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Journal of Investigational Allergology... 2009
Topics: Adolescent; Dimenhydrinate; Drug Eruptions; Drug Hypersensitivity; Dysmenorrhea; Erythema; Female; Histamine Antagonists; Humans; Patch Tests
PubMed: 19639740
DOI: No ID Found -
The American Journal of Psychiatry Aug 2004
Topics: Adult; Antipsychotic Agents; Behavior, Addictive; Clozapine; Dimenhydrinate; Female; Humans; Male; Schizophrenia; Schizophrenic Psychology; Substance-Related Disorders; Treatment Outcome
PubMed: 15285985
DOI: 10.1176/appi.ajp.161.8.1500 -
The Australian & New Zealand Journal of... May 1967
Topics: Adolescent; Adult; Dimenhydrinate; Female; Humans; Labor, Induced; Labor, Obstetric; Muscle Contraction; Oxytocin; Pregnancy; Uterus
PubMed: 5233023
DOI: 10.1111/j.1479-828x.1967.tb02493.x -
Clinical Drug Investigation Sep 2022The source data of four individual randomised, double-blind, reference- and/or placebo-controlled clinical trials with virtually identical study design were pooled for... (Meta-Analysis)
Meta-Analysis
Efficacy and Safety of a Fixed-Dose Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg in the Treatment of Patients with Vestibular Vertigo: An Individual Patient Data Meta-Analysis of Randomised, Double-Blind, Controlled Clinical Trials.
BACKGROUND AND OBJECTIVE
The source data of four individual randomised, double-blind, reference- and/or placebo-controlled clinical trials with virtually identical study design were pooled for the present meta-analysis. The main objective was to further evaluate the efficacy and safety of the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in comparison to various other antivertigo treatments in patients suffering from central and/or peripheral vestibular vertigo.
METHODS
Adult male and female outpatients were subjected to a 4-week treatment with the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg, cinnarizine (20 mg, 50 mg), dimenhydrinate (40 mg, 100 mg), betahistine dimesylate (12 mg), betahistine dihydrochloride (16 mg) and placebo, respectively. The primary efficacy endpoint was the reduction of a validated mean vertigo score (MVS), a composite score of 12 individual vertigo symptoms, the intensities of which were each evaluated by the patients on a 5-point visual analogue scale. For analysis of primary and further secondary efficacy endpoints, baseline-adjusted analysis of covariance (ANCOVA) was used to calculate adjusted least squares means (LSM) with associated two-sided 95% confidence intervals (CIs) for the difference in MVS reductions between treatment groups. Moreover, various sensitivity analyses, responder and subgroup analyses as well as descriptive analyses with respect to safety/tolerability of the treatments were conducted.
RESULTS
Of 795 randomised patients, 779 belonged to the intent-to treat (ITT) and 723 to the per-protocol (PP) population. The main efficacy analysis was based on the ITT population (mean age 52.1 years, 61% female). The mean decrease of the MVS from baseline to Week 4 in the cinnarizine/dimenhydrinate group (-1.10) proved to be significantly larger than in any of the comparator groups. LSM differences for comparators versus the fixed combination ranged between 0.16 (95% confidence interval (CI) 0.03; 0.30, p = 0.017) for cinnarizine 20 mg and 0.60 (95% CI 0.42; 0.78; p < 0.001) for betahistine dimesylate 12 mg in favour of the fixed combination. Furthermore, after 4 weeks of treatment, 74 patients (24.7%) in the cinnarizine/dimenhydrinate group were completely symptom free (MVS = 0), a significantly greater proportion than in any of the comparator groups. Sensitivity analyses showed that baseline characteristics such as age, sex, duration of vertigo and antivertigo pretreatment had only a very minor and clinically non-relevant impact on the efficacy results regarding the primary efficacy outcome. Subgroup analyses with respect to age groups (< 65 years/≥ 65 years) and sex showed no significant differences in efficacy within any of the treatment groups. All treatments were well tolerated. A total of 55 patients (6.9%) reported 75 non-serious adverse events (AEs), and 19 patients (2.4%) discontinued the study prematurely because of AEs. Nearly 95% of the patients (cinnarizine/dimenhydrinate group: 97.9%) rated the tolerability of the study medications as either "good" or "very good".
CONCLUSION
The findings of the present meta-analysis indicate that the fixed combination of cinnarizine and dimenhydrinate is a safe and potentially superior treatment option for patients suffering from central and/or peripheral vestibular vertigo, as compared to current standard treatments such as cinnarizine, dimenhydrinate or betahistine given alone in monotherapy.
Topics: Adult; Aged; Betahistine; Cinnarizine; Dimenhydrinate; Double-Blind Method; Female; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Vertigo
PubMed: 35864302
DOI: 10.1007/s40261-022-01184-0 -
Galen Medical Journal 2018Design, formulation and physicochemical evaluation of dimenhydrinate 25 mg oral tablets that disintegrate in oral cavity in a proper time. This product is easy to use...
BACKGROUND
Design, formulation and physicochemical evaluation of dimenhydrinate 25 mg oral tablets that disintegrate in oral cavity in a proper time. This product is easy to use for babies, geriatrics and people who have difficulty in swallowing.
MATERIALS AND METHODS
31 formulations were designed in 3 categories via Design-Expert software version 7. Group 1 consist of super-disintegrating bases, group 2 consist of effervescent bases and group 3 consist of super-disintegrating and effervescent bases together. Proposed by DesignExpert software, the optimum formulations were selected in each category and the tablets were produced by direct compression method. Tablets evaluated by friability, thickness, hardness, weight variation, drug content, content uniformity, disintegration time, wetting time, dissolution and moisture uptake tests.
