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Omnicef for sinus infection: Differences, similarities, and which is better for you

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Differences, similarities, and which is better for you

Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ

Cefdinir (Omnicef) and amoxicillin (Amoxil) are two antibiotics used to treat bacterial infections. Both drugs are part of a group of antibiotics called beta-lactams. They can treat a range of different infections such as respiratory tract infections, ear infections, and skin infections.

Like most beta-lactam antibiotics, cefdinir and amoxicillin work by inhibiting a bacteria’s ability to maintain its cell wall. By attacking this process, these antibiotics are able to break down the bacteria’s primary defense and means of reproduction.

Although they work in similar ways, cefdinir and amoxicillin are part of different subclasses of beta-lactam antibiotics. They also vary in how they’re used and which bacteria they’re most effective against.

What are the main differences between cefdinir and amoxicillin?

Cefdinir

Cefdinir is an antibiotic that is further classified as a cephalosporin. More specifically, it is a third-generation cephalosporin that covers different strains of gram-positive and gram-negative bacteria. Compared to earlier cephalosporin antibiotics (e.g., cephalexin, cefuroxime, and cefaclor), cefdinir has broader coverage for gram-negative bacteria.

Cefdinir (What is Cefdinir?) can treat infections such as community-acquired pneumonia, acute otitis media (AOM), bronchitis, and pharyngitis. It is available as an oral capsule and liquid suspension that can be administered once or twice daily depending on the dosage.

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Amoxicillin

Amoxicillin is a penicillin-type antibiotic that has a structure closely related to that of penicillin; however, unlike penicillin, amoxicillin covers more bacterial strains. Amoxicillin is often combined with clavulanic acid, a beta-lactamase inhibitor, which makes it a stronger antibiotic against certain bacteria.

Amoxicillin (What is Amoxicillin?) can treat H. pylori infections, lower respiratory tract infections, and gonorrhea among other infections. It is available as an oral capsule, tablet, chewable tablet, and liquid oral suspension. Amoxicillin is typically taken two or three times per day depending on the dosage and infection being treated.

Main differences between cefdinir and amoxicillin
Drug class Antibiotic
Beta-lactam
Cephalosporin
Antibiotic
Beta-lactam
Penicillin-type
Brand/generic status Only available as a generic drug (brand name discontinued) Brand and generic versions available
What is the brand name? Omnicef Moxatag, Amoxil
What form(s) does the drug come in? Oral capsule
Oral powder for suspension
Oral capsule
Oral powder for suspension
Oral tablet
Chewable tablet
What is the standard dosage? 300 mg every 12 hours or 600 mg once daily

Dosing depends on the infection being treated

500 mg every 12 hours or 250 mg every 8 hours

Dosing depends on the infection being treated

How long is the typical treatment? 5–10 days

Duration depends on the infection being treated

7–10 days

Duration depends on the infection being treated

Who typically uses the medication? Adults, children, and infants 6 months and older Adults, children, and infants 3 months and older

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Conditions treated by cefdinir and amoxicillin

Cefdinir is FDA-approved to treat acute otitis media, or middle ear infection, as well as skin and soft tissue infections. Cefdinir is also approved to treat upper and lower respiratory tract infections. Upper respiratory tract infections include sinusitis, pharyngitis, and tonsillitis. Lower respiratory tract infections include community-acquired pneumonia, which cefdinir can treat in adults and children 13 years of age and older.

Amoxicillin is approved to treat ear, nose, and throat infections like sinusitis, pharyngitis, and tonsillitis. Amoxicillin is also approved to treat lower respiratory tract infections such as community-acquired pneumonia caused by streptococcus pneumonia. Unlike cefdinir, amoxicillin is also commonly used to treat gonorrhea and H. pylori infections.

Acute otitis media Yes Yes
Chronic bronchitis Yes Yes
Sinusitis Yes Yes
Pharyngitis/Tonsillitis Yes Yes
Community-acquired pneumonia Yes Yes
Skin and soft tissue infections Yes Yes
Gonorrhea No Yes
H. Pylori infection No Yes

Is cefdinir or amoxicillin more effective?

Cefdinir is effective against infections caused by gram-positive bacteria including Staphylococcus aureus, Streptococcus pneumoniae (penicillin-susceptible strains only), and Streptococcus pyogenes. Cefdinir is also effective against gram-negative bacteria such as Haemophilus influenzae, Haemophilus parainfluenzae, and Moraxella catarrhalis.

Amoxicillin is effective against infections caused by gram-positive bacteria such as Streptococcus and Staphylococcus species. Amoxicillin is also active against gram-negative bacteria including Haemophilus influenzae, Escherichia coli, Helicobacter pylori, and Neisseria gonorrhoeae.

Clinical Trials

There are not many strong studies that have been performed to show a direct comparison of cefdinir and amoxicillin. However, some multicenter clinical trials in the United States and Europe have shown that cefdinir and amoxicillin/clavulanate are similar in effectiveness. When treating bacterial sinusitis, cefdinir was just as effective as amoxicillin/clavulanate after 10 days of treatment.

In another study, the tolerability of cefdinir and amoxicillin/clavulanate liquid suspensions were compared in pediatric patients. In a sample of 715 young children four to eight years old, 85% of them rated the taste of cefdinir as good or really good compared to 63% of them who rated amoxicillin/clavulanate, cefprozil, and azithromycin the same.

The effectiveness of these antibiotics will depend on which bacteria is causing the infection. Talk to your doctor or healthcare provider about which antibiotic will work best for you. Because of growing antibiotic resistance, it’s important that an antibiotic is only used after determining the susceptible bacteria causing the infection.

Coverage and cost comparison of cefdinir vs. amoxicillin

As generic antibiotics, cefdinir and amoxicillin are widely available. Almost all Medicare Part D and insurance plans will cover cefdinir and amoxicillin. The typical retail cost of generic cefdinir more than $100. With a SingleCare coupon, this cost can be reduced to less than $25 for a 10-day supply of 300 mg capsules.

Amoxicillin is available in generic and brand-name versions. The average cost of generic amoxicillin capsules is around $24. Using a SingleCare discount card can lower the price to around $5 for a 10-day supply of 500 mg capsules.

Typically covered by insurance? Yes Yes
Typically covered by Medicare? Yes Yes
Standard dosage 300 mg tablets (quantity of 20) 500 mg tablets (quantity of 20)
Typical Medicare copay $0–$49 $0–$10
SingleCare cost $24-$63 $5+

Common side effects of cefdinir vs. amoxicillin

The most common side effects associated with cefdinir and amoxicillin are diarrhea, nausea, and vomiting.

Amoxicillin is more likely to cause headache when taken with clarithromycin and lansoprazole for H. pylori infections. Amoxicillin may also have a higher incidence of rash after taking it.

More serious side effects of cefdinir and amoxicillin include allergic or hypersensitivity reactions. If you experience adverse events like trouble breathing or severe rash, seek medical attention immediately.

Side effect Applicable? Frequency Applicable? Frequency
Diarrhea Yes 15% Yes >1%
Nausea Yes 3% Yes >1%
Vomiting Yes 0.7% Yes >1%
Headache Yes 2% Yes 6%
Rash Yes 0.9% Yes >1%

This may not be a complete list. Consult your doctor or pharmacist for possible side effects.
Source: DailyMed (Cefdinir), DailyMed (amoxicillin)

Drug interactions of cefdinir vs. amoxicillin

Cefdinir interacts with antacids as well as iron supplements. Antacids and iron supplements can lower the absorption of cefdinir and decrease its effectiveness. Cefdinir should be taken at least two hours before or after administering these other medications.

Both cefdinir and amoxicillin can interact with anti-gout medications like probenecid and allopurinol. Anti-gout agents can increase the blood levels of cefdinir and amoxicillin, which can lead to increased side effects.

Cefdinir and amoxicillin have been known to cause prolonged prohrombin time in those who are also taking warfarin. This drug interaction can cause an increased risk of bleeding.

Antibiotics have been known to decrease the effectiveness of oral contraceptives. Alternate birth control methods may be needed to reduce the risk of pregnancy.

Aluminum hydroxide
Magnesium hydroxide
Antacids Yes No
Ferrous sulfate
Ferrous gluconate
Ferrous fumarate
Iron supplements Yes No
Probenecid
Allopurinol
Antigout Yes Yes
Warfarin Anticoagulant Yes Yes
Ethinyl estradiol
Levonorgestrel
Norethindrone
Oral contraceptives Yes Yes

This may not be a complete list of all possible drug interactions. Consult a doctor with all the medications you may be taking.

Warnings of cefdinir and amoxicillin

Cefdinir and amoxicillin should be avoided if you have a penicillin allergy. Because these drugs are chemically similar to penicillin, they may cause a severe allergic reaction if you have an established penicillin allergy.

Diarrhea is one of the most common side effects of antibiotics like cefdinir and amoxicillin. These antibiotics can also increase the risk of a more severe type of diarrhea caused by Clostridium difficile. If you have a medical history of C. diff infections, the use of these antibiotics may need to be monitored or discontinued.

These antibiotics should only be prescribed for infections caused by bacteria. They are not effective against viral infections such as COVID-19. Cefdinir and amoxicillin are most effective when they are targeting susceptible bacteria. If they are used inappropriately, the bacteria can gain antibiotic resistance and cause a more severe infection.

Frequently asked questions about cefdinir vs. amoxicillin

What is cefdinir?

Cefdinir is a third-generation cephalosporin that is used to treat bacterial infections like acute otitis media and pharyngitis. It is also FDA-approved to treat certain skin infections and lower respiratory tract infections. Cefdinir is also known by its brand name Omnicef.

What is amoxicillin?

Amoxicillin is a penicillin-type antibiotic that is used to treat various bacterial infections of the ear, nose, and throat. It can also treat lower respiratory tract infections, H. pylori infections, and gonorrhea. Amoxicillin is often combined with clavulanate, or clavulanic acid, under the brand name Augmentin.

Are cefdinir and amoxicillin the same?

Cefdinir and amoxicillin are not the same. Although they are both part of an umbrella group of antibiotics called beta-lactams, they have different nuances in how they’re used and dosed.

Is cefdinir or amoxicillin better?

The more effective antibiotic is the one that works best against the bacterial strain causing the infection. For example, amoxicillin is better for H. pylori infections. However, some people may prefer cefdinir in a once-daily option for other infections.

Can I use cefdinir or amoxicillin while pregnant?

There have been no adequate clinical studies to show that cefdinir or amoxicillin are safe while pregnant. They are both deemed Pregnancy Category B drugs, which indicates a low risk for birth defects. Still, they should only be used if necessary. Consult a healthcare provider for medical advice on the best option during pregnancy.

Can I use cefdinir or amoxicillin with alcohol?

Alcohol does not directly interact with cefdinir or amoxicillin. However, it is not generally recommended to drink alcohol with antibiotics. Consuming excessive amounts of alcohol can increase the risk of adverse side effects like nausea and vomiting. Alcohol can also weaken the immune system and make it harder for the body to fight infections.

