AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium  tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat 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 tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . caused by beta-lactamase–producing
Product summary:
Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with X on one side and score line in between 3 and 2 on the other side. NDC 68071-5065-3 BOTTLES OF 3 Dispense in a tight container [see USP]. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-5065-3

AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate

potassium tablet, film coated

NuCare Pharmaceuticals,Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE

POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and

CLAVULANATE POTASSIUM TABLETS.

AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use

Initial U.S. Approval: 1984

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and

clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets

should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

INDICATIONS AND USAGE

Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor

indicated for treatment of the following:

Lower respiratory tract infections (1.1)

Acute bacterial otitis media (1.2)

Sinusitis (1.3)

Skin and skin structure infections (1.4)

Urinary tract infections (1.5)

DOSAGE AND ADMINISTRATION

Adults and Pediatric Patients > 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500

mg/125 mg every 8 hours. (2.1, 2.2)

Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every

8 hours, up to the adult dose. (2.2)

Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.

Use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended. (2.2)

DOSAGE FORMS AND STRENGTHS

Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored (3)

CONTRAINDICATIONS

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and

clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins). (4)

History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets. (4)

WARNINGS AND PRECAUTIONS

Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium if a reaction

occurs. (5.1)

Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function

tests in patients with hepatic impairment. (5.2)

Clostridium difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. (5.3)

Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash. Avoid amoxicillin and

clavulanate potassium use in these patients. (5.4)

Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.

(5.5)

ADVERSE REACTIONS

The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria

(3%), vomiting (1%) and vaginitis (1%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Co-administration with probenecid is not recommended. (7.1)

Concomitant use of amoxicillin and clavulanate potassium and oral anticoagulants may increase the prolongation of

prothrombin time. (7.2)

Coadministration with allopurinol increases the risk of rash. (7.3)

Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives. (7.4)

USE IN SPECIFIC POPULATIONS

Pediatric Use: Modify dose in patients 12 weeks or younger. (8.4)

Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR< 30 mL/min). (2.3, 8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Lower Respiratory Tract Infections

1.2 Acute Bacterial Otitis Media

1.3 Sinusitis

1.4 Skin and Skin Structure Infections

1.5 Urinary Tract Infections

1.6 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Adults

2.2 Pediatric Patients

2.3 Patients with Renal Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Serious Hypersensitivity Reactions

4.2 Cholestatic Jaundice/Hepatic Dysfunction

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

5.2 Hepatic Dysfunction

5.3 Clostridium difficile-Associated Diarrhea (CDAD)

5.4 Skin Rash in Patients with Mononucleosis

5.5 Potential for Microbial Overgrowth

5.7 Development of Drug-Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Probenecid

7.2 Oral Anticoagulants

7.3 Allopurinol

7.4 Oral Contraceptives

7.5 Effects on Laboratory Tests

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Dosing in Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Lower Respiratory Tract and Complicated Urinary Tract Infections

14.2 Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and

clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets

should be used only to treat 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 tablets are a combination penicillin-class antibacterial and beta-

lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated

bacteria in the conditions listed below*:

1.1 Lower Respiratory Tract Infections

caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

1.2 Acute Bacterial Otitis Media

caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

1.3 Sinusitis

caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

Sections or subsections omitted from the full prescribing information are not listed.

1.4 Skin and Skin Structure Infections

caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella

species.

1.5 Urinary Tract Infections

caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

1.6 Limitations of Use

When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase

production, amoxicillin and clavulanate potassium tablets should not be used.

2 DOSAGE AND ADMINISTRATION

Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however,

absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are

administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin

and clavulanate potassium tablets should be taken at the start of a meal.

2.1 Adults

The usual adult dose is one amoxicillin and clavulanate potassium tablet 500 mg/125 mg every 12 hours

or one amoxicillin and clavulanate potassium tablet 250 mg/125 mg every 8 hours. For more severe

infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate

potassium tablet 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet 500

mg/125 mg every 8 hours. 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/125 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/125 mg tablet.

Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should not be substituted for one

amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate

potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125

mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and

clavulanate potassium tablet 500 mg/125 mg.

The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable

tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and

clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the

same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium tablet

250 mg/125 mg contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet

contains 62.5 mg of clavulanic acid.

2.2 Pediatric Patients

Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as

follows:

Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and

clavulanate potassium tablets is 30 mg/kg/day divided every 12 hours, based on the amoxicillin

component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and

thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended.

Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1. The every 12

hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies

(14.2)] . However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5

mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used

by phenylketonurics .

Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older

Each strength of suspension of amoxicillin and clavulanate potassium is available as a

chewable tablet for use by older children.

Duration of therapy studied and recommended for acute otitis media is 10 days.

INFECTION

DOSING REGIMEN

Every 12 hours

Every 8 hours

200 mg/28.5 mg per 5 mL or

400 mg/57 mg per 5 mL oral

suspension

125 mg/31.25 mg per 5 mL or

250 mg/62.5 mg per 5 mL oral

suspension

Otitis media

, sinusitis,

lower respiratory tract

infections, and more severe

infections

45 mg/kg/day every 12 hours

40 mg/kg/day every 8 hours

Less severe infections

25 mg/kg/day every 12 hours

20 mg/kg/day every 8 hours

Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed

according to adult recommendations.

The amoxicillin and clavulanate potassium tablet 250 mg/125 mg should not be used until the child

weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and

clavulanate potassium tablet 250 mg/125 mg versus the amoxicillin and clavulanate potassium chewable

tablet 250 mg/62.5 mg.

