Used it once and it cleared up the urinary tract infection. The second time I used it I developed tendonitis.
I react to every antibiotic out there. Levaquin is the only one I can take with no side effects. This is an excellent drug and gets rid of my urinary tract infections fast, with no yeast infection after it.
Levaquin (levofloxacin) for Bacterial Infection: My doctor prescribed Levaquin (500 mg for 10 days) because she said it would take care of both my UTI and sore throat without having to take 2 different antibiotics. After the first two days I felt better, but the 3rd day my sore throat returned and I began to ache all over like flu symptoms. The 4th and 5th days the calves of my legs hurt, and the 5th night I couldn't sleep because my calves were hurting so badly, I wondered if I had blood clots. Today (6th), my calves, neck and ankles hurt -- I just took my 6th pill and my upper lip is swelling is looked up the side effects and it seems I have most of them. The first 2 days I was very short of breath when walking and climbing the stairs and always have had a headache -- will stop!
poniedziałek, 5 listopada 2012
Levaquin (levofloxacin) for Bronchitis
On my third day with Levaquin. Only problem that I am having is insomnia. Tired during the day, completely awake at night. Cough is pretty much gone. I feel great, just need to go to bed.
I have been using this for 4 days now. I was taking this for bronchitis. My throat was so sore from an unproductive cough. After the first day of using this, the soreness in my throat went away. Everything is now loosening and feel so much better. I haven't had much of an appetite but have not had any trouble sleeping. I have not experienced any of the symptoms other reviewers have noted.
I had a very negative reaction to this antibiotic. Extreme fatigue, continuing muscle weakness (after approximately 5 weeks), very vivid and frightening dreams, slow improvement in my bronchitis. I will never take this again.
I was perscribed Levaquin for bronchitis and it was completely effective. Now six months later I have developed a full compliment of the drugs side effects. Thrush, hives, yeast infection(vaginal), leg cramps and a knotted tendon. I am 65.
I have been using this for 4 days now. I was taking this for bronchitis. My throat was so sore from an unproductive cough. After the first day of using this, the soreness in my throat went away. Everything is now loosening and feel so much better. I haven't had much of an appetite but have not had any trouble sleeping. I have not experienced any of the symptoms other reviewers have noted.
I had a very negative reaction to this antibiotic. Extreme fatigue, continuing muscle weakness (after approximately 5 weeks), very vivid and frightening dreams, slow improvement in my bronchitis. I will never take this again.
I was perscribed Levaquin for bronchitis and it was completely effective. Now six months later I have developed a full compliment of the drugs side effects. Thrush, hives, yeast infection(vaginal), leg cramps and a knotted tendon. I am 65.
Levaquin (levofloxacin) for Pneumonia
I've been given this medicine twice - once for serious bronchitis/pneumonia that nearly required hospitialization. Since I am a well trained athlete, hospitalization for a lung infection was serious. Doctors tried several other drugs before the Levaquin, but Levaquin was best. Now dealing with a relatively minor bronchitis and have it again. I've never had any of the side effects others listed - bear in mind that weakness and headaches and many other symptoms might just be the progression of the disease and not due to the drug. It's hard to tell since each bout is different but compared to many other drugs, this is statistically a very good bet. If you have bronchitis or a respiratory infection, take your medicines with lots of fluids.
I had mild to severe coughing for several months, tried several other antibiotics and nothing worked until Lavaquin. I almost gave up. Two weeks ago went into the emergency room on Las Vegas with increased breathing and coughing problems. Blood tests, lung xrays, cat scan, oxygen, etc. etc. Two to three days after taking some prednisone, and a 10 day prescription for Levaquin all seems to have completely cleared up!!!
I had mild to severe coughing for several months, tried several other antibiotics and nothing worked until Lavaquin. I almost gave up. Two weeks ago went into the emergency room on Las Vegas with increased breathing and coughing problems. Blood tests, lung xrays, cat scan, oxygen, etc. etc. Two to three days after taking some prednisone, and a 10 day prescription for Levaquin all seems to have completely cleared up!!!
