Amoxicillin Capsule [Northwind Health Company, Llc]

Adults and Pediatric PatientsUpper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. Infections of the Genitourinary Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. Infections of the Skin and Skin Structure:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), Staphylococcusspp., or E. coli. Infections of the Lower Respiratory Tract:Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcusspp., or H. influenzae. Adult Patients onlyHelicobacter pyloriInfection and Duodenal Ulcer Disease: 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. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pyloriwith lansoprazole: Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected.(See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. UsageTo 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 may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop skin rash they should be monitored closely, and amoxicillin discontinued if lesions progress.

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-Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4)]

Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy, including amoxicillin. Discontinue amoxicillin if a reaction occurs ( 5.1). Severe cutaneous adverse reactions (SCAR): Monitor closely. Discontinue if rash progresses. ( 5.2) Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use. If this occurs, discontinue amoxicillin and institute appropriate therapy. ( 5.3) Clostridioides difficile-associated diarrhea (CDAD) (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. ( 5.4) 5.1 Anaphylactic ReactionsSerious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. 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, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued, and appropriate therapy instituted.5.2 Severe Cutaneous Adverse ReactionsAmoxicillin may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop skin rash they should be monitored closely, and amoxicillin discontinued if lesions progress.5.3 Drug-Induced Enterocolitis Syndrome (DIES)Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use [see Adverse Reactions ( 6.2)] , with most cases occurring in pediatric patients ≤18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue amoxicillin and institute appropriate therapy. 5.4 Clostridioides difficile-Associated Diarrhea (CDAD) Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficilecause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficilemay need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. 5.5 Development of Drug-Resistant BacteriaPrescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.5.6 Skin Rash in Patients with MononucleosisA high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, amoxicillin should not be administered to patients with mononucleosis.

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. ( 2.2, 2.3) The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. ( 2.3) Dosing for H. pyloriInfection (in Adults): Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.4) Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). ( 2.5) 2.1 Important Administration InstructionsTo minimize the potential for gastrointestinal intolerance, amoxicillin should be taken at the start of a meal. 2.2 Dosage for Adults and Pediatric Patients Aged 3 Months (12 weeks) and OlderTreatment 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 pyogenesto prevent the occurrence of acute rheumatic fever. 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.Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and OlderInfectionSeverity a Recommended Dosage for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kgRecommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kgEar/Nose/Throat Skin/Skin Structure Genitourinary TractMild/Moderate500 mg every 12 hours or250 mg every 8 hours25 mg/kg/day in divided doses every 12 hoursor20 mg/kg/day in divided doses every 8 hoursSevere875 mg every 12 hours or500 mg every 8 hours45 mg/kg/day in divided doses every 12 hoursor40 mg/kg/day in divided doses every 8 hoursLower Respiratory TractMild/Moderate or Severe875 mg every 12 hours or500 mg every 8 hours45 mg/kg/day in divided doses every 12 hoursor40 mg/kg/day in divided doses every 8 hoursaDosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. 2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months)It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. 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.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.2.4 Dosage for H. pyloriInfection in Adults Triple therapy:The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy:The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.2.5 Dosage in Renal Impairment for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kgPatients 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 NOTreceive the 875 mg dose. See dosage regimens in patients with severe renal impairment provided in Table 2. Table 2. Dosing in Patients with Severe Renal ImpairmentPatients with Renal ImpairmentDosage RegimenGFR 10 to 30 mL/min500 mg or 250 mg every 12 hours, depending on the severity of the infectionGFR less than 10 mL/min500 mg or 250 mg every 24 hours, depending on severity of the infectionHemodialysis500 mg or 250 mg every 24 hours, depending on severity of the infectionAdminister an additional dose both during and at the end of dialysis2.6 Directions for Mixing Oral SuspensionPrepare 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 vigorouslyto wet powder. Add remaining water. Replace cap and shake vigorously. Table 3. Amount of Water for Mixing For Oral SuspensionStrengthBottle SizeTotal Amount of Water Required for Reconstitution For Oral Suspension 200 mg/5 mL50 mL39 mL75 mL57 mL100 mL75 mLFor Oral Suspension 250 mg/5 mL80 mL47 mL100 mL60 mL150 mL90 mLFor Oral Suspension 400 mg/5 mL50 mL35 mL75 mL51 mL100 mL67 mLAfter 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.SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

