CALCULATION OF INTRAVENOUS INFUSION RATES

STEP 1:

Determine the amount of fluid that will be administered per unit of time (usually 60 minutes or 1 hour).

Example: 1000 ml./8 hours = 125 ml./hr

STEP 2:

Identify the type of drip chamber that is on the IV administration set.

Alaris sets: 20 drops/ml.

Macro Drip: 10 or 15 drops/ml., (varies with the manufacturer). Drip rate for the chamber is marked on the IV set box. Baxter (formerly Travenol) macro drip sets deliver 10 drops per ml.

Micro Drip: 60 drops/ml.

STEP 3:

To calculate infusion rate, multiply amount to be infused per period of time (from step 1) by the drip rate (from step 2).

Example: How many drops per minute should be administered to deliver 125 ml/hr. using an Alaris drip set (20 drops per ml.)?

    Amount to be administered: 125 ml

    Administration time (in minutes): 60 min

    Drip chamber size: 20 drops/ml

    125 ml./60 min. X 20 drops/ml = 41.7 drops per minute

    Answer: 42 drops per minute to deliver 125 ml. in 60 minutes using an Alaris drip chamber.

TABLE 1: Frequently Used Infusion Rates (ml/hr)

 

Infusion Time	250.0 ml	500.0 ml	1000.0 ml
4 hrs 6 hrs 8 hrs 10 hrs 12 hrs 24 hrs	62.0 ml/hr   41 31 25 20 10	125.0 ml/hr 83 62 50 41 21	250.0 ml/hr 166 125 100 83 42

TABLE 2: Frequently Used Drip Rates (drops per minute)

Administration Set drop size	Infusion Rate (ml/hr)
	41	83	100	125	166	250
60 drops/ml 20 drops/ml 15 drops/ml 10 drops/ml	41 14 10 7	83 26 21 13	100 32 25 16	125 42 31 21	166 54 41 27	250 82 62 41

(Quantities are in drops per minute to deliver infusion rate)

US-FDA Drugs Approved in 2012

January

Brentuximab Vedotin
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin)Prescribing Information

Glucarpidase Injection
FDA Approves Voraxaze (glucarpidase) to Treat Patients with Toxic Methotrexate Levels


Tenofovir
U.S. Food and Drug Administration Approves New Formulations of Viread (tenofovir disoproxil fumarate) for Use by Children Living With HIV

Bortezomib
FDA Approves Subcutaneous Administration of Velcade (bortezomib) In All Approved Indications

Ciclesonide
FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis

Ezetimibe and simvastatin
New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease

Levetiracetam
UCB Announces FDA Approval for Keppra (levetiracetam) in Infants and Children from One Month of Age with Partial Onset Seizures

Ingenol Mebutate Topical Gel
FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing

Axitinib Tablets
FDA Approves Inlyta (axitinib) for Advanced Renal Cell Carcinoma Exenatide
FDA Approves Bydureon (exenatide) - The First and Only Once-Weekly Treatment for Type 2 Diabetes

Vismodegib
FDA Approves Erivedge (vismodegib) for Basal Cell Carcinoma
Ivacaftor
FDA Approves Kalydeco (ivacaftor) to Treat Rare Form of Cystic Fibrosis

Imatinib
FDA Approves Gleevec (imatinib mesylate) for Expanded Use in Patients with Rare Gastrointestinal Cancer
Linagliptin And Metformin Hydrochloride
FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes

February

Sitagliptin-Metformin
FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience

Lisdexamfetamine
Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD

Ivermectin
Sanofi Announces FDA Approval of Sklice (ivermectin)Lotion for the Treatment of Head Lice

Mitomycin
Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol (mitomycin)

March

Influenza Virus Vaccine
FDA Approves FluMist (Influenza Virus Vaccine, Live, Intranasal) to Prevent Seasonal Influenza

Pancrelipase
Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules

Lucinactant
Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome

Dienogest And Estradiol Valerate
U.S. FDA Approves Natazia (dienogest and estradiol valerate) First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)

Alendronate
FDA Approves Binosto(alendronate), First and Only Effervescent Osteoporosis Treatment in a Buffered Solution

Beclomethasone Dipropionate
Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis

Etravirine
FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review

Peginesatide
Affymax and Takeda Announce FDA Approval of Omontys (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis

April

Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) Pregnancy Category Change for Women with Diabetes

Rotigotine
Neupro (Rotigotine )Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome

Everolimus
Novartis drug Afinitor ( Everolimus) approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC

Pazopanib
FDA Approves Votrient ( Pazopanib) for Advanced Soft Tissue Sarcoma

Avanafil
FDA Approves Stendra ( Avanafil) for Erectile Dysfunction Levofloxacin
FDA Approves Levaquin (Levofloxacin) as an Antibacterial Treatment for Plague

Florbetapir F 18
FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline

Liraglutide
Victoza (Liraglutide) Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia

May

Taliglucerase Alfa
FDA Approves New Orphan Drug Elelyso (Taliglucerase alfa) to Treat a Form of Gaucher Disease

Azelastine And Fluticasone
MEDA Announces Dymista (Azelastine and Fluticasone) Approved by the FDA for Allergic Rhinitis

Tazarotene
Fabior (tazarotene) FDA Approval History for acne Pancrelipase
Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules

Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes

June

Gabapentin Enacarbil
GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia

Pertuzumab
FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine
MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)

Pregabalin
FDA Approved Lyrica (Pregabalin) For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review

Immune Globulin Infusion (Human)
Baxter Announces FDA Approval for Gammagard Liquid ( immune globulin infusion (human)) as a Treatment for Multifocal Motor Neuropathy

Lorcaserin
FDA Approves Belviq (Lorcaserin) to Treat Some Overweight or Obese Adults

July

Prednisone
Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications

Emtricitabine And Tenofovir
FDA Approves Truvada (emtricitabine and tenofovir) for Reducing the Risk of Sexually Acquired HIV Infection

Sodium Picosulfate, Magnesium Oxide And Citric Acid
FDA Approves Prepopik(sodium picosulfate, magnesium oxide and citric acid) for Oral Solution for
Colonoscopy Prep

Phentermine And Topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)

Carfilzomib
FDA Approves Kyprolis (carfilzomib) for Patients with Advanced Multiple Myeloma

Everolimus
FDA Approves Afinitor (everolimus) for Advanced Breast Cancer

Aclidinium Bromide
FDA Approves Tudorza (aclidinium bromide) Pressair to Treat Chronic Obstructive Pulmonary Disease

Icosapent Ethyl
Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia

Emtricitabine And Tenofovir
FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection

phentermine and topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)

August

Ziv-Aflibercept
FDA Approves Zaltrap (ziv-aflibercept) for Metastatic Colorectal Cancer

Vincristine Sulfate Liposomes
FDA Approves Marqibo (vincristine sulfate liposomes) for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Ranibizumab
FDA Approves Lucentis (ranibizumab injection) for Treatment of Diabetic Macular Edema (DME)

Epinephrine
Sanofi Announces FDA Approval for Auvi-Q(epinephrine), First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies

Linagliptin
FDA approves updated prescribing information for Tradjenta (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes

Buprenorphine And Naloxone
Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone (buprenorphine and naloxone) Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence

Hydromorphone
FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain

Cobicistat-Elvitegravir-Emtricitabine-Tenofovir
FDA Approves New Combination Pill Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir)for HIV Treatment

Tapentadol
FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Everolimus
FDA Approves Afinitor Disperz (everolimus)- First Drug Formulated for Children with Rare Brain Tumor

Tbo-Filgrastim
FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients

Linaclotide
FDA Approves Linzess (linaclotide)to Treat Certain Cases of Irritable Bowel Syndrome and Constipation

Enzalutamide
FDA Approves Xtandi (enzalutamide)for Late-Stage Castration-Resistant Prostate Cancer

September

Rivastigmine
Higher Dose of Novartis Drug Exelon (rivastigmine) Patch Approved By FDA for Patients With Mild to Moderate Alzheimer's Disease

Bosutinib
FDA Approves Bosulif (bosutinib)for Chronic Myelogenous Leukemia

Teriflunomide
FDA Approves New Multiple Sclerosis Treatment Aubagio (teriflunomide)

Denosumab
FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture

Regorafenib
FDA Approves Stivarga (regorafenib) for Advanced Colorectal Cancer

Adalimumab
FDA Approves Humira (adalimumab) to Treat Ulcerative Colitis

Methylphenidate
NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR(methylphenidate) for Once-Daily Treatment of ADHD

October

Cysteamine Ophthalmic Solution
Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution)

0.44% Paclitaxel Protein-Bound
FDA Approves Abraxane (paclitaxel protein-bound) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Ocriplasmin
FDA Approves Jetrea (ocriplasmin) for Symptomatic Vitreomacular Adhesion in the Eyes

Perampanel
FDA Approves Fycompa (perampanel) to Treat Seizures

Omacetaxine Mepesuccinate
FDA Approves Synribo (omacetaxine mepesuccinate) for Chronic Myelogenous Leukemia

November

Rivaroxaban
FDA Expands Use of Xarelto (rivaroxaban) to Treat, Reduce Recurrence of Blood Clots

Tofacitinib
FDA Approves Xeljanz (tofacitinib) for Rheumatoid Arthritis

DECEMBER

The following drugs have recently been approved by the FDA.

