18 novembro 2013

Livro Manual de Drogas Injetáveis, 3ª edição


07 outubro 2013


04 outubro 2013

XILOMETAZOLINA spray nasal



Cloridrato de xilometazolina.........................................................................100 mg
Cloreto de Sódio.............................................................................................850 mg
Cloreto de Benzalcônio.....................................................................................10 mg
Água para Injeção q.s.p..................................................................................100 mL

Em recipiente adequado, dissolver os sólidos em 60 mL do veículo. Adicionar os componentes líquidos e misturar. Adicionar o veículo em porções geométricas, misturando. Adicionar veículo suficiente para 100 mL. Filtrar através de um filtro de 0,2 micra. Solução spray nasal.

Referência bibliográfica: Allen Jr LV. Xylometazoline hydrochloride nasal drops. Compounding nasal preparations. Disponível em: http://www.perrigo.com. Acesso em: 26 de setembro de 2013.

11 setembro 2013

FDA Approved Drugs 2013

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

Cardiology/Vascular Diseases

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Dermatology

Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013
Mirvaso (brimonidine); Galderma Labs; For the treatment of facial erythema of rosacea, Approved August 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Devices

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Endocrinology

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013
Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Family Medicine

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013
Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013
Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Gastroenterology

Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Genetic Disease

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Healthy Volunteers

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Hematology

Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia, Approved July 2013
Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013
Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June 2013
Rixubis (Coagulation Factor IX (Recombinant)]; Baxter International; For the routine prophylaxis and control of hemophilia B, Approved June 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Immunology

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013
Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

Infections and Infectious Diseases

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013
Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 2013

Musculoskeletal

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Nephrology

Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia, Approved July 2013
Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of nephropathic cystinosis, Approved May 2013

Neurology

Fetzima (levomilnacipran); Forest Labs; For the treatment of major depressive disorder, Approved July 2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013
Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid dependence, Approved July 2013

Nutrition and Weight Loss

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Obstetrics/Gynecology (Women’s Health)

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate); Warner Chilcott; For the prevention of pregnancy, Approved July 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013

Oncology

Gilotrif (afatinib); Boehringer Ingelheim; For the treatment of metastatic non-small cell lung cancer with EGFR mutations, Approved July 2013
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June 2013
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013
Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013
Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013
Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

Orthopedics/Orthopedic Surgery

Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013

Pediatrics/Neonatology

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013
Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013

Pharmacology/Toxicology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Psychiatry/Psychology

Fetzima (levomilnacipran); Forest Labs; For the treatment of major depressive disorder, Approved July 2013
Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid dependence, Approved July 2013

Pulmonary/Respiratory Diseases

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013
Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 2013

Rheumatology

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Trauma (Emergency, Injury, Surgery)

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Urology

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

Vaccines

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

28 agosto 2013

Intranasal fentanyl for palliative care



Mercadante, S., et al., A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin, 2009[12]

This is a landmark trial regarding intranasal fentanyl for the treatment of breakthrough pain. The authors randomized 139 patients to either oral transmucosal fentanyl – OTFC (Actiq) versus intranasal fentanyl (Instanyl) in a cross over trial where the patients served as their own control by being subjected to both treatments. Instanyl is a highly concentrated form of fentanyl – ranging from 500 mcg/ml to 2000 mcg/ml delivered at a 0.1 ml dose of 50 to 200 mcg) into one nostril, with the option of a second dose at 10 minutes via an atomizer device. Patients had to have cancer associated breakthrough pain occurring at least 3 times per week to be eligible. In the initial part of the trial they had a dose titration phase to determine both the proper dose of Actiq and of Instanyl to control their usual pain – this dose was then used for treatment of breakthrough pain during the randomization phase. Once dosing was determined patients were treated with either method for a maximum of 2 weeks until they had used the study drug 6 times, at which point they crossed over and used the alternate drug six times.  The patients were not blinded to the treatment medication. The primary outcome was time until meaningful pain reduction as per patients opinion. Secondary outcome was pain relief based on a numerical rating scale (0 to 10) with time to achieving at least 33% reduction and 50% reduction recorded.

10 julho 2013

La calidad en las publicaciones biosanitarias sobre la elaboración de medicamentos de forma individualizada


 
 
 
 
 
 
 
 
A excepción de International Journal of Pharmaceutical Compounding ( IJPC) revista especializada en la publicación de artículos sobre la elaboración de medicamentos de forma individualizada, fórmulas magistrales y mezclas parenterales, no son muy frecuentes las publicaciones sobre estos temas en las revistas de farmacia hospitalaria y  del ámbito farmacéutico.  
 
En los últimos años si se han incrementado las publicaciones sobre estudios de eficacia y casos clínicos de fórmulas magistrales en las revistas de las especialidades de dermatología y oftalmología  debido a la demanda en la prescripción de medicamentos no elaborados por la industria farmacéutica y acordes con las características específicas de un determinado paciente.  Tanto en estas publicaciones como en las específicas de la formación farmacéutica detectamos muchas deficiencias en cuanto a la calidad del contenido en la composición,, elaboración y período de validez de las formulas objeto de estudio. Aunque son más frecuentes los estudios de eficacia que los de estabilidad debido a la dificultad que entrañan estos últimos desde un punto de vista técnico y económico, consideramos imprescindible en ambos casos la descripción completa de los siguientes datos:
  • -   Composición completa y cuantitativa de todos los componentes de la fórmula o mezcla parenteral ( principio activo , vehículo y excipientes) Especificación de la forma en la que se presentan los componentes : acido , base , sal , nº de moléculas de agua en el caso de moléculas hidratadas.  Puede utilizarse el PM , fórmula química y /o referencia del número de la monografía correspondiente de la farmacopea si es que el principio activo está descrito en ella. 
  • -     PNT (protocolo normalizado de trabajo) de la fórmula ensayada. Incluir siempre en los estudios de estabilidad y recomendable en los estudios de eficacia.
  • -     Caducidad o período de validez. Tanto si se ha establecido de forma empírica teniendo en cuenta forma farmacéutica , vía de administración y esterilidad ( USP 795 y 797 )como basada en referencias bibliográficas .
El objetivo principal para el  lector de artículos científicos es que la experiencia publicada en la revista,  en nuestro caso eficacia o estabilidad pueda reproducirse.  Si los datos son incompletos o no están lo suficientemente especificados no podremos aplicar la misma estabilidad evaluada , factor imprescindible para garantizar la utilización , seguridad y calidad de la fórmula. 
 

18 maio 2013

Infusão em mL/hora para dobutamina 500 mcg/mL.




Peso Paciente
30 kg
40 kg
50 kg
60 kg
70 kg
80 kg
90 kg
100 kg
Dose
mcg/kg/min
(mL/h)
(mL/h)
(mL/h)
(mL/h)
(mL/h)
(mL/h)
(mL/h)
(mL/h)
0,5
1,8
2,4
3
3,6
4,2
4,8
5,4
6
1
3,6
4,8
6
7,2
8,4
9,6
10,8
12
2,5
9
12
15
18
21
24
27
30
5
18
24
30
36
42
48
54
60
7,5
27
36
45
54
63
72
81
90
10
36
48
60
72
84
96
108
120
12,5
45
60
75
90
105
120
135
150
15
54
72
90
108
126
144
162
180
17,5
63
84
105
126
147
168
189
210
20
72
96
120
144
168
192
216
240

Referência: Souza GB. Manual de Drogas Injetáveis, 2ª ed. Editora Medfarma. São Paulo. 2012