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Primlev 1143A00 10-13_10-13 10/30/13 5:28 PM Page 1
extent with sulfuric acid and cysteine. After hepatic conjugation, 90
TM should be given with caution to patients with CNS
to 100% of the drug is recovered in the urine within the first day.
depression, elderly or debilitated patients, patients with severe
About 4% of acetaminophen is metabolized via cytochrome P450
impairment of hepatic, pulmonary, or renal function, hypothyroidism,
oxidase to a toxic metabolite which is further detoxified by conjugation
Addison's disease, prostatic hypertrophy, urethral stricture, acute
with glutathione, present in a fixed amount. It is believed that the toxic
alcoholism, delirium tremens, kyphoscoliosis with respiratory
metabolite NAPQI (N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone)
depression, myxedema, and toxic psychosis.
is responsible for liver necrosis. High doses of acetaminophen may
Available in 5/300, 7.5/300 & 10/300 mg
may obscure the diagnosis or clinical course in patients
deplete the glutathione stores so that inactivation of the toxic
with acute abdominal conditions. Oxycodone may aggravate
metabolite is decreased. At high doses, the capacity of metabolic
convulsions in patients with convulsive disorders, and al opioids may
pathways for conjugation with glucuronic acid and sulfuric acid
induce or aggravate seizures in some clinical settings.
may be exceeded, resulting in increased metabolism of
acetaminophen by alternate pathways.
Fol owing administration of PRIMLEV
TM, anaphylactic reactions have
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF
been reported in patients with a known hypersensitivity to codeine, a
INDICATIONS AND USAGE
ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER
compound with a structure similar to morphine and oxycodone. The
TM (oxycodone and acetaminophen tablets, USP) is
TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER
frequency of this possible cross-sensitivity is unknown.
indicated for the relief of moderate to moderately severe pain.
INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN
Interactions with Other CNS Depressants
AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND
Patients receiving other opioid analgesics, general anesthetics,
OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-
TM should not be administered to patients with known
phenothiazines, other tranquilizers, central y-acting anti-emetics,
hypersensitivity to oxycodone, acetaminophen, or any other
sedative-hypnotics or other CNS depressants (including alcohol)
concomitantly with PRIMLEV
TM may exhibit an additive CNS
Oxycodone is contraindicated in any situation where opioids are
depression. When such combined therapy is contemplated, the dose
Each tablet, for oral administration, contains oxycodone hydrochloride
of one or both agents should be reduced.
and acetaminophen in the fol owing strengths:
contraindicated including patients with significant respiratory
depression (in unmonitored settings or the absence of resuscitative
Interactions with Mixed Agonist/Antagonist Opioid Analgesics
equipment) and patients with acute or severe bronchial asthma or
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and
hypercarbia. Oxycodone is contraindicated in the setting of suspected
butorphanol) should be administered with caution to a patient who has
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
received or is receiving a course of therapy with a pure opioid agonist
analgesic such as oxycodone. In this situation, mixed agonist/antagonist
Misuse, Abuse and Diversion of Opioids
analgesics may reduce the analgesic effect of oxycodone and/or may
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone is an opioid agonist of the morphine-type. Such drugs are
precipitate withdrawal symptoms in these patients.
sought by drug abusers and people with addiction disorders and are
Ambulatory Surgery and Postoperative Use
Oxycodone and other morphine-like opioids have been shown to
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
Oxycodone can be abused in a manner similar to other opioid
decrease bowel motility. Ileus is a common postoperative
Al strengths of PRIMLEV
TM also contain the fol owing inactive
agonists, legal or il icit. This should be considered when prescribing
complication, especial y after intra-abdominal surgery with use of
ingredients: col oidal silicon dioxide, croscarmel ose sodium,
opioid analgesia. Caution should be taken to monitor for decreased
TM in situations where the physician or
crospovidone, microcrystal ine cel ulose, povidone, pregelatinized
pharmacist is concerned about an increased risk of misuse, abuse,
bowel motility in postoperative patients receiving opioids. Standard
supportive therapy should be implemented.
or diversion. Concerns about misuse, addiction, and diversion should
In addition, the 5 mg/300 mg strength contains D&C Yel ow #10; the
not prevent the proper management of pain.
