Safety alert for transdermal patches.
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Administration, Cutaneous↗
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[Effective pain therapy with good tolerability. New opioid administration form by transdermal patch].
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Administration, Cutaneous↗
Transdermal patch poisoning.
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Administration, Cutaneous↗
The nicotine transdermal patch: use in the dental office tobacco cessation program.
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Administration, Cutaneous↗
Transport of testosterone through rat skin from transdermal patch formulations.
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Administration, Cutaneous↗
[Administration of nitroglycerin using transdermal patches].
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Administration, Cutaneous↗
Effect of application sites and multiple doses on nicotine pharmacokinetics in healthy male Japanese smokers following application of the transdermal nicotine patch.
The transdermal nicotine patch, which contains 25 mg nicotine per 30 cm(2), is designed to deliver approximately 15 mg nicotine to the blood circulation in 16 hours of application for the treatment of smoking cessation. It was applied to 3 different skin sites (upper arm, abdomen, and back) to examine regional variations in percutaneous nicotine absorption in a single-dose, 3-period, crossover study involving 9 healthy male Japanese smokers. Nicotine pharmacokinetics during once-daily application of the transdermal nicotine patch for 5 days was also investigated in 10 healthy smokers. There were statistically significant effects of application sites on percutaneous nicotine absorption. The ratios (90% confidence intervals) of AUC and C(max) for comparison to the upper arm were 102% (88, 117%) and 106% (95, 119%) for the back and 75% (65, 87%) and 75% (66, 84%) for the abdomen, respectively. These suggest that systemic exposure after application to the upper arm was greater compared with the abdomen but equivalent to the back. Following multiple doses, linear pharmacokinetics and no significant accumulation of nicotine concentrations were observed, and steady state was reached by day 2. Only mild itching and erythema were observed at the application sites. The transdermal nicotine patch was well tolerated in both studies.
Abdomen↗
Comparison of the steady-state pharmacokinetics, metabolism, and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal men.
AIM: To compare the pharmacokinetics (PK), metabolism, intra- and inter-subject variability of a permeation-enhanced testosterone patch versus a topical testosterone gel. METHODS: 28 hypogonadal men were treated with a testosterone patch (5 mg/day applied at 2200 h) and a 1% testosterone gel (5 g/day applied at 0800 h; nominal delivery 5 mg/day), each for 14 days, in an open-label crossover design. PK profiles of total testosterone (TT) and calculated free testosterone (cFT) were measured on day 7 and day 14 of each treatment, with patches or gel applied to the abdomen; dihydrotestosterone (DHT) and estradiol (E2) profiles were measured on day 14. The time-average (Cavg), maximum (Cmax), time of maximum (Tmax) and minimum concentrations (Cmin) were derived from each profile. The intra- and inter-subject coefficients of variation (CVintra and CVinter) of the TT and cFT parameters were computed by ANOVA. RESULTS: Nightly applications of the patch produced a mean TT profile that mimicked the circadian pattern of healthy men. Morning applications of the gel produced a flatter mean profile; though individual subjects exhibited significant peaks at variable times. For TT, the mean and 90% confidence intervals of the patch/gel ratio of Cavg (1.030; 0.936-1.133; P > 0.05) and Cmax (1.086; 0.974-1.211; P > 0.05) met the criteria for bioequivalence. Cmin was lower for the patch. DHT levels and DHT/T ratios were 2 to 3-fold higher for the gel (P < 0.0001). E2 levels and E2/T ratios were comparable. CVintra and CVinter for Tmax approached 100% for the gel and were 23% and 42%, respectively, for the patch (P < 0.0001). Other variability parameters were generally comparable. Both products were well tolerated, and the patches adhered well. CONCLUSIONS: These findings reflect the different mechanisms of transdermal absorption from the patch and gel and provide new considerations for selecting testosterone replacement therapies in hypogonadal men.
Administration, Cutaneous↗
Bupropion (Zyban, Wellbutrin) inhibits nicotine-induced viral reactivation in herpes simplex virus type 1 latent rabbits.
