Primlev
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Questions & Answers
Side Effects & Adverse Reactions
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 PRIMLEVTM 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 PRIMLEVTM should be closely monitored for the following potentially serious adverse reactions and complications:
Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in PRIMLEVTM, 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).
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.
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.
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.
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.
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included 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 PRIMLEVTM immediately and seek medical care if they experience these symptoms. Do not prescribe PRIMLEVTM for patients with acetaminophen allergy.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PRIMLEVTM (oxycodone and acetaminophen tablets, USP) is indicated for the relief of moderate to moderately severe pain.
History
There is currently no drug history available for this drug.
Other Information
Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:
Oxycodone Hydrochloride, USP …... 5 mg*
Acetaminophen, USP ……………… 300 mg
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Oxycodone Hydrochloride, USP …... 7.5 mg*
Acetaminophen, USP ……………… 300 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride, USP …... 10 mg*
Acetaminophen, USP ……………… 300 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
All strengths of PRIMLEVTM also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
In addition, the 5 mg/300 mg strength contains D&C Yellow #10; the 7.5 mg/300 mg strength contains FD&C Red #40 Aluminum Lake; the 10 mg/300 mg strength contains FD&C Yellow #6 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 is 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:
C18H21NO4 · HCl MW 351.82
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 151.16. It may be represented by the following structural formula
C8H9NO2 MW 151.16
Sources
Primlev Manufacturers
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Akrimax Pharmaceuticals, Llc
![Primlev (Oxycodone And Acetaminophen) Tablet [Akrimax Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Primlev | Akrimax Pharmaceuticals, Llc
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. PRIMLEVTM is given orally.
The usual adult dosage of PRIMLEVTM is as follows. The total daily dose of acetaminophen should not exceed 4 grams.
Strength
Usual Adult Dose
Maximal Daily Dose
5 mg/300 mg
One Tablet every 6 hours as needed for pain
12 Tablets
7.5 mg/300 mg
One Tablet every 6 hours as needed for pain
8 Tablets
10 mg/300 mg
One Tablet every 6 hours as needed for pain
6 Tablets
Cessation of TherapyIn patients treated with PRIMLEVTM 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.
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Akrimax Pharmaceuticals, Llc
Primlev | Akrimax Pharmaceuticals, Llc
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 effects of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. PRIMLEVTM is given orally.
The usual adult dosage of PRIMLEVTM is as follows. The total daily dose of acetaminophen should not exceed 4 grams.
Strength
Usual Adult Dose
Maximal Daily Dose
5 mg/300 mg
One Tablet every 6 hours as needed for pain
12 Tablets
7.5 mg/300 mg
One Tablet every 6 hours as needed for pain
8 Tablets
10 mg/300 mg
One Tablet every 6 hours as needed for pain
6 Tablets
Cessation of TherapyIn patients treated with PRIMLEVTM 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.
![Primlev (Oxycodone And Acetaminophen) Tablet [Akrimax Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=616098ee-42dd-4d10-badb-be628e7763fb&name=47563909-f924-455d-8d76-755c76bb3056-03.jpg)
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