Co-Cyprindiol 2000-35 Tabs PIL (AXP030FUL)
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35 Cyproterone Acetate and Ethinyl Estradiol Tablets 2 Mg/0
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCYESTRA®-35 cyproterone acetate and ethinyl estradiol tablets 2 mg/0.035 mg THERAPEUTIC CLASSIFICATION Acne Therapy Paladin Labs Inc. Date of Preparation: 100 Alexis Nihon Blvd, Suite 600 January 17, 2019 St-Laurent, Quebec H4M 2P2 Version: 6.0 Control # 223341 _____________________________________________________________________________________________ CYESTRA-35 Product Monograph Page 1 of 48 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................. 3 INDICATION AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................ 3 WARNINGS AND PRECAUTIONS ....................................................................................................... 4 ADVERSE REACTIONS ....................................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................................... 16 DOSAGE AND ADMINISTRATION ................................................................................................ 20 OVERDOSAGE .................................................................................................................................... -
Revised 4/1/2021 GEORGIA MEDICAID FEE-FOR-SERVICE HIV
GEORGIA MEDICAID FEE-FOR-SERVICE HIV-AIDS PA SUMMARY Preferred (may not be all inclusive) Non-Preferred Abacavir generic Abacavir/lamivudine/zidovudine generic Abacavir/lamivudine generic Aptivus (tipranavir) Complera (emtricitabine/rilpivirine/tenofovir disoproxil Atazanavir capsules generic fumarate) Atripla (efavirenz/emtricitabine/tenofovir disoproxil Crixivan (indinavir) fumarate) Biktarvy (bictegravir/emtricitabine/tenofovir Delstrigo (doravirine/lamivudine/tenofovir disoproxil alafenamide) fumarate) Cimduo (lamivudine/tenofovir disoproxil fumarate) Fuzeon (enfuvirtide) Descovy (emtricitabine/tenofovir alafenamide) Intelence (etravirine) Dovato Invirase (saquinavir) Edurant (rilpivirine)* Lexiva (fosamprenavir) Efavirenz tablets generic Nevirapine extended-release generic Emtriva (emtricitabine) Norvir Powder (ritonavir) Epivir solution (lamivudine) Pifeltro (doravirine) Evotaz (atazanavir/cobicistat)* Reyataz Powder (atazanavir) Genvoya (elvitegravir/cobicistat/emtricitabine/ Ritonavir tablets generic tenofovir alafenamide) Isentress and Isentress HD (raltegravir)* Rukobia (fostemsavir) Juluca (dolutegravir/rilpivirine) Selzentry (maraviroc) Kaletra (lopinavir/ritonavir) Stavudine generic^ Stribild (elvitegravir/cobicistat/emtricitabine/ tenofovir Lamivudine generic disoproxil fumarate) Symfi (efavirenz 600 mg/lamivudine/tenofovir Lamivudine/zidovudine generic disoproxil fumarate) Symfi Lo (efavirenz 400 mg/lamivudine/tenofovir Nevirapine immediate-release tablets generic disoproxil fumarate) Norvir (ritonavir) Temixys (lamivudine/tenofovir -
Clotrimazole Loaded Ufosomes for Topical Delivery: Formulation Development and In-Vitro Studies
molecules Article Clotrimazole Loaded Ufosomes for Topical Delivery: Formulation Development and In-Vitro Studies Pradeep Kumar Bolla 1 , Carlos A. Meraz 1, Victor A. Rodriguez 1, Isaac Deaguero 1, Mahima Singh 2 , Venkata Kashyap Yellepeddi 3,4 and Jwala Renukuntla 5,* 1 Department of Biomedical Engineering, College of Engineering, The University of Texas at El Paso, 500 W University Ave, El Paso, TX 79968, USA 2 Department of Pharmaceutical Sciences, University of the Sciences in Philadelphia, Philadelphia, PA 19104, USA 3 Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, UT 84112, USA 4 Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA 5 Department of Basic Pharmaceutical Sciences, Fred Wilson School of Pharmacy, High Point University, High Point, NC 27240, USA * Correspondence: [email protected] Received: 9 August 2019; Accepted: 28 August 2019; Published: 29 August 2019 Abstract: Global incidence of superficial fungal infections caused by dermatophytes is high and affects around 40 million people. It is the fourth most common cause of infection. Clotrimazole, a broad spectrum imidazole antifungal agent is widely used to treat fungal infections. Conventional topical formulations of clotrimazole are intended to treat infections by effective penetration of drugs into the stratum corneum. However, drawbacks such as poor dermal bioavailability, poor penetration, and variable drug levels limit the efficiency. The present study aims to load clotrimazole into ufosomes and evaluate its topical bioavailability. Clotrimazole loaded ufosomes were prepared using cholesterol and sodium oleate by thin film hydration technique and evaluated for size, polydispersity index, and entrapment efficiency to obtain optimized formulation. -