We reported that nicotine applied via a transdermal patch (21 mg/day) induced viral reactivation and ocular shedding in herpes simplex virus type 1 (HSV-1) latent rabbits. One possible mechanism of action involves the release of catecholamines and other similar agents, triggering HSV reactivation. Bupropion (Zyban, Wellbutrin), a non-nicotine aid to smoking cessation, inhibits neuronal uptake of norepinephrine, serotonin, and dopamine. To determine whether bupropion inhibits HSV reactivation, rabbits latent with HSV-1 were grouped (at least 10 rabbits/group) and treated as follows: nicotine patch (transdermal delivery) and bupropion [Zyban sustained-release tablets (150 mg) twice a day (oral)], nicotine patch only, Zyban tablets only [twice a day (oral)], nicotine patch with oral placebo [twice a day (oral)], or no drug treatment. Eyes were swabbed for 22 consecutive days. The appearance of HSV-1 in the tear film was significantly less frequent in the bupropion-treated rabbits, in terms of positive rabbits/total rabbits, positive eyes/total eyes, and positive swabs/total swabs. Nicotine-treated rabbits had 78/440 (17.7%) positive/total swabs, and nicotine/placebo-treated rabbits had 149/792 (18.8%) positive/total swabs, whereas bupropion-treated rabbits had 23/440 (5.2%), and nicotine/bupropion-treated rabbits had 47/792 (5.9%) positive/total swabs. Thus, bupropion significantly reduces nicotine-induced HSV reactivation in latent rabbits.
Animals↗
A study of the use of a transdermal fentanyl patch in cats.
A transdermal therapeutic system (TTS) has been developed for the continuous delivery of fentanyl citrate to provide ongoing analgesia in human patients with chronic pain. Several researchers believe that fentanyl transdermal patches have a place in postoperative pain control. The purpose of this study was to determine whether transdermal technology is an effective way of administering fentanyl to feline patients. Fentanyl patches were applied to the skin of six cats, and blood samples for fentanyl analysis were collected over 104 hours. This study establishes that the transdermal patch technology is an effective, long-lasting, cost-effective, noninvasive, and well-tolerated mode of deliverying fentanyl to cats.
Administration, Cutaneous↗
Comparative serum estradiol profiles from a new once-a-week transdermal estradiol patch and a twice-a-week transdermal estradiol patch.
Two identical open-label, randomized crossover studies were conducted to compare serum estradiol profiles from the new 12.5- and 25-cm2 once-a-week adhesive patches with those from the 10- and 20-cm2 commercially available twice-a-week Estraderm patches when applied as directed during a 1-week patch-wear period. Both studies were conducted in healthy postmenopausal women; serum estradiol levels were determined by gas chromatography/mass spectroscopy (GC/MS). Although both sizes of both patch treatments produced mean serum estradiol levels in the therapeutic range, the once-a-week patch provided more constant mean levels, avoiding large peak-to-trough fluctuations. As expected, the differences in mean serum estradiol concentrations between the two patch treatments occurred during the second application of the twice-a-week patch. Based on these results, the once-a-week drug in adhesive patch appears to be an acceptable means of hormone replacement therapy.
Administration, Cutaneous↗
Which smokers are helped to give up smoking using transdermal nicotine patches? Results from a randomized, double-blind, placebo-controlled trial.