Use in Pancreatic/Biliary Tract Disease
7.5 mg/300 mg strength contains FD&C Red #40 Aluminum Lake; the
Oxycodone may cause spasm of the Sphincter of Oddi and should be
10 mg/300 mg strength contains FD&C Yel ow #6 Aluminum Lake.
Healthcare professionals should contact their State Professional
used with caution in patients with biliary tract disease, including acute
Licensing Board or State Control ed Substances Authority for
Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid
pancreatitis. Opioids like oxycodone may cause increases in the
information on how to prevent and detect abuse or diversion of
analgesic which occurs as a white, odorless, crystal ine powder
having a saline, bitter taste. The molecular formula for oxycodone
Tolerance and Physical Dependence
Administration of PRIMLEV
TM should be closely monitored for the
18H21NO4•HCl and the molecular weight is 351.82.
Tolerance is the need for increasing doses of opioids to maintain a
It is derived from the opium alkaloid thebaine, and may be represented
fol owing potential y serious adverse reactions and complications:
defined effect such as analgesia (in the absence of disease
progression or other external factors). Physical dependence is
Respiratory depression is a hazard with the use of oxycodone, one
manifested by withdrawal symptoms after abrupt discontinuation of
of the active ingredients in PRIMLEV
TM, as with al opioid agonists.
a drug or upon administration of an antagonist. Physical dependence
Elderly and debilitated patients are at particular risk for respiratory
and tolerance are not unusual during chronic opioid therapy.
depression as are non-tolerant patients given large initial doses of
The opioid abstinence or withdrawal syndrome is characterized by
oxycodone or when oxycodone is given in conjunction with other
some or al of the fol owing: restlessness, lacrimation, rhinorrhea,
agents that depress respiration. Oxycodone should be used with
yawning, perspiration, chil s, myalgia, and mydriasis. Other symptoms
extreme caution in patients with acute asthma, chronic obstructive
also may develop, including: irritability, anxiety, backache, joint pain,
pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory
weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting,
impairment. In such patients, even usual therapeutic doses of
diarrhea, or increased blood pressure, respiratory rate, or heart rate.
oxycodone may decrease respiratory drive to the point of apnea. In
In general, opioids should not be abruptly discontinued (see DOSAGE
these patients alternative non-opioid analgesics should be considered,
AND ADMINISTRATION: Cessation of Therapy).
and opioids should be employed only under careful medical
Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate
Information for Patients/Caregivers
supervision at the lowest effective dose.
1143A00 ߑ Only
analgesic and antipyretic which occurs as a white, odorless,
The fol owing information should be provided to patients receiving
crystal ine powder, possessing a slightly bitter taste. The molecular
In case of respiratory depression, a reversal agent such as naloxone
TM by their physician, nurse, pharmacist, or caregiver:
hydrochloride may be utilized (see OVERDOSAGE).
1. Patients should be aware that PRIMLEV
TM contains oxycodone,
151.16. It may be represented by the fol owing structural formula:
Head Injury and Increased Intracranial Pressure
which is a morphine-like substance.
The respiratory depressant effects of opioids include carbon dioxide
2. Patients should be instructed to keep PRIMLEV
TM in a secure
retention and secondary elevation of cerebrospinal fluid pressure, and
place out of the reach of children. In the case of accidental
may be markedly exaggerated in the presence of head injury, other
ingestions, emergency medical care should be sought immediately.
intracranial lesions or a pre-existing increase in intracranial pressure.
