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Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

Aidarex Pharmaceuticals LLC

POWDER, FOR SUSPENSION

Strength 60042.9 mg/5mLmg/5mL

AMOXICILLIN; CLAVULANATE POTASSIUM Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium) which is also known as Amoxicillin and Clavulanate Potassium and Manufactured by Aidarex Pharmaceuticals LLC. It is available in strength of 600; 42.9 mg/5mL; mg/5mL per ml. Read more

Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 1111PRESCRIBING INFORMATION
  • To reduce the development of drug-resistant bacteria and maintain then effectiveness of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL and othern antibacterial drugs, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be used only to treat or preventn infections that are proven or strongly suspected to be caused byn bacteria.
  • Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is an oral antibacterial combination consisting of then semisynthetic antibiotic amoxicillin and the u03b2-lactamase inhibitor, clavulanaten potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog ofn ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanicn acid. The amoxicillin molecular formula isn CHNOSu20223HO, andn the molecular weight is 419.46. Chemically, amoxicillin is (2,5,6)-6-[()-(-)-2-Amino-2-(-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicn acid trihydrate and may be represented structurally as:
  • Clavulanic acid is produced by the fermentation of . It is a u03b2-lactamn structurally related to the penicillins and possesses the ability to inactivaten a wide variety of u03b2-lactamases by blocking the active sites of these enzymes.n Clavulanic acid is particularly active against the clinically importantn plasmid-mediated u03b2-lactamases frequently responsible for transferred drugn resistance to penicillins and cephalosporins. The clavulanate potassiumn molecular formula is CHKNO, and then molecular weight is 237.25. Chemically, clavulanate potassium is potassiumn ()-(2,5)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylaten and may be represented structurally as:
  • The pharmacokinetics of amoxicillin and clavulanate were determined inn a study of 19 pediatric patients, 8 months to 11 years, given Amoxicillin andn Clavulanate Potassium 600 mg/42.9 mg per 5 mL at an amoxicillin dose of 45n mg/kg q12h with a snack or meal. The mean plasma amoxicillin andn clavulanate pharmacokinetic parameter values are listed in the following table.n
  • The effect of food on the oral absorption of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL has not been studied.
  • Approximately 50% to 70% of the amoxicillin and approximately 25% ton 40% of the clavulanic acid are excreted unchanged in urine during the first 6n hours after administration of 10 mL of 250 mg/5 mL suspension of amoxicillinn and clavulanate potassium.
  • Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.
  • Neither component in Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound.
  • Oral administration of a single dose of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL at 45 mg/kg (based on the amoxicillin component) to pediatric patients, 9 months to 8 years, yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF).
  • Dose administered immediately prior to eating.
  • Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.
  • Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL isn indicated for the treatment of pediatric patients with recurrent or persistentn acute otitis media due to n (penicillin MICs u2264 2 mcg/mL), (including u03b2-lactamaseu2013producing strains), or n (includingn u03b2-lactamaseu2013producing strains) characterized by the following riskn factors:
  • [See , .]
  • NOTE:n- S. pneumoniaen- S. pneumoniae
  • Therapy may be instituted prior to obtaining the results fromn bacteriological studies when there is reason to believe the infection mayn involve both (penicillinn MIC u2264 2 mcg/mL) and the u03b2-lactamaseu2013producing organisms listedn above.
  • To reduce the development of drug-resistant bacteria and maintain then effectiveness of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mLn and other antibacterial drugs, Amoxicillin and Clavulanate Potassium 600n mg/42.9 mg per 5 mL should be used only to treat or prevent infections that aren proven or strongly suspected to be caused by susceptible bacteria. When culturen and susceptibility information are available, they should be considered inn selecting or modifying antibacterial therapy. In the absence of such data,n local epidemiology and susceptibility patterns may contribute to the empiricn selection of therapy.
  • Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AMOXICILLIN AND CLAVULANATE POTASSIUM.
  • SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC)n REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONSn ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLINn HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THEREn HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITYn WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFOREn INITIATING THERAPY WITH AMOXICILLIN AND CLAVULANATE POTASSIUM 600 MG/42.9 MG PER 5 ML, CAREFUL INQUIRY SHOULD BE MADEn CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS,n OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN AND CLAVULANATE POTASSIUM 600 MG/42.9 MG PER 5 ML SHOULD BEn DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED. n