Levaquin (levofloxacin) for Sinusitis
My doctor always prescribes Levaquin for bad sinus infections and congestion because of my many drug allergies. I LOVE Levaquin. Within hours of the first dose all of the mucus in my head and/or chest starts to make a mass exodus. At times, the volume and swiftness that it drains can choke you -- but this medicine works and it works FAST. It's made me cough so hard I gag, but all of my coughs are super productive, if not overly so. I recommend this to anyone wanting to get better and back in the saddle at warp speed.
Levaquin was prescribed for a sinus infection. I had the same problem with sleeping the other two people had. No sleep at night for 2 days.
Was prescribed levaquin 750mg/5 day dose on June 22, 2009. First week no bad symptoms except for insomnia and nightmares. It did knock out sinus infection temporarily (10 days) but then sinusitis returned. It wasn't until week 3 after using this drug that I started noticing joint pain in elbows, knees, shoulders and lower back. It's November now and things haven't improved. Along with tendinitis symptoms I've also loss muscle strength in calf's, biceps and will experience burning in hamstrings after doing simple things like cutting my lawn. I hope this goes away or somebody offers a remedy to counter these effects.
I have a sinus infection that hasn't responded to any other treatments and I had decided to ignore it but 3 months have passed and it's gotten into my chest too. I was put on a Bacitrin and that did nothing so the Dr put me on Levaquin and thus far, I can say i haven't had any issues with sleep, I actually fell asleep watching TV last night and slept fairly well considering I have a ton of coughing congestion in my chest and that awful sinus discharge-we'll see how the rest goes/if it works.
Levaquin was prescribed for a sinus infection. I had the same problem with sleeping the other two people had. No sleep at night for 2 days.
Was prescribed levaquin 750mg/5 day dose on June 22, 2009. First week no bad symptoms except for insomnia and nightmares. It did knock out sinus infection temporarily (10 days) but then sinusitis returned. It wasn't until week 3 after using this drug that I started noticing joint pain in elbows, knees, shoulders and lower back. It's November now and things haven't improved. Along with tendinitis symptoms I've also loss muscle strength in calf's, biceps and will experience burning in hamstrings after doing simple things like cutting my lawn. I hope this goes away or somebody offers a remedy to counter these effects.
I have a sinus infection that hasn't responded to any other treatments and I had decided to ignore it but 3 months have passed and it's gotten into my chest too. I was put on a Bacitrin and that did nothing so the Dr put me on Levaquin and thus far, I can say i haven't had any issues with sleep, I actually fell asleep watching TV last night and slept fairly well considering I have a ton of coughing congestion in my chest and that awful sinus discharge-we'll see how the rest goes/if it works.
FDA Extends Marketing Exclusivity for Levaquin
The U.S. Food and Drug Administration (FDA) has granted LEVAQUIN(R) (levofloxacin) an additional six months of marketing exclusivity, known as "pediatric exclusivity." The action attaches to the U.S. patent covering LEVAQUIN, extending exclusivity from December 2010 to June 2011. This decision was based on five, company-sponsored pediatric studies conducted at the request of the FDA.
The studies included trials to determine the pharmacokinetic profile and the efficacy and safety of LEVAQUIN in children with community-acquired pneumonia (CAP) and recurrent and/or persistent acute otitis media. The studies were conducted in close collaboration with leaders in the pediatric and infectious disease communities and in consultation with the FDA. LEVAQUIN is not indicated for use in children and adolescents (under 18 years of age).
Since its U.S. introduction in 1996, LEVAQUIN has gained widespread use in the treatment of adults for a variety of bacterial infections caused by specific pathogens(1), including: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections (mild to moderate), chronic bacterial prostatitis, complicated and uncomplicated urinary tract infections (mild to moderate) and acute pyelonephritis (mild to moderate).
