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41. Famciclovir 500 mg Tablets Under Non-Fasting Conditions

Famciclovir 500 mg Tablets Under Non-Fasting Conditions Famciclovir 500 mg Tablets Under Non-Fasting Conditions - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Famciclovir 500 mg Tablets Under Non-Fasting (...) Study Description Go to Brief Summary: The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under non-fasting conditions. Condition or disease Intervention/treatment Phase Healthy Drug: Famciclovir 500 mg Tablets Drug: Famvir® 500 mg Tablets Phase 1 Detailed Description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA

2009 Clinical Trials

42. Famciclovir 500 mg Tablets Under Fasting Conditions

Famciclovir 500 mg Tablets Under Fasting Conditions Famciclovir 500 mg Tablets Under Fasting Conditions - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Famciclovir 500 mg Tablets Under Fasting Conditions (...) Description Go to Brief Summary: The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions. Condition or disease Intervention/treatment Phase Healthy Drug: Famciclovir 500 mg Tablets Drug: Famvir® 500 mg Tablets Phase 1 Detailed Description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical

2009 Clinical Trials

43. Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (...) (100). Please remove one or more studies before adding more. Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00878072 Recruitment Status : Completed First Posted : April 8, 2009 Last Update

2009 Clinical Trials

44. Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. (PubMed)

Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Episodic therapy of genital herpes is usually recommended for patients with infrequent symptomatic recurrences and where transmission is not a concern. While shorter courses are as effective as standard 5-day regimens, it is unknown whether abbreviated therapy has detrimental effects on natural history and the development of antiviral resistance.To (...) assess time to next recurrence and development of antiviral resistance in patients with recurrent genital herpes treated with either single-day famciclovir (1 g twice-daily) or 3-day valacyclovir (500 mg twice-daily).Longer-term, follow-up data on the time to next recurrence and antiviral sensitivity were collected from a previously reported multicenter, multinational, double-blind, parallel group study in which 1179 immunocompetent adults were randomized 1 : 1 to receive either single-day

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2009 Current medical research and opinion Controlled trial quality: uncertain

45. Safety and effectiveness of the herpes zoster vaccine to prevent postherpetic neuralgia: 2014 update and consensus statement from the Canadian Pain Society

it be given to individuals who are taking high doses of corticosteroids (>20 mg/day of prednisone) or other immunosuppressive drugs. POSITION 3 Drug treatment (eg, antivirals, corticosteroids) of active shingles has not been shown to decrease the risk of PHN Rationale: Shingles can be treated with antiviral drugs such as acyclovir, famciclovir and valacyclovir. However, these drugs are effective only if given within 72 h of the first signs of the initial pain or rash. Antivirals have been shown

2015 CPG Infobase

46. Oral antiviral therapy for prevention of genital herpes outbreaks in immunocompetent and nonpregnant patients. (PubMed)

Oral antiviral therapy for prevention of genital herpes outbreaks in immunocompetent and nonpregnant patients. Genital herpes is caused by herpes simplex virus 1 (HSV-1) or 2 (HSV-2). Some infected people experience outbreaks of genital herpes, typically, characterized by vesicular and erosive localized painful genital lesions.To compare the effectiveness and safety of three oral antiviral drugs (acyclovir, famciclovir and valacyclovir) prescribed to suppress genital herpes outbreaks in non (...) trials including patients with recurrent genital herpes caused by HSV, whatever the type (HSV-1, HSV-2, or undetermined), with at least four recurrences per year (trials concerning human immunodeficiency virus (HIV)-positive patients or pregnant women were not eligible) and comparing suppressive oral antiviral treatment with oral acyclovir, famciclovir, and valacyclovir versus placebo or another suppressive oral antiviral treatment.Two review authors independently selected eligible trials

