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.
poniedziałek, 5 listopada 2012
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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