APRES 29-5 for Pdf.Indd

6. Voigt JU, Exner B, Schmiedehausen K, Huchzermeyer C, Conflict of interest: none declared Reulbach U, Nixdorff U, et al. Strain-rate imaging during dobutamine stress echocardiography provides objective Self-test questions evidence of inducible ischemia. Circulation 2003;107:2120-6. The following statements are either true or false Further reading (answers on page 143) ACC/AHA/ASE 2003 Guideline update for the clinical application 3. Arrhythmias limit the usefulness of echocardiography in of echocardiography. American College of Cardiology/American the diagnosis of diastolic heart failure. Heart Association Task Force on Practice Guidelines. 4. Echocardiography is useful for detecting small pulmonary http://guideline.gov/summary/summary.aspx?doc_id=4020 [cited 2006 Sep 12] emboli. New drugs Some of the views expressed in the following notes on newly approved products should be regarded as tentative, as there may have been little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. As a result of fuller experience, initial comments may need to be modified. The Committee is prepared to do this. Before new drugs are prescribed, the Committee believes it is important that full information is obtained either from the manufacturer's approved product information, a drug information centre or some other appropriate source. Butoconazole nitrate 2% compared with 29% of women given oral fluconazole. The time to complete relief of symptoms was similar in both Gynazole-1 (Arrow Pharmaceuticals) treatment groups. Yeast cultures to confirm the presence or single dose applicator containing 5 g of cream absence of candida were not performed in this study so the Approved indication: local treatment of candidal vulvovaginitis true microbiological cure rates could not be assessed. The Australian Medicines Handbook section 17.11.1 most common butoconazole-related adverse events were Candida albicans is a common cause of vulvovaginitis.1,2 These vulvovaginal pruritis (3 events) and vulvovaginal burning infections are usually treated with imidazole antifungal drugs. (3 events). In the fluconazole group, headache (6 events), Butoconazole nitrate is the fifth imidazole agent to be registered diarrhoea, nausea, skin sensitivity and upset stomach were the 4 in Australia, after clotrimazole, ketoconazole, miconazole most common drug-related adverse events. and econazole. These drugs come in a number of different In another trial, a single-dose butoconazole cream was formulations (including cream, pessaries and oral tablets) and compared to a seven-day miconazole cream. Similar levels of dosing regimens. Although butoconazole nitrate 2% cream is a drug efficacy in both treatment groups were observed with new product in Australia, it was first introduced in the USA as a regard to clinical symptoms and microbiological cultures.5 prescription drug in 1986 and is currently marketed there as an Two unpublished studies compared butoconazole nitrate over-the-counter product. 2% cream with a clotrimazole pessary (500 mg) in women Depending on the formulation, up to 6% of an intravaginal dose with confirmed vulvovaginal Candida albicans infection. is absorbed, with peak plasma levels being reached 12–24 hours Microbiological and symptomatic signs of candidiasis were after administration. The drug is excreted mainly as metabolites resolved 30 days after treatment in 79 of 118 (67%) women in the urine and faeces. treated with butoconazole compared with 71 of 116 (61%) given The Australian butoconazole cream has been formulated clotrimazole. to adhere to the vaginal wall for longer than the standard In trials comparing butoconazole and clotrimazole vaginal butoconazole cream.3 The prolonged retention time means that treatments, irritation of the vulva, vagina or urethra were the most this formulation can be given as a single-dose application rather common drug-related adverse event. These were reported by than a three-day course. approximately 1% of patients receiving either treatment. In a randomised open-label trial of 181 American women with The use of latex or rubber products such as condoms or vulvovaginal candidiasis, a single application of butoconazole contraceptive diaphragms is not recommended within 72 hours of cream was compared to a single 150 mg oral tablet of butoconazole application. Additional topical antifungal cream may fluconazole. Twelve hours after treatment, 44.4% of women be required for the treatment of external vulval or perianal areas. given topical butoconazole experienced first relief of symptoms In Australia, 10% clotrimazole is the only single-dose cream 138 | VOLUME 29 | NUMBER 5 | OCTOBER 2006 already available for the treatment of candidal vulvovaginitis. It tricyclic antidepressants and drugs for Parkinson's disease may is not known whether the single-dose butoconazole formulation be increased by darifenacin. will be more effective. In one trial 561 patients were randomised to take darifenacin 3.75 mg, 7.5 mg, 15 mg or a placebo for 12 weeks. The T T manufacturer provided some data respective median reductions in weekly incontinence episodes were 8.6, 9.0, 10.4 and 7.6. The reduction in weekly incontinence References * episodes was 68% with 7.5 mg and 73% with 15 mg. This was 1. Dennerstein G. The treatment of Candida vaginitis and 1 vulvitis. Aust Prescr 2001;24:62-4. significantly greater than the 56% reduction with placebo. 