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2014 Cochrane

47. Antiviral treatment for preventing postherpetic neuralgia. (PubMed)

) of antiviral treatment given within 72 hours after the onset of herpes zoster for preventing PHN. There were no language restrictions.Two authors independently selected trials, evaluated the risk of bias in included trials, and extracted and analysed data.Six RCTs with a total of 1211 participants were eligible; five trials evaluated oral aciclovir, and one, with 419 participants, evaluated oral famciclovir. We were able to conduct meta-analyses as there were sufficient similarities in the included studies (...) ). In four of the trials (692 participants), there was some evidence for a reduction in the incidence of pain four weeks after the onset of rash. In the trial of famciclovir versus placebo, neither 500 mg nor 750 mg doses of famciclovir reduced the incidence of herpetic neuralgia significantly. The most commonly reported adverse events were nausea, vomiting, diarrhoea and headache for aciclovir, and headache and nausea for famciclovir. For neither treatment was the incidence of adverse events

2014 Cochrane

48. Chickenpox in Pregnancy

that there is no increase in the risk of major fetal malformation with aciclovir exposure in pregnancy. 42–44 A Danish registry-based cohort study of 837 795 live births between 1996 and 2008 43 reported the pregnancy outcome in 1804 pregnancies exposed to aciclovir, valciclovir or famciclovir in the first trimester. The rate of major birth defects in the exposed group was 2.2% compared to 2.4% in the unexposed (adjusted prevalence odds ratio 0.89, 95% CI 0.65–1.22). The most common antiviral drug used was aciclovir (...) systemic prenatal acyclovir exposure: Conclusions from the international acyclovir pregnancy registry, 1984–99. Birth Defects Res A Clin Mol Teratol 2004;70:201–7. 43. Pasternak B, Hviid A. Use of acyclovir, valacyclovir and famciclovir in the first trimester of pregnancy and the risk of birth defects. JAMA 2010;304:859–66. 44. Mills JL, Carter TC. Acyclovir exposure and birth defects: an important advance, but more are needed. JAMA 2010;304:905–6. 45. Daley AJ, Thorpe S, Garland SM. Varicella

2015 Royal College of Obstetricians and Gynaecologists

49. Management of Genital Herpes in Pregnancy

effects have been reported. Aciclovir is well tolerated in pregnancy. For treatment courses no dose adjustment is necessary. 23,24 There is no evidence of an increased risk of birth defects with aciclovir, famciclovir or valaciclovir if used in the first trimester. 22 Safety data for aciclovir may be extrapolated to valaciclovir in late pregnancy, as it is the valine ester, but as there is less experience with the use of valaciclovir or famciclovir, they are not recommended as a first- line treatment (...) , Sørensen HT. Adverse pregnancy outcome in women exposed to acyclovir during pregnancy: a population-based observational study. Scand J Infect Dis 2003;35:255–9. 22. Pasternak B, Hviid A. Use of acyclovir, valacyclovir, and famciclovir in the first trimester of pregnancy and the risk of birth defects. JAMA 2010;304:859–66. 23. Frenkel LM, Brown ZA, Bryson YJ, Corey L, Unadkat JD, Hensleigh PA, et al. Pharmacokinetics of acyclovir in the term human pregnancy and neonate. Am J Obstet Gynecol 1991;164:569

2014 Royal College of Obstetricians and Gynaecologists

50. Shingles

neuralgia [Chen, 2014]. The review found insufficient evidence from RCTs to ascertain whether this is also the case for other antiviral drugs. Previous changes Previous changes May 2018 — minor update. Eligible ages for the shingles vaccination has been updated in line with Public Health England (PHE) guidance. See the section on for more information. October 2017 — minor update. Seizure has been included as a possible adverse effect of famciclovir. January 2017 — minor update. Correction made to advice (...) in immunocompromised people, and recurrences are more likely to be associated with aciclovir-resistant strains [ ]. Pain inadequately controlled or considering a strong opioid This recommendation is based on what CKS considers to be good clinical practice. Antiviral treatment When should I prescribe oral antiviral treatment? If admission or immediate specialist advice is not , c onsider the need for oral antiviral treatment (aciclovir, valaciclovir, or famciclovir). Prescribe an oral antiviral treatment within 72

