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Duragesic

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Duragesic

Duragesic

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Because 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 in clinical practice.

Clinical Trial Experience

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.

The most common adverse reactions (≥5%) in a double-blind, randomized, placebo-controlled clinical trial in patients with severe pain were nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, and anorexia. Other common adverse reactions (≥5%) reported in clinical trials in patients with chronic malignant or nonmalignant pain were headache and diarrhea. Adverse reactions reported for ≥1% of DURAGESIC-treated patients and with an incidence greater than placebo-treated patients are shown in Table 3.

The most common adverse reactions that were associated with discontinuation in patients with pain (causing discontinuation in ≥1% of patients) were depression, dizziness, somnolence, headache, nausea, vomiting, constipation, hyperhidrosis, and fatigue.

Table 3: Adverse Reactions Reported by ≥1% of DURAGESIC-treated Patients and With an Incidence Greater Than Placebo-treated Patients in 1 Double-Blind, Placebo-Controlled Clinical Trial of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=216)
Placebo %
(N=200)
Cardiac disorders
Palpitations 4 1
Ear and labyrinth disorders
Vertigo 2 1
Gastrointestinal disorders
Nausea 41 17
Vomiting 26 3
Constipation 9 1
Abdominal pain upper 3 2
Dry mouth 2 0
General disorders and administration site conditions
Fatigue 6 3
Feeling cold 6 2
Malaise 4 1
Asthenia 2 0
Edema peripheral 1 1
Metabolism and nutrition disorders
Anorexia 5 0
Musculoskeletal and connective tissue disorders
Muscle spasms 4 2
Nervous system disorders
Somnolence 19 3
Dizziness 10 4
Psychiatric disorders
Insomnia 10 7
Depression 1 0
Skin and subcutaneous tissue disorders
Hyperhidrosis 6 1
Pruritus 3 2
Rash 2 1

Adverse reactions not reported in Table 1 that were reported by ≥1% of DURAGESIC-treated adult and pediatric patients (N=1854) in 11 controlled and uncontrolled clinical trials of DURAGESIC used for the treatment of chronic malignant or nonmalignant pain are shown in Table 4.

Table 4: Adverse Reactions Reported by ≥1% of DURAGESIC-treated Patients in 11 Clinical Trials of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=1854)
Gastrointestinal disorders
Diarrhea 10
Abdominal pain 3
Immune system disorders
Hypersensitivity 1
Nervous system disorders
Headache 12
Tremor 3
Paresthesia 2
Psychiatric disorders
Anxiety 3
Confusional state 2
Hallucination 1
Renal and urinary disorders
Urinary retention 1
Skin and subcutaneous tissue disorders
Erythema 1

The following adverse reactions occurred in adult and pediatric patients with an overall frequency of <1% and are listed in descending frequency within each System/Organ Class:

Cardiac disorders: cyanosis

Eye disorders: miosis

Gastrointestinal disorders: subileus

General disorders and administration site conditions: application site reaction, influenza-like illness, application site hypersensitivity, drug withdrawal syndrome, application site dermatitis

Musculoskeletal and connective tissue disorders: muscle twitching

Nervous system disorders: hypoesthesia

Psychiatric disorders: disorientation, euphoric mood

Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction

Respiratory, thoracic and mediastinal disorders: respiratory depression

Skin and subcutaneous tissue disorders: eczema, dermatitis allergic, dermatitis contact

Pediatrics

The safety of DURAGESIC was evaluated in three open-label trials in 289 pediatric patients with chronic pain, 2 years of age through 18 years of age. Adverse reactions reported by ≥1% of DURAGESIC-treated pediatric patients are shown in Table 5.

Table 5: Adverse Reactions Reported by ≥1% of DURAGESIC-treated Pediatric Patients in 3 Clinical Trials of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=289)
Gastrointestinal disorders Vomiting 34
Nausea 24
Constipation 13
Diarrhea 13
Abdominal pain 9
Abdominal pain upper 4
Dry mouth 2
General disorders and administration site conditions Edema peripheral 5
Fatigue 2
Application site reaction 1
Asthenia 1
Immune system disorders Hypersensitivity 3
Metabolism and nutrition disorders Anorexia 4
Musculoskeletal and connective tissue disorders Muscle spasms 2
Nervous system disorders Headache 16
Somnolence 5
Dizziness 2
Tremor 2
Hypoesthesia 1
Psychiatric disorders Insomnia 6
Anxiety 4
Depression 2
Hallucination 2
Renal and urinary disorders Urinary retention 3
Respiratory, thoracic and mediastinal disorders Respiratory depression 1
Skin and subcutaneous tissue disorders Pruritus 13
Rash 6
Hyperhidrosis 3
Erythema 3

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of DURAGESIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Cardiac Disorders: Tachycardia, Bradycardia

Eye Disorders: Vision blurred

Gastrointestinal Disorders: Ileus, Dyspepsia

General Disorders and Administration Site Conditions: Feeling of body temperature change

Immune System Disorders: Anaphylactic shock, Anaphylactic reaction, Anaphylactoid reaction

Investigations: Weight decreased

Nervous System Disorders: Convulsions (including Clonic convulsions and Grand mal convulsion), Amnesia

Psychiatric Disorders: Agitation

Respiratory, Thoracic, and Mediastinal Disorders: Respiratory distress, Apnea, Bradypnea, Hypoventilation, Dyspnea

Vascular Disorders: Hypotension, Hypertension

Read the Duragesic (fentanyl transdermal) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Agents Affecting Cytochrome P450 3A4 Isoenzyme System

Fentanyl is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4). Coadministration with agents that induce CYP3A4 activity may reduce the efficacy of DURAGESIC. The concomitant use of DURAGESIC with a CYP3A4 inhibitor (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfanivir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, or grapefruit juice) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause fatal respiratory depression. Closely monitor patients receiving DURAGESIC and any CYP3A4 inhibitor and reduce the dosage of DURAGESIC if warranted [see CLINICAL PHARMACOLOGY].

Central Nervous System Depressants

The concomitant use of DURAGESIC with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation, or potentially result in coma or death. Monitor patients closely when central nervous system depressants are used concomitantly with DURAGESIC and reduce the dose of one or both agents.

MAO Inhibitors

Avoid use of DURAGESIC in 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 potentiation by MAO inhibitors has been reported with opioid analgesics.

Drug Abuse And Dependence

Controlled Substance

DURAGESIC contains fentanyl, a potent Schedule II opioid agonist. Schedule II opioid substances, which include hydromorphone, methadone, morphine, oxycodone, and oxymorphone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. DURAGESIC can be abused and is subject to criminal diversion [see WARNINGS AND PRECAUTIONS].

Abuse

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“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 addiction.

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 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. Since DURAGESIC may be diverted for non-medical use, careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests 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.

Dependence

Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood concentration of the drug, and/or administration of an antagonist. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, 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].

Last reviewed on RxList: 10/29/2013
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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