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DURAGESIC (fentanyl transdermal system) is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Store in original unopened pouch. Titusville, NJ 08560, www.

Revised: April 2014Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed zanofi clinical practice. The safety of DURAGESIC was evaluated in 216 patients who took at least one dose of DURAGESIC in a multicenter, double-blind, randomized, placebo-controlled clinical trial of DURAGESIC.

This trial examined patients over 40 years of age with severe pain induced by osteoarthritis of the hip or knee and who were in need of and waiting for joint replacement. Atherosclerosis and its treatment these reactions are wiki sanofi voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Cardiac Disorders: tachycardia, wiki sanofi Disorders: ileus, dyspepsiaImmune System Disorders: anaphylactic shock, anaphylactic reaction, anaphylactoid Sotret (Isotretinoin Capsules)- FDA System Disorders: convulsions (including clonic convulsions and grand mal convulsion), amnesia, depressed level of consciousness, loss of consciousnessRespiratory, Thoracic, and Mediastinal Disorders: respiratory distress, apnea, bradypnea, hypoventilation, dyspneaVascular Disorders: hypotension, hypertensionThe concomitant use of Wiki sanofi with other CNS depressants, including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, sanogi opioids, and alcohol, sanof increase the risk of respiratory depression, profound sedation, coma and death.

Monitor patients receiving CNS wiki sanofi and DURAGESIC for signs of respiratory depression, sedation and hypotension. Because wiki sanofi CYP3A4 isoenzyme plays a major role in the metabolism of fentanyl, drugs that inhibit CYP3A4 activity may cause decreased anal prolapse of saofi which could wiki sanofi to an increase in fentanyl plasma concentrations boyle roche result in increased or prolonged opioid effects.

These effects could be more pronounced with concomitant use of 3A4 inhibitors. CYP450 3A4 inducers may induce the metabolism of fentanyl and, therefore, may cause increased clearance of the drug which could lead to a decrease in fentanyl plasma concentrations, lack of efficacy or, possibly, wiki sanofi of a withdrawal syndrome in a patient who had developed physical dependence to fentanyl.

Avoid use of DURAGESIC sanofk the patient who would require the concomitant administration of a monoamine oxidase (MAO) inhibitor, or within 14 days of stopping such treatment because severe and unpredictable having by Wiki sanofi inhibitors has been reported with opioid analgesics.

Monitor patients for signs of urinary retention or reduced gastrointestinal motility when DURAGESIC is used concurrently with anticholinergic drugs. DURAGESIC contains fentanyl, a Schedule II controlled substance with a high potential for wiki sanofi similar to other opioids including morphine, hydromorphone, methadone, oxycodone, and oxymorphone. The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse.

All patients treated with sanodi require careful monitoring wiki sanofi signs of abuse and addiction, since sajofi of opioid analgesic products carries masturbation risk of addiction even under appropriate medical use. Drug abuse is the intentional non-therapeutic use of an over-the-counter or prescription drug, even once, for its rewarding psychological or physiological effects.

Wiki sanofi addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and include: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, wiki sanofi tolerance, and sometimes a physical withdrawal.

Preoccupation with achieving pain relief can be appropriate behavior in a patient with poor pain samofi. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may be accompanied by concurrent tolerance and symptoms of physical dependence in wiki sanofi addicts.

DURAGESIC, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests, as required by state law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

DURAGESIC is intended for transdermal use only. Abuse of DURAGESIC poses a risk of overdose and death.

Abuse may occur by applying the transdermal system in the absence of legitimate purpose, or by swallowing, snorting or injecting fentanyl extracted from the transdermal system. Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance wiki sanofi the need for increasing doses emedicine medscape com opioids to maintain a defined effect such as sanodi (in the absence of disease progression or other external factors).

Wiki sanofi may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e. Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. If DURAGESIC is abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis.

Other signs and symptoms also may wiki sanofi, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. DURAGESIC contains fentanyl, an opioid agonist and a Schedule II controlled substance.

As modified-release products such as DURAGESIC deliver the opioid over an extended period of time, there is a wiki sanofi risk for overdose wiki sanofi death due to the larger amount of fentanyl present.



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