Sirturo (bedaquiline)
Date of Approval: December 31, 2012
as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.

Eliquis (apixaban) Tablets
Date of Approval: December 28, 2012
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation

Adasuve (loxapine) Inhalation Powder
Date of Approval: December 21, 2012
Treatment for: Agitation, Schizophrenia, Bipolar Disorder

Juxtapid (lomitapide) Capsules
Date of Approval: December 21, 2012
Treatment for: Homozygous Familial Hypercholesterolemia

Gattex (teduglutide) for Injection
Date of Approval: December 21, 2012
Treatment for: Short Bowel Syndrome

Bivigam (immune globulin intravenous) Infusion
Date of Approval: December 21, 2012
Treatment for: Primary Immunodeficiency Syndrome

Varizig (varicella zoster immune globulin) for Injection
Date of Approval: December 20, 2012
Treatment for: Varicella-Zoster

Iclusig (ponatinib) Tablets
Date of Approval: December 14, 2012
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Signifor (pasireotide) Injection
Date of Approval: December 14, 2012
Treatment for: Cushing's Syndrome

Evarrest (fibrin sealant) Patch
Date of Approval: December 5, 2012
Treatment for: Bleeding

Regards
Gaurav Taneja,
Pharmafrontiers.

Time and Concentration Dependent Effect of Antibiotics

b-lactam antibiotics and Vancomycin . . . . . .................. are antibiotics that exhibit time-dependent inhibition of microorganism.

Aminoglycosides, Fluoroquinolones, Daptomycin, Metronidazole, Azythromycin, Ketolides.................................................concenrtation dependent inhition

of microorganisms by these antibiotics.

Macrolides, Clindamycin, Streptogramins, Tetracyclines, and Linezolid . . . . .. . . . . ... . . .. ...............................The third group includes drugs that are predominantly bacteriostatic and produce moderate to prolonged Post antibiotic effects. Because of their prolonged Post antibiotic effects, their efficacy is determined less by time and more by AUC once concentrations exceed the MIC.

Drugs Approved by US-FDA in 2011: A Glance

Cardiology/Vascular Diseases

Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome, Approved July 2011

Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011

Edarbyclor (azilsartan medoxomil and chlorthalidone); Takeda Pharmaceutical; For the treatment of hypertension, Approved December of 2011

Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting from atrial fibrillation, Approved November 2011

Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011

Dermatology/Plastic Surgery

Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

laViv (azficel-T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Endocrinology

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Juvisync (sitagliptin and simvastatin); Merck; For the treatment of type II diabetes, Approved October 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011

Gastroenterology

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Rectiv (nitroglycerin) ointment 0.4%; ProStrakan; For the treatment of chronic anal fissure, Approved June 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Hematology

Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011

Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011

Ferriprox (deferiprone); Apotex; For the treatment of transfusional iron overload due to thalassemia, Approved October 2011

Jakafi (ruxolitinib); Incyte; For the treatment of myelofibrosis, Approved November 2011

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011

Immunology/Infectious Diseases

Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011

Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 in treatment-naive adults, Approved August of 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011

Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

Musculoskeletal

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Nephrology/Urology

Anturol (oxybutynin) Gel; Antares Pharma; For the treatment of overactive bladder, Approved December 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Neurology

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011

Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011

Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011

Obstetrics/Gynecology

Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved February 2011

Oncology

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011

Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011

Ophthalmology

Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of neovascular (wet) age-related macular degeneration, Approved November 2011

Otolaryngology

Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011

Pediatrics/Neonatology

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011

Pharmacology/Toxicology

Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Psychiatry/Psychology

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011

Pulmonary/Respiratory Diseases

Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Rheumatology

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Trauma/Emergency Medicine

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011

Xanthelasmata Identified as Independent CV Risk Factor

A large new study from Denmark finds that xanthelasmata (raised yellow patches around the eyelids) but not arcus cornae (white or grey rings around the cornea) is an independent risk factor for cardiovascular disease.

