Omeprazen may be available in the countries listed below.
Omeprazole is reported as an ingredient of Omeprazen in the following countries:
Omeprazole sodium salt (a derivative of Omeprazole) is reported as an ingredient of Omeprazen in the following countries:
International Drug Name Search
Céfaloject may be available in the countries listed below.
Cefapirin sodium salt (a derivative of Cefapirin) is reported as an ingredient of Céfaloject in the following countries:
International Drug Name Search
Acido Ursodesossicolico Mylan may be available in the countries listed below.
Ursodeoxycholic Acid is reported as an ingredient of Acido Ursodesossicolico Mylan in the following countries:
International Drug Name Search
Avistar may be available in the countries listed below.
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Avistar in the following countries:
International Drug Name Search
Trimethosel may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadimidine sodium salt (a derivative of Sulfadimidine) is reported as an ingredient of Trimethosel in the following countries:
Trimethoprim is reported as an ingredient of Trimethosel in the following countries:
International Drug Name Search
Generic Name: acetic acid, antipyrine, benzocaine, and polycosanol otic (a SEE tik AS id, AN tee PYE reen, BENZ oh kane, pol ee KOE san ol OH tic)
Brand Names: Otic Edge, Treagan
Acetic acid is an antibiotic that treats infections caused by bacteria or fungus.
Antipyrine is a pain reliever.
Benzocaine is a numbing medicine.
Polycosanol is an extract of natural plant waxes.
The combination of acetic acid, antipyrine, benzocaine, and polycosanol otic (for the ear) is used to treat ear infection and related pain, swelling, itching, and build-up of excessive earwax.
Acetic acid, antipyrine, benzocaine, and polycosanol otic may also be used for purposes not listed in this medication guide.
Before using this medication, tell your doctor if you have severe ear pain, fever, or hearing problems.
Use this medication for the full prescribed length of time. Your symptoms may improve before the condition is completely cleared. Call your doctor if your symptoms do not improve, or if they get worse while using the medication.
To make sure you can safely use this medication, tell your doctor if you have severe ear pain, fever, or hearing problems.
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Warm the container by holding it in your hands for at least a minute. Using cold ear drops may cause dizziness when you place the medicine into your ear.
To use the ear drops:
Remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. To give this medicine to a child, pull down on the earlobe to open the ear canal.
Hold the dropper upside down over the ear canal and drop in enough medicine to fill your ear canal.
Wet a small piece of cotton with the medicine by placing a few drops on it. Place the cotton into the ear canal to plug the ear and keep the medicine from draining out.
You may need to use this medicine every 1 to 2 hours until your pain is relieved. Follow your doctor's instructions.
To remove earwax, use this medication for 2 or 3 days. Then gently rinse your ear canal with warm water using a bulb syringe to remove leftover earwax.
Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.
Do not place the dropper tip into your ear, or allow the tip to touch any surface, including your ears or hands. It may become contaminated.
Use this medication for the full prescribed length of time. Your symptoms may improve before the condition is completely cleared. Call your doctor if your symptoms do not improve, or if they get worse while using the medication.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
It is not likely that other drugs you take orally or inject will have an effect on medication used in the ears. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Otic Edge side effects (in more detail)
Rev. B 5/2011
0658
Rx only
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.
Oxycodone, USP 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine and may be represented by the following structural formula:
Acetaminophen, USP 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. It may be represented by the following structural formula:
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 1, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Red No. 40, gelatin, iron oxide black, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, shellac glaze and titanium dioxide.
Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably μ and κ) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla.
Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.
Oxycodone reduces motility by increasing smooth muscle tone in the stomach and duodenum. In the small intestine, digestion of food is delayed by decreases in propulsive contractions. Other opioid effects include contraction of biliary tract smooth muscle, spasm of the Sphincter of Oddi, increased ureteral and bladder sphincter tone, and a reduction in uterine tone.
Oxycodone may produce a release of histamine and may be associated with orthostatic hypotension, and other symptoms, such as pruritus, flushing, red eyes, and sweating.
Pharmacokinetics
The mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%. Oxycodone has been shown to be 45% bound to human plasma proteins in vitro. The volume of distribution after intravenous administration is 211.9 ± 186.6 L.
Absorption of acetaminophen is rapid and almost complete from the GI tract after oral administration. With overdosage, absorption is complete in 4 hours. Acetaminophen is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; only 20% to 50% may be bound at the concentrations encountered during acute intoxication.
A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism. Oxymorphone is formed by the O-demethylation of oxycodone. The metabolism of oxycodone to oxymorphone is catalyzed by CYP2D6. Free and conjugated noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone. Approximately 8% to 14% of the dose is excreted as free oxycodone over 24 hours after administration. Following a single, oral dose of oxycodone, the mean ± SD elimination half-life is 3.51 ± 1.43 hours.