Producing In-Situ Nanoparticles of Griseofulvin Using Supercritical Antisolvent Methodology
University of Rhode Island DigitalCommons@URI Open Access Dissertations 2013 Producing In-Situ Nanoparticles of Griseofulvin using Supercritical Antisolvent Methodology Pratik Sheth University of Rhode Island, [email protected] Follow this and additional works at: https://digitalcommons.uri.edu/oa_diss Recommended Citation Sheth, Pratik, "Producing In-Situ Nanoparticles of Griseofulvin using Supercritical Antisolvent Methodology" (2013). Open Access Dissertations. Paper 25. https://digitalcommons.uri.edu/oa_diss/25 This Dissertation is brought to you for free and open access by DigitalCommons@URI. It has been accepted for inclusion in Open Access Dissertations by an authorized administrator of DigitalCommons@URI. For more information, please contact [email protected]. PRODUCING IN-SITU NANOPARTICLES OF GRISEOFULVIN USING SUPERCRITICAL ANTISOLVENT METHODOLOGY BY PRATIK SHETH A DISSERTATION SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY IN BIOMEDICAL AND PHARMACEUTICAL SCIENCES UNIVERSITY OF RHODE ISLAND 2013 DOCTOR OF PHILOSOPHY DISSERTATION OF PRATIK SHETH APPROVED: Dissertation Committee: Major Professor M. Serpil Kislalioglu Ph.D David Worthen Ph.D. Michael L. Greenfield Ph.D Nasser H. Zawia Ph.D DEAN OF THE GRADUATE SCHOOL UNIVERSITY OF RHODE ISLAND 2013 ABSTRACT Poor aqueous solubility of drug candidates is a major challenge for the pharmaceutical scientists involved in drug development. Particle size reduction to nano scale appears as an effective and versatile option for -
UTROGESTAN 100Mg Capsules Progesterone
NEW ZEALAND DATA SHEET UTROGESTAN 100mg capsules Progesterone 1 PRODUCT NAME UTROGESTAN 100MG CAPSULES 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Soft, round, slightly yellow capsule containing a whitish oily suspension of 100 mg progesterone (micronised). Excipient(s) with known effect: Soya lecithin For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules, soft 4 CLINICAL PARTICULARS 4.1 Therapeutic indications UTROGESTAN 100 mg capsule is indicated in adults, via the oral route, for: Hormone replacement therapy • Adjunctive use with an oestrogen in postmenopausal women with an intact uterus (for hormone replacement therapy [HRT]) 4.2 Dose and method of administration Dosage The recommended dose is as follows, according to the indication: Oral Route • In the treatment of menopause: oestrogen alone therapy is not recommended on its own in menopausal women with an intact uterus. The usual dose is 200 mg/day at bedtime at least 12 to 14 days per month, i.e. on days 15 to 26 of each cycle or in the last 2 weeks of each treatment sequence of oestrogen therapyfollowed by approximately one week without any replacement therapy and during which withdrawal bleeding may occur. Alternatively 100 mg can be given at bedtime, from days 1 to 25 of each cycle, withdrawal bleeding being less with this treatment schedule. Method of Administration This product is intended only for oral use. UTROGESTAN 100 mg should not be taken with food; it is preferable to take the capsules in the evening at bedtime. UTROGESTAN 100mg caps UTROGEST005 Jan 2018 Page 1 of 9 NEW ZEALAND DATA SHEET Oral Route Each capsule of UTROGESTAN 100 mg must be swallowed with a little water. -
Recommendations for the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection Table of Contents Table 1
Recommendations for the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection Table of Contents Table 1. Outline of the Guidelines Development Process..........................................................................................................................1 Table 2. Rating Scheme for Recommendations........................................................................................................................................3 Table 3. Sample Schedule for Clinical and Laboratory Monitoring of Children Before and After Initiation of Combination Antiretroviral Therapy .................................................................................................................4 Table 4. Primary FDA-Approved Assays for Monitoring Viral Load D-8 Table 5. HIV Infection Stage Based on Age-Specific CD4 Count or Percentage ........................................................................................4 Table 6. HIV-Related Symptoms and Conditions ......................................................................................................................................5 Table 7. Antiretroviral Regimens Recommended for Initial Therapy for HIV Infection in Children ...........................................................................................................................................................................................7 Table 8. Advantages and Disadvantages of Antiretroviral Components Recommended for Initial Therapy in Children ............................................................................................................................................................10 -
Divestra Leaflet
• Known or suspected estrogen-dependent neoplasia Drugs which may decrease the therapeutic effect of Cyproterone acetate+Ethinyl Pregnancy and Breastfeeding • Undiagnosed abnormal vaginal bleeding Combination of Cyproterone acetate and Ethinyl estradiol is contraindicated during estradiol and increase the incidence of breakthrough bleeding • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete pregnancy and breastfeeding. loss of vision or defect in visual fields Effects on ability to drive and use machines • Concomitant use with other Estrogen+Progestogen combinations or estrogens or Unknown progestogens alone • When pregnancy is suspected or diagnosed Adverse Reactions • Severe diabetes with vascular changes Common adverse reactions includes headaches, nausea, abdominal pain, weight gain, • A history of otosclerosis with deterioration during pregnancy depressed or altered mood and breast pain or tenderness. • Hypersensitivity to this drug or to any ingredient in the formulation or component of the Uncommon adverse reactions include vomiting, diarrhea, fluid retention and migraine. container. Overdose (Cyproterone acetate + Warnings and Precautions There is no antidote and treatment should be symptomatic. Ethinyl estradiol) Discontinue Cyproterone acetate+Ethinyl estradiol tablets at the earliest manifestation of the following: PHARMACOLOGICAL PROPERTIES • Thromboembolic and Cardiovascular Disorders such as thrombophlebitis, pulmonary Pharmacotherapeutic group: Sex hormones and modulators of the genital system, QUALITATIVE AND QUANTITATIVE COMPOSITION embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, and anti-androgens and estrogens. ATC code: G03HB01 Each film-coated tablet contains: retinal thrombosis. Cyproterone acetate (Ph.Eur.)………...2 mg • Conditions that predispose to Venous Stasis and to Vascular Thrombosis (eg. Mechanism of action Ethinyl estradiol (USP)……………...0.035 mg immobilization after accidents or confinement to bed during long-term illness). -
Original Article Factors Influencing Efavirenz and Nevirapine Plasma Concentration: Effect of Ethnicity, Weight and Co-Medication
Antiviral Therapy 13:675–685 Original article Factors influencing efavirenz and nevirapine plasma concentration: effect of ethnicity, weight and co-medication Wolfgang Stöhr1, David Back 2, David Dunn1, Caroline Sabin3, Alan Winston4, Richard Gilson5, Deenan Pillay 6, Teresa Hill 3, Jonathan Ainsworth7, Anton Pozniak8, Clifford Leen9, Loveleen Bansi3, Martin Fisher10, Chloe Orkin11, Jane Anderson12, Margaret Johnson13, Phillippa Easterbrook14, Sara Gibbons2 and Saye Khoo2* on behalf of the Liverpool TDM Database and the UK CHIC Study 1MRC Clinical Trials Unit, London, UK 2University of Liverpool, Liverpool, UK 3Department of Primary Care and Population Sciences, Royal Free and University College Medical School, London, UK 4St. Mary’s Hospital, London, UK 5Mortimer Market Centre, Royal Free and University College Medical School (RFUCMS), London, UK 6Department of Infection, RFUCMS, Centre for Infection, Health Protection Agency, London, UK 7North Middlesex University Hospital, London, UK 8Chelsea and Westminster NHS Trust, London, UK 9University of Edinburgh, Western General Hospital, Edinburgh, UK 10Brighton and Sussex University Hospitals NHS Trust, Sussex, UK 11Barts and The London NHS Trust, London, UK 12Homerton Hospital, London, UK 13Royal Free NHS Trust and RFUCMS, London, UK 14King’s College Hospital, London, UK *Corresponding author: E-mail: [email protected] Background: The aim of this study was to examine and zidovudine (25% lower; P=0.010). Notably, without factors influencing plasma concentration of efavirenz and adjustment for other factors, patients on rifampicin had nevirapine. 48% higher efavirenz concentration, as these patients Methods: Data from the Liverpool Therapeutic Drug Mon- were mostly black and on 800 mg/day. For nevirapine the itoring (TDM) registry were linked with the UK Collabora- predictors were black ethnicity (39% higher; P=0.002), tive HIV Cohort (CHIC) Study. -
Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis
Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of Tuberculosis Elimination Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis Centers for Disease Control and Prevention Office of Infectious Diseases National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of Tuberculosis Elimination June 2013 This document is accessible online at http://www.cdc.gov/tb/TB_HIV_Drugs/default.htm Suggested citation: CDC. Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis [online]. 2013. Available from URL: http://www.cdc.gov/tb/TB_HIV_Drugs/default.htm Table of Contents Introduction 1 Methodology for Preparation of these Guidelines 2 The Role of Rifamycins in Tuberculosis Treatment 4 Managing Drug Interactions with Antivirals and Rifampin 5 Managing Drug Interactions with Antivirals and Rifabutin 9 Treatment of Latent TB Infection with Rifampin or Rifapentine 10 Treating Pregnant Women with Tuberculosis and HIV Co-infection 10 Treating Children with HIV-associated Tuberculosis 12 Co-treatment of Multidrug-resistant Tuberculosis and HIV 14 Limitations of these Guidelines 14 HIV-TB Drug Interaction Guideline Development Group 15 References 17 Table 1a. Recommendations for regimens for the concomitant treatment of tuberculosis and HIV infection in adults 21 Table 1b. Recommendations for regimens for the concomitant treatment of tuberculosis and HIV infection in children 22 Table 2a. Recommendations for co-administering antiretroviral drugs with RIFAMPIN in adults 23 Table 2b. Recommendations for co-administering antiretroviral drugs with RIFAMPIN in children 25 Table 3. Recommendations for co-administering antiretroviral drugs with RIFABUTIN in adults 26 ii Introduction Worldwide, tuberculosis is the most common serious opportunistic infection among people with HIV infection. -
Fatal Nevirapine-Induced Stevens- Johnson Syndrome with HIV-Associated Mania
CASE REPORT Fatal nevirapine-induced Stevens- Johnson syndrome with HIV-associated mania Z Zingela,1 MB ChB, MMed (Psych), FC Psych (SA); A Bronkhorst,1 MB ChB, DMH (SA); W M Qwesha,2 MB ChB; B P Magigaba,2 MB ChB, FC Derm (SA) 1 Department of Psychiatry, Port Elizabeth Hospital Complex, Walter Sisulu University, South Africa 2 Department of Dermatology, Port Elizabeth Hospital Complex, Walter Sisulu University, South Africa Corresponding author: Z Zingela ([email protected]) Mania with psychotic features is one of the common presenting clusters of psychiatric symptoms in HIV-infected patients. Commonly, patients with HIV-associated mania receive antiretroviral treatment, mood stabilisers and antipsychotics. This case of Stevens-Johnson syndrome highlights the dilemmas and complications that may arise when prescribing multiple medications in HIV-associated psychiatric disorders. S Afr J HIV Med 2014;15(2):65-66. DOI:10.7196/SAJHIVMED.1011 HIV enters the central nervous system early status and CD4+ count, ethnic background, age and gender. in the course of HIV infection and causes a Affected individuals with SJS/TEN are genetically predisposed range of neuropsychiatric complications, inclu- to developing severe cutaneous reactions based on the major ding HIV encephalopathy, depression, ma- histocompatibility complex molecules on their leukocyte cell [1] [10] nia, cognitive disorders and frank demen tia. surface. A study in Taiwan showed that 100% of Han Chinese Mania is one of the most common psychiatric presentations in patients who developed SJS in response to carbamazepine HIV-infected patients and requires antiretroviral therapy (ART), had an HLA B*1502 allele.[11] Comorbidity of SJS/TEN and mood stabilisers and antipsychotics to increase patient quality of HIV is posing a challenge in sub-Saharan Africa due to the life and decrease mortality.[1-3] ART may also protect from further high prevalence of HIV. -
Emerging Threat in Antifungal Resistance on Superficial Dermatophyte Infection R Sultana1, M Wahiduzzaman2
Bang Med J Khulna 2018; 51 : 21-24 ORIGINAL ARTICLE Emerging threat in antifungal resistance on superficial dermatophyte infection R Sultana1, M Wahiduzzaman2 Abstract Background: Dermatophytosis are most common fungul infection globally and according to WHO the prevalence is about 20-25% and does not spare people of any race or age. Over the past few years antifungal resistance has been emerged due to irrational use of antifungal drugs in cutaneous mycosis. Objective: The aim of the study is to evaluate the efficacy of different antifungul drugs (Terbinafin. Fluconazole, Itraconazole, Griseofulvin) on superficial mycosis depending on various factors. Methods: This prospective study was conducted among the Superficial fungul infected patients from April' 2017 to October 2017 in Khulna Medical College Hospital (KMCH) and dermatologist's private chamber in Khulna city. All the enrolled patients were put on oral Terbinafin, Fluconazole, Itraconazole and Griseofulvin. Each patient was given single antifungal drug orally. These cases were thus followed up after two months of treatment to look for persistent infection, cure or any relapse clinically. Result: Among 194 patient 89 were given Tab. Terbinafin (250mg) where resistance cases were 20.22%. More cases (33.96%) were resistant to Cap. Fluconazol (50mg). High percentage of cases were resistant to Cap. Itraconazole (76.47%). Griseofulvin resistant cases were observed in 25.71%. Drug response is very poor (69%) in patient who had been suffering from diabetes mellitus. Conclusion: Appropriate antifungal drugs should be chosen with strict indication, dose, duration, selection of perfect local preparation and taking laboratory facilities where necessary. Keywords : Dermatophytosis, Antifungal resistance, Public health. -
(Nevirapine) Oral Suspension
NDA 20-636 NDA 20-933 Page 3 Viramune® (nevirapine) Tablets Viramune® (nevirapine) Oral Suspension Rx only WARNING Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, has been reported in patients treated with VIRAMUNEâ. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. Patients with signs or symptoms of hepatitis must seek medical evaluation immediately and should be advised to discontinue VIRAMUNE. (See WARNINGS) Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue VIRAMUNE as soon as possible. (See WARNINGS) It is essential that patients be monitored intensively during the first 12-16 weeks of therapy with VIRAMUNE to detect potentially life-threatening hepatotoxicity or skin reactions. However, the risk continues past this period and monitoring should continue at frequent intervals. VIRAMUNE should not be restarted following severe hepatic, skin or hypersensitivity reactions. In addition, the 14-day lead-in period with VIRAMUNE 200 mg daily dosing must be strictly followed. (See WARNINGS) DESCRIPTION VIRAMUNE IS THE BRAND NAME FOR NEVIRAPINE (NVP), A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR WITH ACTIVITY AGAINST HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1). NEVIRAPINE IS STRUCTURALLY A MEMBER OF THE DIPYRIDODIAZEPINONE CHEMICAL CLASS OF COMPOUNDS. VIRAMUNE TABLETS ARE FOR ORAL ADMINISTRATION. EACH TABLET CONTAINS 200 MG OF NEVIRAPINE AND THE INACTIVE INGREDIENTS MICROCRYSTALLINE CELLULOSE, LACTOSE MONOHYDRATE, POVIDONE, SODIUM STARCH GLYCOLATE, COLLOIDAL SILICON DIOXIDE AND MAGNESIUM STEARATE.