Omnicef Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Diarrhea, headache, or nausea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may cause your stools to turn a reddish color, especially if you also take iron products. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these rare but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, unusual fatigue, new signs of infection (e.g., persistent sore throat, fever), easy bruising/bleeding, signs of kidney problems (such as change in the amount of urine), mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea or opioid medications if you have the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Comparison of a 5 day regimen of cefdinir with a 10 day regimen of cefprozil for treatment of acute exacerbations of chronic bronchitis | Journal of Antimicrobial Chemotherapy

Abstract

Patients with acute exacerbations of chronic bronchitis were treated with cefdinir 300 mg bd for 5 days or cefprozil 500 mg bd for 10 days in a prospective, randomized, double-blind, multicentre study. Of the 548 patients enrolled, 281 (51%) were evaluable. The clinical cure rates at the test-of-cure visit were 80% (114/142) and 72% (100/139) for the evaluable patients treated with cefdinir and cefprozil, respectively. Respiratory tract pathogens were isolated from 409 (75%) of 548 admission sputum specimens, with the predominant pathogens being Haemophilus parainfluenzae, Haemophilus influenzae, Staphylococcus aureus and Moraxella catarrhalis. The microbiological eradication rates at the test-of-cure visit were 81% (157 of 193 pathogens) and 84% (166 of 198 pathogens) for the evaluable patients treated with cefdinir and cefprozil, respectively. Adverse event rates while on treatment were equivalent between the two treatment groups. The incidence of diarrhoea during therapy was higher for patients treated with cefdinir (17%) than for patients treated with cefprozil (6%) (P < 0.01), but most cases were mild and did not lead to discontinuation of treatment. These results indicate that a 5 day regimen of cefdinir is as effective and safe in the treatment of patients with acute exacerbations of chronic bronchitis as a 10 day regimen of cefprozil.

Introduction

Chronic bronchitis is an inflammatory condition of the lower respiratory tract and is characterized by cough and sputum production on most days during three consecutive months for more than two successive years.1 Contributing conditions leading to the development of the disease include a history of smoking, exposure to airborne particulate and gaseous irritants, previous episodes of respiratory tract disease, and familial and genetic factors.15 Acute exacerbations of chronic bronchitis (AECB) are frequently experienced by patients with chronic bronchitis and are characterized by symptoms such as increased cough and shortness of breath and increased sputum volume and purulence. 6,7

While viral infection, allergy, exposure to pollutants (including cigarette smoke) and even congestive heart failure have been implicated in the aetiology of AECB, bacterial infection also plays a significant role.2,8,9 This was well demonstrated in a study using fibre optic bronchoscopy with a protected specimen brush to sample distal secretions in patients with severe AECB, thus minimizing contamination from the oropharyngeal cavity.10 Pathogens were isolated in 50% of patients, the predominant organisms being Haemophilus parainfluenzae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae.

Given the multifactorial aetiology of AECB, studies examining the role of antibiotic therapy have yielded conflicting results until recently.8 A meta-analysis done to clarify the divergent results of these studies suggested a small but statistically significant improvement in clinical outcome in patients given antibiotic therapy, particularly those with severe symptoms. 11 A landmark study by Anthonisen and colleagues12 found that antibiotic-treated patients had a significantly better success rate than placebo-treated patients. Antibiotic-treated patients were also significantly less likely to have clinical deterioration after the first 72 h of treatment. Overall, the efficacy of antibiotic treatment varied with the amount of sputum produced, sputum appearance and dyspnoea seen at the start of exacerbations. Those in whom all three cardinal symptoms were, at the time of admittance to the study, worse than their normal condition showed the most improvement after antibiotic treatment compared with placebo controls.

Cefdinir (CI-983, FK482, Omnicef) is a semisynthetic, extended-spectrum oral cephalosporin antibiotic approved for use in patients with mild to moderate AECB, community-acquired pneumonia, acute otitis media, acute maxillary sinusitis, pharyngitis/tonsillitis and skin and soft tissue infections. For these infections treatment is usually given for 10 days. However, according to information supplied with Omnicef packages, cefdinir is also effective as a 5 day treatment in adults and children with tonsillitis/ pharyngitis. Given issues such as patient compliance and the benefits of prompt control with short-term therapy, this study was conducted to evaluate a 5 day course of cefdinir for patients with AECB.

Patients and methods

Patient selection

This was a double-blind, prospective, randomized, study conducted at 32 sites in the USA between January 1996 and July 1997. Patients all had chronic bronchitis, defined as cough and sputum production for at least three consecutive months in at least two years. Inclusion criteria included: AECB (confirmed by the presence of increased cough/ sputum production in the absence of an infiltrate on a chest X-ray) and age ≥13 years. Women of child-bearing potential were required to have a negative urine pregnancy test. Patients were excluded from the study if they were pregnant or lactating, had concomitant diseases which may have precluded proper assessment of the disease under study, had hepatic disease or obstruction of the biliary tract, had a baseline serum creatinine level more than twice the upper limit of normal or a known creatinine clearance of <30 mL/min, were allergic to β-lactam antibiotics, had concomitant infections requiring systemic antibacterial therapy, received any other investigational compound within 4 weeks before entering this study, participated in any other cefdinir study, were receiving probenecid or iron-containing supplements, or had taken an antibiotic within 7 days before anticipated study admission. All investigators received Institutional Review Board approval for the protocol before beginning the study and all patients (or their guardians) provided written informed consent before study entry. The study was conducted according to the Declaration of Helsinki.

Microbiological investigations

All patients produced a sputum specimen at study entry. Those specimens that contained >25 neutrophils and ≤10 epithelial cells per low-power (100×) microscopical field were submitted for culture. A central laboratory (Mayo Medical Laboratories, Rochester, MN, USA) performed cultures and susceptibility testing according to NCCLS criteria.13,14 Cefdinir was tested by disc diffusion (with a 5 μg disc) and microdilution (with Sensititre plates). Cefprozil was tested by disc diffusion only. For cefdinir testing by disc diffusion, susceptibility was defined as a zone diameter of ≥20 mm, intermediate susceptibility as a zone diameter of 17–19 mm, and resistance as a zone diameter of ≤16 mm. For cefdinir testing by microdilution, susceptibility was defined as an MIC of ≤1 mg/L, intermediate susceptibility as an MIC of 2 mg/L, and resistance as an MIC of ≥4 mg/L. Published standards were used for the cefprozil susceptibility breakpoints. Penicillin susceptibility results were used to define susceptibility of Streptococcus pneumoniae to cefdinir and cefprozil. Appropriate strains (Haemophilus spp. and M. catarrhalis) were also tested for β-lactamase production with nitrocefin discs.

Antimicrobial therapy

Patients were randomized (1:1) to either cefdinir 300 mg bd or cefprozil 500 mg bd. Cefprozil was chosen as the comparator agent because it is approved for the treatment of patients with AECB and for more severe lower respiratory infections such as pneumonia. Medication was supplied as capsules in a double-blind, double-dummy fashion. Patients were asked not to take antacids for 2 h before and after study medication dosing. Medication was taken without regard to meals. The investigator, the patient and the sponsor were blinded to the treatment regimen until all patients had completed the study and all assessments had been performed.

Clinical, microbiological and safety assessments

Each patient was assessed at admission (study entry) and on study days 12–16, 17–21 and 28–42. The test-of-cure (TOC) visit for each regimen was conducted 7–11 days after patients had stopped taking study medication. A constant time interval between completion of study medication and assessment would allow equal intervals for suppressed clinical symptoms and cultures to reappear in the two groups. Thus the TOC for those patients randomized to cefdinir was on study days 12–16 and that for patients randomized to cefprozil was on study days 17–21. The long-term follow-up visit (LTFU), conducted to examine long-term clinical and microbiological outcomes, was not considered as crucial as the TOC and, hence, was conducted on study days 28–42 for both regimens.

Clinical signs and symptoms of cough, sputum production and dyspnoea were graded at each study visit as absent, mild, moderate or severe. Sputum was graded as absent, mucoid, mucopurulent/blood-streaked or purulent. Rales, rhonchi, wheezing and pleural rub were graded as absent or present. Fremitus was graded as increased, normal or decreased. Temperature was recorded. Sputum was collected for culture at the admission visit and, if available, at subsequent visits. Blood and urine were collected for safety tests at the admission visit and at the first visit after therapy. If abnormalities were seen at the first visit after therapy, a repeat test was performed at the next visit. A brief physical examination was performed at study entry and at all visits after therapy. Patients were queried in a non-specific fashion for adverse events at each visit.

Efficacy criteria

Overall clinical efficacy was assessed by the investigators at the TOC and LTFU visits. Clinical cure was defined as absence or significant remission of all admission signs and symptoms. Failure was defined as lack of significant remission of signs and symptoms and/or the requirement for further antibiotic treatment. Recurrence was defined as worsening of signs and symptoms at the LTFU after cure at the TOC visit. Admission pathogens that were not present at the follow-up visit were classified as eradicated, and those that remained were defined as persistent. If clinical improvement occurred such that no sputum was available for culture at follow-up visits, the pathogen was considered to have been eradicated. Superinfection was defined as the appearance of a new pathogen between the admission and TOC visits with a concomitant worsening of clinical condition. Reinfection was deemed to have occurred if any new pathogen was seen between the TOC visit and the LTFU visit with an accompanying worsening of clinical condition.

Evaluability criteria

Patients were classified as evaluable if the admission chest X-ray did not indicate a pulmonary infiltrate or consolidation, at least one respiratory tract pathogen was isolated from the admission sputum specimen, each respiratory tract pathogen isolated at admission was susceptible (or intermediately susceptible) to both study drugs, clinical and microbiological assessments were available 7–11 days after therapy (except for failures before this visit), no non-study antimicrobials were given in the 7 days before the beginning of this study, study medication was taken as prescribed, ≥80% of assigned study medication was taken (i. e. for ≥4 days for cefdinir, and ≥8 days for cefprozil) (≥2 days for early failures), no concurrent systemic antimicrobials were taken, there were no concurrent infections which could have confounded the assessment of AECB and there was no intentional violation of randomization. A subset of evaluable patients, the ‘qualified patients’, was examined at LTFU. Qualified patients were evaluable patients who did not have any additional protocol violations between the TOC and LTFU visits.

Patients were deemed clinically evaluable if they had clinical evidence of AECB without radiographic evidence of pneumonia, had no resistant organisms at baseline, took study drug as prescribed, did not take non-study systemic antibacterial therapy for concurrent infections and were clinically assessed on the days specified in the protocol. Therapy duration and prior antibacterial rules described above for evaluable patients also applied for clinically evaluable patients. Patients were not excluded from this data set as a result of inadequate microbiological data (i. e. no baseline pathogen, missing microbiological data at baseline or follow-up, or microbiological data collected on days other than those specified in the protocol).

Patients in the intent-to-treat population were all those randomized to treatment.

Statistical analyses

The study was designed with a sample size of 190 evaluable patients per treatment group. Assuming a clinical response rate of 90%, this sample size would provide at ≥80% power to assess the equivalence of the cefdinir and cefprozil treatment groups.

Two-tailed 95% confidence intervals (CI) were calculated around the difference between microbiological eradication and clinical response rates (e.g. cefdinir minus cefprozil) and compared with a set of fixed criteria. For the treatments to be equivalent, each 95% CI had to contain 0 and fall within specific boundaries (if the estimated response rate was ≥90%, the 95% CI for the difference had to be ±10%; if the estimated response rate was 80–89%, the 95% CI had to be ±15%; and if the estimated response rate was 70–79%, the 95% CI had to be ±20%).

