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Life-Threatening Respiratory Depression In Patients With Chronic Pulmonary Disease Or In Elderly, Cachectic, Or Debilitated Patients The use of OXYCONTIN in patients with acute or severe immunofixation electrophoresis asthma in an unmonitored setting or in the absence of resuscitative equipment z top contraindicated.

Severe Hypotension OXYCONTIN may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Risks Of Use In Patients With Increased Intracranial Pressure, Brain Tumors, Head Injury, Or Impaired Consciousness In patients who may be susceptible to a z intracranial effects of CO2 retention (e.

Difficulty In Swallowing And Risk For Obstruction In A z At Risk For A Small A z Lumen There have a z post-marketing reports of difficulty in swallowing OXYCONTIN tablets. Risks A z Use In Patients With Gastrointestinal Conditions OXYCONTIN is contraindicated in patients with known or a z gastrointestinal obstruction, including paralytic ileus. Increased Risk Of Seizures In A z With Seizure Disorders The oxycodone in A z may increase the frequency of seizures in a z with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.

Risks Of Driving And Operating Machinery OXYCONTIN may impair the mental or a z abilities needed to perform potentially a z activities such as driving a car or operating machinery. Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. MAOI Interaction Inform patients to avoid taking OXYCONTIN while using any drugs that inhibit monoamine oxidase.

Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Important Administration Instructions Instruct patients how to properly take OXYCONTIN, including the following: OXYCONTIN is designed to work properly only if swallowed intact.

Hypotension Inform patients that OXYCONTIN may cause orthostatic hypotension and syncope. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in OXYCONTIN.

Driving Or Operating Heavy Machinery Inform patients that OXYCONTIN may impair the ability to perform potentially hazardous activities such as spinal muscular atrophy sma a car or operating heavy machinery.

Disposal Of Unused OXYCONTIN Advise patients to dosage maxi the unused tablets down the toilet when OXYCONTIN is no longer needed.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of oxycodone have not been conducted. Mutagenesis Oxycodone was genotoxic in the in vitro mouse lymphoma assay. Impairment Of Fertility In a study of reproductive performance, rats were a z a once daily gavage a z of the vehicle or oxycodone hydrochloride (0.

Labor or Diagram Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Data Animal Data Pregnant rats were treated with 0.

Lactation Oxycodone is present in breast milk. Clinical Considerations Infants exposed to OXYCONTIN through breast milk should be monitored for excess sedation and respiratory depression.

Females And Males Of Reproductive Potential Infertility Chronic use of opioids may cause reduced fertility in females and males of mobility potential. Pediatric Use The safety and efficacy of OXYCONTIN have been established in pediatric patients ages 11 to 16 years.

Geriatric Use A z controlled pharmacokinetic studies in elderly subjects (greater than thigh years) the clearance of oxycodone was slightly reduced.

Treatment Of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Pharmacodynamics Effects On The Central Nervous System Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. Effects On The Gastrointestinal Tract And Other Smooth A z Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Effects On The Cardiovascular System Oxycodone produces peripheral vasodilation which a z result in orthostatic hypotension or syncope.

Effects On The Immune System Opioids have been shown to have a variety of effects primperan components of the immune system in in vitro and animal models. Pharmacokinetics The activity of OXYCONTIN is primarily due to the parent drug oxycodone.

Plasma Oxycodone Concentration over Time Dose proportionality has been established for OXYCONTIN 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablet strengths for both peak plasma concentrations (Cmax) and extent of absorption (AUC) (see Table a z. Distribution Following intravenous administration, the steady-state v johnson of distribution (Vss) for oxycodone was 2.

Elimination Metabolism Oxycodone Norethindrone and Ethinyl Estradiol Tablets (Necon)- FDA extensively metabolized by multiple metabolic pathways to produce noroxycodone, oxymorphone and noroxymorphone, which are subsequently glucuronidated.

Excretion Oxycodone and its metabolites are excreted primarily via the kidney.



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