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Product Name: Alcepid

Salt & Composition: Cefpodoxime Proxetil 100mg/200mg

Mode of Actions: Cefpodoxime is an oral third generation cephalosporin antibiotic. Cefpodoxime fights bacteria in the
body. It is active against most Gram positive and Gram negative bacteriaCefpodoxime proxetil is a prodrug which is
absorbed and de-esterified by the intestinal mucosa to Cefpodoxime.

Pharmacokinetic Action: Cefpodoxime proxetil is an orally administered, extended-spectrum, semi-synthetic
antibiotic of the cephalosporin class. Cefpodoxime is stable in the presence of betalactamase enzymes. As a result,
many organisms resistant to penicillins and cephalosporins, due to their production of beta-lactamase, may be
susceptible to cefpodoxime. Cefpodoxime is inactivated by certain extended-spectrum betalactamases. The
bactericidal activity of cefpodoxime results from its inhibition of cell wall synthesis.

Drug Class and Mechanism: Broad and medium spectrum antibiotics. Cefpodoxime is an antibiotic in a class of drugs
called cephalosporins. Cefpodoxime proxetil is a semi-synthetic beta-lactam antibiotic belonging to the third
generation oral cephalosporin group. Cefpodoxime proxetil is the prodrug of the bactericidal antibiotic cefpodoxime.
The antibacterial action of cefpodoxime is through inhibition of bacterial cell wall synthesis probably by acylation of
membrane bound transpeptidase enzymes; this prevents cross linkage of peptidoglycan chains, which is necessary for
bacterial cell wall strength and rigidity.

Prescribed For: many different types of bacterial infections such as bronchitis, pneumonia, tonsillitis, ear infections,
sinus infections, skin infections, gonorrhea, and urinary tract infections. It is commonly used to treat acute otitis
media, pharyngitis, and sinusitis.

Mode of use: Take this medicine by mouth after food with a full glass of water. It is recommended to take the
medicine at regular intervals. Take the medicine as directed by the physician. Do not skip doses or stop your medicine
early.

Dosage: As directed by the physician. The recommended dosage and duration of treatment in adults may vary from
200mg to 800mg per day for 5-14 days depending on the type and severity of the infection as per the following chart:
In case of a missed dose: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take
only that dose. Do not take double or extra doses. There should be an interval of at least 12 hours between doses.

Interaction: Cefpodoxime proxetil is contra-indicated in patients who are allergic to cefpodoxime or to cephalosporin
group of antibiotics. Safety of cefpodoxime proxetil for use in pregnancy and lactation has not been established.

Some of the diuretics, antacids, medicines for stomach acid or ulcer and sodium bicarbonate may interfere with the
performance of Cefpodoxime. Hence its advisable to inform your doctor in advance about all the other medicines
being taken. Smoking, caffine and use of alcohol can also affect the outcome of the drug use.

Side effects: Side effects that you should report to your doctor as soon as possible include allergic reactions like skin
rash, itching, swelling of the face, lips, or tongue, breathing problems, fast, irregular heartbeat, redness, blistering,
peeling or loosening of the skin, including inside the mouth and unusually weakness or tiredness.

Packaging: Each box contains 1 strip of 10 tablets each




NEWS HIGHLIGHTS
Media Articles Related to Floxin (Ofloxacin)

Aradigm Reports Successful Phase 2b Bronchiectasis Study With Inhaled Liposomal Ciprofloxacin
Source: Cystic Fibrosis News From Medical News Today [2010.10.22]
Aradigm Corporation (OTCBB:ARDM) (the "Company") announced positive top line data from its
recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release
ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis.
Statistical significance was achieved in the primary endpoint and one of the secondary endpoints...
ciprofloxacin ointment - ophthalmic, Ciloxan
Source: MedicineNet ciprofloxacin Specialty [2010.09.22]
Title: ciprofloxacin ointment - ophthalmic, Ciloxan
Category: Medications
Created: 3/2/2005
Last Editorial Review: 9/22/2010

ciprofloxacin/hydrocortisone suspension - otic, Cipro HC
Source: MedicineNet ciprofloxacin Specialty [2010.09.22]
Title: ciprofloxacin/hydrocortisone suspension - otic, Cipro HC
Category: Medications
Created: 3/2/2005
Last Editorial Review: 9/22/2010

ciprofloxacin drops - ophthalmic, Ciloxan
Source: MedicineNet ciprofloxacin Specialty [2010.09.22]
Title: ciprofloxacin drops - ophthalmic, Ciloxan
Category: Medications
Created: 3/2/2005
Last Editorial Review: 9/22/2010

ciprofloxacin/dexamethasone suspension - otic, Ciprodex
Source: MedicineNet levofloxacin Specialty [2010.09.22]
Title: ciprofloxacin/dexamethasone suspension - otic, Ciprodex
Category: Medications
Created: 3/2/2005
Last Editorial Review: 9/22/2010

