Prolate 300 mg/1

oxycodone and acetaminophen · TABLET · Forte Bio-Pharma LLC

No Recall HistoryCurrently in Shortage

Plain English

Prolate is a tablet containing oxycodone and acetaminophen at 300 mg/1, taken oral. Manufactured by Forte Bio-Pharma LLC.

Key Facts

Brand Name: Prolate
Generic Name: oxycodone and acetaminophen
NDC Code (Product): 72245-681
Manufacturer: Forte Bio-Pharma LLC
Strength: 300 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: ANDA040608
Marketing Start: 02/17/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain1,487 reports

fatigue1,431 reports

drug ineffective1,418 reports

dyspnoea1,047 reports

nausea963 reports

arthralgia958 reports

headache899 reports

rash869 reports

pruritus845 reports

peripheral swelling821 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over course of therapy [see WARNINGS ], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Dosage & Administration

DOSAGE AND ADMINISTRATION - Important Dosage and Administration Instructions Oxycodone and acetaminophen tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of oxycodone and acetaminophen tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into acc…

Warnings

WARNINGS - Addiction, Abuse, and Misuse Oxycodone and acetaminophen tablets contain oxycodone, a Schedule II controlled substance. As an opioid, oxycodone and acetaminophen tablets expose users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see ADVERSE REACTIONS ]. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone and acetaminophen tablets, and reassess all patients receiving oxycodone and acetaminophen tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addi…

Contraindications

CONTRAINDICATIONS Oxycodone and acetaminophen tablets are contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see WARNINGS , ADVERSE REACTIONS ]

Drug Interactions

Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of oxycodone and acetaminophen tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of oxycodone and acetaminophen tablets and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of oxycodone and acetaminophen tablets is achieved [see WARNINGS ]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see CLINICAL PHARMACOLOGY ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone and acetaminophen tablets. If concomitant use is necessary, consider dosage reduction of oxycodone and acetaminophen tablets until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinu…

Adverse Reactions

ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of oxycodone and acetaminophen tablets. 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. Serious adverse reactions that may be associated with oxycodone and acetaminophen use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see OVERDOSAGE ]. The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus. Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis have likewise been associated with ace…

Frequently Asked Questions

What is Prolate used for?

Prolate contains oxycodone and acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.

Is Prolate a controlled substance?

Yes, Prolate is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Prolate?

The generic name for Prolate is oxycodone and acetaminophen. There are 12 other brand versions of oxycodone and acetaminophen.

What is the NDC code for Prolate 300 mg/1?

The NDC (National Drug Code) for Prolate 300 mg/1 is 72245-681, listed by Forte Bio-Pharma LLC.

Product NDC

72245-681

Package NDC

72245-681-03

Other Oxycodone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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