 7.5 mg/325 mg 8 Tablets
Oxycodone and Acetaminophen Tablets, USP 10 mg/325 mg 6 Tablets

Conversion from Oxycodone and Acetaminophen to Extended-Release Oxycodone

The relative bioavailability of Oxycodone Hydrochloride and Acetaminophen Tablets or Oral Solution compared to extended-release oxycodone is unknown, so conversion to extended-release oxycodone must be accompanied by close observation for signs of excessive sedation and respiratory depression.

Titration and Maintenance of Therapy

Individually titrate Oxycodone and Acetaminophen Tablets or Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Oxycodone and Acetaminophen Tablets or Oral Solution to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. 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.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Oxycodone and Acetaminophen Tablets or Oral Solution dosage. 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.
Safe Reduction or Discontinuation of Oxycodone and Acetaminophen Tablets
Do not abruptly discontinue Oxycodone and Acetaminophen Tablets in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking Oxycodone and Acetaminophen Tablets there are a variety of factors that should be considered, including the dose of Oxycodone and Acetaminophen Tablets the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.
There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on Oxycodone and Acetaminophen Tablets who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.
It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see WARNINGS/ Withdrawal, DRUG ABUSE AND DEPENDENCE ].

HOW SUPPLIED

Oxycodone and Acetaminophen Tablets, USP are supplied as follows:
2.5 mg/325 mg
White to off-white, round tablets, debossed with “U14” on one side and plain on the other side.
Bottles of 30 NDC 13107-043-30
Bottles of 100 NDC 13107-043-01
Bottles of 500 NDC 13107-043-05
Bottles of 1000 NDC 13107-043-99
5 mg/325 mg
White to off-white, capsule-shaped tablets, debossed with “U15” on one side and break line on the other side.
Bottles of 30 NDC 13107-044-30
Bottles of 100 NDC 13107-044-01
Bottles of 500 NDC 13107-044-05
Bottles of 1000 NDC 13107-044-99
7.5 mg/325 mg
White to off-white, oval-shaped tablets, debossed with “U16” on one side and plain on the other side.
Bottles of 30 NDC 13107-045-30
Bottles of 100 NDC 13107-045-01
Bottles of 500 NDC 13107-045-05
Bottles of 1000 NDC 13107-045-99
10 mg/325 mg
White to off-white, capsule-shaped tablets, debossed with “U17” on one side and plain on the other side.
Bottles of 30 NDC 13107-046-30
Bottles of 100 NDC 13107-046-01
Bottles of 500 NDC 13107-046-05
Bottles of 1000 NDC 13107-046-99
Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
DEA Order Form Required.

Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Revised: 04/2019

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