Amoxicillin and Clavulanate Potassium (Powder, For Suspension)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1009

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
rdfs:label
Amoxicillin and Clavulanate Potassium (Powder, For Suspension)
dailymed-instance:dosage
Dosage:<br/>Pediatric Patients: Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows:<br/>Adults: Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg tablet. See dosage recommendations above for children weighing 40 kg or more. The amoxicillin 250 mg and clavulanate potassium tablet and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin 250 mg and clavulanate potassium tablet contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin 250 mg and clavulanate potassium tablet and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable. Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin 250 mg and clavulanate potassium tablet (250 mg/125 mg) versus the amoxicillin 250 mg and clavulanate potassium chewable tablet (250 mg/62.5 mg), the amoxicillin 250 mg and clavulanate potassium tablet should not be used until the child weighs at least 40 kg and more.<br/>Directions for Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously. Each teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt. Each teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt. Note: SHAKE ORAL SUSPENSION WELL BEFORE USING. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.<br/>Administration: Reconstituted amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
dailymed-instance:descripti...
Amoxicillin and clavulanate potassium for oral suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the��-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic acid trihydrate and has the following structural formula: CHNOS��3HO M.W. 419.46 Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a��-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of��-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid mediated��-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and has the following structural formula: CHKNOM.W. 237.25 After reconstitution each teaspoonful (5 mL) of suspension will contain 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt or 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 200 mg/28.5 mg per 5 mL contains 0.14 mEq potassium. Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 400 mg/57 mg per 5 mL contains 0.29 mEq of potassium.<br/>Inactive Ingredients: Powder for oral suspension - artificial raspberry powder, aspartame*, citric acid, colloidal silicon dioxide, mannitol, hypromellose, natural orange flavor, sodium citrate, sodium saccharin and xanthan gum.
dailymed-instance:clinicalP...
Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of amoxicillin and clavulanate potassium. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While amoxicillin and clavulanate potassium can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when amoxicillin and clavulanate potassium was dosed at 30 and 150 minutes after the start of a high fat breakfast. The safety and efficacy of amoxicillin and clavulanate potassium have been established in clinical trials where amoxicillin and clavulanate potassium was taken without regard to meals. Oral administration of single doses of 400 mg amoxicillin and clavulanate potassium chewable tablets and 400 mg/57 mg per 5 mL suspension to 28 adult volunteers yielded comparable pharmacokinetic data: Oral administration of 5 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension or the equivalent dose of 10 mL amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL suspension provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg.hr./mL for amoxicillin and 2.9 mcg.hr./mL forclavulanic acid when 5 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension or equivalent dose of 10 mL of amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL suspension was administered to adult volunteers. One amoxicillin 250 mg and clavulanate potassium chewable tablet or 2 amoxicillin 125 mg and clavulanate potassium chewable tablets are equivalent to 5 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension and provide similar serum levels ofamoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with amoxicillin and clavulanate potassium are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after the oral administration of amoxicillin and clavulanate potassium is 1.3 hours and that of clavulanic acid is 1.0 hour. Time above the minimum inhibitory concentration of 1.0 mcg/mL for amoxicillin has been shown to be similar after corresponding q12h and q8h dosing regimens of amoxicillin and clavulanate potassium in adults and children. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension. Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid. Neither component in amoxicillin and clavulanate potassium for oral suspension is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. 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. Two hours after oral administration of a single 35 mg/kg dose of amoxicillin and clavulanate potassiumsuspension to fasting children, average concentrations of 3.0 mcg/mL of amoxicillin and 0.5 mcg/mL of clavulanic acid were detected in middle ear effusions. Microbiology: Amoxicillin is a semisynthethic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by��-lactamases and, therefore, the spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a��-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of��-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid mediated��-lactamases frequently responsible for transferred drug resistance. The formulation of amoxicillin and clavulanic acid in amoxicillin and clavulanate potassium protects amoxicillin from degradation by��-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other��-lactam antibiotics. Thus, amoxicillin and clavulanate potassium possesses the distinctive properties of a broad-spectrum antibiotic and a��-lactamase inhibitor. Amoxicillin/clavulanic acid has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.<br/>Gram-Positive Aerobes: Staphylococcus aureus (��-lactamase and non-��-lactamase producing)<br/>Gram-Negative Aerobes: Enterobacter species (Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with amoxicillin and clavulanate potassium in urinary tract infections caused by these organisms.) Escherichia coli (��-lactamase and non-��-lactamase producing) Haemophilus influenzae (��-lactamase and non-��-lactamase producing) Klebsiella species (All known strains are��-lactamase producing) Moraxella catarrhalis (��-lactamase and non-��-lactamase producing) The following in vitro data are available, but their clinical significance is unknown. Amoxicillin/clavulanic acid exhibits in vitro minimal inhibitory concentrations (MICs) of 0.5 mcg/mL or less against most (���90%) strains of Streptococcus pneumoniaeMICs of 0.06 mcg/mL or less against most (���90%) strains of Neisseria gonorrhoeae; MICs of 4 mcg/mL or less against most (���90%) strains of staphylococci and anaerobic bacteria; and MICs of 8 mcg/mL or less against most (���90%) strains of other listed organisms. However, with the exception of organisms shown to respond to amoxicillin alone, the safety and effectiveness of amoxicillin/clavulanic acid in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.