BACKGROUND: Nicotine replacement therapy is effective in helping people to give up smoking. The three forms now available--transdermal patches, chewing gum and nasal spray--deliver nicotine at different rates and to different levels. Therefore, it might be expected that smokers with different characteristics, and at different levels of nicotine dependence, will be helped more by one or other method. AIM: The aim of the study was to examine whether the effectiveness of transdermal patches is related to nicotine dependence or to other smoker characteristics and to investigate factors predicting smoking cessation using patches. METHOD: Data from a randomized, double-blind, placebo-controlled trial of nicotine transdermal patches were analysed retrospectively. The trial, conducted in 1990-1992, involved 1686 patients recruited from 19 general practices in Oxfordshire. The main outcome measure was continuous smoking cessation from 8 to 52 weeks after the start of patch use, biochemically validated at 12, 24 and 52 weeks. The effectiveness of the patches was measured by the relative odds of sustained cessation using nicotine patches compared with placebo patches. RESULTS: Nicotine transdermal patches were more effective in smokers with moderate nicotine dependence [odds ratio (OR) 1.94; 95% confidence interval (CI) 1.24-3.04] than in mildly or highly dependent smokers (OR 0.98; 95% CI 0.58-1.65) (difference in ORs P < 0.05) and more effective in those aged 24-49 years (OR 1.89; 95% CI 1.24-2.87) than in older smokers aged 50-65 years (OR 0.88; 95% CI 0.49-1.59) (difference in ORs P < 0.05). Abstinence from smoking in the first week of the trial was the strongest predictor of sustained cessation and was more common among smokers using nicotine patches than those using placebo patches (33% of 842 compared with 22% of 844; P < 0.001). Of first-week abstainers, 25 and 28% of 277 and 182 in the nicotine and placebo groups, respectively, achieved sustained cessation compared with 4% of 565 and 2% of 662 first-week smokers. CONCLUSION: Nicotine transdermal patches were most effective for smokers with moderate nicotine dependence and for younger smokers. Early abstinence from smoking was the strongest predictor of sustained cessation. A week's trial of the patch proceeding to longer term use if abstinence is achieved may be an effective policy.
Administration, Cutaneous↗
Long-term evaluation of the use of the transdermal contraceptive patch in adolescents.
The transdermal contraceptive patch, Ortho Evra, was approved in December 2001 and released on the market in June 2002. In this study, we reviewed clinical data of young women who started the patch between June 2002 and December 2003 in the adolescent medicine clinic at a university-based outpatient center. A total of 62 patients started the patch in that period and two of them were lost to follow-up. Mean age of patients was 17.9 years and mean length of use was 10 cycles. Only 10 patients (16.7%) discontinued use. Reasons for discontinuation were moderate to severe skin irritation (3 patients, 5%), complete detachment (3 patients, 5%), and economic reasons (4 patients, 6.7%). Compliance was excellent overall and the side-effects profile was good. No pregnancies occurred during this period. These results confirmed that the transdermal contraceptive patch is easy to use and an effective method of birth control that may be better tolerated by young women. It also seemed to improve contraceptive compliance in this population.
Administration, Cutaneous↗
Comparison of nicotine pharmacokinetics in healthy Japanese male smokers following application of the transdermal nicotine patch and cigarette smoking.
Transdermal nicotine patch (TNP) contains approximately 16.6 and 24.9 mg of nicotine per 20 and 30 cm2 (TNP-20 and TNP-30). The aims of the study are to investigate linearity of nicotine pharmacokinetics after single application of different strengths of TNP and to directly compare plasma nicotine concentrations with those during cigarette smoking. Twelve healthy Japanese male smokers were randomly allocated to 1 of 2 cohorts consisting of 6 subjects each. Cohort 1 subjects received 1 sheet of TNP-20 (TNP-20x1) in period 1, and 2 sheets of TNP-20 (TNP-20x2) in period 3. Cohort 2 subjects were received 1 sheet of TNP-30 (TNP-30x1) in period 2, and smoked a total of 12 cigarettes at 1 h intervals in period 4. Each TNP was applied to the upper arm for 16 h. After TNP-20x1 or TNP-20x2 treatment in cohort 1, the amount of nicotine delivered from TNP (Dose) was proportional to surface area of TNP. Cmax and AUC of nicotine increased with the surface area (Dose), and tmax, t(1/2), CL/F and percentage of dose excreted in urine were almost the same between both treatments. These suggest the linear pharmacokinetics of nicotine in proportion to the surface area and Dose following single application of TNP in identical subjects. In cohort 2, the plasma nicotine concentrations after TNP-30x1 treatment were approximately half those just before each smoking.
Administration, Cutaneous↗
A comparison of measures used to assess effectiveness of the transdermal nicotine patch at 1 year.
This study examines outcome measures of abstinence among studies reporting 12-month outcomes of the nicotine transdermal patch using different measures of effectiveness. This was achieved by reviewing published randomized controlled studies reporting 1-year abstinence rates of the nicotine transdermal patch. Comparisons are made across studies of three outcome measures used to report abstinence: point prevalence, continuous, and prolonged abstinence. Studies that measured outcome in terms of continuous and prolonged abstinence at 1 year showed double the effect for the active patch compared to placebo; however, this difference was not always apparent in those studies using point prevalence as the outcome measure.
