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The role of benzydamine in the topical treatment of the so-called non-specific vaginitis.

The authors report the preliminary results of their investigation of the efficacy of benzydamine in the treatment of the so-called non-specific vaginitis. An initial in vitro study to test its bacteriostatic and/or bactericidal activity on Gardnerella vaginalis showed that the drug has high activity even at the lowest concentrations, and completely inhibits this micro-organism at 1000 micrograms/ml which is the usual concentration employed in therapy. The first pilot study performed in vivo on 14 selected vaginitis cases which were found positive for G. vaginalis by culture test appears to confirm the therapeutic efficacy of benzydamine; however, this confirmation must await the results of a double-blind clinical trial which is still in progress.

Administration, Intravaginal↗

[The effect of benzydamine on prostaglandin synthesis in macrophages].

The influence of benzydamine (Tantum) on the prostaglandin metabolism of rat peritoneal macrophages was studied. Contrary to conventional non-steroidal antiinflammatory drugs, e.g. piroxicam and acetylsalicylic acid, benzydamine did not inhibit PGE1/2 synthesis, but was rather stimulatory at 10(-4) mol/l. The increase of PGE1/2 synthesis might be explained by the inhibition of the lysophosphatide acyltransferase. This enzyme together with the arachidonic acid liberating phospholipase A2 regulates the concentration of arachidonic acid by the reincorporation into membrane phospholipids. Enhanced arachidonic acid may be metabolized via the cyclooxygenase to prostanoids.

Alprostadil↗

Portable thermogram technique for topically applied benzydamine cream in acute soft-tissue injuries.

A double-blind, parallel trial was undertaken with 3% benzydamine cream compared with a matching placebo, on patients suffering acute soft-tissue injuries. 21 patients received active material and 22 received placebo material. Patients applied the cream lightly 6 times a day for 6 days. Assessments were made (by the same physician) on days 0, 2, 4 and 6, and signs and symptoms were graded as "absent", "slight", "moderate" or "severe". Thermograms were taken on day 0 and day 6. The results showed significant relief of spontaneous pain, significant reduction in tenderness on pressure and in swelling on days 2, 4 and 6 of the trial, and a significant reduction in functional impairment on days 4 and 6, in the patients who had received the 3% benzydamine cream.

Administration, Topical↗

Benzydamine for the prevention of pharyngo-laryngeal pathology following tracheal intubation.

A clinical study was carried out to assess the antiinflammatory effectiveness and related properties of this drug. It was performed double-blind in 40 adult patients (ASA I, and II) undergoing major otorhinolaryngological surgical procedures with tracheal intubation. The patients received benzydamine at random (n = 20), or a similar solution without the active substance (n = 20). The following parameters were considered: physical examination, sensations referred from patient, cytologic examination, glottographic examination, and spectrographic examination. The results suggest that benzydamine applied locally at a concentration of 0.3% has therapeutic efficacy without local or systemic side-effects.

Administration, Topical↗

A comparative study of benzydamine hydrochloride ("Difflam" pump spray) and placebo as analgesics following tonsillectomy.

The use of benzydamine hydrochloride pump spray as a post-operative analgesic in children undergoing tonsillectomy was assessed in a double-blind trial in 56 subjects of ages ranging from 4-11 years. The raw tonsil bed was sprayed before the childrens' mealtimes and the appraisal of post-operative pain was made on the soreness of the throat as assessed by child, parent and surgeon; also assessed were the degree of referred earache, the ability of the child to swallow without discomfort, and the macroscopic appearance of the healing tonsillar bed. Results showed that the benzydamine spray was more effective than placebo in the control of post-operative pain.

Administration, Topical↗

Clinical evaluation of benzydamine for treatment of vaginitis: results of a randomized study with emphasis on functional symptoms.

The antiinflammatory effect of benzydamine compared with a placebo in a randomized study is reported in the treatment of trichomonas- and candida-induced vaginitis. The reduction of inflammation and its clinical manifestations was determined and statistically analysed, demonstrating that benzydamine has a definite effect on the early reduction of functional pain and symptoms.

Administration, Intravaginal↗

A controlled clinical study on the efficacy of benzydamine in the topical treatment of non-specific cervicitis and vaginitis.

The authors report the results achieved in a controlled clinical study carried out for evaluating the efficacy of some topical preparations in the treatment of the so-called non-specific cervicovaginitis. The best results have been observed in 55 patients treated with a 0.1% benzydamine solution, whose efficacy was found to be significantly greater than that of povidone-iodine vaginal suppositories or a 0.2% aluminium acetate solution that were used in an additional 45 patients suffering from non-specific vulvovaginitis and exocervicitis, according to a fully randomized experimental study protocol. The results obtained in the non-selected population of the present study confirm the usefulness of benzydamine vaginal douches in the therapy of non-specific inflammations involving the lower female genital apparatus.

Acetates↗

Pharmacokinetics of benzydamine.

Benzydamine is a non-steroidal anti-inflammatory drug especially used topically for the treatment of primary or normoreactive types of inflammation. The pharmacokinetics of benzydamine are reported after both topical and systemic administration, and the available data are reviewed with particular reference to its topical use.

Absorption↗

The chemistry of benzydamine.