Acetaminophen is metabolized in the liver via cytochrome P450 microsomal enzyme. About 80 to 85% of the acetaminophen in the body is conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine. After hepatic conjugation, 90 to 100% of the drug is recovered in the urine within the first day.
About 4% of acetaminophen is metabolized via cytochrome P450 oxidase to a toxic metabolite which is further detoxified by conjugation with glutathione, present in a fixed amount. It is believed that the toxic metabolite NAPQI (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone) is responsible for liver necrosis. High doses of acetaminophen may deplete the glutathione stores so that inactivation of the toxic metabolite is decreased. At high doses, the capacity of metabolic pathways for conjugation with glucuronic acid and sulfuric acid may be exceeded, resulting in increased metabolism of acetaminophen by alternate pathways.
Oxycodone and Acetaminophen Capsules USP are indicated for the relief of moderate to moderately severe pain.
Oxycodone and Acetaminophen Capsules 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.
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 Capsules 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 Capsules 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 Oxycodone and Acetaminophen Capsules, 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 preexisting 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.
There have been postmarketing 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 Oxycodone and Acetaminophen Capsules USP immediately and seek medical care if they experience these symptoms. Do not prescribe Oxycodone and Acetaminophen Capsules USP for patients with acetaminophen allergy.
Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.
The administration of Oxycodone and Acetaminophen Capsules or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Oxycodone and Acetaminophen Capsules should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.
Oxycodone and Acetaminophen Capsules may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.
Following administration of Oxycodone and Acetaminophen Capsules, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown.
Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Oxycodone and Acetaminophen Capsules may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.
Oxycodone and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a common postoperative complication, especially after intra-abdominal surgery with use of opioid analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.
Oxycodone may cause spasm of the Sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION, Cessation of Therapy).
The following information should be provided to patients receiving Oxycodone and Acetaminophen Capsules USP by their physician, nurse, pharmacist, or caregiver:
Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens. However, based on pharmacokinetic data, the approximate duration of detectability for a single dose of oxycodone is roughly estimated to be one to two days following drug exposure.
Urine testing for opiates may be performed to determine illicit drug use and for medical reasons such as evaluation of patients with altered states of consciousness or monitoring efficacy of drug rehabilitation efforts. The preliminary identification of opiates in urine involves the use of an immunoassay screening and thin-layer chromatography (TLC). Gas chromatography/mass spectrometry (GC/MS) may be utilized as a third-stage identification step in the medical investigational sequence for opiate testing after immunoassay and TLC. The identities of 6-keto opiates (e.g., oxycodone) can further be differentiated by the analysis of their methoximetrimethylsilyl (MO-TMS) derivative.
Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.
Patients receiving CNS depressants such as other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Oxycodone and Acetaminophen Capsules may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The concurrent use of anticholinergics with opioids may produce paralytic ileus.
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, naltrexone, and butorphanol) should be administered with caution to a patient who has received or is receiving a pure opioid agonist such as oxycodone. These agonist/antagonist analgesics may reduce the analgesic effect of oxycodone or may precipitate withdrawal symptoms.
Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.
Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.
Charcoal (activated): Reduces acetaminophen absorption when administered as soon as possible after overdose.
Beta Blockers (Propranolol): Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.
Loop diuretics: The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced nonhepatic or renal clearance of zidovudine.
Depending on the sensitivity/specificity and the test methodology, the individual components of Oxycodone and Acetaminophen Capsules may cross-react with assays used in the preliminary detection of cocaine (primary urinary metabolite, benzoylecgonine) or marijuana (cannabinoids) in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Moreover, clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Acetaminophen may interfere with home blood glucose measurement systems; decreases of > 20% in mean glucose values may be noted. This effect appears to be drug, concentration and system dependent.
Animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been performed.
The combination of oxycodone and acetaminophen has not been evaluated for mutagenicity. Oxycodone alone was negative in a bacterial reverse mutation assay (Ames), an in vitro chromosome aberration assay with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay. Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation.
Animal studies to evaluate the effects of oxycodone on fertility have not been performed.
Animal reproductive studies have not been conducted with Oxycodone and Acetaminophen Capsules. It is also not known whether Oxycodone and Acetaminophen Capsules can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and Acetaminophen Capsules should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
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.
Oxycodone and Acetaminophen Capsules are not recommended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn.
Ordinarily, nursing should not be undertaken while a patient is receiving Oxycodone and Acetaminophen Capsules 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.
Safety and effectiveness in pediatric patients have not been established.