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 pyogenesto prevent the occurrence of acute rheumatic fever. 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.Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and OlderInfectionSeverity a Recommended Dosage for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kgRecommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kgEar/Nose/Throat Skin/Skin Structure Genitourinary TractMild/Moderate500 mg every 12 hours or250 mg every 8 hours25 mg/kg/day in divided doses every 12 hoursor20 mg/kg/day in divided doses every 8 hoursSevere875 mg every 12 hours or500 mg every 8 hours45 mg/kg/day in divided doses every 12 hoursor40 mg/kg/day in divided doses every 8 hoursLower Respiratory TractMild/Moderate or Severe875 mg every 12 hours or500 mg every 8 hours45 mg/kg/day in divided doses every 12 hoursor40 mg/kg/day in divided doses every 8 hoursaDosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenesto prevent the occurrence of acute rheumatic fever. 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.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.

Triple therapy:The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy:The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. 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 NOTreceive the 875 mg dose. See dosage regimens in patients with severe renal impairment provided in Table 2. Table 2. Dosing in Patients with Severe Renal ImpairmentPatients with Renal ImpairmentDosage RegimenGFR 10 to 30 mL/min500 mg or 250 mg every 12 hours, depending on the severity of the infectionGFR less than 10 mL/min500 mg or 250 mg every 24 hours, depending on severity of the infectionHemodialysis500 mg or 250 mg every 24 hours, depending on severity of the infectionAdminister 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 vigorouslyto wet powder. Add remaining water. Replace cap and shake vigorously. Table 3. Amount of Water for Mixing For Oral SuspensionStrengthBottle SizeTotal Amount of Water Required for Reconstitution For Oral Suspension 200 mg/5 mL50 mL39 mL75 mL57 mL100 mL75 mLFor Oral Suspension 250 mg/5 mL80 mL47 mL100 mL60 mL150 mL90 mLFor Oral Suspension 400 mg/5 mL50 mL35 mL75 mL51 mL100 mL67 mLAfter 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.SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

Amoxicillin:Tablets:500 mg: Each tablet contains 500 mg of amoxicillin, USP as the trihydrate. Each film-coated, capsule-shaped, off-white, tablet is debossed with “93” on one side and “2263” on the other side.875 mg: Each tablet contains 875 mg of amoxicillin, USP as the trihydrate. Each film-coated, capsule-shaped, off-white tablet is scored on one side, debossed with “93” on one side of the score and “2264” on the other side of the score. For Oral Suspension:200 mg/5 mL: Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 200 mg amoxicillin, USP as the trihydrate.250 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 250 mg amoxicillin, USP as the trihydrate.400 mg/5 mL: Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 400 mg amoxicillin, USP as the trihydrate.Tablets (Chewable):125 mg: Each white to off-white, capsule-shaped tablet, debossed 93 on one side and 2267 on the other side and contains 125 mg of amoxicillin, USP as the trihydrate.250 mg: Each white to off-white, capsule-shaped tablet, debossed 93 (partial bisect between 9 and 3) on one side and 2268 on the other side and contains 250 mg of amoxicillin, USP as the trihydrate.Capsules: 250 mg: Opaque caramel cap and opaque buff body, hard gelatin capsule. Printed black “TEVA” on cap and “3107” on body portions of the capsule and contain 250 mg amoxicillin, USP as the trihydrate. 500 mg: Opaque buff cap and opaque buff body, hard gelatin capsules. Printed black “TEVA” on cap and “3109” on body portions of the capsules and contain 500 mg amoxicillin, USP as the trihydrate.

Coadministration with probenecid is not recommended. ( 7.1) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2) Coadministration with allopurinol increases the risk of rash. ( 7.3) Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4) 7.1 ProbenecidProbenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.7.2 Oral AnticoagulantsAbnormal 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.7.3 AllopurinolThe 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.7.4 Oral ContraceptivesAmoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.7.5 Other AntibacterialsChloramphenicol, 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. 7.6 Effects on Laboratory TestsHigh 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, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ®) be used. 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.