LEVAQUIN is available in 250 mg, 500 mg and 750 mg doses in both oral and I.V. formulations. The safety profile of LEVAQUIN is similar across doses. LEVAQUIN is marketed to healthcare providers by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil, Inc.
Important Safety Information
The most common drug-related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%). The safety and efficacy of LEVAQUIN in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. LEVAQUIN is contraindicated in persons with a history of hypersensitivity to LEVAQUIN, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions, as well as some of unknown etiology have been reported in patients receiving therapy with quinolones, including LEVAQUIN. These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
As with other quinolones, LEVAQUIN should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.
Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including LEVAQUIN, during and after therapy. This risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. The quinolone should be discontinued in patients experiencing pain, inflammation, or rupture of a tendon.
Some quinolones, including LEVAQUIN, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. LEVAQUIN should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.
Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx(R)* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after LEVAQUIN administration.
The studies included trials to determine the pharmacokinetic profile and the efficacy and safety of LEVAQUIN in children with community-acquired pneumonia (CAP) and recurrent and/or persistent acute otitis media. The studies were conducted in close collaboration with leaders in the pediatric and infectious disease communities and in consultation with the FDA. LEVAQUIN is not indicated for use in children and adolescents (under 18 years of age).
Since its U.S. introduction in 1996, LEVAQUIN has gained widespread use in the treatment of adults for a variety of bacterial infections caused by specific pathogens(1), including: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections (mild to moderate), chronic bacterial prostatitis, complicated and uncomplicated urinary tract infections (mild to moderate) and acute pyelonephritis (mild to moderate).
LEVAQUIN is available in 250 mg, 500 mg and 750 mg doses in both oral and I.V. formulations. The safety profile of LEVAQUIN is similar across doses. LEVAQUIN is marketed to healthcare providers by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil, Inc.
Important Safety Information
The most common drug-related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%). The safety and efficacy of LEVAQUIN in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. LEVAQUIN is contraindicated in persons with a history of hypersensitivity to LEVAQUIN, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions, as well as some of unknown etiology have been reported in patients receiving therapy with quinolones, including LEVAQUIN. These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
As with other quinolones, LEVAQUIN should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.
Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including LEVAQUIN, during and after therapy. This risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. The quinolone should be discontinued in patients experiencing pain, inflammation, or rupture of a tendon.
Some quinolones, including LEVAQUIN, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. LEVAQUIN should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.
Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx(R)* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after LEVAQUIN administration.
Generic Versions of Antibiotic Levaquin
The Food and Drug Administration said Monday it approved the first generic versions of Johnson & Johnson's antibiotic Levaquin, which treats bacterial infections that cause bronchitis or pneumonia.
The antibiotic, known generically as levofloxacin, also treats infections of the skin, sinuses, kidney, bladder and prostate. Regulators approved applications from 12 manufacturers for generic versions of the drug. Those companies include Akorn Inc., Dr. Reddy's Laboratories Ltd., Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA.
Levaquin is made by Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson.
I was perscribed Levaquin for a sinus infection. I had nausea and vomitting, and could not sleep at night. I also was itchy all over.
I've been taking levaquin for a sinus infection. I am on only my second dose, but yesterday after taking my first dose I felt immediate results. Much less nasal discharge than in the days and even hours prior. I had no problems with sleep, in fact that night was the first time I slept through the entire night in weeks, without even waking up to go to the bathroom.
The antibiotic, known generically as levofloxacin, also treats infections of the skin, sinuses, kidney, bladder and prostate. Regulators approved applications from 12 manufacturers for generic versions of the drug. Those companies include Akorn Inc., Dr. Reddy's Laboratories Ltd., Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA.
Levaquin is made by Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson.
I was perscribed Levaquin for a sinus infection. I had nausea and vomitting, and could not sleep at night. I also was itchy all over.
I've been taking levaquin for a sinus infection. I am on only my second dose, but yesterday after taking my first dose I felt immediate results. Much less nasal discharge than in the days and even hours prior. I had no problems with sleep, in fact that night was the first time I slept through the entire night in weeks, without even waking up to go to the bathroom.