<br/>Gram-Positive Aerobes: Enterococcus faecalis Staphylococcus epidermidis (��-lactamase and non-��-lactamase producing) Staphylococcus saprophyticus (��-lactamase and non-��-lactamase producing) Streptococcus pneumoniae Streptococcus pyogenes viridans group Streptococcus<br/>Gram-Negative Aerobes: Eikenella corrodens (��-lactamase and non-��-lactamase producing) Neisseria gonorrhoeae(��-lactamase and non-��-lactamase producing) Proteus mirabilis(��-lactamase and non-��-lactamase producing)<br/>Anaerobic Bacteria: Bacteroides species, including Bacteroides fragilis (��-lactamase and non-��-lactamase producing) Fusobacterium species (��-lactamase and non-��-lactamase producing) Peptostreptococcus species<br/>Susceptibility Testing:<br/>Dilution Techniques: Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method(broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of amoxicillin/clavulanate potassium powder. The recommended dilution pattern utilizes a constant amoxicillin/clavulanate potassium ratio of 2 to 1 in all tubes with varying amounts of amoxicillin. MICs are expressed in terms of the amoxicillin concentration in the presence of clavulanic acid at a constant 2 parts amoxicillin to 1 part clavulanic acid. The MIC values should be interpreted according to the following criteria: Recommended Ranges for Amoxicillin/Clavulanic Acid Susceptibility Testing: For gram-negative enteric aerobes: For StaphylococcusandHaemophilus species: For Streptococcus pneumoniae: Isolates should be tested using amoxicillin/clavulanic acid and the following criteria should be used: A report of���Susceptible���indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentration usually achievable. A report of���Intermediate���indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of���Resistant���indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected. Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard amoxicillin/clavulanate potassium powder should provide the following MIC values:<br/>Diffusion Techniques: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedurerequires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg of amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) to test the susceptibility of microorganisms to amoxicillin/clavulanic acid. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 mcg amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) disk should be interpreted according to the following criteria: Recommended Ranges for Amoxicillin/Clavulanic Acid Susceptibility Testing For Staphylococcusspecies and H. influenzae: For other organisms except S. pneumoniaeand N. gonorrhoeae: Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for amoxicillin/clavulanic acid. As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30 mcg amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) disk should provide the following zone diameters in these laboratory quality control strains:
dailymed-instance:activeIng...
dailymed-instance:contraind...
Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of amoxicillin and clavulanate potassium-associated cholestatic jaundice/hepatic dysfunction.
dailymed-instance:supply
Amoxicillin and clavulanate potassium for oral suspension USP, 200 mg/28.5 mg per 5 mL is a white to off-white powder���Each 5 mL of reconstituted orange-raspberry-flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL. Amoxicillin and clavulanate potassium for oral suspension USP, 400 mg/57 mg per 5 mL is a white to off-white powder���Each 5 mL of reconstituted orange-raspberry-flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL. Store at 20��- 25��C (68��- 77��F) [See USP Controlled Room Temperature]. Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.
dailymed-instance:activeMoi...
dailymed-instance:inactiveI...
dailymed-instance:precautio...
General: Prescribing amoxicillin and clavulanate potassium for oral suspension USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. While amoxicillin and clavulanate potassium possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, is advisable during prolonged therapy. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin class antibiotics should not be administered to patients with mononucleosis. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.<br/>Information for the Patient: Patients should be counseled that antibacterial drugs including amoxicillin and clavulanate potassium for oral suspension USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium for oral suspension USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium for oral suspension USP or other antibacterial drugs in the future. Amoxicillin and clavulanate potassium may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset. Many antibiotics can cause diarrhea. If diarrhea is severe or lasts more than 2 or 3 days, call your doctor. Make sure your child completes the entire prescribed course of treatment, even if he/she begins to feel better after a few days. Keep suspension refrigerated. Shake well before using. When dosing a child with amoxicillin and clavulanate potassium suspension (liquid), use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of amoxicillin and clavulanatepotassium suspension may contain more liquid than required. Follow your doctor's instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.<br/>Phenylketonurics: Each 5 mL of the 200 mg/28.5 mg per 5 mL oral suspension contains 0.67 mg phenylalanine. Each 5 mL of the 400 mg/57 mg per 5 mL oral suspension contains 1.12 mg phenylalanine. Contact your physician or pharmacist.<br/>Drug Interactions: Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid cannot be recommended. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with amoxicillinand clavulanate potassium and allopurinol administered concurrently. In common with other broad-spectrum antibiotics, amoxicillin and clavulanate potassium may reduce the efficacy of oral contraceptives.<br/>Drug/Laboratory Test Interactions: Oral administration of amoxicillin and clavulanate potassium will result in high urine concentrations of amoxicillin. High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict's Solution or Fehling's Solution. Since this effect may also occur with amoxicillin and therefore amoxicillin and clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix) be used. Following administration of ampicillin to pregnant women a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has been noted. This effect may also occur with amoxicillin and therefore amoxicillin and clavulanate potassium.