Cochran–Mantel–Haenszel tests using a 5% level of significance, stratified by study centre, were performed to detect treatment differences with respect to the incidence of adverse events, associated adverses and diarrhoea, and to discontinuation of study medication owing to adverse events, as well as differences in baseline susceptibility to study drugs. All statistical tests were performed with SAS software.

Results

Of the 548 patients enrolled, 278 were randomized to the cefdinir group and 270 to the cefprozil group. Patients were evenly distributed by gender, race and age across both treatment groups. About one-third of the patients in each treatment group were aged ≥65 years (Table I).

The median time for which patients took study medication was 5 days for cefdinir and 10 days for cefprozil.

The presence and severity of clinical signs and symptoms at study admission were similar for patients in the two treatment groups (data not shown). Most of the patients in both treatment arms were current or former smokers.

Evaluable patients were classified according to sputum production, sputum purulence and dyspnoea at admission using the criteria proposed by Anthonisen et al.12 Table II shows that the majority of the evaluable patients were of type 1 or type 2.

Antimicrobial susceptibility

Of the 548 patients enrolled, 409 (75%) had at least one respiratory tract pathogen isolated from the admission sputum specimen. For the most prevalent of these isolates, their susceptibilities to the study drugs are shown in Table III. At admission, 6% (37/598) of the pathogens were resistant to cefdinir and 10% (61/594) to cefprozil. (These rates include S. pneumoniae strains intermediately susceptible to penicillin.) This difference in resistance rates was statistically significant (P < 0.01). Twenty-five per cent of the H. influenzae, 7% of the H. parainfluenzae and 87% of the M. catarrhalis obtained at admission were β-lactamase producers.

Efficacy

Of the 548 randomized patients, 281 (51%) were fully evaluable, 142 in the cefdinir arm and 139 in the cefprozil arm. Table IV presents the microbiological and clinical efficacy outcomes at TOC for these patients. The observed clinical cure rate among cefdinir-treated patients of 80% was not equivalent to that for cefprozil-treated patients (72%), since the 95% CI around the difference in clinical cure rates (–1.6%, 18.3%) exceeded the predefined criterion of ±15%.

The overall rates of microbiological eradication of pathogens were 81% for cefdinir-treated patients and 84% for cefprozil-treated patients (95% CI: –10.0%, 5%), demonstrating equivalence. Table IV also presents microbiological eradication data at TOC for the most prevalent pathogens.

Patients were most frequently excluded from the evaluable subset because no respiratory tract pathogen was isolated from the admission sputum specimen (83 cefdinir-treated patients, 56 cefprozil-treated patients). Other common reasons for exclusion included clinical and microbiological assessments having been done at different times from those specified in the protocol, both occurring slightly more frequently in the cefprozil treatment group. Patients could have been excluded for more than one reason.

Among qualified patients who had all admission pathogens eradicated at the TOC visit, the rates of microbiological eradication by pathogen at the LTFU visit were 94% (135/143) in the cefdinir group and 89% (127/142) in the cefprozil group. Among qualified patients who were classified as cures at the TOC visit, the continued cure rates at the LTFU visit were 84% (84/100) in the cefdinir group and 87% (82/94) in the cefprozil group.

In the clinically evaluable population at the TOC visit, the overall clinical cure rates were 82% (180/220) in the cefdinir group and 74% (142/192) in the cefprozil group (95% CI: –17.2%, 15.90%).

In the intent-to-treat population, the clinical cure rate in cefdinir-treated patients (78%, 217/278) was equivalent to that of cefprozil-treated patients (74%, 200/270) (95% CI: –3. 2%, 11.1%). The overall rate of microbiological eradication of admission pathogens in cefdinir-treated patients (79%, 225/286) was equivalent to that in cefprozil-treated patients (81%, 255/316) (95% CI: –8.5%, 4.4%).

No admission strains of H. influenzae resistant or intermediate to cefdinir were isolated from cefdinir-treated patients. Three admission strains of H. influenzae resistant to cefprozil were isolated from three cefprozil-treated patients. All three of these patients were classified as cures at the TOC visit; two of the three strains were eradicated at the TOC visit. Six admission strains of H. influenzae intermediately susceptible to cefprozil were isolated from six cefprozil-treated patients. Four of these six patients were classified as cures at TOC; all but one strain was eradicated at TOC.

Four admission isolates of S. aureus were methicillin resistant (MRSA). One of these strains was isolated from a patient randomized to cefdinir. This patient was lost to follow up. Three of the admission MRSAs were isolated from patients randomized to cefprozil. Two of these three patients were classified as a cure at TOC and one was a failure. All three strains were eradicated at TOC.

One admission isolate of S. pneumoniae was resistant to penicillin. This strain was isolated from a cefprozil-treated patient and was susceptible to cefprozil. The patient was classified as a failure at TOC and the strain persisted at TOC. Ten admission isolates of S. pneumoniae were intermediately susceptible to penicillin. Four of these isolates were from four patients randomized to cefdinir. Three of these four strains were susceptible to cefdinir; one was intermediately susceptible to cefdinir. All four patients were cures at TOC and all four strains were eradicated at TOC. Six admission isolates of S. pneumomiae intermediately susceptible to penicillin were from six patients randomized to cefprozil. All of these isolates were susceptible to cefprozil. Four of these six patients were classified as failures at TOC, one was a cure and one was unknown. Five of the six strains persisted at TOC; the status of the sixth strain was unknown.

Nineteen (7%) cefdinir patients and 21 (8%) cefprozil patients experienced superinfections. The most prevalent superinfecting pathogen was H. parainfluenzae (in seven patients in the cefdinir group and six in the cefprozil group). None of these superinfecting H. parainfluenzae were resistant to cefdinir, but two of six were resistant to cefprozil. Reinfections were seen in eight patients in the cefdinir arm and five patients in the cefprozil arm.

Ten cefdinir-treated patients satisfied all evaluability criteria except that they had at least one admission pathogen that was susceptible to cefdinir and resistant to cefprozil. Cefdinir eradicated 75% (nine of 12) of admission pathogens from these patients at the TOC visit. Six of the 10 patients were assessed as clinical cures at the TOC visit.

Safety

Safety of the drugs was analysed for all patients who received study medication. Of these patients, 95 (34%) patients receiving cefdinir and 89 (33%) patients receiving cefprozil experienced at least one adverse event during treatment (P = 0.90). Sixty-two (22%) of the patients treated with cefdinir and 51 (19%) of patients treated with cefprozil experienced at least one adverse event during the treatment phase which the investigator considered to be drug-related (possibly, probably or definitely caused by the study drug) (P = 0.39).

The most frequent adverse events on therapy for both cefdinir- and cefprozil-treated patients were diarrhoea and headache. Seventeen per cent of cefdinir-treated patients and 6% of cefprozil-treated patients experienced diarrhoea during treatment (P < 0.01).

Eleven (4%) patients treated with cefdinir and seven (3%) treated with cefprozil stopped treatment as a result of an adverse event (P= 0. 44). The most common adverse events given as reasons for discontinuing cefdinir were diarrhoea and abdominal pain.

Two patients died during the study, one in the cefdinir arm and one in the cefprozil arm. Neither death was related to study medication.

The clinical laboratory changes from admission to the first visit after therapy showed no clinically significant changes except for a trend toward lower leucocyte and polymorphonuclear leucocyte counts, as well as lower urine leucocyte counts and urine ketone concentrations, for both treatment groups. Cefprozil patients also tended to have lower urine protein, urine blood and urine bilirubin concentrations at the first visit after therapy compared with admission values.

Discussion

This study demonstrated that a 5 day course of cefdinir was associated with improved clinical outcome and equivalent microbiological outcome, compared with a conventional 10 day course of cefprozil.

These results confirm those of several other studies which have shown that AECB can be treated successfully with short-course therapy. In one study, a favourable clinical response (cure or improvement) was seen in 89.5% of dirithromycin-treated patients (5 days of therapy) and 94.8% of patients treated with the comparative agent, clarithromycin (7 days of therapy), at the first visit after therapy.15 At the same visit, a favourable bacteriological response was seen in 68.8% of dirithromycin-treated patients and 71.9% of clarithromycin-treated patients.

A study involving AECB patients treated with cefixime for 5 or 10 days demonstrated clinical efficacy (cure or improvement) in 91% of patients who received cefixime for 5 days and in 89% of those patients who received cefixime for 10 days.16 Successful bacteriological efficacy was achieved in 71% of patients in the 5 day group and 82% of those in the 10 day group. Langan and colleagues treated AECB patients with cefuroxime axetil for 5 days. 17 In this study, clinical success (cure or improvement) in the intent-to-treat population was achieved in 82% of patients who received cefuroxime axetil for 5 days and 82% in patients who received clarithromycin for 7 days. Post-treatment bacteriological response in those patients who had a pre-treatment pathogen was 73% for cefuroxime axetil and 82% for clarithromycin. Guest & Langan18 found clinical success (cure or improvement) at the end of therapy was 92% for patients who received ceftibuten for 5 days and 93% for those who received amoxycillin–clavulanate for 10 days.

Staphylococcus aureus was one of the most common isolates from patients in this study. Traditionally, this organism has not been considered a common respiratory tract pathogen in patients with AECB. However, there are now many reports in the literature suggesting that the organism is isolated regularly from patients with AECB.4,10,1517,2027 The presence of purulent or mucopurulent sputum in all admission sputum specimens, and the presence of Gram-positive cocci in the majority of sputum specimens in evaluable patients whose admission cultures yielded S. aureus (data not shown), also support the pathogenic role of this organism.

Anthonisen and colleagues have proposed a grading scale for chronic bronchitis exacerbations:12 type 1 exacerbations are those in which increased dyspnoea, sputum volume and sputum purulence all occur; type 2 exacerbations are those where two of the three above symptoms are present; type 3 exacerbations are those in which only one of the three above symptoms is present with at least one of several additional respiratory tract findings. In a placebo-controlled trial of patients with AECB, Anthonisen’s group found c. 40% of the exacerbations were classified as type 1 and 40% as type 2. Similar findings were observed in our evaluable patient population: 87.3% of cefdinir-treated patients and 91.4% of cefprozil-treated patients were of type 1 or 2 (Table II).

The incidence of adverse events or drug-associated adverse events experienced by patients while on treatment, and the incidence of treatment discontinuations owing to adverse events, did not differ between the two treatment groups. Significantly more patients in the cefdinir group experienced diarrhoea during study therapy than in the cefprozil group, but most cases were mild and did not lead to discontinuation of treatment.

In this study, clinical outcomes were better in cefdinir-treated patients than in cefprozil-treated patients. Cefdinir and cefprozil were microbiologically equivalent in the eradication of admission pathogens. The advantage of less drug exposure (leading to a decreased risk of selecting resistant organisms), the convenience of 5 day dosing and the greater in vitro antimicrobial activity of cefdinir compared with cefprozil,28 make cefdinir an attractive agent for the treatment of AECB.