  • Pseudomembranous colitis has been reported withn nearly all antibacterial agents, including amoxicillin/clavulanaten potassium, and has ranged in severity from mild to life-threatening.n Therefore, it is important to consider this diagnosis in patients whon present with diarrhea subsequent to the administration of antibacterialn agents.
  • Treatment with antibacterial agents alters the normal flora of then colon and may permit overgrowth of clostridia. Studies indicate that a toxinn produced by is one primary cause ofn u201cantibiotic-associated colitis.u201d
  • After the diagnosis of pseudomembranous colitis has been established,n appropriate therapeutic measures should be initiated. Mild cases ofn pseudomembranous colitis usually respond to drug discontinuation alone. Inn moderate to severe cases, consideration should be given to management withn fluids and electrolytes, protein supplementation, and treatment with ann antibacterial drug clinically effective against n
  • Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL should be used with caution in patients with evidencen of hepatic dysfunction. Hepatic toxicity associated with the use ofn amoxicillin/clavulanate potassium is usually reversible. On rare occasions,n deaths have been reported (less than 1 death reported per estimated 4 millionn prescriptions worldwide). These have generally been cases associated withn serious underlying diseases or concomitant medications. (See n and .)
  • No data
  • Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is generally well tolerated. The majority of siden effects observed in pediatric clinical trials of acute otitis media were eithern mild or moderate, and transient in nature; 4.4% of patients discontinuedn therapy because of drug-related side effects. The most commonly reported siden effects with probable or suspected relationship to Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL weren contact dermatitis, i.e., diaper rash (3.5%), diarrhea (2.9%), vomiting (2.2%),n moniliasis (1.4%), and rash (1.1%). The most common adverse experiences leadingn to withdrawal that were of probable or suspected relationship to Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL were diarrhea (2.5%) and vomiting (1.4%).
  • The following adverse reactions have been reported for ampicillin-class antibiotics:
  • Following overdosage, patients have experienced primarilyn gastrointestinal symptoms including stomach and abdominal pain, vomiting, andn diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a smalln number of patients.
  • In the case of overdosage, discontinue Amoxicillin and Clavulanaten Potassium 600 mg/42.9 mg per 5 mL, treatn symptomatically, and institute supportive measures as required. If then overdosage is very recent and there is no contraindication, an attempt atn emesis or other means of removal of drug from the stomach may be performed. An prospective study of 51 pediatric patients at a poison control center suggested thatn overdosages of less than 250u00a0mg/kg of amoxicillin are not associated withn significant clinical symptoms and do not require gastric emptying.n
  • Interstitial nephritis resulting in oliguric renal failure has beenn reported in a small number of patients after overdosage with amoxicillin.
  • Crystalluria, in some cases leading to renal failure, has also beenn reported after amoxicillin overdosage in adult and pediatric patients. In casen of overdosage, adequate fluid intake and diuresis should be maintained ton reduce the risk of amoxicillin crystalluria.
  • Renal impairment appears to be reversible with cessation of drugn administration. High blood levels may occur more readily in patients withn impaired renal function because of decreased renal clearance of bothn amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed fromn the circulation by hemodialysis.
  • Amoxicillin and Clavulanate Potassium, 600 mg/42.9 mg per 5 mL, does notn contain the same amount of clavulanic acid (as the potassium salt) as anyn of the other suspensions of AMOXICILLIN AND CLAVULANATE POTASSIUM. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL containsn 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspensionn of AMOXICILLIN AND CLAVULANATE POTASSIUM contains 28.5 mg ofn clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mgn of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400n mg/57 mg/5 mL suspensions of AMOXICILLIN AND CLAVULANATEn POTASSIUM should be substituted for Amoxicillin and Clavulanaten Potassium 600 mg/42.9 mg per 5 mL as they are not interchangeable.
  • Amoxicillin and Clavulanate Potassium, 600 mg/5 mL, for Oral Suspension:
  • HOW SUPPLIED
  • NDC 33261-0970-01u00a0u00a0u00a0u00a0u00a0200u00a0mL bottle
  • Store reconstituted suspension under refrigeration. Discard unused suspensionn after 10 days. Store dry powder for oral suspension at or below 25u00b0C (77u00b0F).n Dispense in original container.
  • Two clinical studies were conducted in pediatric patients with acute otitis media.
