مدونة صيدلاوى

Serious Liver Injury Tied to HCV Drugs in Rare Cases, FDA Warns The US Food and Drug Agency (FDA) warned on Wednesday that three direct-acting antiviral drugs have been associated with rare cases of severe liver injury in patients being treated for chronic hepatitis C virus (HCV) infection. The agency has identified 63 cases of liver decompensation, including liver failure and death, among patients treated with glecaprevir/​pibrentasvir ( Mavyret , AbbVie; n = 46), elbasvir/​grazoprevir ( Zepatier,  Merck & Co; n = 14), and sofosbuvir/​velpatasvir/​voxilaprevir ( Vosevi,  Gilead; n = 3). The cases were reported to the  FDA Adverse Event Reporting System (FAERS) database  or identified in the medical literature through January 8, 2019. All three drugs are approved to treat chronic HCV infection in patients without liver impairment or mild liver impairment (Child-Pugh A). However, the cases were concentrated in patients wh...

The US Food and Drug Administration (FDA) h احدث علاجات الازمة فى الاطفال من هيئة الغذاء و الدواء الامريكية  expanded  the indication for mepolizumab ( Nucala , GlaxoSmithKline)to children as young as 6 years old with severe eosinophilic asthma. Mepolizumab subcutaneous injection was first approved in the United States in 2015 as an add-on maintenance treatment for patients with severe asthma who were aged 12 years or older and who had an eosinophilic phenotype. Expanded approval in children aged 6 to 11 years is supported by an open-label study conducted in that age group that investigated mepolizumab's pharmacokinetics, pharmacodynamics, and long-term safety, the company said in a news release. Evidence from trials in adults and adolescents also supported approval in this age group. The safety profile of mepolizumab in children as young as 6 years was similar to the known safety profile in patients aged 12 years or older, the compan...

اضرار حبوب منع التدخين champix   تحذير من احتمالية ظهور أعراض نفسية وعصبية خطيرة على المرضى المستخدمين للأدوية التي تساعد على وقف التدخين ( Varenicline  Bupropion ) طالبت إدارة الغذاء والدواء الأمريكية المماثلة في سلطتها للهيئة العامة للغذاء والدواء بالمملكة العربية السعودية مصنعي الأدوية التي تساعد على وقف التدخين ( Varenicline & Bupropion ) بإضافة تحذير بارز على النشرة الداخلية وعبوة الدواء و تطوير دليل إرشادي يسلط الضوء على احتمال ظهور أعراض نفسية وعصبية خطيرة على المرضى المستخدمين لهذه الأدوية . اضرار حبوب champix اضرار حبوب منع  التدخين سعر دواء champix في مصر افضل علاج للاقلاع  عن التدخين اضرار حبوب ترك  التدخين حبوب تساعد  على  الاقلاع  عن التدخين champix سعر في السعودية champix اعراض جانبية وتشمل هذه الأعراض تغير في السلوك ،العدوانية ،الانفعال ، الاكتئاب ، بالإضافة إلى التفكير في الانتحار أو حتى الانتحار وسوف يتم تطبيق هذه التغييرات على معلومات الوصف و دليل الأدوية للمرضى المستخدمين...

New Liquid Colchicine Dosage Form On January 30, 2019, the FDA has approved a new formulation of cholchicine for the prevention of gout flares in adults.  The new product, Gloperba (Romeg Therapeutics), is an oral solution to be marketed in a 0.6 mg/5 mL concentration, and is the first commercially available liquid formulation of colchicine. The new dosage form may provide value for pediatric patients, or for adults who have difficulty swallowing solid dosage forms, and the manufacturer is also suggesting it may have value in making dosage adjustments.  It should be noted, however, that colchicine does not generally require precise dosage adjustments for the safe and effective prevention or treatment of of gout flares.  There are no specific dosage adjustment recommendations in the package label for patients with mild or moderate renal or hepatic failure, and those with severe renal or hepatic dysfunction should avoid the use of colchicine altogether.  W...

The FDA has approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema in patients aged 2 years and older.  The FDA has approved Eucrisa (crisaborole) ointment  Eucrisa is applied topically twice daily. Side effects include hypersensitivity reactions, and Eucrisa should not be used in patients who have had a hypersensitivity reaction to crisaborole. The most common side effect is application site pain, including burning or stinging. The safety and efficacy of Eucrisa were established in 2 placebo-controlled trials with a total of 1,522 participants ranging in age from 2 to 79 years of age with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment. Atopic dermatitis is the most common of the many types of eczema and typically begins in childhood and lasts through adulthood. The cause of atopic dermatitis is a combination of genetic,...