Administration, Cutaneous↗
Controlled trial of transdermal nicotine patch in tobacco withdrawal.
A transdermal nicotine patch, which delivers 0.7 mg/cm2 per 24 h and is available in sizes of 10, 20, and 30 cm2 was tested in subjects from 21 general medical practices in a 3-month, placebo-controlled randomised double-blind study. The nicotine group (n = 100) and the placebo group (n = 99) were similar at entry. Participants who smoked more than 20 cigarettes a day were treated with the 30 cm2 patch and the others with the 20 cm2 patch. When abstinence, defined as smoking 0-3 cigarettes per week and verified by CO measurement, was achieved, the next smallest patch was applied. After 1, 2, and 3 months of treatment 41, 36, and 36%, respectively, in the nicotine group were abstinent. The corresponding figures in the placebo group were 19, 20, and 23%. The differences were significant for all 3 months. Body weight did not increase in the nicotine group, but in the placebo group the mean increase was 4.4 kg. Craving and withdrawal symptoms decreased more with nicotine substitution for cigarettes. The patches were generally well tolerated, although 25% of subjects in the nicotine group and 13% in the placebo group had transient local erythema after application of the patch; 5 members of the nicotine group withdrew because of poor cutaneous tolerance.
Administration, Cutaneous↗
Dose effects and predictors of outcome in a randomized trial of transdermal nicotine patches in general practice.
The transdermal nicotine patch has proved an effective aid to smoking cessation. The ease of securing good compliance gives it a potential advantage over nicotine gum as an adjunct to brief advice and support in primary care settings where the major public health impact is obtained. In a preliminary report of half the sample of a randomized placebo controlled trial, we showed the patch to be effective in a general practice setting. We report here the definitive results of the full sample, including dose effects, predictors of outcome and other issues of theoretical and practical interest. A total of 1200 heavy smokers (> or = 15 per day), attending 30 general practices in 15 English counties received brief GP advice, a booklet and 16 hours per day patch treatment for 18 weeks. Dose increase and abrupt vs. gradual reduction of patch dosage were also randomized and follow-ups conducted at 1, 3, 6, 12, 26 and 52 weeks. Outcome was measured by self-reported complete abstinence from week 3 to 52 with biochemical validation at all follow-up points. Nicotine patch treatment doubled the rate of continuous abstinence up to 1 year (nicotine 9.6%, placebo 4.8%, p < 0.01); it most likely worked by reducing withdrawal symptoms. It enhanced cessation during the first week and reduced relapse during the second week. The dose increase after week 1 produced no sustained increase in cessation. Gradual reduction was no better at preventing relapse than abrupt withdrawal of patches after week 12. Whether relapse would have increased by ending treatment at some point between weeks 3 and 12 was not tested. Although pre-treatment dependence on cigarettes was prognostic of failure, the patches were equally helpful to both highly and less dependent smokers. Patches were particularly helpful to smokers with pre-treatment subclinical dysthymic symptoms. All but one of the 96 subjects eventually achieving long-term abstinence in the study quit during the first week of cessation.
Administration, Cutaneous↗
Fatal outcome in a child after ingestion of a transdermal fentanyl patch.
The case history and toxicological findings of a fatal fentanyl intoxication due to ingestion of a transdermal patch are presented. A 1-year-old otherwise healthy girl was put to bed and 2 h later she was found dead. The autopsy revealed a 25-microg/h (4.2 mg) transdermal fentanyl patch in the stomach. Toxicological analysis by liquid chromatography-tandem mass spectrometry with positive electrospray ionization yielded fentanyl and norfentanyl concentrations in the peripheral blood of 5.6 and 5.9 ng/ml, heart blood 19.0 and 8.9 ng/ml, and liver 235 and 26 ng/g, respectively. The cause of death was determined to be a fentanyl overdose. The investigation established that the child has unintentionally swallowed the patch, which had been lying on the floor.
Administration, Oral↗