  • A non-comparative, open-label study assessed the bacteriologic andn clinical efficacy of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5n mL (90/6.4 mg/kg/day, divided every 12 hours) for 10 days in 521 pediatricn patients (3 to 50 months) with acute otitis media. The primary objective was ton assess bacteriological response in children with acute otitis media due to with amoxicillin/clavulanic acid MICs of 4 mcg/mL. The study soughtn the enrollment of patients with the following risk factors: Failure ofn antibiotic therapy for acute otitis media in the previous 3 months, history ofn recurrent episodes of acute otitis media, u2264 2 years, or daycare attendance.n Prior to receiving Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5n mL, all patients had tympanocentesis to obtain middle ear fluid forn bacteriological evaluation. Patients from whom (alone or inn combination with other bacteria) was isolated had a second tympanocentesis 4 ton 6 days after the start of therapy. Clinical assessments were planned for alln patients during treatment (4-6 days after starting therapy), as well as 2-4n days post-treatment and 15-18 days post-treatment. Bacteriological success wasn defined as the absence of the pretreatment pathogen from the on-therapyn tympanocentesis specimen. Clinical success was defined as improvement orn resolution of signs and symptoms. Clinical failure was defined as lack ofn improvement or worsening of signs and/or symptoms at any time following atn least 72 hours of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5n mL; patients who received an additional systemic antibacterial drug for otitisn media after 3 days of therapy were considered clinical failures.n Bacteriological eradication on therapy (day 4-6 visit) in the per protocoln population is summarized in the following table:
  • Clinical assessments were made in the per protocol population 2-4 daysn post-therapy and 15-18 days post-therapy. Patients who responded to therapy 2-4n days post-therapy were followed for 15-18 days post-therapy to assess them forn acute otitis media. Nonresponders at 2-4 days post-therapy were consideredn failures at the latter timepoint.
  • In the intent-to-treat analysis, overall clinical outcomes at 2-4 daysn and 15-18 days post-treatment in patients with with penicillinn MIC = 2 mcg/mL and 4 mcg/mL were 29/41 (71%) and 17/41 (41.5%), respectively.n
  • In the intent-to-treat population of 521 patients, the most frequentlyn reported adverse events were vomiting (6.9%), fever (6.1%), contact dermatitisn (i.e., diaper rash) (6.1%), upper respiratory tract infection (4.0%), andn diarrhea (3.8%). Protocol-defined diarrhea (i.e., 3 or more watery stools inn one day or 2 watery stools per day for 2 consecutive days as recorded on diaryn cards) occurred in 12.9% of patients.
  • A double-blind, randomized, clinical study compared Amoxicillin andn Clavulanate Potassium 600 mg/42.9 mg per 5 mL (90/6.4 mg/kg/day, divided everyn 12 hours) to AMOXICILLIN AND CLAVULANATE POTASSIUM (45/6.4 mg/kg/day, dividedn every 12 hours) for 10 days in 450 pediatric patients (3 months to 12 years)n with acute otitis media. The primary objective of the study was to compare then safety of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL ton AMOXICILLIN AND CLAVULANATE POTASSIUM. There was no statistically significantn difference between treatments in the proportion of patients with 1 or moren adverse events. The most frequently reported adverse events for Amoxicillinn and Clavulanate Potassium 600 mg/42.9 mg per 5 mL and the comparator ofn AMOXICILLIN AND CLAVULANATE POTASSIUM were coughing (11.9% versus 6.8%),n vomiting (6.5% versus 7.7%), contact dermatitis (i.e., diaper rash, 6.0% versusn 4.8%), fever (5.5% versus 3.9%), and upper respiratory infection (3.0% versusn 9.2%), respectively. The frequencies of protocol-defined diarrhea withn Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL(11.1%) andn AMOXICILLIN AND CLAVULANATE POTASSIUM (9.4%) were similar (95% confidencen interval on difference: u20134.2% to 7.7%). Only 2 patients in the group treatedn with Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5mL and 1 patientn in the group treated with AMOXICILLIN AND CLAVULANATE POTASSIUM were withdrawnn due to diarrhea.
  • CLINITEST is a registered trademark of Miles, Inc.
  • CLINISTIX is a registered trademark of Bayer Corporation.
  • FLAVORx is a trademark of FLAVORx. Inc.n n
  • Mfd. by:
  • Dr. Reddy's Laboratories Inc.,
  • Bridgewater, NJ 08807
  • Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880
  • NDC 33261-0970-01
  • 600 mg/42.9 mg per 5 mL
  • AMOXICILLIN/CLAVULANATE POTASSIUM
  • Arrayn- powder for oral suspension
  • When reconstituted, each 5 mL contains:
  • Arrayn- AMOXICILLIN,
  • as the trihydrate
  • Arrayn- CLAVULANIC ACID,
  • as clavulanate potassium
  • 200u00a0mL (when reconstituted)
  • R only
  • Directions for mixing:
  • 1. Tap bottle until all powder flows freely. ADD 70 mL OF WATER IN TWOn PARTS. 2. Add approximately 2/3 of the water for reconstitution. Shake vigorously.n 3. Add remaining water; shake vigorously.
  • Dosage
  • Phenylketonurics
  • Keep tightly closed.
  • Shake well before using.
  • Must be refrigerated.
  • Discard after 10 days.
  • Use only if inner seal is intact.
  • Net contents
  • Store dry powder at room temperature.
  • Mfd. By: Dr. Reddy's Laboratories Inc.,
  • Bridgewater, NJ 08807
  • Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880
  • I1111
  • 150035376

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