Levaquin as an Antibacterial Treatment for Plague
The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.
Plague is extremely rare in most parts of the world, including the United States, with 1,000 to 2,000 cases worldwide each year. The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood).
Primarily an animal disease, plague can be spread to humans through bites from infected fleas, contact with infected animals or humans, or laboratory exposure. Yersinia pestis also is considered a biological threat agent, which could potentially be used as a bioterrorism agent.
The FDA approved Levaquin for plague under the agency's Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to be used in cases where it is not feasible or ethical to conduct trials in humans. Because plague is such a rare disease, it would not be possible to conduct adequate efficacy trials in humans.
Levaquin's approval was based on an efficacy study conducted in African green monkeys that were infected with the plague bacterium in a laboratory setting. Animals were randomly selected to receive a 10-day regimen of Levaquin or placebo within six hours of the onset of fever after being infected. The primary endpoint was survival at the end of the study. Of the 17 monkeys treated with Levaquin, 94 percent survived. None of the seven monkeys treated with placebo survived.
"Today's approval broadens the available therapeutic treatments for plague," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. "It also further demonstrates the usefulness of animal model studies to collect needed efficacy data in cases where human trials are not ethical or feasible."
Levaquin's safety has been evidenced by studies and post-marketing information for the drug's existing medical uses. Common side effects reported in more than 3 percent of patients were nausea, headache, diarrhea, insomnia, constipation, and dizziness.
Serious but rare side effects include tendinitis and tendon rupture, worsening of muscle weakness in people with the neuromuscular disorder myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm. However, given that plague is a very serious and often deadly condition, the benefit of Levaquin for treating plague outweighs these potential risks.
The application for Levaquin was granted a priority review by the FDA. It joins streptomycin, doxycycline, tetracycline, and other antibacterial drugs in the tetracycline group as FDA-approved treatments for plague.
Plague is extremely rare in most parts of the world, including the United States, with 1,000 to 2,000 cases worldwide each year. The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood).
Primarily an animal disease, plague can be spread to humans through bites from infected fleas, contact with infected animals or humans, or laboratory exposure. Yersinia pestis also is considered a biological threat agent, which could potentially be used as a bioterrorism agent.
The FDA approved Levaquin for plague under the agency's Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to be used in cases where it is not feasible or ethical to conduct trials in humans. Because plague is such a rare disease, it would not be possible to conduct adequate efficacy trials in humans.
Levaquin's approval was based on an efficacy study conducted in African green monkeys that were infected with the plague bacterium in a laboratory setting. Animals were randomly selected to receive a 10-day regimen of Levaquin or placebo within six hours of the onset of fever after being infected. The primary endpoint was survival at the end of the study. Of the 17 monkeys treated with Levaquin, 94 percent survived. None of the seven monkeys treated with placebo survived.
"Today's approval broadens the available therapeutic treatments for plague," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. "It also further demonstrates the usefulness of animal model studies to collect needed efficacy data in cases where human trials are not ethical or feasible."
Levaquin's safety has been evidenced by studies and post-marketing information for the drug's existing medical uses. Common side effects reported in more than 3 percent of patients were nausea, headache, diarrhea, insomnia, constipation, and dizziness.
Serious but rare side effects include tendinitis and tendon rupture, worsening of muscle weakness in people with the neuromuscular disorder myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm. However, given that plague is a very serious and often deadly condition, the benefit of Levaquin for treating plague outweighs these potential risks.
The application for Levaquin was granted a priority review by the FDA. It joins streptomycin, doxycycline, tetracycline, and other antibacterial drugs in the tetracycline group as FDA-approved treatments for plague.
Levaquin Approved for Treatment of Sinusitis
he U.S. Food and Drug Administration (FDA) has approved a new five-day, 750 mg once-daily regimen for Levaquin (levofloxacin) tablets to treat acute bacterial sinusitis. This regimen is available in the convenient Leva-pak and is the first and only short course fluoroquinolone regimen approved for the treatment of acute bacterial sinusitis. The approval is based on a clinical study that found this shorter treatment regimen as effective as a traditional regimen of Levaquin 500 mg for 10 days.