3. When PRIMLEV
TM is no longer needed, the unused tablets
Oxycodone produces effects on pupil ary response and consciousness
should be destroyed by flushing down the toilet.
which may obscure neurologic signs of worsening in patients with
4. Patients should be advised not to adjust the medication dose
themselves. Instead, they must consult with their prescribing
Oxycodone may cause severe hypotension particularly in individuals
5. Patients should be advised that PRIMLEV
TM may impair mental
whose ability to maintain blood pressure has been compromised by
and/or physical ability required or the performance of potential y
Central Nervous System
a depleted blood volume, or after concurrent administration with
hazardous tasks (e.g., driving, operating heavy machinery).
Oxycodone is a semisynthetic pure opioid agonist whose principal
drugs which compromise vasomotor tone such as phenothiazines.
therapeutic action is analgesia. Other pharmacological effects of
6. Patients should not combine PRIMLEV
TM with alcohol, opioid
oxycodone include anxiolysis, euphoria and feelings of relaxation.
Oxycodone, like al opioid analgesics of the morphine-type, should
analgesics, tranquilizers, sedatives, or other CNS depressants
These effects are mediated by receptors (notably µ and k) in the
be administered with caution to patients in circulatory shock, since
unless under the recommendation and guidance of a physician.
central nervous system for endogenous opioid-like compounds
vasodilation produced by the drug may further reduce cardiac output
When co-administered with another CNS depressant, PRIMLEV
such as endorphins and enkephalins. Oxycodone produces
and blood pressure. Oxycodone may produce orthostatic hypotension
can cause dangerous additive central nervous system or
respiratory depression through direct activity at respiratory centers
respiratory depression, which can result in serious injury or death.
in the brain stem and depresses the cough reflex by direct effect
7. The safe use of PRIMLEV
TM during pregnancy has not been
Acetaminophen has been associated with cases of acute liver failure,
established; thus, women who are planning to become pregnant
Acetaminophen is a non-opiate, non-salicylate analgesic and
at times resulting in liver transplant and death. Most of the cases of
or are pregnant should consult with their physician before taking
antipyretic. The site and mechanism for the analgesic effect of
liver injury are associated with the use of acetaminophen at doses
acetaminophen has not been determined. The antipyretic effect of
that exceed 4000 mil igrams per day, and often involve more than one
8. Nursing mothers should consult with their physicians about
acetaminophen is accomplished through the inhibition of endogenous
acetaminophen-containing product. The excessive intake of
whether to discontinue nursing or discontinue PRIMLEV
pyrogen action on the hypothalamic heat-regulating centers.
acetaminophen may be intentional to cause self-harm or unintentional
of the potential for serious adverse reactions to nursing infants.
Gastrointestinal Tract and Other Smooth Muscle
as patients attempt to obtain more pain relief or unknowingly take
9. Patients who are treated with PRIMLEV
TM for more than a few
Oxycodone reduces motility by increasing smooth muscle tone in the
other acetaminophen-containing products.
weeks should be advised not to abruptly discontinue the
stomach and duodenum. In the smal intestine, digestion of food is
The risk of acute liver failure is higher in individuals with underlying
medication. Patients should consult with their physician for a
delayed by decreases in propulsive contractions. Other opioid effects
liver disease and in individuals who ingest alcohol while taking
gradual discontinuation dose schedule to taper off the medication.
include contraction of biliary tract smooth muscle, spasm of the
10. Patients should be advised that PRIMLEV
TM is a potential drug
Sphincter of Oddi, increased ureteral and bladder sphincter tone, and
Instruct patients to look for acetaminophen or APAP on package
of abuse. They should protect it from theft, and it should never
labels and not to use more than one product that contains
be given to anyone other than the individual for whom it was
acetaminophen. Instruct patients to seek medical attention
Oxycodone may produce a release of histamine and may be
immediately upon ingestion of more than 4000 mil igrams of
11. Do not take PRIMLEV
TM if you are al ergic to any of its ingredients.
associated with orthostatic hypotension, and other symptoms, such
acetaminophen per day, even if they feel wel .