Special precaution should be given when determining the dosing amount and frequency of Oxycodone and Acetaminophen Capsules for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients.
In a pharmacokinetic study of oxycodone in patients with end-stage liver disease, oxycodone plasma clearance decreased and the elimination half-life increased. Care should be exercised when oxycodone is used in patients with hepatic impairment.
In a study of patients with end stage renal impairment, mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Oxycodone should be used with caution in patients with renal impairment.
Serious adverse reactions that may be associated with oxycodone and acetaminophen capsule 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 Capsules are listed by organ system and in decreasing order of severity and/or frequency as follows:
Body as a Whole: Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose
Cardiovascular: Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias
Central and Peripheral Nervous System: Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness
Fluid and Electrolyte: Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis
Gastrointestinal: Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus
Hepatic: Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder
Hearing and Vestibular: Hearing loss, tinnitus
Hematologic: Thrombocytopenia
Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction
Metabolic and Nutritional: Hypoglycemia, hyperglycemia, acidosis, alkalosis
Musculoskeletal: Myalgia, rhabdomyolysis
Ocular: Miosis, visual disturbances, red eye
Psychiatric: Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide
Respiratory System: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema
Skin and Appendages: Erythema, urticaria, rash, flushing
Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention
Oxycodone and Acetaminophen Capsules are a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.
Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and 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 seeking behavior of patients whose pain is poorly managed. It is considered an iatrogenic effect of ineffective pain management. The health care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from 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 syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered. Physical dependence can be detected after a few days of opioid therapy. However, clinically significant physical dependence is only seen after several weeks of relatively high dosage therapy. In this case, abrupt discontinuation of the opioid may result in a withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2 week period will prevent withdrawal symptoms. The severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical status of the individual.
The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and depression.
“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor Shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated infection.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxycodone, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Like other opioid medications, Oxycodone and Acetaminophen Capsules are subject to the Federal Controlled Substances Act. After chronic use, Oxycodone and Acetaminophen Capsules should not be discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.
Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.
Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
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.
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.
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 narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, 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. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
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.
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 Capsules USP are given orally.
The usual adult dosage is one capsule every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.
In patients treated with Oxycodone and Acetaminophen Capsules USP 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.
Oxycodone and Acetaminophen Capsules USP are available as:
5 mg / 500 mg: Red opaque cap and white opaque body filled with white powder. Imprinted in black ink stylized barr 658. Available in bottles of 100 capsules.
Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
PROTECT FROM MOISTURE
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. B 5/2011
NDC 0555-0658-02
OXYCODONE and
ACETAMINOPHEN
Capsules USP
5 mg/500 mg*
Rx only
100 Capsules
TEVA
| OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen capsule | ||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA040289 | 08/17/2011 | |
| Labeler - Barr Laboratories Inc. (802716563) |
Chunlin may be available in the countries listed below.
Nifuroxazide is reported as an ingredient of Chunlin in the following countries:
International Drug Name Search
Salbutamolo may be available in the countries listed below.
Salbutamolo (DCIT) is also known as Salbutamol (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Lusopress may be available in the countries listed below.
Nitrendipine is reported as an ingredient of Lusopress in the following countries:
International Drug Name Search
Vetrimosulf may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadimidine sodium salt (a derivative of Sulfadimidine) is reported as an ingredient of Vetrimosulf in the following countries:
Trimethoprim is reported as an ingredient of Vetrimosulf in the following countries:
International Drug Name Search
Flutamida Stada may be available in the countries listed below.
Flutamide is reported as an ingredient of Flutamida Stada in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
P01AX10
0023110-15-8
C26-H34-O7
458
Antibacterial
Antibiotic obtained from cultures of Aspergillus fumigatus, or the same substance produced by any other means
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Digoxine Sine may be available in the countries listed below.
Digoxin is reported as an ingredient of Digoxine Sine in the following countries:
International Drug Name Search
Emezin may be available in the countries listed below.
Meclozine dihydrochloride (a derivative of Meclozine) is reported as an ingredient of Emezin in the following countries:
International Drug Name Search
Active ingredients (in each packet) Purpose
Acetaminophen 650 mg .......................................Pain reliever/Fever reducer
Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant
Phenylephrine hydrochloride 10 mg .................................Nasal decongestant
Uses
- temporarily relieves
- minor aches and pains - minor sore throat pain
- headache - nasal and sinus congestion
- runny nose - sneezing
- itchy nose and throat - itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription and non prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- with any other product containing diphenhydramine, even one used on the skin
-If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before us if you have
- liver disease - heart disease - high blood pressure
- thyroid disease - diabetes - glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema, asthma, or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.