Sinusitis is one of the most common conditions seen by primary care physicians, and according to the National Ambulatory Medical Care Survey, is the fifth most common condition for which an antibiotic is prescribed. Each year in the United States there are an estimated 20 million cases of acute bacterial sinusitis.
"This new dosing regimen for sinusitis falls in line with the American Academy of Family Physicians and World Health Organization antibiotic recommendations which call for more aggressive, shorter courses of therapy that could also help reduce bacterial resistance," said Michael D. Poole, MD, PhD, Georgia Ear and Sinus Institute, Savannah, Georgia. "Physicians now have another effective dosing option that provides patients with favorable symptom improvement and increased dosing convenience."
The approval is based on a multi-center, randomized, double-blind clinical study that evaluated 780 adult outpatients diagnosed with acute bacterial sinusitis. The primary outcome measured in this study was the complete or partial resolution of the signs and symptoms of acute bacterial sinusitis to the degree that no further antibiotic treatment was necessary. Levaquin is indicated for adults with acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. These pathogens are the most common causes of acute bacterial sinusitis.
Clinical success rates of 91.4% (n=139/152) were seen in the 750 mg/five- day group and 88.6% (n=132/149) for the 500 mg/10-day group. This means that the high-dose, short-course regimen delivered comparable efficacy in half the treatment time. More importantly, these high rates of clinical success were maintained at one month. No new or unexpected adverse events were seen in either treatment group.
In this clinical trial, the in vitro susceptibilities of S. pneumoniae and H. influenzae to Levaquin were both 100%. These susceptibility results are consistent with existing in vitro data from the Tracking Resistance in the United States Today (TRUST) study. TRUST has demonstrated sustained susceptibility to Levaquin among S. pneumoniae (99%) and H. influenzae (99.7%), as well as M. catarrhalis (100%) isolates, since the study began nearly nine years ago. TRUST is the largest continuous, comprehensive respiratory pathogen surveillance study in the United States and is supported by Ortho-McNeil, Inc. In vitro susceptibility activity does not necessarily reflect clinical results.
This five-day, 750 mg once-daily dosing regimen of Levaquin is also approved in adults for community-acquired pneumonia due to penicillin- susceptible Streptococcus pneumoniae (excluding multi-drug-resistant strains*), Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, or Mycoplasma pneumoniae. The overall tolerability of Levaquin is similar across doses.
The most common drug related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%).
The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions may occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.
Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx** (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least two hours before or two hours after levofloxacin administration.
Sinusitis is one of the most common conditions seen by primary care physicians, and according to the National Ambulatory Medical Care Survey, is the fifth most common condition for which an antibiotic is prescribed. Each year in the United States there are an estimated 20 million cases of acute bacterial sinusitis.
"This new dosing regimen for sinusitis falls in line with the American Academy of Family Physicians and World Health Organization antibiotic recommendations which call for more aggressive, shorter courses of therapy that could also help reduce bacterial resistance," said Michael D. Poole, MD, PhD, Georgia Ear and Sinus Institute, Savannah, Georgia. "Physicians now have another effective dosing option that provides patients with favorable symptom improvement and increased dosing convenience."
The approval is based on a multi-center, randomized, double-blind clinical study that evaluated 780 adult outpatients diagnosed with acute bacterial sinusitis. The primary outcome measured in this study was the complete or partial resolution of the signs and symptoms of acute bacterial sinusitis to the degree that no further antibiotic treatment was necessary. Levaquin is indicated for adults with acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. These pathogens are the most common causes of acute bacterial sinusitis.
Clinical success rates of 91.4% (n=139/152) were seen in the 750 mg/five- day group and 88.6% (n=132/149) for the 500 mg/10-day group. This means that the high-dose, short-course regimen delivered comparable efficacy in half the treatment time. More importantly, these high rates of clinical success were maintained at one month. No new or unexpected adverse events were seen in either treatment group.