12. If you develop signs of al ergy such as a rash or difficulty
as pruritus, flushing, red eyes, and sweating.
Serious Skin Reactions
breathing, stop taking PRIMLEV
TM and contact your healthcare
Rarely, acetaminophen may cause serious skin reactions such as acute
generalized exanthematous pustulosis (AGEP), Stevens-Johnson
13. Do not take more than 4000 mil igrams of acetaminophen per day.
The mean absolute oral bioavailability of oxycodone in cancer patients
Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be
Cal your doctor if you took more than the recommended dose.
was reported to be about 87%. Oxycodone has been shown to be
fatal. Patients should be informed about the signs of serious skin
45% bound to human plasma proteins in vitro. The volume of
distribution after intravenous administration is 211.9 ±186.6 L.
reactions, and use of the drug should be discontinued at the first
Although oxycodone may cross-react with some drug urine tests, no
appearance of skin rash or any other sign of hypersensitivity.
available studies were found which determined the duration of
Absorption of acetaminophen is rapid and almost complete from the
detectability of oxycodone in urine drug screens. However, based on
GI tract after oral administration. With overdosage, absorption is
pharmacokinetic data, the approximate duration of detectability for a
complete in 4 hours. Acetaminophen is relatively uniformly distributed
There have been post-marketing reports of hypersensitivity and
single dose of oxycodone is roughly estimated to be one to two days
throughout most body fluids. Binding of the drug to plasma proteins
anaphylaxis associated with use of acetaminophen. Clinical signs
is variable; only 20% to 50% may be bound at the concentrations
included swel ing of the face, mouth, and throat, respiratory distress,
encountered during acute intoxication.
urticaria, rash, pruritus, and vomiting. There were infrequent reports
Urine testing for opiates may be performed to determine il icit drug
use and for medical reasons such as evaluation of patients with
Metabolism and Elimination
of life-threatening anaphylaxis requiring emergency medical attention.
altered states of consciousness or monitoring efficacy of drug
A high portion of oxycodone is N-dealkylated to noroxycodone during
Instruct patients to discontinue PRIMLEV
TM immediately and seek
rehabilitation efforts. The preliminary identification of opiates in urine
first-pass metabolism. Oxymorphone, is formed by the O-
medical care if they experience these symptoms. Do not prescribe
involves the use of an immunoassay screening and thin-layer
demethylation of oxycodone. The metabolism of oxycodone to
TM for patients with acetaminophen al ergy.
chromatography (TLC). Gas chromatography/mass spectrometry
oxymorphone is catalyzed by CYP2D6. Free and conjugated
(GC/MS) may be utilized as a third-stage identification step in the
noroxycodone, free and conjugated oxycodone, and oxymorphone are
medical investigational sequence for opiate testing after immunoassay
excreted in human urine fol owing a single oral dose of oxycodone.
Opioid analgesics should be used with caution when combined with
and TLC. The identities of 6-keto opiates (e.g., oxycodone) can further
Approximately 8% to 14% of the dose is excreted as free oxycodone
CNS depressant drugs, and should be reserved for cases where the
be differentiated by the analysis of their methoxime-trimethylsilyl
over 24 hours after administration. Fol owing a single, oral dose of
benefits of opioid analgesia outweigh the known risks of respiratory
oxycodone, the mean ± SD elimination half-life is 3.51 ± 1.43 hours.
depression, altered mental state, and postural hypotension.
Drug/Drug Interactions with Oxycodone
Acetaminophen is metabolized in the liver via cytochrome P450
Acute Abdominal Conditions
Opioid analgesics may enhance the neuromuscular-blocking action
microsomal enzyme. About 80 to 85% of the acetaminophen in the
The administration of PRIMLEV
TM or other opioids may obscure the
of skeletal muscle relaxants and produce an increase in the degree of
body is conjugated principal y with glucuronic acid and to a lesser
diagnosis or clinical course in patients with acute abdominal conditions.