Value for group
Variable
cefdinir
cefprozil
No. of patients  278  270 
Gender, n (%)     
male  142 (51. 1)  137 (50.7) 
female  136 (48.9)  133 (49.3) 
Race, n (%)     
White, non-Hispanic  254 (91.4)  251 (93.0) 
Black, non-Hispanic  17 (6.1)  14 (5.2) 
Hispanic, White or Black  5 (1.8)  3 (1.1) 
Asian or Pacific islander  1 (0.4)  1 (0.4) 
American Indian or Alaskan native  1 (0.4)  1 (0.4) 
Age (years)     
median  54.0  57.0 
range  15.0–84.0  13.0–87.0 
distribution, n (%)     
13 to <18 years  2 (0.7)  5 (1.9) 
18 to <65 years  186 (66.9)  175 (64.8) 
≥65 years  90 (32.4)  90 (33.3) 
Smoking status     
never smoked  49 (17. 6)  46 (17.0) 
past smoker  114 (41.0)  106 (39.3) 
current smoker  115 (41.4)  118 (43.7)118 (43.7) 
Value for group
Variable
cefdinir
cefprozil
No. of patients  278  270 
Gender, n (%)     
male  142 (51.1)  137 (50.7) 
female  136 (48.9)  133 (49.3) 
Race, n (%)     
White, non-Hispanic  254 (91.4)  251 (93.0) 
Black, non-Hispanic  17 (6.1)  14 (5.2) 
Hispanic, White or Black  5 (1.8)  3 (1.1) 
Asian or Pacific islander  1 (0. 4)  1 (0.4) 
American Indian or Alaskan native  1 (0.4)  1 (0.4) 
Age (years)     
median  54.0  57.0 
range  15.0–84.0  13.0–87.0 
distribution, n (%)     
13 to <18 years  2 (0.7)  5 (1.9) 
18 to <65 years  186 (66.9)  175 (64.8) 
≥65 years  90 (32.4)  90 (33.3) 
Smoking status     
never smoked  49 (17.6)  46 (17.0) 
past smoker  114 (41.0)  106 (39.3) 
current smoker  115 (41.4)  118 (43.7)118 (43.7) 
Value for group
Variable
cefdinir
.  
cefprozil
No. of patients  278  270 
Gender, n (%)     
male  142 (51.1)  137 (50.7) 
female  136 (48.9)  133 (49.3) 
Race, n (%)     
White, non-Hispanic  254 (91.4)  251 (93.0) 
Black, non-Hispanic  17 (6.1)  14 (5.2) 
Hispanic, White or Black  5 (1.8)  3 (1.1) 
Asian or Pacific islander  1 (0.4)  1 (0.4) 
American Indian or Alaskan native  1 (0.4)  1 (0.4) 
Age (years)     
median  54.0  57.0 
range  15.0–84.0  13.0–87.0 
distribution, n (%)     
13 to <18 years  2 (0. 7)  5 (1.9) 
18 to <65 years  186 (66.9)  175 (64.8) 
≥65 years  90 (32.4)  90 (33.3) 
Smoking status     
never smoked  49 (17.6)  46 (17.0) 
past smoker  114 (41.0)  106 (39.3) 
current smoker  115 (41.4)  118 (43.7)118 (43.7) 
Value for group
Variable
cefdinir
cefprozil
No. of patients  278  270 
Gender, n (%)     
male  142 (51.1)  137 (50.7) 
female  136 (48.9)  133 (49.3) 
Race, n (%)     
White, non-Hispanic  254 (91. 4)  251 (93.0) 
Black, non-Hispanic  17 (6.1)  14 (5.2) 
Hispanic, White or Black  5 (1.8)  3 (1.1) 
Asian or Pacific islander  1 (0.4)  1 (0.4) 
American Indian or Alaskan native  1 (0.4)  1 (0.4) 
Age (years)     
median  54.0  57.0 
range  15.0–84.0  13.0–87.0 
distribution, n (%)     
13 to <18 years  2 (0.7)  5 (1.9) 
18 to <65 years  186 (66.9)  175 (64.8) 
≥65 years  90 (32.4)  90 (33.3) 
Smoking status     
never smoked  49 (17.6)  46 (17.0) 
past smoker  114 (41.0)  106 (39.3) 
current smoker  115 (41. 4)  118 (43.7)118 (43.7) 

Table II.

Exacerbation type (%) in evaluable patientsa


Cefdinir (n = 142)
Cefprozil (n = 139)
Type 1
57.0
59.0
aType 1 exacerbations were those with increased dyspnoea, sputum volume and sputum purulence. Type 2 exacerbations occurred when two of the three above symptoms were present. Type 3 exacerbations include patients with one of the three above symptoms present with or without at least one of several additional respiratory tract findings (does not conform to the strict definition described in ref. 12). 
Type 2  30.3  32.4 
Type 3  12. 8.6 

Cefdinir (n = 142)
Cefprozil (n = 139)
Type 1
57.0
59.0
aType 1 exacerbations were those with increased dyspnoea, sputum volume and sputum purulence. Type 2 exacerbations occurred when two of the three above symptoms were present. Type 3 exacerbations include patients with one of the three above symptoms present with or without at least one of several additional respiratory tract findings (does not conform to the strict definition described in ref. 12). 
Type 2  30.3  32.4 
Type 3  12.7  8.6 

Table II.

Exacerbation type (%) in evaluable patientsa


.  
Cefdinir (n = 142)
Cefprozil (n = 139)
Type 1
57.0
59.0
aType 1 exacerbations were those with increased dyspnoea, sputum volume and sputum purulence. Type 2 exacerbations occurred when two of the three above symptoms were present. Type 3 exacerbations include patients with one of the three above symptoms present with or without at least one of several additional respiratory tract findings (does not conform to the strict definition described in ref. 12). 
Type 2  30.3  32.4 
Type 3  12.7  8.6 

Cefdinir (n = 142)
Cefprozil (n = 139)
Type 1
.  
57.0
59.0
aType 1 exacerbations were those with increased dyspnoea, sputum volume and sputum purulence. Type 2 exacerbations occurred when two of the three above symptoms were present. Type 3 exacerbations include patients with one of the three above symptoms present with or without at least one of several additional respiratory tract findings (does not conform to the strict definition described in ref. 12). 
Type 2  30.3  32.4 
Type 3  12.7  8.6 

Table III.

Susceptibilities of the most prevalent admission pathogens to cefdinir and cefprozil




Categorya (n)
.  
Pathogen and characteristic
Number of isolates
Antimicrobial agent
S
I
R
U
aS, susceptible; I, intermediate; R, resistant; U, unknown. 
bRefers to penicillin susceptibility 
H. influenzae             
β-lactamase-negative  80  cefdinir  78 
    cefprozil  68 
β-lactamase-positive  27  cefdinir  27 
    cefprozil  17 
H. parainfluenzae             
β-lactamase-negative  154  cefdinir  150 
    cefprozil  150 
β-lactamase-positive  11  cefdinir  10 
    cefprozil 
M. catarrhalis             
β-lactamase-negative  cefdinir 
    cefprozil 
β-lactamase-positive  41  cefdinir  40 
    cefprozil  33 
S. aureus  78  cefdinir  75 
    cefprozil  74 
S. pneumoniaeb  30  cefdinir  19  10 
    cefprozil  19  10 
    cefprozil  19  10 



Categorya (n)
Pathogen and characteristic
Number of isolates
Antimicrobial agent
S
I
R
U
aS, susceptible; I, intermediate; R, resistant; U, unknown.  
bRefers to penicillin susceptibility 
H. influenzae             
β-lactamase-negative  80  cefdinir  78 
    cefprozil  68 
β-lactamase-positive  27  cefdinir  27 
    cefprozil  17 
H. parainfluenzae             
β-lactamase-negative  154  cefdinir  150 
    cefprozil  150 
β-lactamase-positive  11  cefdinir  10 
    cefprozil 
M. catarrhalis             
β-lactamase-negative  cefdinir 
    cefprozil 
β-lactamase-positive  41  cefdinir  40 
    cefprozil  33 
S. aureus  78  cefdinir  75 
    cefprozil  74 
S. pneumoniaeb  30  cefdinir  19  10 
    cefprozil  19  10 
    cefprozil  19  10 

Table III.

Susceptibilities of the most prevalent admission pathogens to cefdinir and cefprozil




Categorya (n)
Pathogen and characteristic
Number of isolates
Antimicrobial agent
S
I
R
U
aS, susceptible; I, intermediate; R, resistant; U, unknown. 
bRefers to penicillin susceptibility 
H. influenzae             
β-lactamase-negative  80  cefdinir  78 
    cefprozil  68 
β-lactamase-positive  27  cefdinir  27 
    cefprozil  17 
H. parainfluenzae             
β-lactamase-negative  154  cefdinir  150 
    cefprozil  150 
β-lactamase-positive  11  cefdinir  10 
    cefprozil 
M. catarrhalis             
β-lactamase-negative  cefdinir 
    cefprozil 
β-lactamase-positive  41  cefdinir  40 
    cefprozil  33 
S. aureus  78  cefdinir  75 
    cefprozil  74 
S. pneumoniaeb  30  cefdinir  19  10 
    cefprozil  19  10 
    cefprozil  19  10 



Categorya (n)
Pathogen and characteristic
Number of isolates
Antimicrobial agent
S
I
R
U
aS, susceptible; I, intermediate; R, resistant; U, unknown.  
bRefers to penicillin susceptibility 
H. influenzae             
β-lactamase-negative  80  cefdinir  78 
    cefprozil  68 
β-lactamase-positive  27  cefdinir  27 
    cefprozil  17 
H. parainfluenzae             
β-lactamase-negative  154  cefdinir  150 
    cefprozil  150 
β-lactamase-positive  11  cefdinir  10 
    cefprozil 
M. catarrhalis             
β-lactamase-negative  cefdinir 
    cefprozil 
β-lactamase-positive  41  cefdinir  40 
    cefprozil  33 
S. aureus  78  cefdinir  75 
    cefprozil  74 
S. pneumoniaeb  30  cefdinir  19  10 
    cefprozil  19  10 
    cefprozil  19  10 

Table IV.

Efficacy rates in evaluable patients at the TOC visit


Value for group

cefdinir
cefprozil
Efficacy parameter
n/Na
%
n/N
%
an/N (clinical) is the number of clinical cures divided by the number of patients; n/N (microbiological) is the number of pathogens eradicated divided by the number of pathogens isolated. 
bAll were susceptible to penicillin. 
Clinical cure  114/142  80.3  100/139  71.
Microbiological eradication         
H. influenzae  32/43  74.4  26/33  78.8 
H. parainfluenzae  48/57  84.2  49/58  84.5 
M. catarrhalis  16/19  84.2  15/18  83.3 
S. aureus  29/30  96.7  24/26  92.3 
S. pneumoniaeb  3/4  75.0  9/11  81.8 
other  29/40  72.5  43/52  82.7 
total  157/193  81.3  166/198  83.8 

Value for group

cefdinir
cefprozil
.  
Efficacy parameter
n/Na
%
n/N
%
an/N (clinical) is the number of clinical cures divided by the number of patients; n/N (microbiological) is the number of pathogens eradicated divided by the number of pathogens isolated. 
bAll were susceptible to penicillin. 
Clinical cure  114/142  80.3  100/139  71.9 
Microbiological eradication         
H. influenzae  32/43  74.4  26/33  78.8 
H. parainfluenzae  48/57  84.2  49/58  84.
M. catarrhalis  16/19  84.2  15/18  83.3 
S. aureus  29/30  96.7  24/26  92.3 
S. pneumoniaeb  3/4  75.0  9/11  81.8 
other  29/40  72.5  43/52  82.7 
total  157/193  81.3  166/198  83.8 

Table IV.