2018 NICE Clinical Knowledge Summaries

52. Herpes zoster involving the abducens and vagus nerves without typical skin rash: A case report and literature review. (PubMed)

for VZV DNA was positive at the skin lesion. The patient was diagnosed as having herpes zoster associated with vagus and sixth nerve palsy.She received famciclovir at a dose of 500 mg 3 times daily for 7 days and coadministered methylprednisolone. At the 4-month follow-up, her diplopia and eye movement had resolved completely.In patients with abducens nerve palsy without typical vesicular lesion, herpes zoster may not be detected early. In that case, systemic examination is very important

2019 Medicine

54. Herpes simplex - genital

five times a day for 5–10 days, or alternatively: Valaciclovir 500 mg orally twice a day for 5–10 days. Famciclovir 250 mg orally three times a day for 5–10 days. Advise all people about appropriate to help relieve symptoms. Topical antiviral drugs are not recommended, as they offer minimal clinical benefit. Basis for recommendation Basis for recommendation These recommendations are based on the British Association for Sexual Health and HIV (BASHH) UK national guideline for the management (...) recommends using clinical judgement when determining the dose of antivirals and the duration of treatment. Topical antivirals Topical agents are less effective than oral agents, and combining oral and topical treatment is of no additional benefit over oral treatment alone [ ]. Choice of oral antiviral There is no evidence of a difference in efficacy, tolerability, or toxicity between aciclovir, valaciclovir, or famciclovir in the management of primary genital herpes [ ]. UK guidelines recommend aciclovir

2017 NICE Clinical Knowledge Summaries

56. UK National Guideline for the Management of Anogenital Herpes

with the probability of this over HSV-2 being greater at younger age, (females 500) although there is very limited trial evidence to support this approach. One trial with famciclovir has reported this effect. 85 Dosage of antivirals • Providing there is no evidence of immune failure standard doses of antivirals should suffice (Ib,A). In those with advanced disease it may be necessary to double the standard dose and to continue therapy beyond 5 days (Ib,B). Currently there is no evidence to support the use (...) be substituted. In others, where the pre-treatment pattern of recurrences resumes, suppressive treatment may need to restart (Evidence level IV, C) • Recommended drug regimens for daily suppressive treatment 23,86,87 o Aciclovir 400 mg orally twice to three times a day o Valaciclovir 500 mg orally twice a day • If these options do not adequately control disease then the first option should be to double the dose. If control is still not achieved then famciclovir 500 mg orally twice a day can be tried. (IIa,B

2015 British Association for Sexual Health and HIV

57. Pharmacologic Interventions for Bell's Palsy

% confidence intervals [CI], -18% to 17.6%). However, the analysis lacked the statistical precision to exclude an important beneficial effect (or harm) from the addition of valacyclovir. A Class IV study observed a significant improvement in recovery (RD 26.6%) between patients with severe Bell palsy treated with prednisone alone and patients with severe Bell palsy treated with prednisone plus famciclovir (House-Brackmann Scale score of 5 or 6). This study had a high risk of bias because

2014 National Guideline Clearinghouse (partial archive)

60. Variation in the Reported Management of Canine Prolapsed Nictitans Gland and Feline Herpetic Keratitis (PubMed)

FHV-1 keratitis with topical antibiotics (76.4%), with a minority suggesting topical antivirals (32.2%). GPs favoured topical acyclovir whilst PGs more frequently recommended topical trifluorothymidine. A significantly larger proportion of PGs nominated systemic famciclovir and lysine supplement for FHV-1 keratitis. This survey revealed moderate treatment variation for these conditions, both between and within practitioner groups. Additional research is needed to assess the reasons

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2018 Veterinary Sciences

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