AMOXICILLIN- amoxicillin_capsule

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www. Amoxicillin is an antibacterial drug [see Microbiology ( 12. 4 Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3. 5 mcg/mL to 5. 0 mcg/mL and 5. 5 mcg/mL to 7. 5 mcg/mL, respectively. Mean amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence 875 mg of amoxicillin with 875 mg of AUGMENTIN registered 0-infinity max Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1. 5 mcg/mL to 3. 0 mcg/mL and 3. 0 mcg/mL, respectively. Distribution Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. Following a 1-gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Metabolism and Excretion The half-life of amoxicillin is 61. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions ( 7. 1 Mechanism of Action Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria. Resistance Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive. Antimicrobial Activity Amoxicillin has been shown to be active against most isolates of the following microorganisms, both in vitro [see Indications And Usage ( 1 Gram-Positive Bacteria Enterococcus faecalis Staphylococcus spp. Streptococcus pneumoniae Streptococcus spp. (alpha and beta-hemolytic) Gram-Negative Bacteria Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.

Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Streptococcus Streptococcus pneumoniae Staphylococcus spp. Haemophilus influenzae. Infections of the Genitourinary Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. Infections of the Skin and Skin Structure Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Streptococcus spp. Staphylococcus spp. Infections of the Lower Respiratory Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamaseen dashnegative) isolates of Streptococcus spp. pneumoniae, Staphylococcus spp. Adult Patients Only Helicobacter pylori Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori Dual therapy for H. pylori with lansoprazole Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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 is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 Adults and Pediatric Patients ( 1 ) Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients Only ( 1 ) Helicobacter pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Click or tap here to enter text. In Adults, 750 to1750 mg/day in divided doses every 8 to12 hours. In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to12 hours. Refer to full prescribing information for specific dosing regimens. 3 The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. 3 Dosing for H. 4 Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). 5 To minimize the potential for gastrointestinal intolerance, amoxcillin should be taken at the start of a meal. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 Weeks) and Older Infection Severity Recommended Dosage for Adult and Pediatrics Patients Aged 3 Months and Older and Weight Greater than 40 kg Recommended Dosage for Pediatric Patient Aged 3 Months and Older and Weight Less than 40 kg Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. Triple therapy: Dual therapy: Please refer to clarithromycin and lansoprazole full prescribing information. Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of less than 30 mL/min, should NOT receive the 875 mg dose. See dosage regimens in patients with severe renal impairment provided in Table 2. Dosing in Patients with Severe Renal Impairment Patients with Renal Impairment Dosage Regimen GFR 10 to 30 mL/min 500 mg or 250 mg every 12 hours, depending on the severity of the infection GFR less than 10 mL/min 500 mg or 250 mg every 24 hours, depending on severity of the infection Hemodialysis 500 mg or 250 mg every 24 hours, depending on severity of the infection Administer an additional dose both during and at the end of dialysis Prepare a suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see Table 3). Add approximately 1/3 of the water to powder. Replace cap and shake vigorously to wet powder. Add remaining water. Replace cap and shake vigorously. Amount of Water for Mixing For Oral Suspension Strength Bottle Size Total Amount of Water Required for Reconstitution For Oral Suspension 125 mg/5 mL 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL For Oral Suspension 200 mg/5 mL 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL For Oral Suspension 250 mg/5 mL 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL For Oral Suspension 400 mg/5 mL 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5. 1 Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5. 2 Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5. 3 Clostridioides difficile [see Warnings and Precautions ( 5. 4 The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or for oral suspension were diarrhea, rash, vomiting, and nausea. 1 To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www. gov/medwatch Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy : Dual therapy : In addition to adverse events reported from clinical trials, the following events have been identified during post-marketing use of penicillins. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin. Infections and Infestations: Gastrointestinal: Immune: [see Warnings and Precautions ( 5. 1 Skin and Appendages: Liver: Renal: [see Overdosage ( 10 Hemic and Lymphatic Systems: Central Nervous System: Miscellaneous:.

Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e. , anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactam antibacterial drugs (e. , penicillins and cephalosporins). History of a serious hypersensitivity reaction (e. , anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e. , penicillins or cephalosporins) ( 4.

Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman. The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of amoxicillin for the treatment of H. Pylori patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger). [See Dosage and Administration ( 2. 3 An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Dosing in Renal Impairment ( 2.

Co-administration with probenicid is not recommended ( 7. 1 Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. 2 Coadministration with allopurinol increases the risk of rash. 3 Amoxicillin may reduce the efficacy of oral contraceptives. 4 Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of rashes is due to allopurinol or the hyperuricemia present in these patients. Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented. High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST registered registered Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

OVERDOSAGE
In case of overdosage, discontinue amoxicillin, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin 1 Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. 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 amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.
Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
NONCLINICAL TOXICOLOGY
Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium was nonmutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and clavulanate potassium was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Amoxicillin and clavulanate potassium was negative in the mouse micronucleus test and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).
CLINICAL STUDIES
Randomized, double-blind clinical studies performed in the United States in patients with H. pylori H. pylori Triple therapy: Table 5 Dual therapy: Table 6 H. pylori H. pylori Table 5. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen Study Triple Therapy Triple Therapy Evaluable Analysis This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest registered, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy. [95% Confidence Interval] (number of patients) Study 1 92 [80.0 to 97.7] (n equals 48) 86 [73.3 to 93.5] (n equals 55) Study 2 86 [75.7 to 93.6] (n equals 66) 83 [72.0 to 90.8] (n equals 70) Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen Study Dual Therapy Dual Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 77 [62.5 to 87.2] (n equals 51) 70 [56.8 to 81.2] (n equals 60) Study 2 66 [51.9 to 77.5] (n equals 58) 61 [48.5 to 72.9] (n equals 67) This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori Patients were included in the analysis if they had documented H. pylori
REFERENCES
Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.

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