In this clinical trial, the in vitro susceptibilities of S. pneumoniae and H. influenzae to Levaquin were both 100%. These susceptibility results are consistent with existing in vitro data from the Tracking Resistance in the United States Today (TRUST) study. TRUST has demonstrated sustained susceptibility to Levaquin among S. pneumoniae (99%) and H. influenzae (99.7%), as well as M. catarrhalis (100%) isolates, since the study began nearly nine years ago. TRUST is the largest continuous, comprehensive respiratory pathogen surveillance study in the United States and is supported by Ortho-McNeil, Inc. In vitro susceptibility activity does not necessarily reflect clinical results.
This five-day, 750 mg once-daily dosing regimen of Levaquin is also approved in adults for community-acquired pneumonia due to penicillin- susceptible Streptococcus pneumoniae (excluding multi-drug-resistant strains*), Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, or Mycoplasma pneumoniae. The overall tolerability of Levaquin is similar across doses.
The most common drug related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%).
The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions may occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.
Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx** (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least two hours before or two hours after levofloxacin administration.
Albendazole Side effects
Get emergency medical help if you have any of these signs of an allergic reaction while taking albendazole (the active ingredient contained in Albenza) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
easy bruising or bleeding, unusual weakness;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
fever with chills, body aches, or flu-like symptoms.
Less serious side effects of albendazole may include:
stomach pain;
nausea, vomiting;
headache, dizziness; or
temporary hair loss.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to albendazole: compounding powder, oral tablet
General
The side effects of albendazole (the active ingredient contained in Albenza) differ between hydatid disease and neurocysticercosis. The symptoms were generally mild and resolved without treatment. Treatment was discontinued primarily due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease).
Dermatologic
Dermatologic side effects have included reversible alopecia (1.6% in hydatid disease; less than 1% in neurocysticercosis). Erythema multiforme and Stevens-Johnson syndrome have been reported during postmarketing experience.
Hypersensitivity
Hypersensitivity side effects have included hypersensitivity reactions (including rash and urticaria) in less than 1% of patients.
Renal
Renal side effects have included acute renal failure during postmarketing experience.
Hepatic
Hepatic side effects have included abnormal liver function tests (15.6% in hydatid disease; less than 1% in neurocysticercosis) and hepatotoxicity (greater than or equal to 1%). Hepatic abnormalities, acute liver failure, elevations of hepatic enzymes, and hepatitis have been reported during postmarketing experience.
Hematologic
Hematologic side effects have rarely included granulocytopenia, agranulocytosis, pancytopenia, and thrombocytopenia. Leukopenia has been reported in less than 1% of patients. Aplastic anemia, bone marrow suppression, and neutropenia have been reported during postmarketing experience.
Gastrointestinal
Gastrointestinal side effects have included abdominal pain (6% in hydatid disease), nausea/vomiting (3.7% in hydatid disease; 6.2% in neurocysticercosis).
Nervous system
Nervous system side effects have included headache (1.3% in hydatid disease; 11% in neurocysticercosis), dizziness/vertigo (1.2% in hydatid disease; less than 1% in neurocysticercosis), raised intracranial pressure (1.5% in neurocysticercosis), meningeal signs (1% in neurocysticercosis).
Other
Other side effects have included fever (1% in hydatid disease).
Ocular
Ocular side effects have included retinal damage.
Call your doctor at once if you have any of these serious side effects:
easy bruising or bleeding, unusual weakness;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
fever with chills, body aches, or flu-like symptoms.
Less serious side effects of albendazole may include:
stomach pain;
nausea, vomiting;
headache, dizziness; or
temporary hair loss.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to albendazole: compounding powder, oral tablet
General
The side effects of albendazole (the active ingredient contained in Albenza) differ between hydatid disease and neurocysticercosis. The symptoms were generally mild and resolved without treatment. Treatment was discontinued primarily due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease).
