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TEVA-FENTANYL is a brand name for Fentanyl, supplied as a patch. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................4 WARNINGS AND PRECAUTIONS.............................................................................5 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Cancer Trials – Adults Open-Label and Active-Control Double-Blind Studies The safety of fentanyl transdermal system has been evaluated in 153 cancer patients and 357 post-operative patients. The duration of fentanyl transdermal system use varied in cancer patients: 56% of patients used fentanyl transdermal system for over 30 days, 28% continued treatment for more than 4 months, and 10% used fentanyl transdermal system for more than 1 year.
In cancer patients, fentanyl transdermal system was administered in doses of 25 mcg/h to 600 mcg/h. Patients with acute pain used fentanyl transdermal system for 1 to 3 days. Respiratory depression, the most serious adverse reaction, was observed in 3 (2%) of the cancer patients and 13 (4%) of post-operative patients.
Hypotension and hypertension were observed in 11 (3%) and 4 (1%) of the opioid-naive patients. Placebo-Controlled Study Adverse events occurring at a greater frequency than placebo were identified in a placebo- controlled clinical trial of fentanyl transdermal system (25 mcg/h to 100 mcg/h) in cancer patients.
Patients were stabilized on morphine for 7 days, and those who achieved adequate pain relief (n=131) were then switched to fentanyl transdermal system. During the initial open-label dose-titration and stabilization period of 15 days, a total of 43 patients dropped out; four experienced dyspnea, 3 nausea and 1 severe hallucinations.
Following this stabilization period, the nine-day double-blind period began, with patients randomized to either continue the dose of fentanyl transdermal system achieved during stabilization (n=47) or to switch to placebo (n=48). Rescue morphine was available.
The median dose of fentanyl transdermal system was 50 mcg/h. 1% vs 0%: abscess, vertigo, hemorrhage, abdominal pain and jaundice. Chronic Non-Cancer Pain Trials - Adults The safety findings from the two primary trials (FEN-INT-12, n=248 patients; and FEN-INT-13, n=532 patients) are described below (see Product Monograph, Part II: CLINICAL TRIALS, Chronic Non-Cancer Pain (CNCP) Trials for methodological details on the trials).
4%) of the CNCP patients, leading to discontinuation in all three cases. There were nine deaths (all in the one-year trial): four were due to cardiac events, three to pneumonia, one to a cerebrovascular event, and one to cancer. TEVA-FENTANYL (12, 25, 50, 75 and 100 mcg/h) Page 19 of 60 The discontinuation rates were 16% for the one-month crossover trial (FEN-INT-12) and 43% for the one-year trial (FEN-INT-13).
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Of the 780 patients, 149 (19%) received less than one month fentanyl transdermal system treatment, 272 (35%) used fentanyl transdermal system for one to six months, 137 (18%) for six months to one year and 222 patients (28%) continued treatment for more than one year.
4 mcg/h, with the most common dose being 75 mcg/h. Most Common Adverse Events A causal relationship of adverse events to fentanyl transdermal system was not always determined. The most commonly observed adverse events in the non-cancer chronic pain clinical trials, regardless of causal relationship, are: nausea or vomiting, somnolence, constipation, sweating, headache, dizziness, pruritus and depression.
Other reported adverse reactions occurring in > 1% of patients that are probably or likely related to fentanyl transdermal system treatment are: Application Site: application site reaction Body as a Whole: fatigue, pain, malaise, asthenia, hot flushes, withdrawal syndrome, back pain, rigors, temperature changed sensation Central and Peripheral Nervous System: tremor, vertigo, hypertonia Gastrointestinal System: dry mouth, diarrhea, abdominal pain, dyspepsia Heart Rate and Rhythm: palpitation Liver and Biliary System: hepatic enzymes increased, gamma-GT increased Metabolic and Nutritional: weight decreased, LDH increased Psychiatric: anorexia, anxiety, confusion, insomnia, nervousness, agitation, hallucination, concentration impaired, emotional lability, amnesia Respiratory System: dyspnea Skin and Appendages: rash erythematous, skin disorder Chronic Pain Trials - Pediatrics The safety of fentanyl transdermal system has been evaluated in 293 opioid-tolerant pediatric patients (age 18 years or less) with chronic pain, with n=63 receiving fentanyl transdermal system for at least 2 months.
Approximately 60% of the patients had underlying pain due to malignancy. The number of patients in the lower age ranges were as follows: n=2 patients < 2 years old; n=65 patients 2 to < 6 years old; n=100 patients 6 to <12 years old.
8%). Three patients experienced respiratory depression within 96 hours of beginning fentanyl transdermal system; two of these patients died. The underlying condition of the patients contributed to the deaths. The third patient’s decreased respiratory rate was resolved after temporary discontinuation of fentanyl transdermal system.
TEVA-FENTANYL (12, 25, 50, 75 and 100 mcg/h) Page 20 of 60 Dosing recommendations for the safe and effective use of fentanyl transdermal systems in this patient population have not been established, in view of the combination of: i) the variety of factors which could lead to overexposure from fentanyl transdermal systems in children as compared to adults (including smaller body weight and significantly different body surface area; […]