                                                                                  more news >>


Published Studies Related to Floxin (Ofloxacin)

Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500
mg for 4 weeks in treating chronic bacterial prostatitis. [2010.06]
CONCLUSIONS: Higher doses for shorter durations were determined to be no worse than standard
therapy with levofloxacin 500 mg for a longer duration at the TOC visit. However, at the 6-month
follow-up visit, the levofloxacin 750-mg dose administered for either 2 weeks or 3 weeks was
inferior to the standard therapy, suggesting that a longer duration of treatment may help extend the
relapse-free interval in patients with CBP. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov,
nct00402688.

Pharmacokinetics of antofloxacin hydrochloride, a novel fluoroquinolone, after single-dose
intravenous administration in healthy Chinese male volunteers. [2010.05]
The purpose of the study was to evaluate the pharmacokinetic characteristics of a single,
intravenous dose of antofloxacin hydrochloride in healthy Chinese male volunteers. Twelve
subjects were randomly assigned to groups that received a single, intravenous dose of 200, 300, or
400 mg antofloxacin hydrochloride in a three-way crossover design study...

Doxycycline vs. levofloxacin in the treatment of community-acquired pneumonia. [2010.04]
BACKGROUND: Community-acquired pneumonia (CAP) affects 5-10 million adults annually in
the United States with approximately 1.1 million hospitalizations. Current guidelines recommend
fluoroquinolones as monotherapy for treatment of CAP in general medical wards and doxycycline
monotherapy for outpatient therapy only. Fluoroquinolones are expensive and development of
bacterial resistance to them has become a concern. Therefore, we studied whether doxycycline is as
efficacious as levofloxacin in treatment of CAP in general medical wards... CONCLUSIONS: Our
study supports doxycycline as an effective and economical alternative therapy for levofloxacin in
the empirical treatment of CAP in general medical wards.

Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy
volunteers. [2010.04]
AIMS: To characterize the effects of levofloxacin on QT interval in healthy subjects and the most
appropriate oral positive control treatments for International Conference on Harmonization (ICH)
E14 QT/QTc studies... CONCLUSIONS: Both levofloxacin and moxifloxacin can fulfil the criteria
for a positive comparator. The ICH E14 guidelines recommend a threshold of around 5 ms for a
positive QT/QTc study. The largest time-matched difference in QTc for levofloxacin suggests the
potential for use in more rigorous QT/QTc studies. This study has demonstrated the utility of
levofloxacin on the assay in measuring mean QTc changes around 5 ms.

A randomized controlled trial: efficacy and safety of azithromycin, ofloxacin, bismuth, and
omeprazole compared with amoxicillin, clarithromycin, bismuth, and omeprazole as second-line
therapy in patients with Helicobacter pylori infection. [2010.04]
BACKGROUND: Helicobacter pylori infection of the stomach is widespread among human
populations and is considered to play a major role in the pathogenesis of various diseases such as
peptic ulcer, adenocarcinoma, and mucosa associated lymphoid tissue (MALT) lymphoma of the
stomach. To increase H. pylori eradication rate without increasing bacterial resistance, various
regimens have been recommended. Commonly the association of at least two antibiotics with a
proton-pump inhibitor is used. The treatment regimens for second-line therapy, suggested in studies
from the western world may not be ideal in Iran. Aim: In this study, we evaluated the safety and
efficacy of a new quadruple therapy regimen and compared it with the standard second-line
treatment for H. pylori eradication... CONCLUSION: Two weeks of treatment with ofloxacin,
azithromycin, omeprazole, and bismuth is an effective and safe regimen for H. pylori eradication as
second-line therapy.

                                                                                more studies >>


Clinical Trials Related to Floxin (Ofloxacin)

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis [Active, not recruiting]
The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2
weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of
chronic prostatitis.
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
[Completed]
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or
ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
[Completed]
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or
ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution
Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
[Completed]
The primary objective of the study was to assess the bioequivalence of the oral suspension
formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with
the marketed tablet as the reference.

Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for
Bacterial Conjunctivitis [Completed]
The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily
administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8
times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with
bacterial conjunctivitis.

                                                                                   more trials >>

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Alcipid

  • 1. Product Name: Alcepid Salt & Composition: Cefpodoxime Proxetil 100mg/200mg Mode of Actions: Cefpodoxime is an oral third generation cephalosporin antibiotic. Cefpodoxime fights bacteria in the body. It is active against most Gram positive and Gram negative bacteriaCefpodoxime proxetil is a prodrug which is absorbed and de-esterified by the intestinal mucosa to Cefpodoxime. Pharmacokinetic Action: Cefpodoxime proxetil is an orally administered, extended-spectrum, semi-synthetic antibiotic of the cephalosporin class. Cefpodoxime is stable in the presence of betalactamase enzymes. As a result, many organisms resistant to penicillins and cephalosporins, due to their production of beta-lactamase, may be susceptible to cefpodoxime. Cefpodoxime is inactivated by certain extended-spectrum betalactamases. The bactericidal activity of cefpodoxime results from its inhibition of cell wall synthesis. Drug Class and Mechanism: Broad and medium spectrum antibiotics. Cefpodoxime is an antibiotic in a class of drugs called cephalosporins. Cefpodoxime proxetil is a semi-synthetic beta-lactam antibiotic belonging to the third generation oral cephalosporin group. Cefpodoxime proxetil is the prodrug of the bactericidal antibiotic cefpodoxime. The antibacterial action of cefpodoxime is through inhibition of bacterial cell wall synthesis probably by acylation of membrane bound transpeptidase enzymes; this prevents cross linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity. Prescribed For: many different types of bacterial infections such as bronchitis, pneumonia, tonsillitis, ear infections, sinus infections, skin infections, gonorrhea, and urinary tract infections. It is commonly used to treat acute otitis media, pharyngitis, and sinusitis. Mode of use: Take this medicine by mouth after food with a full glass of water. It is recommended to take the medicine at regular intervals. Take the medicine as directed by the physician. Do not skip doses or stop your medicine early. Dosage: As directed by the physician. The recommended dosage and duration of treatment in adults may vary from 200mg to 800mg per day for 5-14 days depending on the type and severity of the infection as per the following chart:
  • 2. In case of a missed dose: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. There should be an interval of at least 12 hours between doses. Interaction: Cefpodoxime proxetil is contra-indicated in patients who are allergic to cefpodoxime or to cephalosporin group of antibiotics. Safety of cefpodoxime proxetil for use in pregnancy and lactation has not been established. Some of the diuretics, antacids, medicines for stomach acid or ulcer and sodium bicarbonate may interfere with the performance of Cefpodoxime. Hence its advisable to inform your doctor in advance about all the other medicines being taken. Smoking, caffine and use of alcohol can also affect the outcome of the drug use. Side effects: Side effects that you should report to your doctor as soon as possible include allergic reactions like skin rash, itching, swelling of the face, lips, or tongue, breathing problems, fast, irregular heartbeat, redness, blistering, peeling or loosening of the skin, including inside the mouth and unusually weakness or tiredness. Packaging: Each box contains 1 strip of 10 tablets each NEWS HIGHLIGHTS Media Articles Related to Floxin (Ofloxacin) Aradigm Reports Successful Phase 2b Bronchiectasis Study With Inhaled Liposomal Ciprofloxacin Source: Cystic Fibrosis News From Medical News Today [2010.10.22] Aradigm Corporation (OTCBB:ARDM) (the "Company") announced positive top line data from its recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis. Statistical significance was achieved in the primary endpoint and one of the secondary endpoints...