Efficacy rates in evaluable patients at the TOC visit


Value for group

cefdinir
cefprozil
Efficacy parameter
n/Na
%
n/N
.  
%
an/N (clinical) is the number of clinical cures divided by the number of patients; n/N (microbiological) is the number of pathogens eradicated divided by the number of pathogens isolated. 
bAll were susceptible to penicillin. 
Clinical cure  114/142  80.3  100/139  71.9 
Microbiological eradication         
H. influenzae  32/43  74.4  26/33  78.8 
H. parainfluenzae  48/57  84.2  49/58  84.5 
M. catarrhalis  16/19  84.2  15/18  83.3 
S. aureus  29/30  96.7  24/26  92.
S. pneumoniaeb  3/4  75.0  9/11  81.8 
other  29/40  72.5  43/52  82.7 
total  157/193  81.3  166/198  83.8 

Value for group

cefdinir
cefprozil
Efficacy parameter
n/Na
%
n/N
%
an/N (clinical) is the number of clinical cures divided by the number of patients; n/N (microbiological) is the number of pathogens eradicated divided by the number of pathogens isolated.  
bAll were susceptible to penicillin. 
Clinical cure  114/142  80.3  100/139  71.9 
Microbiological eradication         
H. influenzae  32/43  74.4  26/33  78.8 
H. parainfluenzae  48/57  84.2  49/58  84.5 
M. catarrhalis  16/19  84.2  15/18  83.3 
S. aureus  29/30  96.7  24/26  92.3 
S. pneumoniaeb  3/4  75.0  9/11  81.8 
other  29/40  72.5  43/52  82.7 
total  157/193  81.3  166/198  83.8 

The participation of the following investigators in the USA is gratefully acknowledged: Jackson Rhudy, Salt Lake City, UT; Robert Bettis, Edmonds, WA; Robert E. Bryant, Pinson, AL; Dennis K. Ledford, Tampa, FL; Marshall Fogel and Kathleen Collins, Champaign, IL; Robert E. Broker, Greer, SC; Malik N. Baz and Ajit S. Arora, Fresno, CA; James H. Henderson, Lackland AFB, TX; William P. Saliski, Jr, Montgomery, AL; Alan B. Storrow, Lackland AFB, TX; John Hastings and Noel Radcliffe, Chanhassen, MN; Michael Habib, Tucson, AZ; Boyde J. Harrison, Haleyville, AL; John G. Stauffer, Auburn, AL; Charles M. Fogarty, Spartanburg, SC; Steven A. Wool, Tucson, AZ; Stephen A. Farkas, Mogadore, OH; Dale Terrell, St Louis, MO; J. Allen Meadows, Montgomery, AL; Charles J. VanHook, Longmont, CO; Selwyn Spangenthal, Charlotte, NC; Darryl D. Binschadler, Cheyenne, WY; Kenneth L. Sanders, Fort Myers, FL; Boris Kerzner, Baltimore, MD; Timothy E. Bruya, Spokane, WA; Blair K. Christensen, Savannah, GA; John A. Jernigan, Montgomery, AL; Michael Rosemore, Hueytown, AL; Ronald Ovetsky, Atlanta, GA; Gerald Shockey, Mesa, AZ; Douglas C. Owens, Greer, SC; Raymond W. Urbanski, Philadelphia, PA. Funding for this study was provided by a grant from Parke-Davis Pharmaceutical Research.

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). Efficacy and safety of a 10-day course of 400 or 600 milligrams of grepafloxacin once daily for treatment of acute bacterial exacerbations of chronic bronchitis: comparison with a 10-day course of 500 milligrams of ciprofloxacin twice daily.

Antimicrobial Agents and Chemotherapy

42

,

114

–20.24

Davies, B. I., Maesen, F. P. & Teengs, J. P. (

1987

). Cefuroxime axetil in acute purulent exacerbations of chronic bronchitis.

Infection

15

,

253

–6.25

Ellner, J. J. (

1988

). Management of acute and chronic respiratory tract infections.

American Journal of Medicine

85, Suppl. 3A

,

2

–5.26

Fraschini, F. (

1990

). Clinical efficacy and tolerance of two new macrolides, clarithromycin and josamycin, in the treatment of patients with acute exacerbations of chronic bronchitis.

Journal of International Medical Research

18

,

171

–6.27

Reynolds, H. Y. (1995). Chronic bronchitis and acute infectious exacerbations. In Mandell, Douglas and Bennett’s Principles and Practice of Infectious Diseases, 4th edn, (Mandell, G. L., Bennett, J. E. & Dolin, R., Eds), pp. 608–12. Churchill Livingstone, New York.

28

Fung-Tomc, J. C., Huczko, E., Stickle, T., Minassian, B., Kolek, B., Debblekher, K. et al. (

1995

). Antibacterial activities of cefprozil compared with those of 13 oral cephems and 3 macrolides.

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© 2000 The British Society for Antimicrobial Chemotherapy

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People with sinus infections stay on antibiotics too long

By Lisa Rapaport, Reuters Health

(Reuters Health) – Most people prescribed antibiotics for sinus infections are on treatment courses of 10 days or longer even though infectious disease doctors recommend five to seven days for uncomplicated cases, a U.S. study suggests.

Researchers examined data from a sample representing an estimated 3.7 million adults treated for sinusitis and prescribed antibiotics in 2016. Overall, 70 percent of antibiotics prescribed were for 10 days or longer, the study found.

“Any time antibiotics are used, they can cause side effects and lead to antibiotic resistance,” said senior study author Dr. Katherine Fleming-Dutra, deputy director of the Office of Antibiotic Stewardship at the U.S. Centers for Disease Control and Prevention in Atlanta.

“This is why it is so important to only use antibiotics when they are needed and to use the right antibiotic for the minimum effective duration,” Fleming-Dutra said by email.

Common side effects of antibiotics can include rash, dizziness, nausea, diarrhea and yeast infections, she said. More serious side effects may include life-threatening allergic reactions and Clostridium difficile infection, which causes diarrhea that can lead to severe colon damage and death.

Antibiotic resistance occurs when bacteria develop the ability to defeat the drugs designed to kill them and can make infections harder to treat.

When antibiotics are prescribed for sinus infections, only five to seven days of therapy are needed for uncomplicated cases, when patients start to recover within a few days of starting treatment and if they don’t have signs that the infection has spread beyond the sinuses, according to the Infectious Diseases Society of America (IDSA).

These guidelines are relatively new, however, and it’s possible some of the longer courses of antibiotics prescribed in the study occurred because not all doctors have absorbed the new practice recommendations, Fleming-Dutra said. Prior to 2012, the IDSA recommended 10 to 14 days of antibiotics for sinus infections in adults.

In the study, no penicillin or tetracycline prescriptions were for five-day courses and only 5 percent of prescriptions were for seven-day courses of penicillins, tetracyclines or fluoroquinolones.

When researchers excluded azithromycin, an antibiotic that’s not recommended for sinus infections, they found that 91 percent of all antibiotic courses prescribed for sinus infections were for 10 days or longer.

The study didn’t examine whether or how the duration of antibiotics prescriptions impacted treatment of sinus infections or the potential for side effects.

Researchers also focused only on acute sinus infections, and by excluding some cases where the type of infection was unclear, they may have left out some acute cases, the study team notes in JAMA Internal Medicine.

It’s also possible that in some cases, doctors prescribed antibiotics for 10 days or longer and instructed patients to stop after five to seven days unless they were still experiencing symptoms, said Dr. Sharon Meropol, a researcher at Case Western Reserve University School of Medicine in Cleveland, Ohio, who wasn’t involved in the study.

One pitfall in this approach is that when patients improve slowly, it’s possible they’re infected with organisms that are resistant to the antibiotic they got prescribed, and they would recover faster if they switched to a different antibiotic instead of continuing the current one longer, Meropol said by email.

“Older . . . acute bacterial sinusitis guidelines were written with the belief that if antibiotics were taken for shorter durations of time, that the bacteria would not be completely eradicated and that would risk persistent, recurrent and antibiotic resistant infections,” Meropol said.

“But the recommendations have changed on this because subsequent studies have shown the opposite is true, that in fact if the patient is responding to treatment, five to seven days is safe and is usually enough,” Meropol added. “A longer treatment is not usually needed.”

SOURCE: bit.ly/2Gpq29Z JAMA Internal Medicine, online March 26, 2018.

Don’t treat sinus infections with antibiotics

By MyHealthNewsDaily Staff

Most people who have sinus infections should not be treated with antibiotics because the drugs are unlikely to help, according to new guidelines from infectious disease experts.

Although sinus infections are the fifth-leading reason for antibiotic prescriptions, 90 to 98 percent of cases are caused by viruses, which are not affected by antibiotics, according to the guidelines issued today (March 21) by the Infectious Diseases Society of America. Used inappropriately, antibiotics spur the development of drug-resistant superbugs, the IDSA says.

“There is no simple test that will easily and quickly determine whether a sinus infection is viral or bacterial, so many physicians prescribe antibiotics ‘just in case,'” said Dr. Anthony Chow, professor emeritus of infectious diseases at the University of British Columbia, Vancouver and chairman of the guidelines panel.

“However, if the infection turns out to be viral — as most are — the antibiotics won’t help and in fact can cause harm by increasing antibiotic resistance, exposing patients to drug side effects unnecessarily and adding cost,” Chow said.

A study of 166 people with sinus infections published in February in the Journal of the American Medical association showed that those who took antibiotics saw no better improvement in their symptoms than those taking a placebo.

The new guidelines provide specific characteristics of the illness to help doctors distinguish between viral and bacterial sinus infections.

How to tell if it’s bacterial

A sinus infection, properly called acute rhinosinusitis, is inflammation of the nasal and sinus passages that can cause uncomfortable pressure on either side of the nose, and last for weeks. Most sinus infections develop during or after a cold or other upper respiratory infection, but other factors such as allergens and environmental irritants may play a role.

According to the guidelines, a sinus infection is likely caused by bacteria, and should be treated with antibiotics, if any of these criteria are met:

  • symptoms last for 10 days or more and are not improving (previous guidelines suggested waiting seven days)
  • symptoms are severe, including fever of 102 degrees Fahrenheit or higher, nasal discharge and facial pain lasting three to four days in a row
  • symptoms get worse, with new fever, headache or increased nasal discharge

For adults, 5 to 7 days is enough

The guidelines recommend treating bacterial sinus infections with amoxicillin-clavulanate, instead of the drug currently used, amoxicillin, because the addition of clavulanate helps to thwart the development of antibiotic resistance. The guidelines also recommend against using other commonly used antibiotics, due to increasing drug resistance.

While previous guidelines have recommended taking antibiotics for 10 days to two weeks, the new guidelines suggest five to seven days of antibiotics is long enough for the treatment of adults, and will not encourage bacterial resistance. The IDSA guidelines still recommend children receive antibiotic treatment for 10 days to two weeks.

