oxyCODONE HCl 10 MG / acetaminophen 325 MG Oral Tablet
Generic Name: OXYCODONE AND ACETAMINOPHEN
Brand Name: Oxycodone and Acetaminophen
- Substance Name(s):
- OXYCODONE HYDROCHLORIDE
- ACETAMINOPHEN
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 particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration.
Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment.
In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea.
In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE).
Head Injury and Increased Intracranial Pressure The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure.
Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.
Hypotensive Effect Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines.
Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
Oxycodone may produce orthostatic hypotension in ambulatory patients.
Hepatoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.
The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen.
Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hypersensitivity / Anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
Clinical signs including swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting.
There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention.
Instruct patients to discontinue Oxycodone and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms.
Do not prescribe Oxycodone and Acetaminophen Tablets for patients with acetaminophen allergy.
OVERDOSAGE
Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
Signs and Symptoms Toxicity from oxycodone poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness.
Serious overdosage with oxycodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension.
In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.
In acetaminophen overdosage: dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect.
Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise.
Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Treatment A single or multiple drug overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.
Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.
Assisted or controlled ventilation should also be considered.
Oxycodone Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation.
The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including oxycodone.
Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
An opioid antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
Acetaminophen Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.
Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading.
To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected.
Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication.
Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
DESCRIPTION
Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride, USP 5 mg* Acetaminophen, USP 325 mg *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
All strengths of Oxycodone and Acetaminophen Tablets also contain the following inactive ingredients: Pregelatinized cornstarch, povidone, lactose monohydrate, crospovidone, and stearic acid.
In addition, the 5 mg/325 mg strength contains FD&C Blue No.
1 Aluminum Lake.
The 7.5 mg/325 mg strength contains FD&C Yellow No.
6 Aluminum Lake.
The 10 mg/325 mg strength contains D&C Yellow No.
10 Aluminum Lake.
Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste.
The molecular formula for oxycodone hydrochloride is C18H21NO4•HCl and the molecular weight 351.82.
It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula: Acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17.
It may be represented by the following structural formula: c78d66e2-figure-01 c78d66e2-figure-02
HOW SUPPLIED
Oxycodone and Acetaminophen Tablets are supplied as follows: 5 mg/325 mg Blue, round tablet, debossed with “ALV” and “196”, separated by a bisect, on one side, and plain on the other side.
Bottles of 12: NDC 63187-719-12 Bottles of 15: NDC 63187-719-15 Bottles of 20: NDC 63187-719-20 Bottles of 30: NDC 63187-719-30 Bottles of 60: NDC 63187-719-60 10 mg/325 mg Yellow, round tablet, debossed with “230” on one side and “” on the other side.
Bottles of 12: NDC 63187-363-12 Bottles of 15: NDC 63187-363-15 Bottles of 20: NDC 63187-363-20 Bottles of 30: NDC 63187-363-30 Bottles of 60: NDC 63187-363-60 Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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GERIATRIC USE
Geriatric Use Special precaution should be given when determining the dosing amount and frequency of Oxycodone and Acetaminophen Tablets for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients.
INDICATIONS AND USAGE
Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PREGNANCY
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproductive studies have not been conducted with Oxycodone and Acetaminophen Tablets.
It is also not known whether Oxycodone and Acetaminophen Tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Oxycodone and Acetaminophen Tablets should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
Nonteratogenic Effects Opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression.
Opioid use during pregnancy may result in a physically drug-dependent fetus.
After birth, the neonate may suffer severe withdrawal symptoms.
NUSRING MOTHERS
Nursing Mothers Ordinarily, nursing should not be undertaken while a patient is receiving Oxycodone and Acetaminophen Tablets because of the possibility of sedation and/or respiratory depression in the infant.
Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product.
Acetaminophen is also excreted in breast milk in low concentrations.
BOXED WARNING
WARNING Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
INFORMATION FOR PATIENTS
Information for Patients/Caregivers The following information should be provided to patients receiving Oxycodone and Acetaminophen Tablets by their physician, nurse, pharmacist, or caregiver: 1.Do not take Oxycodone and Acetaminophen Tablets if you are allergic to any of its ingredients.
2.If you develop signs of allergy such as a rash or difficulty breathing stop taking Oxycodone and Acetaminophen Tablets and contact your healthcare provider immediately.
3.Do not take more than 4000 milligrams of acetaminophen per day.
Call your doctor if you took more than the recommended dose.
4.Patients should be aware that Oxycodone and Acetaminophen Tablets contain oxycodone, which is a morphine-like substance.
5.Patients should be instructed to keep Oxycodone and Acetaminophen Tablets in a secure place out of the reach of children.
In the case of accidental ingestions, emergency medical care should be sought immediately.
6.When Oxycodone and Acetaminophen Tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.
7.Patients should be advised not to adjust the medication dose themselves.
Instead, they must consult with their prescribing physician.
8.Patients should be advised that Oxycodone and Acetaminophen Tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
9.Patients should not combine Oxycodone and Acetaminophen Tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician.
When co-administered with another CNS depressant, Oxycodone and Acetaminophen Tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
10.The safe use of Oxycodone and Acetaminophen Tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking Oxycodone and Acetaminophen Tablets.
11.Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue Oxycodone and Acetaminophen Tablets because of the potential for serious adverse reactions to nursing infants.
12.Patients who are treated with Oxycodone and Acetaminophen Tablets for more than a few weeks should be advised not to abruptly discontinue the medication.
Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
13.Patients should be advised that Oxycodone and Acetaminophen Tablets are a potential drug of abuse.
They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
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 symptoms of withdrawal in the physically dependent patient.