2. Fischer G. Treatment of vaginitis and vulvitis. Aust Prescr Other placebo-controlled studies had similar results so the 2001;24:59-61. recommended starting dose is 7.5 mg daily, increasing if 3. Weinstein L, Henzel MR, Tsina IW. Vaginal retention of 2% necessary after two weeks to 15 mg daily. In a dose titration butoconazole nitrate cream: comparison of a standard and trial, 59% of patients needed to increase to 15 mg daily. a sustained-release preparation. Clin Ther 1994;16:930-4. Compared with placebo, patients taking darifenacin complain 4. Seidman LS, Skokos CK. An evaluation of butoconazole more frequently of dry mouth and constipation. These adverse nitrate 2% site release vaginal cream (Gynazole-1) compared to fluconazole 150 mg tablets (Diflucan) in the time to relief effects appear to increase with the dose. Other adverse of symptoms in patients with vulvovaginal candidiasis. effects include altered vision, dyspepsia and abdominal pain. Inf Dis Obstet Gynecol 2005;13:197-206. Caution is needed if darifenacin is considered for patients 5. Brown D, Henzl MR, Kaufman RH. Butoconazole nitrate 2% with decreased gastrointestinal motility or at risk of urinary for vulvovaginal candidiasis. New, single-dose vaginal cream retention. formulation vs. seven-day treatment with miconazole nitrate. Darifenacin has been studied in people with overactive bladder. Gynazole 1 Study Group. J Reprod Med 1999;44:933-8. These people have urinary urgency, but not all of them Darifenacin hydrobromide have urge incontinence. The benefits of darifenacin may be less certain in these patients. Although it achieved statistical Enablex (Novartis) advantages over placebo, the absolute changes may be small. 7.5 mg and 15 mg prolonged-release tablets For example, a patient given darifenacin 15 mg will have one Approved indication: overactive bladder less micturition per day than a patient given a placebo. They Australian Medicines Handbook section 13.1.1 may also have one less episode of urgency per day. Darifenacin The contraction of detrusor smooth muscle involves stimulation does not decrease the number of times a patient is awoken by 1 of muscarinic receptors by acetylcholine. Anticholinergic drugs their overactive bladder significantly more than placebo. have therefore been used to relax the bladder in patients with Comparative studies are limited, but tolterodine has urge incontinence. These drugs have unwanted systemic effects been included in a placebo-controlled trial of darifenacin. so there is a need for a drug with an action that is more specific Unfortunately, a comparative analysis of the 15 mg dose of darifenacin was not done for all the outcomes. Darifenacin only to the bladder. The M3 muscarinic receptor has been a target for drug development as it is thought to be the subtype responsible achieved a statistical advantage, over tolterodine, for some for bladder contraction. outcomes if it was given at a daily dose of 30 mg. It appears that darifenacin's selective action does not give it a large clinical Darifenacin is an anticholinergic drug which has a greater advantage. affinity for the M3 receptor than for other subtypes. Its action diminishes the frequency of detrusor contractions and increases X manufacturer did not respond to request for data bladder capacity. † Once-daily dosing is possible with the prolonged-release Reference formulation. Peak plasma concentrations are reached seven 1. Haab F, Stewart L, Dwyer P. Darifenacin, an M3 selective receptor antagonist, is an effective and well-tolerated once- hours after an oral dose, with a steady state reached in six days. daily treatment for overactive bladder. Eur Urol 2004;45:420-9. Bioavailability depends on the patient's metabolism. Darifenacin is extensively metabolised in the liver and its pharmacokinetics Entecavir are affected by moderate hepatic impairment. As the Baraclude (Bristol-Myers Squibb) metabolism involves cytochrome P450 2D6 and 3A4, there are 0.5 mg and 1 mg tablets several potential drug interactions. The

Load more