OXYCODONE AND ACETAMINOPHEN 325 mg/5mL
oxycodone and acetaminophen · SOLUTION · KVK-Tech, Inc.
OXYCODONE AND ACETAMINOPHEN is a solution containing oxycodone and acetaminophen at 325 mg/5mL, taken oral. Manufactured by KVK-Tech, Inc..
Key Facts
- Brand Name
- OXYCODONE AND ACETAMINOPHEN
- Generic Name
- oxycodone and acetaminophen
- NDC Code (Product)
10702-238- Manufacturer
- KVK-Tech, Inc.
- Strength
- 325 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA211499
- Marketing Start
- 12/05/2019
Recall History
Watson Laboratories Inc
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
Mayne Pharma Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Endo Pharmaceuticals, Inc.
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
SpecGx, LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Alvogen, Inc
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
SpecGx, LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Qualitest Pharmaceuticals
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Watson Laboratories Inc
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.
Dosage & Administration
DOSAGE AND ADMINISTRATION Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and Acetaminophen Tablets are given orally. Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg; 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, 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 Cessation of Therapy In patients treated with Oxycodone and Acetaminophen Tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and s…
Warnings
WARNINGS Misuse, Abuse and Diversion of Opioids Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Oxycodone and Acetaminophen Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain. 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. Administration of Oxycodone and Acetaminophen Tablets should be closely monitored for the following potentially serious adverse reactions and complications: Respiratory Depression Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in Oxycodone and Acetaminophen Tablets, as with all opioid agonists. Elderly and debilitated patients are at partic…
Contraindications
CONTRAINDICATIONS Oxycodone and Acetaminophen Tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including 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 is contraindicated in the setting of suspected or known paralytic ileus.
Adverse Reactions
ADVERSE REACTIONS Serious adverse reactions that may be associated with Oxycodone and Acetaminophen Tablets 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 has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur. Other adverse reactions obtained from postmarketing experiences with Oxycodone and Acetaminophen Tablets are listed by organ system …
Frequently Asked Questions
What is OXYCODONE AND ACETAMINOPHEN used for?
OXYCODONE AND ACETAMINOPHEN contains oxycodone and acetaminophen. It is a solution taken oral. Consult your doctor for specific uses.
Is OXYCODONE AND ACETAMINOPHEN a controlled substance?
Yes, OXYCODONE AND ACETAMINOPHEN is classified as CII under the DEA Controlled Substances Act.
What is the generic name for OXYCODONE AND ACETAMINOPHEN?
The generic name for OXYCODONE AND ACETAMINOPHEN is oxycodone and acetaminophen. There are 9 other brand versions of oxycodone and acetaminophen.
What is the NDC code for OXYCODONE AND ACETAMINOPHEN 325 mg/5mL?
The NDC (National Drug Code) for OXYCODONE AND ACETAMINOPHEN 325 mg/5mL is 10702-238, listed by KVK-Tech, Inc..
Other OXYCODONE AND ACETAMINOPHEN Dosages
Other Oxycodone Brands
See all →- oxycodone and acetaminophen300 mg/172887-683
- Oxycodone and Acetaminophen325 mg/113107-045
- Oxycodone and Acetaminophen325 mg/163629-9501
- Oxycodone and Acetaminophen325 mg/168084-699
- Oxycodone and Acetaminophen325 mg/168084-710
- Oxycodone and Acetaminophen325 mg/171205-486
- Oxycodone and Acetaminophen325 mg/171335-0316
- ENDOCET325 mg/171335-2182
- Oxycodone and Acetaminophen325 mg/142806-115
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)