AMOXICILLIN- amoxicillin_tablet, film coated

Amoxicillin is an antibacterial drug [see Microbiology (12. 4) Absorption: two-part crossover bioequivalence comparing 875 mg of amoxicillin with 875 mg of amoxicillin/clavulanate potassium 0-infinity max Table 4. Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults Dose * AUC 0-infinity C max dagger * dagger Amoxicillin Amoxicillin (+/-S. ) Amoxicillin (+/-S. ) 400 mg (5 mL of suspension) 17. 62) 400 mg (1 chewable tablet) 17. 64) Distribution: Metabolism and Excretion: [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 Streptococcus pneumoniae Streptococcus Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis Susceptibility Testing:.

Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Streptococcus Streptococcus pneumoniae Staphylococcus Haemophilus influenzae Infections of the Genitourinary Tract: Escherichia coli, Proteus mirabilis Enterococcus faecalis Infections of the Skin and Skin Structure: Streptococcus Staphylococcus E. coli Infections of the Lower Respiratory Tract: Streptococcus S. pneumoniae, Staphylococcus H. influenzae Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori Dual therapy for H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected H. pylori Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets and other antibacterial drugs, amoxicillin tablets 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 tablets are 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 tablets and other antibacterial drugs, amoxicillin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 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, amoxicillin tablets 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 a Recommended Dosage for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg Recommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kg Ear/Nose/Throat Mild/Moderate 500 mg every 12 hours or 25 mg/kg/day in divided doses every 12 hours or Severe 875 mg every 12 hours or 45 mg/kg/day in divided doses every 12 hours or Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 45 mg/kg/day in divided doses every 12 hours or a 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 tablets 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 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 Hemodialysis 500 mg or 250 mg every 24 hours, depending on severity of the infection.

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 tablets or for oral suspension were diarrhea, rash, vomiting, and nausea. 1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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. Triple therapy: Dual therapy: In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing 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: [see Warnings and Precautions (5. 4) Immune: [see Warnings and Precautions (5. 1) ] Skin and Appendages: Liver: Renal: [see Overdosage (10) Hemic and Lymphatic Systems: Central Nervous System: Miscellaneous:.

Amoxicillin tablets are contraindicated in patients who have experienced a serious hypersensitivity reaction (e. , anaphylaxis or Stevens-Johnson syndrome) to amoxicillin tablets 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 tablets or to other beta-lactams (e. , penicillins or cephalosporins).

Teratogenic Effects : 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 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. 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. 1) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. 2) Co-administration 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 High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST registered registered.

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. 1
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 potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and potassium clavulanate 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 potassium clavulanate 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: Dual therapy: H. pylori H. pylori Table 5. H. pylori Study Triple Therapy Triple Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 92 86 Study 2 86 83 a H. pylori registered b H. pylori Table 6. H. pylori 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 70 Study 2 66 61 a H. pylori registered b 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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