Whether a sinus infection is bacterial or viral, decongestants and antihistamines are not helpful and may make symptoms worse, the guidelines say.

The voluntary guidelines are not intended to take the place of a doctor’s judgment, but rather support the decision-making process, which must be made according to each patient’s circumstances, the IDSA says.

The guidelines will be published in the April 15 issue of the journal Clinical Infectious Diseases.

More from MyHealthNewsDaily:

Cefdinir: Uses, Interactions, Mechanism of Action

Indication

Cefdinir is indicated to treat acute bacterial otitis media, acute maxillary sinusitis, community-acquired (CA) pneumonia, acute bacterial exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections in children and adults.14,6

The organisms susceptible to cefdinir have been listed below in addition to their associated clinical condition that may be treated with cefdinir.14 Various beta-lactamase producing organisms may be treated, as indicated in certain sections below.

Respiratory
Acute bacterial exacerbations of chronic bronchitis caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis

Community-acquired pneumonia caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis

Ear, nose, and throat
Acute bacterial otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae (penicillin-susceptible only)

Tonsillitis caused by Streptococcus pyogenes

Pharyngitis caused by Streptococcus pyogenes

Acute maxillary sinusitis caused by Haemophilus pneumoniae and Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis

Skin and skin structure infections

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes

Reduce drug development failure rates

Build, train, & validate machine-learning modelswith evidence-based and structured datasets.

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Associated Conditions
Contraindications & Blackbox Warnings

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Pharmacodynamics

Cefdinir is a bactericidal agent that treats bacterial infections by interfering with cell wall synthesis.14
Cefdinir exerts broad-spectrum activity against a variety of gram-positive and gram-negative bacterial infections. It is effective against several beta-lactamase enzyme producing bacteria. As a result, many organisms that are resistant to other cephalosporins may be susceptible to cefdinir.3,4,17

Mechanism of action

Five-member thiazolidine rings that make up penicillins are replaced in cephalosporins by a six-member dihydrothiazine ring, conferring greater bactericidal activity. This This 6-member ring enables cefdinir and other cephalosporins to resist inactivation by certain bacterial enzymes.12

With a mechanism similar to other beta-lactam antibiotics, the bactericidal activity of cefdinir is caused by the inhibition of cell wall synthesis via binding to penicillin-binding proteins (PBPs). Cefdinir, like other cephalosporins, penetrates the bacterial cell wall, combats inactivation by beta-lactamase enzymes, and inactivates penicillin-binding proteins.12 This interferes with the final step of transpeptidation in cell walls, eventually leading to cell lysis, which eventually leads to the death of bacteria that are susceptible to this drug.2 Cefdinir has shown affinity to penicillin protein binding proteins 2 and 3. 7,8,9 It has also been shown to inhibit transpeptidase enzymes of various bacteria, which may play a role in its bactericidal action.10,11 One in vitro study suggests that cefdinir inhibits myeloperoxidase release extracellularly.13 The impact of this potential drug target in relation to its mechanism of action is unknown.

Absorption

Maximal plasma cefdinir concentration can be attained between 2-4 hours after an ingested dose.14 The bioavailability of cefdinir depends on the formulation used. The estimated bioavailability of cefdinir in the capsule form is approximately 16%-21%, depending on the dose. Absolute bioavailability after the administration of a suspension of cefdinir is 25%.2. The Cmax of cefdinir is 1.60 μg/mL after a 300 mg dose with an AUC of 7.05. Cmax is 2.87 μg/mL after a 600 mg dose with an AUC of 11.14 A meal high in fat can reduce the absorption of cefdinir by up to 15%, however, this is not a cause for clinically significant changes, therefore cefdinir may be taken with or without food.14 When given with aluminum or magnesium-containing antacids or iron, cefdinir absorption may decrease. It is recommended to allow 2 hours between cefdinir administration and the administration of these agents.2

Volume of distribution

The average volume of distribution of cefdinir in adults is about 0.35 L/kg and 0.67 L/kg in children.14,18 Another resource estimates the volume of distribution in adults at 1.56–2.09 L/kg.2 Cefdinir is found to be distributed in various tissues at clinically effective concentrations. It may be found in the epithelial lining fluid, bronchial mucosa, tonsils, sinuses, skin blister fluid, as well as the middle ear fluid.2 Third-generation cephalosporins such as cefdinir cross the blood-brain barrier and are found in high concentrations in the cerebrospinal fluid, unlike their first and second generation counterparts.12 The wide tissue distribution of cefdinir allows it to treat a variety of infections throughout the body.

Protein binding

The plasma protein binding of cefdinir ranges from 60% to approximately 70%.2,14

Metabolism

This drug is not significantly metabolized and its pharmacological actions are mainly attributed to the parent drug.2,14

Route of elimination

This drug is mainly excreted by the kidneys. Dose adjustments may be required for patients with renal impairment or patients on dialysis.14 Approximately 18.4% of a 300 mg dose of cefdinir was found unchanged in the urine after a 300 mg dose was administered during a pharmacokinetic study of 21 individuals.18 A large proportion of the administered dose is excreted in the feces, although the majority is found in the urine.12

Half-life

The average plasma elimination half-life is about 1.7 hours in adults.14 In children and healthy infants, plasma elimination half-life ranges from 1.2–1.5 hours.2

Clearance

The renal clearance in healthy adults in a pharmacokinetic study was 2.0 (± 1.0) mL/min/kg and the clearance in patients with renal failure was lower, decreasing in proportion to the degree of renal impairment.18 Dose adjustment is required in patients with renal impairment.14

Adverse Effects

Improve decision support & research outcomes

With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.

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Toxicity

LD50 information
Oral LD50 of cefdinir in the rat is >2000 mg/kg.15

There are limited data regarding cefdinir overdose in the literature. In studies of rodents, one 5600-mg/kg dose administered orally did not lead to adverse effects. Signs of toxicity and overdose caused by other beta-lactam antibiotics included nausea, vomiting, diarrhea, abdominal pain, and seizures.16

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

90,000

Clinical study via canal: cefdinir (Omnicef), potato or two – Clinical trial registry

Intervention

Intervention type:

Drug

Intervention name:

cefdinir (Omnicef)

Description:

2.5 ml of strawberry cream flavored oral suspension 125 mg / 5 ml

Arm Group label:

1

Intervention type:

Medicine

Intervention name:

a potato or two

Description:

2.5 ml cherry-flavored oral suspension 100 mg / 5 ml

Arm Group label:

2

Another name:

Zitromax

Eligibility

Criteria:

Inclusion criteria: – A female or male child between the ages of 4 and 8 in good general health.- Minimum weight 16.3 kg (36 lbs). – Ready to follow the relevant instructions provided to complete the study. – Written informed consent of the parent / legal guardian. Exclusion Criteria: – A current health condition that, in the opinion of the investigator or designee, may interfere with the discrimination of taste sensations (eg, colds, sinus infections, bronchial infections, etc.). – History of an allergic reaction to cefdinir, prescription azithromycin (eg, penicillins), or cephalosporins) and / or over-the-counter drugs and / or foods.- A history of serious medical conditions (eg, gastrointestinal disorders, hematologic or bleeding disorders, kidney or liver disease). – Using any oral medications, vitamins or herbal supplements within 6 hours prior to tasting. – Temperature> 99.2 ° F. Participation in clinical or marketing research. within the last 3 months. – A brother or sister of another subject participating in the research, or living in the same household with another subject who participated in a clinical or marketing research study within the last 3 months.- A family member or close friend working for an advertising agency, a market research company, and / or a company that processes or manufactures medical or health care products.

Floor:

All

Minimum age:

4 years

Maximum age:

8 years

Healthy volunteers:

Accepts healthy volunteers

Omnicef ​​/ Omnicef ​​Capsule in English – Item

  • Can Omnicef ​​/ Omnicef ​​Capsule be used for Respiratory Tract Infections and Acute Sinusitis?

    Yes, respiratory tract infections and acute sinusitis are among the most common reported uses for Omnicef ​​/ Omnicef ​​Capsule.Please do not use Omnicef ​​/ Omnicef ​​Capsule for respiratory tract infections and acute sinusitis without consulting first with your doctor. Click here and view the survey results to find out exactly how other users are using Omnicef ​​/ Omnicef ​​Capsule.

  • Is it safe to drive or operate heavy equipment while using this product?

    If you experience drowsiness, dizziness, hypotension, or headache while taking the Omnicef ​​/ Omnicef ​​Capsule, then you may need to give up driving and heavy industrial equipment.You should stop driving if taking the drug makes you drowsy, dizzy, or hypotensive. Doctors recommend to stop drinking alcohol with such drugs, because alcohol significantly increases side effects and drowsiness. Please check your body’s response when you take Omnicef ​​/ Omnicef ​​Capsule. Be sure to contact your healthcare professional for advice based on your body and overall health.

  • Is this medication (product) addictive or addictive?

    Most drugs are not addictive or addictive. In most cases, the government classifies drugs that can be addictive as controlled dispensing drugs. For example, an H or X chart in India and an II-V chart in the United States. Please review the information on the drug packaging to make sure this drug is not a controlled drug.Also, do not self-medicate or train your body to medication without consulting your healthcare professional.

  • Can I stop using this product immediately or do I need to slowly stop using it?

    Some drugs need to be stopped gradually due to the recovery effect. Be sure to contact your healthcare professional for advice based on your body, general health, and other medications you are taking.

  • Cefdinir: Pediatric Medication | Memorial Sloan Kettering Cancer Center

    This document, provided by Lexicomp ® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

    Trade names: Canada

    Omnicef ​​

    What is this drug used for?

    • It is used to treat various types of bacterial infections.

    What should I tell my doctor BEFORE my child takes this drug?

    • If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.

    Combination of this drug with certain medications and medical conditions can be adverse.

    Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns.You need to make sure that this drug is safe for your child’s illness and in combination with other drugs that he or she is already taking. You should not start, stop, or change the dosage of any drug your child is taking without talking to your doctor.

    What do I need to know or do while my child is taking this drug?

    • Tell all health care providers for your child that your child is taking this drug.These are your child’s doctors, nurses, pharmacists and dentists.
    • If your child has high blood sugar (diabetes) and you are having urine glucose tests, talk with your child’s healthcare provider about which tests are best.
    • If your child has high blood sugar (diabetes), talk to your doctor. Some of these preparations contain sugar.
    • This drug may interfere with some laboratory tests.Tell all healthcare professionals and laboratory staff providing your child’s healthcare that your child is taking this drug.
    • Do not give to your child for longer than prescribed. A secondary infection is possible.
    • If a child takes this drug together with an iron supplement, the child’s stool may become reddish in color. This is fine.

    If your daughter is pregnant or breastfeeding:

    • Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding.The benefits and risks for your daughter and her child will need to be discussed.

    What side effects should I report to my child’s healthcare provider right away?

    WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people. Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

    • Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
    • Difficulty urinating or change in the amount of urine excreted.
    • Dark urine or yellowed skin or eyes.
    • Convulsions.
    • Fever, chills, sore throat; the appearance of bruising and bleeding for unexplained reasons; a pronounced feeling of tiredness or weakness.
    • Diarrhea is common with antibiotics. In rare cases, severe diarrhea caused by the bacteria Clostridium difficile (C. diff.) [CDAD]. This sometimes leads to gut problems that end in death. CDAD can occur during or several months after taking antibiotics. If your child has pain, abdominal cramps, or very loose, watery or bloody stools, see your doctor right away. Check with your child’s doctor before treating diarrhea.