Primlev 1143A00 10-13_10-13 10/30/13 5:28 PM Page 2
Patients receiving CNS depressants such as other opioid analgesics,
Hypersensitivity reactions may include: Skin eruptions, urticarial,
general anesthetics, phenothiazines, other tranquilizers, central y-acting
erythematous skin reactions. Hematologic reactions may include:
Fol owing an acute overdosage, toxicity may result from the
anti-emetics, sedative-hypnotics or other CNS depressants (including
Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia.
alcohol) concomitantly with PRIMLEV
TM may exhibit an additive CNS
Rare cases of agranulocytosis has likewise been associated with
Signs and Symptoms
depression. When such combined therapy is contemplated, the dose
acetaminophen use. In high doses, the most serious adverse effect
Toxicity from oxycodone
poisoning includes the opioid triad of:
of one or both agents should be reduced. The concurrent use of
is a dose-dependent, potential y fatal hepatic necrosis. Renal tubular
pinpoint pupils, depression of respiration, and loss of consciousness.
anticholinergics with opioids may produce paralytic ileus.
necrosis and hypoglycemic coma also may occur.
Serious overdosage with oxycodone is characterized by respiratory
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, naltrexone,
Other adverse reactions obtained from postmarketing experiences
depression (a decrease in respiratory rate and/or tidal volume, Cheyne-
and butorphanol) should be administered with caution to a patient who
TM are listed by organ system and in decreasing order
Stokes respiration, cyanosis), extreme somnolence progressing to
has received or is receiving a pure opioid agonist such as oxycodone.
stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and
These agonist/antagonist analgesics may reduce the analgesic effect of
Body as a Whole
sometimes bradycardia and hypotension. In severe overdosage,
oxycodone or may precipitate withdrawal symptoms.
Anaphylactoid reaction, al ergic reaction, malaise, asthenia, fatigue,
apnea, circulatory col apse, cardiac arrest, and death may occur.
Drug/Drug Interactions with Acetaminophen
chest pain, fever, hypothermia, thirst, headache, increased sweating,
overdosage: dose-dependent potential y fatal
Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics
accidental overdose, non-accidental overdose
hepatic necrosis is the most serious adverse effect. Renal tubular
fol owing various dose levels (moderate to excessive) of acetaminophen.
necrosis, hypoglycemic coma and coagulation defects may also
Anticholinergics: The onset of acetaminophen effect may be delayed
Hypotension, hypertension, tachycardia, orthostatic hypotension,
occur. Early symptoms fol owing a potential y hepatotoxic overdose
or decreased slightly, but the ultimate pharmacological effect is not
may include: nausea, vomiting, diaphoresis, and general malaise.
significantly affected by anticholinergics.
Central and Peripheral Nervous System
Clinical and laboratory evidence of hepatic toxicity may not be
Oral Contraceptives: Increase in glucuronidation resulting in increased
Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety,
apparent until 48 to 72 hours post-ingestion.
plasma clearance and a decreased half-life of acetaminophen.
mental impairment, agitation, cerebral edema, confusion, dizziness
Charcoal (activated): Reduces acetaminophen absorption when
Fluid and Electrolyte
A single or multiple drug overdose with oxycodone and acetaminophen
administered as soon as possible after overdose.
Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis
is a potential y lethal polydrug overdose, and consultation with a
Beta Blockers (Propranolol): Propranolol appears to inhibit the
regional poison control center is recommended. Immediate treatment
enzyme systems responsible for the glucuronidation and oxidation of
includes support of cardiorespiratory function and measures to reduce
acetaminophen. Therefore, the pharmacologic effects of
Dyspepsia, taste disturbances, abdominal pain, abdominal distention,
drug absorption. Oxygen, intravenous fluids, vasopressors, and other
sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal
supportive measures should be employed as indicated. Assisted or
disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus
Loop diuretics: The effects of the loop diuretic may be decreased
control ed ventilation should also be considered.
because acetaminophen may decrease renal prostaglandin excretion
Transient elevations of hepatic enzymes, increase in bilirubin,
Primary attention should be given to the reestablishment of adequate
hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder
Lamotrigine: Serum lamotrigine concentrations may be reduced,
respiratory exchange through provision of a patent airway and the
producing a decrease in therapeutic effects.