After a brief introduction on the chemistry of indazoles in general, the most important clinically used drugs of this series, i.e. benzydamine, bendazac and its salts and esters, are mentioned. The possible synthetic processes for benzydamine are then reviewed and any possible occurring by-products and impurities, including their quantitative limits, are discussed.

Benzydamine↗

Treatment of vaginitis with benzydamine: preliminary results of a randomized study.

The therapeutic efficacy of benzydamine vaginal douche is compared with that of placebo in a randomized clinical study presently underway. A total number of 200 patients, grouped according to different types of vaginitis, will be included in the study. Preliminary results on 102 patients confirm the positive therapeutic effect of benzydamine.

Benzydamine↗

Benzydamine: a critical review of clinical data.

Over 40 published and unpublished articles on double-blind controlled clinical trials with the local application of benzydamine as an antiinflammatory drug were reviewed with special reference to the randomization of patients, the description of the disease entity, the clinical trial and its statistical analysis. It was concluded that benzydamine applied locally consistently produced relief of pain with a demonstratable antiinflammatory effect and caused infrequent side-effects. Hence it was considered a safe and effective method of producing pain relief by local application.

Administration, Topical↗

Benzydamine for the topical treatment of vulvovaginitis in children and adolescents.

A study was undertaken in children and adolescents aged 4-18 years on the value of benzydamine vaginal douche in addition to chemotherapy for moderate to severe vulvovaginitis, including those also suffering from insulin-dependent diabetes mellitus (IDDM). It is considered that topical benzydamine gave beneficial results compared with the controls receiving chemotherapy alone and had in the IDDM patients a useful prophylactic effect.

Adolescent↗

Aspects of the mechanisms of action of benzydamine.

Benzydamine shows some properties that are common with other nonsteroidal antiinflammatory drugs (NSAIDs) but displays also properties which are different from those of other NSAIDs. It inhibits prostaglandin and thromboxane biosynthesis at high concentrations, which however can be reached by topical application of the drug. It has no inhibiting effect on amino-acid decarboxylases, which are inhibited by various NSAIDs. Benzydamine has no effect on sulphydryl-group reactivity, contrary to most NSAIDs. It inhibits platelet aggregation and the inhibition of the collagen-induced aggregation appears to be rather selective with respect to other NSAIDs. It displays a stabilizing effect on erythrocyte membranes which appears related to its high affinity for membranes in general, and it inhibits the respiratory burst of stimulated human monocytes and granule enzyme release by human neutrophils.

Animals↗

Therapeutic effects of topical benzydamine in gynecology.

The study was performed on 124 patients divided into 4 groups on the basis of vaginal smears: 1) 60 patients with mild non-specific bacterial vaginitis; 2) 40 patients with moderate or severe non-specific bacterial vaginitis; 3) 10 patients with moderate or severe monilial vaginitis; 4) 14 patients with moderate or severe trichomonal vaginitis. Each group was subsequently divided at random into two subgroups, comprising the same number of patients, who were treated under double blind conditions with vaginal douches of 10/00 benzydamine of placebo (1 douching per day for 10 days). Specific standard therapy with antibiotics, antimycotic and antitrichomonal agents was used concomitantly in groups 2, 3 and 4 respectively. Vaginal smears, performed a few days after the end of the treatment period, and the improvement in symptoms and sings, demonstrated the curative action of benzydamine in mild non-specific vaginitis as well as its symptomatic effect and potentiation of specific therapy in moderate and severe bacterial, monilial and trichomonal vaginitis.

Administration, Topical↗

Serum levels of benzydamine following the topical use of this drug in gynecology.

The serum levels of benzydamine were studied after administration by vaginal douching (at a concentration of 0.0%) to patients with and without vaginal inflammation. In both experimental groups benzydamine produced similar serum concentrations which were lower than those obtained by other administration routes, excluding the possibillity of eventual systemic effects. These data are a further confirmation that, whenever possible, topical use is preferable to systemic use in order to reduce the incidence of systemic side effects to a minimum and to obtain a more selective therapy.

Absorption↗

Benzydamine Hydrochloride (Tantum) in the management of oral inflammatory conditions.

Benzydamine HCL (Tantum) is a topical nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, antipyretic and local anesthetic activity. This paper reviews the pharmacology of benzydamine and surveys the existing literature relating to its applications in medicine and dentistry. Guidelines for its use in dentistry are offered.

Benzydamine↗

An assay of flavin-containing monooxygenase activity with benzydamine N-oxidation.

An assay system of flavin-containing monooxygenase was developed by fluorometric determination of benzydamine (BZY) N-oxidation with HPLC. The apparent Km value for the formation of BZY N-oxide from BZY by rat liver microsomes was similar to that by purified FMO. The Km and Vmax values for the formation of N-desmethylbenzydamine (Nor-BZY) by rat liver microsomes were about 50 times greater and 2000 times less, respectively, than those of BZY N-oxide. Nor-BZY was not formed upon incubation with purified enzyme. BZY N-oxidation activity was completely inhibited both in the absence of NADPH and by heat inactivation. The reaction was inhibited in the presence of 0.5 mM thiourea, but 2 mM SKF-525A did not affect BZY N-oxidation. Moreover, rabbit antibody raised against the rat enzyme inhibited BZY N-oxidation. These results are in accord with a simple, rapid, and sensitive assay for the enzyme.

Animals↗