    What are some other side effects of this drug?

    Any drug can have side effects.However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

    This list of possible side effects is not exhaustive. If you have any questions about side effects, talk to your child’s doctor. Talk to your child’s doctor about side effects.

    You can report side effects to the National Health Office.

    What is the best way to give this drug?

    Give this drug to your child as directed by the doctor. Read all the information provided to you. Follow all instructions strictly.

    All forms of issue:

    • Continue giving this drug as directed by your child’s doctor or other healthcare professional, even if your child is well.
    • Give this drug with or without food. If the drug causes stomach upset, give it with food.
    • Do not take antacids containing aluminum or magnesium within 2 hours of taking this drug.
    • Do not give your child iron supplements within 2 hours before and 2 hours after using this drug.

    Liquid (suspension):

    • Shake well before use.
    • Measure liquid doses with care.Use the dispenser that comes with the medicine. If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.
    • You can give this drug with iron formula.

    What if my child misses a dose of a drug?

    • Give the missed dose as soon as possible.
    • If it is time for your child to take the next dose, do not take the missed dose and then return to your child’s normal schedule.
    • Do not give a double dose at the same time or additional doses.

    How do I store and / or discard this drug?

    Capsules:

    • Store at room temperature in a dry place. Do not store in the bathroom.

    Liquid (suspension):

    • Store liquid (suspension) at room temperature. Throw away any unused portions after 10 days.
    • Store in a dry place.Do not store in the bathroom.

    All forms of issue:

    • Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
    • Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist.Your area may have drug recycling programs.

    General information about medicines

    • If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
    • Do not share your child’s medicine with others or give anyone’s medicine to your child.
    • Some medicines may have other patient information leaflets.If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
    • If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

    Use of information by consumer and limitation of liability

    This information should not be used to make decisions about taking this or any other drug.Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug.This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

    Copyright

    © UpToDate, Inc.and its affiliates and / or licensors, 2021. All rights reserved.

    Cefdin 300 – instructions for use, dosages, composition, analogs, side effects / Pillintrip

    ≥ 43 kg.

    In the above equation, creatinine clearance is expressed in mL / min / 1.73 m2, body length or height in centimeters, and serum creatinine in mg / dL.

    For pediatric patients with creatinine clearance <30 ml / min / 1.73 m2, the dose of Cefdin 300 should be 7 mg / kg (up to 300 mg) once a day.

    Patients On Hemodialysis

    Hemodialysis removes Cefdin 300 from the body. In patients on chronic hemodialysis, the recommended initial dose regimen is 300 mg or 7 mg / kg every other day.

    At the end of each hemodialysis session, 300 mg (or 7 mg / kg) should be given. Subsequent doses (300 mg or 7 mg / kg) are then given every other day.

    Instructions for mixing Cefdin 300 for

    Suspension For Ingestion

    Final concentration Final volume (ml) Amount of water Directions 125 mg / 5 ml 60 100 38 ml 63 ml Water bottle to loosen the powder, then add water in 2 portions.Shake well after each aliquot. 250 mg / 5 ml 60 100 38 ml 63 ml Water bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot.

    After mixing, the suspension can be stored at room temperature (25 ° C / 77 ° F). The container should be kept tightly closed and the suspension should be shaken well before each administration. The suspension can be used within 10 days, after which any unused portion should be discarded.

    How Supplied

    Cefdin 300 Capsules, containing 300 mg Cefdin 300, in lavender and turquoise capsules with imprinted product name, are available as follows:

    60 Capsules / Vial NDC 0074-3769-60

    OMNI-PAC ™ box of 3 use units, 5 days, 10 – capsule blister cards NDC 0074-3769-30

    Cefdin 300 for

    Suspension For Ingestion

    is a creamy powder formulation that, when reconstituted as directed, contains 125 mg Cefdin 300/5 ml or 250 mg Cefdin 300/5 ml.The reconstituted suspensions are creamy and strawberry-flavored. The powder is available as follows:

    125 mg / 5 ml

    60 ml vials NDC 0074-3771-60

    100 ml vials NDC 0074-3771-13

    250 mg / 5 ml 60 ml NDC vials 0074-6151 -60

    100 ml vials NDC 0074-6151-13

    Store capsules and unopened powder at 25 ° C (77 ° F) within 15 ° -30 ° C (59 ° -86 ° F). After reconstitution, the oral suspension can be stored at controlled room temperature for up to 10 days.

    Manufacturer: CEPH International Corporation Carolina, Puerto Rico 00986. For: AbbVie Inc., North Chicago, IL 60064, USA, License: Astellas Pharma Inc., Japan. Revised November 2015

    Cefdin 300 interactions

    See also: What other drugs will affect Cefdin 300?

    sponsored by

    (= window adsbygoogle.adsbygoogle || []). push ({}),

    Antacids (containing aluminum or magnesium)

    Simultaneous administration of 300 mg of Cefdin 300 capsules with 30 ml of Maalox® TS suspension reduces the rate (Cmax) and degree (CAS) for absorption by about 40%.The time to reach Smach is also increased by 1 hour. When the antacid is administered 2 hours before or 2 hours after taking Cefdin 300, no significant effects on the pharmacokinetics of Cefdin 300 are observed. If antacids are necessary during therapy with Cefdin 300, then Cefdin 300 should be taken at least 2 hours before or after taking the antacid.

    Probenecid

    Like other β-lactam antibiotics, probenecid inhibits renal excretion of Cefdin 300, which leads to a doubling of the AUC and and and an approximate increase in peak plasma levels of Cefdin 300 by 54% and an increase of 50% in the apparent elimination of T½ …

    Food Supplements and Products Fortified with Iron

    Simultaneous use of Cefdin 300 with therapeutic iron supplement containing 60 mg of elemental iron (in the form of FeSO4) or vitamins supplemented with 10 mg of elemental iron reduced the absorption rate by 80% and 31%, respectively. If iron supplementation is required during therapy with Cefdin 300, then Cefdin 300 should be taken at least 2 hours before or after taking the supplement.

    The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on the absorption of Cefdin 300 has not been studied.

    Concurrent administration of iron-fortified infant formula (2.2 mg elemental iron / 6 oz.) Does not significantly affect the pharmacokinetics of Cefdin 300. Therefore, Cefdin 300 for

    Oral suspension can be administered with iron-fortified infant formula.

    There have been reports of reddish stools in patients treated with Cefdin 300. In many cases, patients also received iron supplements. The reddish color is due to the formation of a non-absorbable complex between Cefdin 300 or its decay products and iron in the gastrointestinal tract.

    Drug and Laboratory Test Interactions

    A false positive urinary ketone reaction may occur with tests using nitroprusside, but not with tests using nitroferricyanide. Administration of Cefdin 300 may result in a false positive urinary glucose reaction with Clinitest®, Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on the enzymatic reaction of glucose oxidase (eg Clinistix® or TES-Tape®) be used.Cephalosporins are known to sometimes induce a positive direct Coombs’ test.

    Cefdin 300 side effects

    See Also: What are the possible side effects of Cefdin 300?

    Adverse Events
    Clinical Trials – Cefdin 300 Capsules (Adults and Adolescents)

    In clinical trials, 5093 adults and adolescents (3841 American and 1252 non-American) received the recommended dose of Cefdin 300 capsules (600 mg / day). Most adverse events were mild and self-limiting.No death or permanent disability was attributed to Tsefdin 300. One hundred and forty-seven out of 5093 (3%) patients discontinued their medication because of adverse events that, according to the researchers, may be likely or definitely related to therapy with Tsefdin 300. Interruptions were are mainly caused by gastrointestinal disturbances, usually diarrhea or nausea. Nineteen of 5093 (0.4%) patients discontinued due to a rash associated with Cefdin 300

    In the United States, researchers believed that the following side effects may be likely or definitely related to Cefdin 300 capsules in multiple-dose clinical trials ( N = 3841 patients who received Cefdin 300):

    SIDE EFFECTS, 300 300 CAPSULES USA TESTS IN ADULTS AND ADOLESCENT PATIENTS (N = 3841) N = 1387 for these parameters

    Cefdinir CAS 91832-40-5 Manufacturers, suppliers

    Product Description:

    Product Name: Cefdinir CAS Number: 91832-40-5

    Synonyms:

    CI 983;

    Novacef;

    Omnitz;

    Chemical & Physical Properties:

    Appearance: White Powder

    Analysis: ≥99.00%

    Density: 1.89 g / cm3

    Melting Point:> 180 ℃ dec.

    Refractive index: 1.861

    Storage conditions: room temperature

    Solubility in water: soluble in water

    Safety information:

    RTECS: XI0367250

    HS code: 2941

    6 W 9000 3

    A cephalosporin antibiotic structurally similar to cefixime. Cefdinir (Omnitsef) is a broad-spectrum semi-synthetic antibiotic that has proven to be effective against common bacterial infections of the ear, sinuses, throat and skin.Purpose: The antibacterial drug Cefdinir is a third-generation oral cephalosporin antibiotic. Cefdinir (Omnitsef) is a third-generation broad-spectrum semi-synthetic antibiotic of the cephalosporin class that has proven to be effective against common bacterial infections of the ear, sinuses, throat and skin. It can be used to treat infections caused by several gram-negative and gram-positive bacteria. It is available in the US as Omnicef ​​from Abbott Laboratories and in India as Cednir from Abbott, Kefnir from Glenmark, and Cefdiel from Ranbaxy.As of 2008, cefdinir was the top-selling cephalosporin antibiotic in the United States, with retail sales of generic versions alone in excess of US $ 585 million. Cefdinir, a novel oral 2-amino-5-thiazolyl cephalosporin, inhibited the luminol-enhanced chemiluminescence (LACL) response of human neutrophils stimulated by PMA, but not opsonized zymosan, in a concentration-dependent but not-time-dependent manner. However, the LACL response to opsonized zymosan in neutrophils treated with cytochalasin B was inhibited by cefdinir.In addition, cefdinir inhibited the formation of LACL in cell-free systems consisting of h3O2, NaI, and either horseradish peroxidase or a neutrophil extract containing myeloperoxidase. The oxidation of orthodianisidine in these two cell-free systems was inhibited by cefdinir.

    If you are interested in our products or have any questions, please contact us!

    Patented products are offered for R&D purposes only. However, ultimate responsibility rests solely with the purchaser.