Hearing and Vestibular
institution of assisted or control ed ventilation. The narcotic antagonist
naloxone hydrochloride is a specific antidote against respiratory
Probenecid: Probenecid may increase the therapeutic effectiveness
depression which may result from overdosage or unusual sensitivity
to narcotics, including oxycodone. Since the duration of action of
Zidovudine: The pharmacologic effects of zidovudine may be
oxycodone may exceed that of the antagonist, the patient should be
decreased because of enhanced non-hepatic or renal clearance of
kept under continued surveil ance, and repeated doses of the antagonist
Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal
should be administered as needed to maintain adequate respiration. A
Drug/Laboratory Test Interactions
narcotic antagonist should not be administered in the absence of
Depending on the sensitivity/specificity and the test methodology, the
Metabolic and Nutritional
clinical y significant respiratory or cardiovascular depression.
individual components of PRIMLEV
TM may cross-react with assays
Hypoglycemia, hyperglycemia, acidosis, alkalosis
used in the preliminary detection of cocaine (primary urinary
Gastric decontamination with activated charcoal should be
metabolite, benzoylecgonine) or marijuana (cannabinoids) in human
administered just prior to N-acetylcysteine (NAC) to decrease systemic
urine. A more specific alternate chemical method must be used in
absorption if acetaminophen ingestion is known or suspected to have
order to obtain a confirmed analytical result. The preferred
occurred within a few hours of presentation. Serum acetaminophen
confirmatory method is gas chromatography/mass spectrometry
levels should be obtained immediately if the patient presents 4 hours
(GC/MS). Moreover, clinical considerations and professional
or more after ingestion to assess potential risk of hepatotoxicity;
judgment should be applied to any drug-of-abuse test result,
Drug dependence, drug abuse, insomnia, confusion, anxiety,
acetaminophen levels drawn less than 4 hours post-ingestion may be
particularly when preliminary positive results are used.
agitation, depressed level of consciousness, nervousness,
misleading. To obtain the best possible outcome, NAC should be
Acetaminophen may interfere with home blood glucose measurement
hal ucination, somnolence, depression, suicide
administered as soon as possible where impending or evolving liver
systems; decreases of > 20% in mean glucose values may be noted.
injury is suspected. Intravenous NAC may be administered when
This effect appears to be drug, concentration and system dependent.
Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea,
circumstances preclude oral administration.
Carcinogenesis, Mutagenesis, Impairment of Fertility
aspiration, hypoventilation, laryngeal edema
Vigorous supportive therapy is required in severe intoxication.
Skin and Appendages
Procedures to limit the continuing absorption of the drug must be
Animal studies to evaluate the carcinogenic potential of oxycodone
readily performed since the hepatic injury is dose dependent and
and acetaminophen have not been performed.
occurs early in the course of intoxication.
Interstitial nephritis, papil ary necrosis, proteinuria, renal insufficiency
DOSAGE AND ADMINISTRATION
The combination of oxycodone and acetaminophen has not been
Dosage should be adjusted according to the severity of the pain and
evaluated for mutagenicity. Oxycodone alone was negative in a
DRUG ABUSE AND DEPENDENCE
the response of the patient. It may occasional y be necessary to
bacterial reverse mutation assay (Ames), an in vitro
TM is a Schedule II control ed substance. Oxycodone is a
exceed the usual dosage recommended below in cases of more
aberration assay with human lymphocytes without metabolic
mu-agonist opioid with an abuse liability similar to morphine.