In a paper in BMJ, Mette Christoffersen and colleagues report on 12,745 adults in Copenhagen without cardiovascular disease at baseline who were followed for a mean of 22 years. At baseline 4.4% had xanthelasmata and 24.8% had arcus corneae. Here are the main results, comparing the group without xanthelasmata to the group with xanthelasmata:

MI: 65 events versus 121 events per 10,000 person years (multifactorial adjusted HR for xanthelasmata: 1.48, CI 1.23-1.79).

Ischemic heart disease: 134 versus 226 events per 10,000 person years (multifactorial adjusted HR for xanthelasmata: 1.39, CI 1.20-1.60)

Ischemic stroke: 53 versus 64 events per 10,000 person years (multifactorial adjusted HR for xanthelasmata: 0.94, CI 0.73-1.21)

Ischemic cerebrovascular disease: 65 versus 74 events per 10,000 person years (multifactorial adjusted HR for xanthelasmata: 0.91, CI 0.72-1.15)

Total deaths: 293 versus 414 events per 10,000 person years (multifactorial adjusted HR for xanthelasmata: 1.14, CI 1.04-1.26)

The authors write that their results “suggest that xanthelasmata are a cutaneous marker of atherosclerosis independent of lipid concentrations and thus should be considered in clinical practice as an independent and additional risk factor for myocardial infarction and ischaemic heart disease.” They say the findings may be especially useful in places with limited access to laboratories.

In an accompanying editorial, Antonio Fernandez and Paul Thompson write that people with xanthelasmata “may have an enhanced biological propensity to deposition of cholesterol in vascular and soft tissue, which is not fully represented by their fasting lipid profiles. Because xanthelasmata are composed of foam cells similar to those present in atherosclerotic plaque, they may be a better marker than arcus corneae of the intra-arterial atherosclerotic process.” Therefore, they conclude, these patients “may therefore require more aggressive management of risk factors.”

Here is the press release from the BMJ:

Yellow patches around eyelids predict risk of heart problems

Research: Xanthelasmata, arcus corneae, and ischaemic vascular disease and death in general population: prospective cohort study

Editorial: Eye markers of cardiovascular disease

Raised yellow patches of skin (xanthelasmata) around the upper or lower eyelids are markers of an individual’s increased risk of having a heart attack or suffering from heart disease, finds research published on bmj.com today.

The study, led by Professor Anne Tybjærg-Hansen at the University of Copenhagen, also concludes that white or grey rings around the cornea (arcus corneae) are not linked to an increased risk.

Previous research has established that both xanthelasmata and arcus corneae are deposits of cholesterol. However, around half of the individuals who have either or both condition will not test positively for high cholesterol in a blood test.

The researchers wanted to investigate links between xanthelasmata and/or arcus corneae and an increased risk of heart attack, heart disease, stroke, severe thickening of the arteries or premature death in the general population, as the evidence in this area is lacking.

Indeed, many patients are referred to dermatologists so that xanthelasmata can be removed.

The US Food and Drug Administration (FDA) approved a once-daily bronchodilator — indacaterol maleate (Arcapta Neohaler, Novartis Pharmaceuticals) — for chronic obstructive pulmonary disease (COPD). This bronchodilator may offer better patient adherence than twice-a-day bronchodilators on the market.

Indacaterol maleate is a new molecular entity in the ß2-adrenergic agonist class that helps relax muscles around lung airways to prevent COPD symptoms, such as wheezing and breathlessness. The FDA stated that the long-acting drug is not intended to treat asthma or COPD symptoms that come on fast and strong.

Common adverse effects (> 2% and more common than placebo) are runny nose, cough, sore throat, headache, and nausea.

Indacaterol maleate will carry a boxed warning that, like other long-acting ß2-adrenergic agonists (LABAs), may increase the risk for asthma-related death.

Without use of a long-term asthma control medication, indacaterol maleate and all LABAs are contraindicated in patients with asthma. Indacaterol maleate should not be started in patients with acutely deteriorating COPD, nor should it be used to relieve acute symptoms, which should be managed with concomitant short-acting ß2-agonists.

An FDA advisory panel in March recommended approval of indacaterol maleate after 6 confirmatory clinical trials demonstrated the drug's safety and efficacy. The trials included nearly 5500 patients 40 years and older with COPD who had smoked at least 1 pack of cigarettes for 10 years and exhibited moderate to severe decreases in lung function.

During the advisory panel meeting, John Walsh, the president of the nonprofit COPD Foundation, said that getting patients to faithfully take twice-daily LABAs is a challenge.

"The advantage of a once-daily LABA to increase compliance and impact adherence cannot be overstated," Walsh said.