  • 3. ciprofloxacin ointment - ophthalmic, Ciloxan Source: MedicineNet ciprofloxacin Specialty [2010.09.22] Title: ciprofloxacin ointment - ophthalmic, Ciloxan Category: Medications Created: 3/2/2005 Last Editorial Review: 9/22/2010 ciprofloxacin/hydrocortisone suspension - otic, Cipro HC Source: MedicineNet ciprofloxacin Specialty [2010.09.22] Title: ciprofloxacin/hydrocortisone suspension - otic, Cipro HC Category: Medications Created: 3/2/2005 Last Editorial Review: 9/22/2010 ciprofloxacin drops - ophthalmic, Ciloxan Source: MedicineNet ciprofloxacin Specialty [2010.09.22] Title: ciprofloxacin drops - ophthalmic, Ciloxan Category: Medications Created: 3/2/2005 Last Editorial Review: 9/22/2010 ciprofloxacin/dexamethasone suspension - otic, Ciprodex Source: MedicineNet levofloxacin Specialty [2010.09.22] Title: ciprofloxacin/dexamethasone suspension - otic, Ciprodex Category: Medications Created: 3/2/2005 Last Editorial Review: 9/22/2010 more news >> Published Studies Related to Floxin (Ofloxacin) Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500 mg for 4 weeks in treating chronic bacterial prostatitis. [2010.06] CONCLUSIONS: Higher doses for shorter durations were determined to be no worse than standard therapy with levofloxacin 500 mg for a longer duration at the TOC visit. However, at the 6-month follow-up visit, the levofloxacin 750-mg dose administered for either 2 weeks or 3 weeks was inferior to the standard therapy, suggesting that a longer duration of treatment may help extend the relapse-free interval in patients with CBP. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, nct00402688. Pharmacokinetics of antofloxacin hydrochloride, a novel fluoroquinolone, after single-dose intravenous administration in healthy Chinese male volunteers. [2010.05] The purpose of the study was to evaluate the pharmacokinetic characteristics of a single, intravenous dose of antofloxacin hydrochloride in healthy Chinese male volunteers. Twelve
  • 4. subjects were randomly assigned to groups that received a single, intravenous dose of 200, 300, or 400 mg antofloxacin hydrochloride in a three-way crossover design study... Doxycycline vs. levofloxacin in the treatment of community-acquired pneumonia. [2010.04] BACKGROUND: Community-acquired pneumonia (CAP) affects 5-10 million adults annually in the United States with approximately 1.1 million hospitalizations. Current guidelines recommend fluoroquinolones as monotherapy for treatment of CAP in general medical wards and doxycycline monotherapy for outpatient therapy only. Fluoroquinolones are expensive and development of bacterial resistance to them has become a concern. Therefore, we studied whether doxycycline is as efficacious as levofloxacin in treatment of CAP in general medical wards... CONCLUSIONS: Our study supports doxycycline as an effective and economical alternative therapy for levofloxacin in the empirical treatment of CAP in general medical wards. Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy volunteers. [2010.04] AIMS: To characterize the effects of levofloxacin on QT interval in healthy subjects and the most appropriate oral positive control treatments for International Conference on Harmonization (ICH) E14 QT/QTc studies... CONCLUSIONS: Both levofloxacin and moxifloxacin can fulfil the criteria for a positive comparator. The ICH E14 guidelines recommend a threshold of around 5 ms for a positive QT/QTc study. The largest time-matched difference in QTc for levofloxacin suggests the potential for use in more rigorous QT/QTc studies. This study has demonstrated the utility of levofloxacin on the assay in measuring mean QTc changes around 5 ms. A randomized controlled trial: efficacy and safety of azithromycin, ofloxacin, bismuth, and omeprazole compared with amoxicillin, clarithromycin, bismuth, and omeprazole as second-line therapy in patients with Helicobacter pylori infection. [2010.04] BACKGROUND: Helicobacter pylori infection of the stomach is widespread among human populations and is considered to play a major role in the pathogenesis of various diseases such as peptic ulcer, adenocarcinoma, and mucosa associated lymphoid tissue (MALT) lymphoma of the stomach. To increase H. pylori eradication rate without increasing bacterial resistance, various regimens have been recommended. Commonly the association of at least two antibiotics with a proton-pump inhibitor is used. The treatment regimens for second-line therapy, suggested in studies from the western world may not be ideal in Iran. Aim: In this study, we evaluated the safety and efficacy of a new quadruple therapy regimen and compared it with the standard second-line treatment for H. pylori eradication... CONCLUSION: Two weeks of treatment with ofloxacin, azithromycin, omeprazole, and bismuth is an effective and safe regimen for H. pylori eradication as second-line therapy. more studies >> Clinical Trials Related to Floxin (Ofloxacin) An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis [Active, not recruiting] The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.
  • 5. MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers [Completed] 224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic. MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers [Completed] 224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic. A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects [Completed] The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference. Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis [Completed] The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis. more trials >>