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.<br/>Mutagenesis: The mutagenic potential of amoxicillin and clavulanate potassium was investigated in vitro with an Ames test, a human lymphocyte cytogenetic assay, a yeast test and a mouse lymphoma forward mutation assay, and in vivo with mouse micronucleus tests and a dominant lethal test. All were negative apart from the in vitro mouse lymphoma assay where weak activity was found at very high, cytotoxic concentrations.<br/>Impairment of Fertility: Amoxicillin and clavulanate potassium at oral doses of up to 1200 mg/kg/day (5.7 times the maximum human dose, 1480 mg/m/day, based on body surface area) was found to have no effect on fertility and reproductive performance in rats, dosed with a 2:1 ratio formulation of amoxicillin:clavulanate.<br/>Teratogenic Effects:<br/>Labor and Delivery: Oral ampicillin class antibiotics are generally poorly absorbed during labor. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions and duration of contractions. However, it is not known whether the use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary. In a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment withamoxicillin and clavulanate potassium may be associated with an increased risk of necrotizing enterocolitis in neonates.<br/>Nursing Mothers: Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.<br/>Pediatric Use: Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients younger than 12 weeks (3 months). (See DOSAGE AND ADMINISTRATION, Pediatric.)
dailymed-instance:overdosag...
Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In the case of overdosage, discontinue amoxicillin and clavulanate potassium, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.
dailymed-instance:genericMe...
Amoxicillin and Clavulanate Potassium
dailymed-instance:fullName
Amoxicillin and Clavulanate Potassium (Powder, For Suspension)
dailymed-instance:adverseRe...
Amoxicillin and clavulanate potassium is generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature and less than 3% of patients discontinued therapy because of drug-related side effects. From the original premarketing studies, where both pediatric and adult patients were enrolled, the most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: abdominal discomfort, flatulence and headache. In pediatric patients (aged 2 months to 12 years), one U.S./Canadian clinical trial was conducted which compared amoxicillin and clavulanate potassium 45 mg/6.4 mg/kg/day (divided q12h) for 10 days versus amoxicillin and clavulanate potassium 40 mg10 mg/kg/day (divided q8h) for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled and only the suspension formulations were used in this trial. Overall, the adverse event profile seen was comparable to that noted above. However, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes. (See CLINICAL STUDIES.) The following adverse reactions have been reported for ampicillin class antibiotics:<br/>Gastrointestinal: Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black���hairy���tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)<br/>Hypersensitivity Reactions: Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia and frequently fever), erythema multiforme (rarely Stevens-Johnson Syndrome), acute generalized exanthematous pustulosis and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin. (See WARNINGS.)<br/>Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin class antibiotics but the significance of these findings is unknown. Hepatic dysfunction, including increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphatase, has been infrequently reported with amoxicillin and clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications.<br/>Renal: Interstitial nephritis and hematuria have been reported rarely.<br/>Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of the patients treated with amoxicillin and clavulanate potassium. There have been reports of increased prothrombin time in patients receiving amoxicillin and clavulanate potassium and anticoagulant therapy concomitantly.<br/>Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.<br/>Miscellaneous: Tooth discoloration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discoloration as it can usually be removed by brushing.
dailymed-instance:warning
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXICILLIN AND CLAVULANATE POTASSIUM, CAREFULINQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN AND CLAVULANATE POTASSIUM SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin and clavulanate potassium, and has ranged in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of���antibiotic associated colitis.��� After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. Amoxicillin and clavulanate potassiumshould be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use ofamoxicillin and clavulanate potassium is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications. (See CONTRAINDICATIONS and ADVERSE REACTIONS, Liver.)
dailymed-instance:indicatio...
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower Respiratory Tract Infections���caused by��-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. Otitis Media���caused by��-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. Sinusitis���caused by��-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. Skin and Skin Structure Infections���caused by��-lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp. Urinary Tract Infections���caused by��-lactamase-producing strains of Escherichia coli, Klebsiella spp. and Enterobacter spp. While amoxicillin and clavulanate potassium for oral suspension is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to amoxicillin and clavulanate potassium treatment due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and��-lactamase-producing organisms susceptible to amoxicillin and clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against Streptococcus pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin and clavulanate potassium. (See Microbiology subsection.) Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin and clavulanate potassium, should be performed together with any indicated surgical procedures. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies to determine the causative organisms and their susceptibility to amoxicillin and clavulanate potassium when there is reason to believe the infection may involve any of the��-lactamase-producing organisms listed above. Once the results are known, therapy should be adjusted, if appropriate.
dailymed-instance:represent...
dailymed-instance:routeOfAd...
dailymed-instance:name
Amoxicillin and Clavulanate Potassium