Administration and Precautions

Indacaterol maleate is supplied as 75-µg inhalation powder hard capsules that should always be used with the Neohaler inhaler only, 75 µg inhaled once daily every day. The capsules are for oral inhalation only and are not to be swallowed. The recommended dose should not be exceeded because excessive use of indacaterol maleate, or use in conjunction with other LABA-containing medications, may cause clinically significant cardiovascular effects and may even be fatal.

Should life-threatening paradoxic bronchospasm occur, use of indacaterol maleate should immediately be discontinued. The inhaler should be used with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or sensitivity to sympathomimetic drugs.

Indacaterol maleate should be used with caution with other adrenergic drugs, as these may potentiate its effects. It should be used with caution with xanthine derivatives, steroids, diuretics, or non–potassium-sparing diuretics, as these medications may potentiate hypokalemia or electrocardiographic changes. Extreme caution is warranted when indacaterol maleate is used with monoamine oxidase inhibitors, tricyclic antidepressants, and drugs that prolong QTc interval, as these may potentiate cardiovascular effects. Because ß-blockers may reduce the efficacy of indacaterol maleate, these should be used with caution and only when medically necessary.

Indacaterol maleate is pregnancy Category C, and it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because ß-agonists may interfere with uterine contractility, indacaterol maleate should be used during labor only in those patients in whom the benefits clearly outweigh the risks. Caution is warranted when indacaterol maleate is administered to breast-feeding women.

The safety and efficacy of indacaterol maleate in pediatric patients have not been determined; therefore, the drug is not indicated for use in children. No adjustment of dosage is warranted in geriatric patients, based on available data, nor in patients with mild and moderate hepatic impairment. Studies were not performed in patients with severe hepatic impairment nor in those with renal impairment, but the urinary pathway contributes very little to total body elimination.

More information on the FDA's approval of indacaterol maleate is available on the agency's Web site.

Laurie Barclay, MD, contributed to the synopsis.

Clinical Implications

The FDA approved indacaterol maleate as a once-daily bronchodilator to prevent COPD symptoms, such as wheezing and breathlessness. Dosage is 75 µg inhaled once daily every day, which should increase compliance relative to twice-daily inhalers. It is not intended for acute relief of COPD exacerbations.

Common adverse effects seen with use of indacaterol maleate are runny nose, cough, sore throat, headache, and nausea. It will carry a boxed warning that the risk for asthma-related death may be increased. There are several significant drug interactions.

Indacaterol maleate is pregnancy Category C. It should be used during labor only in those patients in whom the benefits clearly outweigh the risks, and caution is warranted when indacaterol maleate is administered to breast-feeding women. Indacaterol maleate is not indicated for use in children. No adjustment of dosage is warranted in geriatric patients nor in patients with mild and moderate hepatic impairment.

courtesy: NIH US-FDA

Ischemic preconditioning

Ischemic preconditioning (IPC) an experimental technique for producing resistance to the loss of blood supply and, thus oxygen, to tissues of many types.

If the blood supply to an organ or a tissue is halted for a short time (usually less than five minutes) and then restored two or more times so that blood flow is resumed, the downstream cells of the tissue or the organ are robustly protected from a final ischemic insult when the blood supply is cut off entirely and permanently.

In an experimental setting if the left anterior descending coronary artery of the animal is ligated the downstream cardiac cellular mass is infarcted and will be injured and then die. If, on the other hand the tissue is subjected to IPC the downstream cellular mass will sustain only minimal to modest damage. IPC protects the tissue by initiating a cascade of biochemical events that allows for an up-regulation of the energetics of the tissue. The locus of this phenomenon is the intracellular organelle, the mitochondrion.

Investigations of various exogenous circulating ligands such as the delta active opiates and opioids simulate the phenomenon of IPC thus protecting the downstream tissues without the IPC intermittent ligating procedure.

The only group of humans who are chronically exposed to an opioid with delta activity are methadone maintained patients treated for heroin dependence and addiction. These patients have a coronary risk profile greater than the general population:

90% smoke. In the general population in the USA ~25% smoke.

Heart Healthy living i.e. attention to lipid control is less frequent than in the general population ~25% of the patients in Methadone Maintenance Programs use the highly ischemogenic cocaine one or more times a year. In the general population in the USA less than 1% are reported to do so.

Preliminary and as yet unpublished surveys of the methadone treated population point to a high degree of protection from myocardial ischemic events. The one published study[citation needed], an autopsy series from the Office of the Chief Medical Examiner of the City of New York demonstrated significantly less evidence for coronary occlusive disease. Simulation of IPC with methadone could not be evaluated in this post mortem investigation.

reffered from : Wikipedia