RESULTS
The angle of repose and compressibility index of formulations were in the range of 24.65-29.08 and 5.02-9.01 % respectively. Thickness, hardness, wetting time, friability and content uniformity of formulations were in the range of 3.36-3.84 mm, 33.25-38.03 N, 19-37 seconds, 0.31-0.42 % and 96.44-99.02 % respectively. Disintegration time of the groups 1, 2 and 3 were in the range of 16-70, 47-72 and 12-35 seconds respectively.
CONCLUSION
Mixture of powders and orally dispersible tablets passed all tests. The results showed that formulations containing both of super-disintegrants and effervescent bases had better disintegration time compare to other formulations.
PubMed: 34466419
DOI: 10.22086/gmj.v0i0.936 -
Nordisk Medicin Sep 1952
Topics: Anti-Allergic Agents; Dimenhydrinate; Histamine H1 Antagonists; Humans; Nausea; Postoperative Care; Postoperative Nausea and Vomiting
PubMed: 13025794
DOI: No ID Found -
Deutsche Medizinische Wochenschrift... Oct 2013A 13-month-old girl suffered from 3 generalized tonic-clonic seizures for several minutes within a total period of 9 hours. History revealed that the child received a...
HISTORY
A 13-month-old girl suffered from 3 generalized tonic-clonic seizures for several minutes within a total period of 9 hours. History revealed that the child received a total of 5 dimenhydrinate containing suppositories à 40 mg during the previous 2 days (i. e. 23 mg dimenhydrinate per kg body weight) due to enteritis with vomiting. The first seizure occurred 10 hours after the last administration.
INVESTIGATIONS
The plasma level of diphenhydramin was 230 µg/l approximately one hour after the first seizure. Electroencephalography showed no pathological signs, an MRI scan of the brain was normal except of several small gliotic spots and body temperature was regularly.
TREATMENT AND COURSE
Two stationary occurring seizures were stopped with 5 mg diazepam rectally. Continued surveillance and an EEG two days later showed age-appropriate normal findings. There were no further seizures in the next 4 years.
CONCLUSION
Infants have the risk to develop dimenhydrinate intoxication, especially in cases where suppositories were given repeatedly because of intermittent defecation.
Topics: Antiemetics; Dimenhydrinate; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Overdose; Electroencephalography; Epilepsy, Tonic-Clonic; Female; Follow-Up Studies; Gastroenteritis; Humans; Infant; Suppositories
PubMed: 24104589
DOI: 10.1055/s-0033-1349550 -
Drug Development and Industrial Pharmacy 2016Dimenhydrinate (DMH)-loaded buccal bioadhesive films for the prevention and treatment of motion sickness were prepared and optimized. This study examines the rate of...
Dimenhydrinate (DMH)-loaded buccal bioadhesive films for the prevention and treatment of motion sickness were prepared and optimized. This study examines the rate of drug release from the films for prolonged periods of time to reduce or limit the frequency of DMH administration. Based on preliminary studies using various polymers and concentrations, hydroxyethylcellulose (2.5, 3.0, and 3.2%), and xanthan gum (2.8%) were chosen as matrix polymers. The films were analyzed with respect to their mechanical, physicochemical, bioadhesive, swelling, and in-vitro release properties. In in-vivo pharmacokinetic studies, xanthan gum-based DMH buccal film was associated with significantly increased DMH plasma levels between 1 h and 5 h after DMH dosing when compared with an oral drug solution. The area under the curve AUC0-7 h value of the mucoadhesive buccal film was two-fold higher than the oral DMH solution. Histological analysis revealed that DMH films cause mild morphological and inflammatory changes in rabbit buccal mucosa. The DMH buccal film is effective for approximately 7 h, thus representing an option for single-dose antiemetic therapy. This dosage regimen could be particularly beneficial for chain travelers who travel for long periods of time.
Topics: Adhesives; Administration, Buccal; Animals; Area Under Curve; Biological Availability; Cellulose; Chemistry, Pharmaceutical; Dimenhydrinate; Male; Mouth Mucosa; Polysaccharides, Bacterial; Rabbits; Surface Properties
PubMed: 26460061
DOI: 10.3109/03639045.2015.1091470 -
British Journal of Anaesthesia Mar 2000We have investigated the effectiveness of rectally administered dimenhydrinate on postoperative vomiting in children undergoing strabismus surgery, in a double-blind,... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
We have investigated the effectiveness of rectally administered dimenhydrinate on postoperative vomiting in children undergoing strabismus surgery, in a double-blind, randomized, placebo-controlled study. In one group, dimenhydrinate 50 mg was administered rectally 30 min before starting anaesthesia, whereas in the control group, placebo suppositories were given. Children who received dimenhydrinate showed a significantly (P < 0.001) lower incidence of vomiting (15%) than those in the control group (75%). We conclude that rectal administration of dimenhydrinate is an effective means of reducing postoperative vomiting in children undergoing strabismus surgery.
Topics: Administration, Rectal; Antiemetics; Child; Child, Preschool; Dimenhydrinate; Double-Blind Method; Female; Humans; Male; Postoperative Nausea and Vomiting; Prospective Studies; Strabismus
PubMed: 10793607
DOI: 10.1093/oxfordjournals.bja.a013450 -
Journal of the American Academy of... Mar 2011
Topics: Aged; Dimenhydrinate; Drug Eruptions; Female; Humans
PubMed: 21315964
DOI: 10.1016/j.jaad.2009.07.001