Dermatologic
Dermatologic side effects have included reversible alopecia (1.6% in hydatid disease; less than 1% in neurocysticercosis). Erythema multiforme and Stevens-Johnson syndrome have been reported during postmarketing experience.
Hypersensitivity
Hypersensitivity side effects have included hypersensitivity reactions (including rash and urticaria) in less than 1% of patients.
Renal
Renal side effects have included acute renal failure during postmarketing experience.
Hepatic
Hepatic side effects have included abnormal liver function tests (15.6% in hydatid disease; less than 1% in neurocysticercosis) and hepatotoxicity (greater than or equal to 1%). Hepatic abnormalities, acute liver failure, elevations of hepatic enzymes, and hepatitis have been reported during postmarketing experience.
Hematologic
Hematologic side effects have rarely included granulocytopenia, agranulocytosis, pancytopenia, and thrombocytopenia. Leukopenia has been reported in less than 1% of patients. Aplastic anemia, bone marrow suppression, and neutropenia have been reported during postmarketing experience.
Gastrointestinal
Gastrointestinal side effects have included abdominal pain (6% in hydatid disease), nausea/vomiting (3.7% in hydatid disease; 6.2% in neurocysticercosis).
Nervous system
Nervous system side effects have included headache (1.3% in hydatid disease; 11% in neurocysticercosis), dizziness/vertigo (1.2% in hydatid disease; less than 1% in neurocysticercosis), raised intracranial pressure (1.5% in neurocysticercosis), meningeal signs (1% in neurocysticercosis).
Other
Other side effects have included fever (1% in hydatid disease).
Ocular
Ocular side effects have included retinal damage.
Albendazole and Alcohol Food Interactions
Food enhances the oral bioavailability of albendazole, which is rapidly converted by hepatocytes and intestinal mucosal cells into the active metabolite, albendazole sulfoxide (ABZSX), following absorption. The proposed mechanism is stimulation of gastric acid secretion, as the absorption of albendazole is thought to be pH-dependent. According to the product labeling, plasma concentrations of ABZSX are up to 5-fold higher on average when albendazole is administered with a fatty meal (fat content approximately 40 g) compared to administration in the fasted state. In one study of six healthy male volunteers, administration of a single 10 mg/kg oral dose of albendazole in combination with a high-fat meal (57 g fat, 1399 kcal) increased the mean ABZSX peak plasma concentration (Cmax) and systemic exposure (AUC) by 6.5- and 9.4-fold, respectively, and delayed the time to reach Cmax (Tmax) from 2.5 to 5.3 hours compared to administration in the fasted state with water. The elimination half-life was not affected.
MONITOR: Grapefruit juice may increase the oral bioavailability of albendazole, which is rapidly converted by hepatocytes and intestinal mucosal cells into the active metabolite, albendazole sulfoxide (ABZSX), following absorption. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. In six healthy male volunteers, administration of a single 10 mg/kg oral dose of albendazole in combination with 250 mL of double-strength grapefruit juice increased the mean ABZSX peak plasma concentration (Cmax) and systemic exposure (AUC) by 3.2- and 3.1-fold, respectively, compared to administration with water. However, because pharmacokinetic interactions involving grapefruit juice are often subject to a high degree of interpatient variability, the extent to which a given patient may be affected is difficult to predict.
MONITOR: Grapefruit juice may increase the oral bioavailability of albendazole, which is rapidly converted by hepatocytes and intestinal mucosal cells into the active metabolite, albendazole sulfoxide (ABZSX), following absorption. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. In six healthy male volunteers, administration of a single 10 mg/kg oral dose of albendazole in combination with 250 mL of double-strength grapefruit juice increased the mean ABZSX peak plasma concentration (Cmax) and systemic exposure (AUC) by 3.2- and 3.1-fold, respectively, compared to administration with water. However, because pharmacokinetic interactions involving grapefruit juice are often subject to a high degree of interpatient variability, the extent to which a given patient may be affected is difficult to predict.
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