Children and teens are more likely to have sugary drinks if they get fast-food combo meals that come with a beverage, a new study suggests. The findings suggest that uncoupling sugary drinks from combo meals may help reduce kids' calorie intake, the researchers said. The researchers reviewed the meal choices of483 boys and girls at McDonald's, Burger King, KFC, Wendy's or Subway locations in New York City and Newark and Jersey City, N.J. On average, kids consumed 179 more calories overall if their combo meal came with a soda, sweetened tea or juice, or flavored milks. They drank 82 more calories than when beverages were bought separately. Parents who picked combo meals were 24 percent more likely than those who ordered item by item to get a sugar-sweetened drink instead of a non-sweetened one or no beverage. The findings were published online Oct. 7 in the American Journal of Public Health. "Our study strongly suggests that uncoupling sugar...

20 August 2014 -- GlaxoSmithKline plc today announced that the Food and Drug Administration has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm. The approved doses are Arnuity Ellipta 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio. Darrell Baker, Senior Vice President & Head, GSK Global Respiratory Franchise, said, “The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to p...

The Food and Drug Administration on Tuesday approved a new capsule-based drug to treat Gaucher's disease.   Regulators approved the new drug, Cerdelga, for patients with the Type 1 form of the rare genetic disorder, which causes excess fat to build up in the spleen, liver and bone marrow.   Cerdelga is from Genzyme, the specialty drugmaker that introduced the first drug for Gaucher's disease 20 years ago. The oral treatment could serve as an alternative to Genzyme's best-selling drug Cerezyme, which is given intravenously.   Cerezyme had sales of $935 million last year. The drug costs $300,000 for a year's supply, on average. Genzyme says it will soon release pricing for its new drug.   Type 1 is the most common form of Gaucher's disease and affects an estimated 6,000 people in the U.S.   Patients with Gaucher's disease lack a certain enzyme that helps the body break down fat. Cerdelga works by reducing levels of the fat that col...

علاج فيرس سي المحتمل نزوله الشهر المقبل بمصر بتكلمفة 900 دولار لمدة 12 اسبوع  FDA Approves Sovaldi ® - On 6th December 2013, The U. S . Food and Drug Administration (FDA) has approved Sov aldi ® (sofosbuvir) 400 mg tablets, a once - daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen . Eff icacy - E fficacy has been established in subjects wit h hepatitis C virus (HCV) genotypes 1, 2, 3 or 4 infections , and to treat HCV and HIV co-infected patients. - The combination therapy includes either riba virin (RBV) alone or Ribavirin and peg-interfero n (PEG-IFN) alfa. Drug categ ory   - Sofosbuvir acts a gainst HCV and is categorized as a Direct-Acting Antiviral agent (DAA). HCV ge no types   - Hepatitis C virus (HCV) is a major cause of chronic liver disease, with an estimated 170 million people infec...

Acetaminophen Prescription Combination Drug Products with More than 325 mg: Recommendation to Discontinue Prescribing and Dispensing The FDA is recommending healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Furthermore, limiting the amount of acetaminophen per dosage until will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death. Cases of severe liver injury with acetaminophen have occurred in patients who: Took more than the prescribed dose of an acetaminophen-containing product in a 24-hours period; Took more than once acetaminophen-containing product at the s...

FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD) May 10, 2013 -- The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third leading cause of death in the United States. Breo Ellipta works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce...

Why Splitting Tablets is Risky You might get confused about the correct dose. There have been cases when people have purchased higher strength tablets intending to split them, but then they forgot to split them. Instead, they took the whole tablet. This led to accidentally taking too much medicine. Equal distribution of medicine in split tablets is questionable. Studies have shown that the actual dose in each half of a split tablet often is different. So while the two halves may look the same, they don't necessarily contain equal amounts of medicine. Even if the tablet is scored with a line that runs down the middle, one half may actually have more medicine than the other.   Some tablets are hard to split. Some tablets are too small to split, may have an unusual shape that makes them hard to split, or may crumble more easily when split. Also, some people may not be able to split tablets correctly. These factors make it difficult to accurately split a table...

Lipsticks, Glosses Contain Toxic Metals: Report Children should not play with these products, researcher says. THURSDAY, May 2 (HealthDay News) -- Lipsticks and lip glosses apparently give you more than colorful kissers, according to a new study by California scientists that contends the products contain lead, cadmium, chromium, aluminum and five other toxic metals. The research team tested 32 different lip glosses and lipsticks commonly sold at drug and department stores. Some metals were detected at levels that could raise potential health concerns, the researchers said. "Lipsticks and lip glosses often have levels of toxic metals which approach or exceed acceptable daily doses based on public health guidelines," said researcher Katharine Hammond, a professor of environmental health sciences at the University of California, Berkeley. Hammond declined to name brands tested. "I would treat these results as applicable to all lipsticks," she said. ...