Ask a doctor or pharmacist before use if you are
When using this product
- do not exceed recommended dosage
- avoid alcoholic drinks - marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days - redness or swelling is present
- new symptoms occur - symptoms do not get better or worsen
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor.
- adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years of age: consult a doctor
- If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
Other information
- each packet contains: potassium 7 mg,
sodium 46 mg
- phenylketonurics: contains phenylalanine
13 mg per packet
- store at controlled room temperature
20-25C (68-77F). Protect from
excessive heat and moisture.
| RITE AID NIGHT TIME SEVERE COLD AND COUGH HONEY LEMON WITH CHAMOMILE AND WHITE TEA FLAVORS acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 10/31/2009 | |
| Labeler - Quality Home Products (205554157) |
Laskarton may be available in the countries listed below.
Elcatonin is reported as an ingredient of Laskarton in the following countries:
International Drug Name Search
Acido Clodronico Mylan may be available in the countries listed below.
Clodronic Acid disodium tetrahydrate (a derivative of Clodronic Acid) is reported as an ingredient of Acido Clodronico Mylan in the following countries:
International Drug Name Search
Tinavate may be available in the countries listed below.
Tolnaftate is reported as an ingredient of Tinavate in the following countries:
International Drug Name Search
In the US, Targretin (bexarotene systemic) is a member of the drug class miscellaneous antineoplastics and is used to treat Cutaneous T-cell Lymphoma.
US matches:
UK matches:
Bexarotene is reported as an ingredient of Targretin in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Artedil may be available in the countries listed below.
Manidipine dihydrochloride (a derivative of Manidipine) is reported as an ingredient of Artedil in the following countries:
International Drug Name Search
Mesalazina Mylan may be available in the countries listed below.
Mesalazine is reported as an ingredient of Mesalazina Mylan in the following countries:
International Drug Name Search
Znkid may be available in the countries listed below.
Zinc is reported as an ingredient of Znkid in the following countries:
International Drug Name Search
Citalopram Atid may be available in the countries listed below.
Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram Atid in the following countries:
International Drug Name Search
Acido Tranexamico Bioindustria Lim may be available in the countries listed below.
Tranexamic Acid is reported as an ingredient of Acido Tranexamico Bioindustria Lim in the following countries:
International Drug Name Search
Fulmicocin may be available in the countries listed below.
Fleroxacin is reported as an ingredient of Fulmicocin in the following countries:
International Drug Name Search
Gentrim may be available in the countries listed below.
Sulfamethoxazole is reported as an ingredient of Gentrim in the following countries:
Trimethoprim is reported as an ingredient of Gentrim in the following countries:
International Drug Name Search
Acido Ursodesossicolico EG may be available in the countries listed below.
Ursodeoxycholic Acid is reported as an ingredient of Acido Ursodesossicolico EG in the following countries:
International Drug Name Search
Inositol Niacinate may be available in the countries listed below.
Inositol Niacinate (USAN) is also known as Inositol Nicotinate (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Pratropil may be available in the countries listed below.
Piracetam is reported as an ingredient of Pratropil in the following countries:
International Drug Name Search
Definition of Peripheral Arterial Disease: Arteriosclerosis of the extremities is a disease of the blood vessels characterized by narrowing and hardening of the arteries that supply the legs and feet. This causes a decrease in blood flow that can injure nerves and other tissues.
The following drugs and medications are in some way related to, or used in the treatment of Peripheral Arterial Disease. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Micromedex Care Notes:
Medical Encyclopedia:
Harvard Health Guide:
Tenerel may be available in the countries listed below.
Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Tenerel in the following countries:
International Drug Name Search
Flumazenilo G.E.S. may be available in the countries listed below.
Flumazenil is reported as an ingredient of Flumazenilo G.E.S. in the following countries:
International Drug Name Search
Flurit-D may be available in the countries listed below.
Fluconazole is reported as an ingredient of Flurit-D in the following countries:
International Drug Name Search
Streptomycin sulfat may be available in the countries listed below.
Streptomycin sulfate (a derivative of Streptomycin) is reported as an ingredient of Streptomycin sulfat in the following countries:
International Drug Name Search
Boluzin may be available in the countries listed below.
Gemfibrozil is reported as an ingredient of Boluzin in the following countries:
International Drug Name Search
Bioflac may be available in the countries listed below.
Meloxicam is reported as an ingredient of Bioflac in the following countries:
International Drug Name Search
Frezylin may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Frezylin in the following countries:
International Drug Name Search
Gemfibrozilo Naturgen may be available in the countries listed below.
Gemfibrozil is reported as an ingredient of Gemfibrozilo Naturgen in the following countries:
International Drug Name Search
