Adult Dosing
Moderate to moderately severe pain
- 1 tab q 6 hrs as needed
- Max: 12 tabs/day
Note: Gradually taper dose to discontinue
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Mild-moderate impairment: Use with caution
- CrCl <10mL/min: Avoid use
Hepatic Dose Adjustment
- Mild-moderate impairment: Use with caution
- Severe impairment: Avoid use
See Supplemental Patient Information
- Exhibits history of abuse; consider this when prescribing or dispensing the formulation. In situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion; do not prevent the proper management of pain for concern about misuse, addiction, and diversion
- Abusers crush, snort or inject the product; may result in overdosage and death
- Contact state professional licensing board, or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product
- Closely monitor for the potentially serious adverse reactions and complications
- Respiratory depression to the point of apnea can occur. Consider alternative non-opioid analgesics in susceptible patients and employ opioids only under careful medical supervision at the lowest effective dose. Use naloxone hydrochloride in case of respiratory depression
- Carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure have occurred in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure
- Produces effects on pupillary response and consciousness, obscures neurologic signs of worsening in patients with head injuries
- Severe hypotension may occur especially in blood volume depleted patients or after concomitant administration with drugs compromising vasomotor tone
- Orthostatic hypotension may occur in ambulatory patients
- Risk of bleeding exists in patients having chronic consumption of alcohol
- Risk of coagulation abnormalities, GI side effects exist
- Avoid therapy in patients having history of active peptic ulcer disease
- Use opioid analgesics with caution when combined with CNS depressant drugs; reserve for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension
- Obscure the diagnosis or clinical course in patients with acute abdominal conditions
- Aggravate convulsions in patients with convulsive disorders
- Anaphylactic reactions have occurred in patients with a known hypersensitivity to codeine
- Elevation of hepatic enzymes, BUN, serum creatinine, hyperkalemia, proteinuria, and prolonged bleeding time have occurred
- Additive CNS depression has occurred on concomitant use with CNS depressants
- Reduction of analgesic effect of oxycodone and precipitation of withdrawal symptoms have occurred in patients with mixed agonist/antagonist analgesics
- Decreases bowel motility; monitor for decreased bowel motility in postoperative patients receiving opioids. Institute standard supportive therapy
- Increases serum amylase levels
- Tolerance and physical dependence has occurred
- Avoid abrupt withdrawal
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- CNS depression
- Acute alcoholism
- Delirium tremens
- Toxic psychosis
- Seizure disorder
- Increased ICP
- Intracranial lesion
- Pulmonary impairment
- Kyphoscoliosis with respiratory depression
- Acute asthma
- COPD
- Cor pulmonale
- Preexisting respiratory impairment
- Adrenal insufficiency
- Hypothyroidism
- Addison's disease
- Myxedema
- Prostatic hypertrophy
- Urethral stricture
- Biliary tract disease
- Acute pancreatitis
- Acute abdomen
- Hypovolemia
- Patients in circulatory shock
- GERD
- Thrombocytopenia
- Surgery or trauma
- Debilitated patients
- Geriatrics
Supplemental Patient Information
- Advise patients to avoid adjusting the medication dose themselves; must consult with their prescribing physician
- Advise patients to avoid engaging in activities requiring mental alertness such as operating hazardous machinery or driving an automobile
- Advise patients to avoid use with other CNS depressants
- Advise women having intention to become pregnant or are pregnant to consult with their physician
- Advise patients to avoid abrupt discontinuation of the medication
Pregnancy Category:D
Breastfeeding: Unsafe; Drowsiness can occur in infants due to maternal doses of oxycodone. Newborn infants are sensitive to the effects of even small dosages of narcotic analgesics particularly in the first week of life It is best to limit maternal intake of oral oxycodone (and combinations) and to supplement analgesia with a nonnarcotic analgesic if necessary. Oxycodone elimination decreases in young infants and inter-individual variability exists. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Immediately contact a physician if the baby shows signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness. Avoid aspirin during breastfeeding, especially with very young infants; although a rare single low dose of aspirin daily is unlikely to cause problems in the infant. The risks with chronic high dose aspirin use are less clear. Monitor infant salicylate serum levels particularly in neonates. Avoid breastfeeding for 1-2 hrs after a dose to minimize antiplatelet effects. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 December 2010). According to manufacturer potential for serious adverse reactions in nursing infants exists, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits to the woman and the possible hazards to the nursing infant.
US Trade Name(s)
US Availability
Percodan (aspirin/oxycodone)
Canadian Trade Name(s)
Canadian Availability
Oxycodan (aspirin/oxycodone)
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Percodan 4.5-0.38-325 MG TABS [Bottle] (ENDO PHARMACEUTICALS)
20 mg = $39.59
30 mg = $52.77
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