    Hot Tags: cefdinir cas 91832-40-5, manufacturers, suppliers, factory, buy, in stock

    (PDF) ANTIBACTERIAL THERAPY OF ACUTE RINOSINUSITIS BY CEFDITOREN

    52 MEDICAL COUNCIL • No. 8, 2017

    ORIGINOLOGY

    eradication of the pathogen is ≥40% of the

    dosing interval. With a dosage regimen of 200 mg 2 r / day

    t> MIC of cefditoren exceeds the 40% dosing interval

    in relation to both susceptible strains of S.

    pneumoniae, and intermediate-resistant strains

    (IPC – 0.5 mg / l). Moreover, in relation to the latter, t> MIC

    cefditoren is 54% and higher than the corresponding

    indicator of other oral beta-lactams, including

    amoxicillin / clavulanate (t> MIC– 40%). With an increase in the dose of cefditoren to 400 mg 2 times a day, it becomes possible to achieve t> MIC of more than 40% even in

    against penicillin-resistant S.pneu-

    moniae [12]. By the severity of the bactericidal effect,

    after 24 hours cefditoren is superior to other oral

    beta-lactams, including amoxicillin / clavulanate (AMK),

    cefuroxime, cefixime, cefpodoxime and at least

    is not inferior to levofloxacin [13]. In addition, cefditoren

    has a proven postantibiotic effect in

    for ≥1 h against S. pneumoniae, S. pyogenes,

    S. aureus, M. catarrhalis [14].According to the Russian study

    , in general, Spectracef was in vitro

    the most active of the tested antimicrobial

    drugs, including amoxicillin, azithromycin, clari-

    thromycin, levofloxacin, cefixime, ceftriaxone, and

    against strains of Streptococcus pneumoniae isolated

    in various regions of the Russian Federation [12].

    An important advantage of Spectracef is also

    its resistance to most of the most widespread –

    chromosomal and plasmid β-lactamases of gram-negative –

    body bacteria.The drug has a high bioavailability

    and creates reliable bactericidal concentrations

    in the lesion focus. Not metabolized in the liver;

    has a good tolerance and safety profile –

    [15, 18]. According to clinical studies,

    therapy with cefditoren both at a dose of 200 mg 2 r / day and at a dose of

    at a dose of 400 mg 2 r / day is well tolerated;

    The frequency of drug withdrawal due to intolerance

    was 2% and 3% in these groups, respectively.

    Diarrhea, nausea and vaginal candidiasis

    in women were the most frequent side effects (AE) observed in both cefditoren therapy and

    comparison drugs. In a study of the clinical efficacy of

    Spectracef in the treatment of patients with purulent sinus –

    volume, adverse reactions were not directly related to the intake of

    of the drug, were mild, had a transient nature –

    ter and in no case did not require discontinuation of the drug –

    ta [6].The drug showed a lower risk of allergic and

    skin reactions in patients with allergic reactions

    to penicillin, less hepatotoxicity in comparison with preparations containing clavulanic acid,

    and macrolides [6, 16]. In clinical studies with

    acute sinusitis, cefditoren was compared with cefurox-

    mum axetil and amoxicillin in standard doses.

    In a pooled analysis of the results of 3 studies with

    participation of 1,817 patients, no significant

    differences were found between the efficacy of cefditoren and the preparations

    comparison rats at the time of the end of therapy (80.2%

    versus 84.8 %, respectively) and at the time of the

    visit to control the cure (71.2% versus 77.4%

    , respectively) [18].

    CONCLUSION

    High activity of Spectracef in relation to key

    pathogens of acute rhinosinusitis, including in relation to

    of penicillin-resistant strains of pneumococcus,

    allows us to consider it as a preferred per- therapy of this disease.

    REFERENCES

    1. Fokkens WJ, Lund VJ, Mullol J et al. EPOS 2012.

    European position paper on rhinosinusitis and

    nasal polyps.Rhinology 2012, 50 (1): 1-12.

    2. Chow AW, Benninger MS, Brook I et al. IDSA

    clinical practice guideline for acute bacterial

    rhinosinusitis in children and adults. Clin Infect

    Dis 2012, 54 (8): 72-112.

    3. Pankey® GA, Gross® CW, Menctelsohn® MG.

    Contemporary Diagnosis and Management of

    Sinusitis. Pennsylvania, 1997, 150.

    4. Lopatin A.S. Principles of treatment of acute and

    chronic sinusitis.Pharmacotherapy

    diseases of the ear, nose and throat from the standpoint of

    evidence-based medicine: Lecture

    educational course. M., 2006: 15-23.

    5. Finlay J, Miller L, Poupard JA. A review of the

    antimicrobial activity of clavulanate. J

    Antimicrob Chemother 2003,52 (1): 18-23.

    6. Gonzalez N et al. Efficacy of simulated cefdi-

    toren versus amoxicillin-clavulanate free con-

    centrations in countering intrastrain ftsI gene

    diffusion in Haemophilus influenzae.

    Antimicrob Agents Chemother, 2011, 55 (6):

    2788-2794.

    7. Ryazantsev S.V. Principles of etiopathogenetic therapy of acute sinusitis. Clinical recommendations

    . 2014.

    8. Handbook of antimicrobial therapy.

    ed. Kozlova R.S., Dekhnich A.V. Smolensk:

    “Smolensk Printing Plant”,

    2010.415 p.

    9. Kozlov R.S. Breeding of resistant microorganisms

    ganisms: the concept of “parallel damage –

    ba”.Clinical Microbiology and Antimicrobial Chemotherapy

    2010, 12 (4): 284-294.

    10. Ferrer P et al. Systematic Review and Meta-

    Analysis: Macrolides- and Amoxicillin.

    Clavulanate-induced Acute Liver Injury. Basic

    Clin Pharmacol Toxicol 2016, 119 (1): 3-9.

    11. Kryukov A.I., Kunelskaya N.L., Gurov A.V.,

    Izotova G.N., Yushkina M.A., Shadrin G.B. et al.

    Efficacy of cefditoren in the treatment of acute

    purulent sinusitis.Honey. Council, 2016, 18: 10-13.

    12. Kozlov R.S., Dekhnich A.V. Cefditoren beer –

    forces: clinical-pharmacological and micro-

    biological characteristics. KMAKH, 2014,

    16 (2): 111-129.

    13. Mezzatesta ML et al. Cefditoren versus commu-

    nity-acquired respiratory pathogens: time-kill

    studies. J Chemother 2009, 21 (4): 378-82.

    14. Wellington K, Curran MP. Cefditoren pivoxil. A

    review of its use in the treatment of bacterial

    infections.Drugs 2004, 64: 2597-618.

    15. Kozlov R.S. Prospects for the use of new

    cephalosporins in the treatment of pneumococcal

    infections. Pulmonology, 2011, (3): 53-8.

    16. Hatzaki D et al. Comparative efficacy with

    other antimicrobials and risk factors for resist-

    ance in clinical isolates causing UTIs in outpa-

    tients. BMC Infect Dis, 2012 (25): 228.

    17. Antimicrobial therapy according to J. Sanford.

    Ed.D. Gilbert. M .: Granat, 2013.640 p.

    18. Granizo JJ et al. Rev. Esp Quimioter, 2008, 21 (1):

    14-21.

    19. Mayanskiy N, Alyabieva N, Ponomarenko O,

    Lazareva A, Katosova L, Ivanenko A, Kulichenko

    T, Namazova-Baranova L, Baranov A. Serotypes

    and antibiotic resistance of noninvasive

    9000 pneumoniac in pedi-

    atric hospitals in Moscow, Russia. Int J Infect

    Dis, 2014, 20: 58-62.

    20. Kalinogorskaya O.S., Belanov S.S., Volkova

    M.O., Gostev V.V., Sidorenko S.V. Antibiotic

    resistance and serotype composition Strepto

    coccus pneumoniae isolated from children in

    St. Petersburg in 2010–2013. Antibiotic

    Tics and Chemotherapy, 2015, 60: 10-18.

    21. Tristram S, Jacobs MR, Appelbaum PC. Anti-

    microbial resistance in Haemophilus in fl uen-

    zae. Clin Microbiol Rev, 2007,20: 368-389.

    22. Jacobs MR. How can we predict bacterial

    eradication? International journal of infectious

    diseases: IJID: official publication of the

    International Society for Infectious Diseases,

    2003, 7 (Suppl 1): 13-20.

    Memorial Sloan Kettering Cancer Center

    This document, provided by Lexicomp ® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

    Trade names: Canada

    Omnicef ​​

    What is this drug used for?

    • It is used to treat various types of bacterial infections.

    What do I need to tell my doctor BEFORE taking this drug?

    • If you are allergic to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergy and how it manifested itself.

    Combination of this drug with certain medications and medical conditions can be adverse.

    Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems. You need to make sure that this drug is safe for your medical conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s approval.

    What do I need to know or do while taking this drug?

    • Tell all healthcare providers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
    • Do not use for longer than the prescribed time. A secondary infection is possible.
    • If you have high blood sugar (diabetes) and are performing urine glucose tests, consult your doctor about the best tests to use.
    • If you have high blood sugar (diabetes), consult your doctor. Some of these preparations contain sugar.
    • This drug may interfere with some laboratory tests. Tell all healthcare providers and lab staff that you are taking this drug.
    • Stool may turn reddish when this drug is taken with a product that contains iron. This is fine.
    • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

    What side effects should I report to my doctor immediately?

    WARNING. In rare cases, some people with this drug can cause serious and sometimes deadly side effects. Call your doctor or get medical help right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

    • Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
    • Difficulty urinating or change in the amount of urine excreted.
    • Dark urine or yellowed skin or eyes.
    • Convulsions.
    • Fever, chills, sore throat; the appearance of bruising and bleeding for unexplained reasons; a pronounced feeling of tiredness or weakness.
    • Diarrhea is common with antibiotics. In rare cases, severe diarrhea caused by the bacteria Clostridium difficile (C. diff.) [CDAD]. This sometimes leads to gut problems that end in death. CDAD can occur during or several months after taking antibiotics. If you have pain, abdominal cramps, or very loose, watery or bloody stools, see your doctor right away. Check with your doctor before treating diarrhea.

    What are some other side effects of this drug?

    Any medicine can have side effects.However, many people have little or no side effects. Call your doctor or get medical help if these or any other side effects bother you or do not go away:

    This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

    You can report side effects to the National Health Office.

    You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

    What is the best way to take this drug?

    Use this drug as directed by your healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.

    All forms of issue:

    • Continue taking this drug as directed by your doctor or other healthcare professional, even if you feel well.
    • Take with or without food. Take with food if the medicine causes nausea.
    • Do not take antacids containing aluminum or magnesium within 2 hours of taking this drug.
    • Do not take iron supplements within 2 hours before and 2 hours after taking this drug.

    Liquid (suspension):

    • Shake well before use.
    • Measure liquid doses with care.Use the dispenser that comes with the medicine. If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.
    • You can give this drug with iron formula.

    What should I do if a dose of a drug is missed?

    • Take the missed dose as soon as you can.
    • If it is time for your next dose, do not take the missed dose and then return to your normal dose schedule.
    • Do not take 2 doses at the same time or an additional dose.

    How do I store and / or discard this drug?

    Capsules:

    • Store at room temperature in a dry place. Do not store in the bathroom.

    Liquid (suspension):

    • Store liquid (suspension) at room temperature. Throw away any unused portions after 10 days.
    • Store in a dry place.Do not store in the bathroom.

    All forms of issue:

    • Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
    • Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist.Your area may have drug recycling programs.

    General information about medicines

    • If your health does not improve or even worsens, see your doctor.
    • You should not give your medicine to anyone and take other people’s medicines.
    • Some medicines may have other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
    • Some medicines may have other patient information leaflets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
    • If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

    Use of information by consumer and limitation of liability

    This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug.