Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis
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Eparate Formulations According to the Prescribed Dosing Recommendations for These Products
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Lamivudine/Zidovudine Teva 150 mg/300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, capsule shaped, biconvex, film-coated scored tablet – engraved with “L/Z” on one side and “150/300” on the other side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2). 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Lamivudine/Zidovudine Teva may be administered with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). Adults and adolescents weighing at least 30 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one tablet twice daily. Children weighing between 21 kg and 30 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken in the morning and one whole tablet taken in the evening. Children weighing from 14 kg to 21 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken twice daily. -
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 -
Epivir, INN-Lamivudine
SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Epivir. This scientific discussion has been updated until 1 July 2005. For information on changes after this date please refer to module 8B. 1. Introduction The Human Immunodeficiency Virus (HIV) is a retrovirus, which replicates by transcribing its viral RNA genome into DNA via the enzyme reverse transcriptase (RT). The HIV results in a chronic, progressive deterioration in overall cell-mediated immunity with a steady depletion of CD4 T-lymphocytes causing Acquired Immunodeficiency Syndrome (AIDS). Agents of the family of 2’, -3’-dideoxynucleoside analogues are designed to suppress viral replication in two ways: by competitive inhibition with cellular nucleotides for the binding site of RT and, after incorporation into the growing viral DNA strand, by preventing further elongation of the viral DNA (chain termination). All the currently available nucleoside analogues have dose-limiting toxicities which may limit their long-term use. The development of resistant viruses in patients treated with these nucleosides analogues also demonstrates the pressing need for new agents to widen the choice of therapeutic agents available for treating patients infected with HIV. Lamivudine is a nucleoside analogue developed as a treatment for HIV infection. It has also activity against hepatitis B virus (HBV). It is metabolised intracellularly to the active moiety, lamivudine 5’- triphosphate. Its main mode of action is as a chain terminator of viral reverse transcription. The triphosphate has selective inhibitory activity against HIV-1 and HIV-2 replication in vitro, it is also active against zidovudine-resistant clinical isolates of HIV. -
Truvada (Emtricitabine / Tenofovir Disoproxil)
Pre-exposure Prophylaxis (2.3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Recommended dose in HIV-1 uninfected adults: One tablet TRUVADA safely and effectively. See full prescribing information (containing 200 mg/300 mg of emtricitabine and tenofovir for TRUVADA. disoproxil fumarate) once daily taken orally with or without food. (2.3) TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Recommended dose in renally impaired HIV-uninfected Initial U.S. Approval: 2004 individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH uninfected individuals while using TRUVADA for PrEP, evaluate STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF potential causes and re-assess potential risks and benefits of HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF continued use. (2.4) TRUVADA FOR PrEP IN UNDIAGNOSED HIV-1 INFECTION -----------------------DOSAGE FORMS AND STRENGTHS------------------- See full prescribing information for complete boxed warning. Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 Lactic acidosis and severe hepatomegaly with steatosis, mg/150 mg of emtricitabine and tenofovir disoproxil fumarate . (3) including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA. (5.1) --------------------------------CONTRAINDICATIONS----------------------------- TRUVADA is not approved for the treatment of chronic Do not use TRUVADA for pre-exposure prophylaxis in individuals with hepatitis B virus (HBV) infection. Severe acute unknown or positive HIV-1 status. TRUVADA should be used in exacerbations of hepatitis B have been reported in patients HIV-infected patients only in combination with other antiretroviral coinfected with HIV-1 and HBV who have discontinued agents. -
RIFAMPICIN Productinformation Sigma Prod
RIFAMPICIN ProductInformation Sigma Prod. No. R3501 CH3 CH3 CAS NUMBER: 13292-46-1 HO SYNONYMS: Tubocin; Sinerdol; Rimactan; L-5103; Dione-21 Acetate; Archidyn; Arficin; 3-(4- CH3 O O OH O Methylpiperazinyliminomethyl)-rifamycin SV; NSC 113926; C OH OH CH 1 2 3 H C Rifampin ; Rifaldazine; Rifamycin AMP H3C 3 O NH H3C PHYSICAL PROPERTIES: CH3 N CH N Appearance: Orange-brown to red-brown powder.3 O OH N Molecular formula: C43H58N4O12 O Molecular weight: 823.0 O CH3 CH3 EmM (max absorbance, phosphate buffer, pH 7.38): 33.20 (237 nm); 32.10 (255 nm); 27.00 (334 nm); 15.40 (475 nm)2,4 pKa (in water):1.7 (4-hydroxyl group), 7.9 (4-piperazine nitrogen); in methylcellosolve-water (4:1): 3.6 (4- hydroxyl group), 6.7 (3-piperazine nitrogen)4 pI (in water): 4.84 25° 4 Optical rotation: [α]D =+10.6° (c=0.5% in CDCl3) Melting point: 183-188°C (dec.)2,4 METHOD OF PREPARATION: Methods of preparation have been reported.4,5 The NMR, UV, IR, Mass spectra, Thin-Layer chromatography and HPLC methods of detection have been reported.4,5,6 A colorimetric test for identification was reported.4 STABILITY / STORAGE: Rifampicin (Rif) should be stable for at least two years when stored desiccated at -20°C and protected from light.3 Rif is stable as a solid at temperatures up to 70EC.4 SOLUBILITY / SOLUTION STABILITY: Rif is soluble in dimethylsulfoxide (~100mg/mL), dimethylformamide, methanol (16 mg/ml, 25EC), chloroform (349 mg/ml, 25°C), ethyl acetate (108 mg/ml, 25°C), and acetone (14 mg/ml, 25°C).4,6,7,8,9 Rif is slightly soluble in water at 25°C: 2.5 mg/ml, pH 7.3; 1.3 mg/ml, pH 4.3; and in 95% ethanol (∼10 mg/mL).4 Rif is soluble at 37°C: in 0.1 N HCl, 200 mg/ml and in phosphate buffer pH 7.4, 9.9 mg/ml.4 R3501 Page 1 of 4 03/28/97 - ARO RIFAMPICIN Sigma Prod. -
Download Article PDF/Slides
New Antiretrovirals in Development: Reprinted from The PRN Notebook,™ june 2002. Dr. James F. Braun, Editor-in-Chief. Tim Horn, Executive Editor. Published in New York City by the Physicians’ Research Network, Inc.,® John Graham Brown, Executive Director. For further information and other articles The View in 2002 available online, visit http://www.PRN.org All rights reserved. © june 2002. Roy “Trip” Gulick, md, mph Associate Professor of Medicine, Weill Medical College of Cornell University Director, Cornell Clinical Trials Unit, New York, New York Summary by Tim Horn Edited by Scott Hammer, md espite the fact that 16 antiretro- tiviral activity of emtricitabine was estab- Preliminary results from two random- virals are approved for use in the lished, with total daily doses of 200 mg or ized studies—FTC-302 and FTC-303—were United States, there is an indis- more producing the greatest median viral reported by Dr. Charles van der Horst and putable need for new anti-hiv com- load suppression: 1.72-1.92 log. Based on his colleagues at the 8th croi, held in Feb- pounds that have potent and these data, a once-daily dose of 200 mg ruary 2001 in Chicago (van der Horst, durable efficacy profiles, unique re- was selected for further long-term clinical 2001). FTC-302 was a blinded comparison sistance patterns, patient-friendly dosing study. “This is what we’re looking forward of emtricitabine and lamivudine, both in schedules, and minimal toxicities. To pro- to with emtricitabine,” commented Dr. combination with stavudine (Zerit) and vide prn with a glimpse of drugs current- Gulick. -
TRIZIVIR® (Abacavir Sulfate, Lamivudine, and Zidovudine) Tablets
NDA 21-205/S-011 Page 4 PRESCRIBING INFORMATION TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine) Tablets WARNINGS TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine, and zidovudine) and is intended only for patients whose regimen would otherwise include these 3 components. Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of TRIZIVIR. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR as soon as a hypersensitivity reaction is suspected. Permanently discontinue TRIZIVIR if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death. Reintroduction of TRIZIVIR or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours (see WARNINGS and PRECAUTIONS: Information -
Review CCR5 Antagonists: Host-Targeted Antivirals for the Treatment of HIV Infection
Antiviral Chemistry & Chemotherapy 16:339–354 Review CCR5 antagonists: host-targeted antivirals for the treatment of HIV infection Mike Westby* and Elna van der Ryst Pfizer Global R&D, Kent, UK *Corresponding author: Tel: +44 1304 649876; Fax: +44 1304 651819; E-mail: [email protected] The human chemokine receptors, CCR5 and suggest that these compounds have a long plasma CXCR4, are potential host targets for exogenous, half-life and/or prolonged CCR5 occupancy, which small-molecule antagonists for the inhibition of may explain the delay in viral rebound observed HIV-1 infection. HIV-1 strains can be categorised by following compound withdrawal in short-term co-receptor tropism – their ability to utilise CCR5 monotherapy studies. A switch from CCR5 to (CCR5-tropic), CXCR4 (CXCR4-tropic) or both (dual- CXCR4 tropism occurs spontaneously in approxi- tropic) as a co-receptor for entry into susceptible mately 50% of HIV-infected patients and has been cells. CCR5 may be the more suitable co-receptor associated with, but is not required for, disease target for small-molecule antagonists because a progression. The possibility of a co-receptor natural deletion in the CCR5 gene preventing its tropism switch occurring under selection pressure expression on the cell surface is not associated by CCR5 antagonists is discussed. The completion with any obvious phenotype, but can confer of ongoing Phase IIb/III studies of maraviroc, resistance to infection by CCR5-tropic strains – the aplaviroc and vicriviroc will provide further insight most frequently sexually-transmitted strains. into co-receptor tropism, HIV pathogenesis and The current leading CCR5 antagonists in clinical the suitability of CCR5 antagonists as a potent development include maraviroc (UK-427,857, new class of antivirals for the treatment of HIV Pfizer), aplaviroc (873140, GlaxoSmithKline) and infection. -
Product Monograph for CELSENTRI
PRODUCT MONOGRAPH PrCELSENTRI maraviroc Tablets 150 and 300 mg CCR5 antagonist ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: July 05, 2019 Submission Control No: 226222 © 2019 ViiV Healthcare group of companies or its licensor. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Page 1 of 60 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................9 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION..............................................................................28 OVERDOSAGE ................................................................................................................31 ACTION AND CLINICAL PHARMACOLOGY ............................................................31 STORAGE AND STABILITY..........................................................................................36 -
Lamivudine/Tenofovir Disoproxil Fumarate 300Mg/300 Mg Tablets*
Lamivudine/Tenofovir Disoproxil Fumarate WHOPAR part 1 11/2010, version 1.0 300mg/300 mg Tablets (Matrix Lab. Ltd), HA414 WHO Prequalification Programme WHO PUBLIC ASSESSMENT REPORT (WHOPAR) Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300 mg Tablets* International Nonproprietary Names (INN)/strength/pharmaceutical form lamivudine/tenofovir disoproxil fumarate 300mg/300mg film-coated tablets Abstract Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg Tablets, manufactured at Matrix Laboratories Limited, Nashik, Maharashtra, India, was included in the WHO list of prequalified medicinal products for the treatment of HIV/AIDS on 30 June 2010. Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg Tablets is indicated in combination with at least one other antiretroviral medicinal product for the treatment of HIV-1 infected adults over 18 years of age. Detailed information on the use of this product is described in the Summary of Product Characteristics (SPC), which can be found in this WHOPAR. The active pharmaceutical ingredient (API) of Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg Tablets are the nucleoside reverse transcriptase inhibitors lamivudine and the nucleotide reverse transcriptase inhibitor tenofovir disoproxil fumarate. The APIs have been investigated in combination therapy in several clinical trials, in both treatment-naïve and treatment- experienced patients. The most frequent adverse reactions observed during treatment of HIV/AIDS were hypophosphataemia, dizziness, headache, insomnia, cough, nasal symptoms, diarrhoea, vomiting, nausea, flatulence, abdominal pain/cramps, rash, hair loss, arthralgia, muscle disorder, fatigue, malaise and fever. The most important safety problems with Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg Tablets are acute renal failure, renal failure and proximal renal tubulopathy. Discontinuation of therapy with Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg Tablets in patients co- infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. -
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