severe pain or in those patients who have become tolerant to the
activation and an in vivo
mouse micronucleus assay. Oxycodone was
Oxycodone, like morphine and other opioids used in analgesia, can
analgesic effect of opioids. If pain is constant, the opioid analgesic
clastogenic in the human lymphocyte chromosomal assay in the
be abused and is subject to criminal diversion.
should be given at regular intervals on an around-the-clock schedule.
presence of metabolic activation and in the mouse lymphoma assay
Drug addiction is defined as an abnormal, compulsive use, use for non-
TM is given oral y.
with or without metabolic activation.
medical purposes of a substance despite physical, psychological,
The usual adult dosage of PRIMLEV
TM is as fol ows. The total daily
occupational or interpersonal difficulties resulting from such use, and
dose of acetaminophen should not exceed 4 grams.
Animal studies to evaluate the effects of oxycodone on fertility have
continued use despite harm or risk of harm. Drug addiction is a treatable
disease, utilizing a multi-disciplinary approach, but relapse is common.
Opioid addiction is relatively rare in patients with chronic pain but may
be more common in individuals who have a past history of alcohol or
substance abuse or dependence. Pseudoaddiction refers to pain relief
Animal reproductive studies have not been conducted with
seeking behavior of patients whose pain is poorly managed. It is
TM. It is also not known whether PRIMLEV
TM can cause
considered an iatrogenic effect of ineffective pain management. The
fetal harm when administered to a pregnant woman or can affect
health care provider must assess continuously the psychological and
reproductive capacity. PRIMLEV
TM should not be given to a pregnant
clinical condition of a pain patient in order to distinguish addiction from
woman unless in the judgment of the physician, the potential benefits
pseudoaddiction and thus, be able to treat the pain adequately.
Physical dependence on a prescribed medication does not signify
addiction. Physical dependence involves the occurrence of a withdrawal
Opioids can cross the placental barrier and have the potential to cause
syndrome when there is sudden reduction or cessation in drug use or
Cessation of Therapy
neonatal respiratory depression. Opioid use during pregnancy may
if an opiate antagonist is administered. Physical dependence can be
In patients treated with PRIMLEV
TM for more than a few weeks who
result in a physical y drug-dependent fetus. After birth, the neonate
detected after a few days of opioid therapy. However, clinical y
no longer require therapy, doses should be tapered gradual y to prevent
may suffer severe withdrawal symptoms.
significant physical dependence is only seen after several weeks of
signs and symptoms of withdrawal in the physical y dependent patient.
Labor and Delivery
relatively high dosage therapy. In this case, abrupt discontinuation of
the opioid may result in a withdrawal syndrome. If the discontinuation
TM is not recommended for use in women during and
TM is supplied as fol ows:
immediately prior to labor and delivery due to its potential effects on
of opioids is therapeutical y indicated, gradual tapering of the drug over
TM 5 mg/300 mg
respiratory function in the newborn.
a 2-week period wil prevent withdrawal symptoms. The severity of the
withdrawal syndrome depends primarily on the daily dosage of the
Yel ow, capsule-shaped, convex face tablets, debossed “A” score “P”
opioid, the duration of therapy and medical status of the individual.
on one side and “681” on the other side.
Ordinarily, nursing should not be undertaken while a patient is
The withdrawal syndrome of oxycodone is similar to that of morphine.
TM because of the possibility of sedation and/or
respiratory depression in the infant. Oxycodone is excreted in breast
This syndrome is characterized by yawning, anxiety, increased heart
TM 7.5 mg/300 mg
milk in low concentrations, and there have been rare reports of
rate and blood pressure, restlessness, nervousness, muscle aches,
Red, capsule-shaped, flat face, beveled edge tablets, debossed “A P”
somnolence and lethargy in babies of nursing mothers taking an
tremor, irritability, chil s alternating with hot flashes, salivation,
on one side and “682” on the other side.
oxycodone/acetaminophen product. Acetaminophen is also excreted
anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils,
in breast milk in low concentrations.
diaphoresis, piloerection, nausea, vomiting, abdominal cramps,
diarrhea and insomnia, and pronounced weakness and depression.
Safety and effectiveness in pediatric patients have not been established.
“Drug-seeking” behavior is very common in addicts and drug
TM 10 mg/300 mg
abusers. Drug-seeking tactics include emergency cal s or visits near
Orange, oval-shaped, convex face tablets, debossed “A P” on one
the end of office hours, refusal to undergo appropriate examination,
side and “683” on the other side.
Special precaution should be given when determining the dosing
testing or referral, repeated “loss” of prescriptions, tampering with
TM for geriatric patients, since
prescriptions and reluctance to provide prior medical records or
clearance of oxycodone may be slightly reduced in this patient
contact information for other treating physician(s). “Doctor Shopping”
population when compared to younger patients.
to obtain additional prescriptions is common among drug abusers
Store at 20° to 25°C (68° to 77°F). [see USP Control ed Room
and people suffering from untreated infection.
In a pharmacokinetic study of oxycodone in patients with end-stage
Abuse and addiction are separate and distinct from physical
Dispense in a tight, light-resistant container as defined in the USP,
liver disease, oxycodone plasma clearance decreased and the
dependence and tolerance. Physicians should be aware that addiction
with a child-resistant closure (as required).
elimination half-life increased. Care should be exercised when
may not be accompanied by concurrent tolerance and symptoms of
oxycodone is used in patients with hepatic impairment.
physical dependence in al addicts. In addition, abuse of opioids can
For further product information, please visit www.akrimax.com or cal
occur in the absence of true addiction and is characterized by misuse
our medical communications department tol -free at 1-888-383-1733.
In a study of patients with end stage renal impairment, mean
for non-medical purposes, often in combination with other psychoactive
elimination half-life was prolonged in uremic patients due to increased
substances. Oxycodone, like other opioids, has been diverted for non-
volume of distribution and reduced clearance. Oxycodone should be
medical use. Careful record-keeping of prescribing information,
used with caution in patients with renal impairment.
including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices,
Manufactured for Akrimax Pharmaceuticals, LLC, Cranford, NJ 07016
Serious adverse reactions that may be associated with PRIMLEV
periodic reevaluation of therapy, and proper dispensing and storage
use include respiratory depression, apnea, respiratory arrest,
are appropriate measures that help to limit abuse of opioid drugs.
circulatory depression, hypotension, and shock (see OVERDOSAGE).
Like other opioid medications, PRIMLEV
TM is subject to the Federal
The most frequently observed non-serious adverse reactions include
Control ed Substances Act. After chronic use, PRIMLEV
lightheadedness, dizziness, drowsiness or sedation, nausea, and
not be discontinued abruptly when it is thought that the patient has
vomiting. These effects seem to be more prominent in ambulatory
become physical y dependent on oxycodone.
than in nonambulatory patients, and some of these adverse reactions
Interactions with Alcohol and Drugs of Abuse
may be al eviated if the patient lies down. Other adverse reactions
Oxycodone may be expected to have additive effects when used in
include euphoria, dysphoria, constipation, and pruritus.
conjunction with alcohol, other opioids, or il icit drugs that cause
Actualización en neuroquímica y terapéutica farmacológica de las ataxias cerebelosas J. Gazulla ACTUALIZACIÓN EN NEUROQUÍMICA Y TERAPÉUTICA FARMACOLÓGICA DE LAS ATAXIAS CEREBELOSAS Resumen. Objetivo . Recopilar los datos neuroquímicos disponibles sobre las diferentes ataxias cerebelosas y los múltiples ensayos terapéuticos realizados hasta el momento actual. Desarrollo . Se h
NEWBORN CARE INFORMED CONSENT The State of New Mexico, Department of Public Health requires the**************************************************************************************A. Neisseria gonorrhoeae bacteria, chlamydia trachomatis, or anyother bacterial infections present at time of birth can cause eyeinfections in the newborn. Undetected infection can lead to conjunctivitis, scarring