2.3 Patients with Renal Impairment

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 <30 mL/min should not receive

the amoxicillin and clavulanate potassium tablets 875 mg/125 mg dose. Patients with a glomerular

filtration rate of 10 to 30 mL/min should receive amoxicillin and clavulanate potassium tablets 500

mg/125 mg or 250 mg/125 mg every 12 hours, depending on the severity of the infection. Patients with a

glomerular filtration rate less than 10 mL/min should receive amoxicillin and clavulanate potassium

tablets 500 mg/125 mg or 250 mg/125 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive amoxicillin and clavulanate potassium tablets 500 mg/125 mg or

250 mg/125 mg every 24 hours, depending on severity of the infection. They should receive an

additional dose both during and at the end of dialysis.

3 DOSAGE FORMS AND STRENGTHS

250 mg/125 mg: White to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one

side and ‘63’ on the other side.

500 mg/125 mg: White to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one

side and ‘33’ on the other side.

875 mg/125 mg: White to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one

side and score line in between 3 and 2 on the other side.

The amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable

tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg/125 mg

tablet should not be used in children weighing less than 40 kg. The amoxicillin and clavulanate

potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount

of clavulanic acid. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of

clavulanic acid whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.

Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should NOT be substituted for one

amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate

potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125

mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets 250 mg/125 mg are not

equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.

4 CONTRAINDICATIONS

4.1 Serious Hypersensitivity Reactions

Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a history of serious

hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate

or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

4.2 Cholestatic Jaundice/Hepatic Dysfunction

Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a previous history of

cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients

receiving beta-lactam antibacterials, including amoxicillin and clavulanate potassium. These reactions

are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of

sensitivity to multiple allergens. Before initiating therapy with amoxicillin and clavulanate potassium,

careful inquiry should be made regarding previous hypersensitivity reactions to penicillins,

cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin and clavulanate potassium

should be discontinued and appropriate therapy instituted.

5.2 Hepatic Dysfunction

Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of

amoxicillin and clavulanate potassium. Hepatic toxicity is usually reversible; however, deaths have

been reported. Hepatic function should be monitored at regular intervals in patients with hepatic

been reported. Hepatic function should be monitored at regular intervals in patients with hepatic

impairment.

5.3 Clostridium difficile-Associated Diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial

agents, including amoxicillin and clavulanate potassium, 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. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-

producing strains of C. difficile cause 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. difficile may 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.

5.4 Skin Rash in Patients with Mononucleosis

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous

skin rash. Thus, amoxicillin and clavulanate potassium should not be administered to patients with

mononucleosis.

5.5 Potential for Microbial Overgrowth

The possibility of superinfections with fungal or bacterial pathogens should be considered during

therapy. If superinfection occurs, amoxicillin and clavulanate potassium should be discontinued and

appropriate therapy instituted.

5.7 Development of Drug-Resistant Bacteria

Prescribing amoxicillin and clavulanate potassium in the absence of a proven or strongly suspected

bacterial infection is unlikely to provide benefit to the patient, and increases the risk of the development

of drug-resistant bacteria.

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

Anaphylactic reactions [see Warnings and Precautions (5.1)]

Hepatic Dysfunction [see Warnings and Precautions (5.2)]

CDAD [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

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 frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin

rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued

therapy because of drug-related adverse reactions. The overall incidence of adverse reactions, and in

particular diarrhea, increased with the higher recommended dose. Other less frequently reported

adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache.

In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which

compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10

days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium 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 reactions seen were comparable to that noted

above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area

rashes [see Clinical Studies (14.2)] .

6.2 Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following have been identified during

postmarketing use of amoxicillin and clavulanate potassium. 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 and clavulanate potassium.

Gastrointestinal: 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 and Precautions (5.3)] .

Hypersensitivity Reactions: Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash

accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-

Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and cases of

exfoliative dermatitis (including toxic epidermal necrolysis) have been reported [see Warnings and

Precautions (5.1)] .

Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum

transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been 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. Deaths have been

reported [see Contraindications (4.2), Warnings and Precautions (5.2)] .

Renal: Interstitial nephritis, hematuria, and crystalluria have been reported [see Overdosage (10)] .

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia,

thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These

reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity

phenomena. 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 [see Drug Interactions

(7.2)] .

Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness,

Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness,

insomnia, and reversible hyperactivity have been reported.

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports

occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning

in most cases.

7 DRUG INTERACTIONS

7.1 Probenecid

Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of

clavulanic acid. Concurrent use with amoxicillin and clavulanate potassium may result in increased and

prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.

7.2 Oral Anticoagulants

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 with amoxicillin and clavulanate potassium.

Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of

anticoagulation.

7.3 Allopurinol

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 amoxicillin rashes is due to allopurinol or the hyperuricemia present in

these patients.

7.4 Oral Contraceptives

Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen

reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

7.5 Effects on Laboratory Tests

High urine concentrations of amoxicillin 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 clavulanate potassium, it is recommended that glucose

tests based on enzymatic glucose oxidase reactions be used.

Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration

of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category B. Reproduction studies performed in pregnant rats and mice

given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral

doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and

clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were

approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours).

For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended

adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled

studies in pregnant women. Because animal reproduction studies are not always predictive of human

response, this drug should be used during pregnancy only if clearly needed.

8.2 Labor and Delivery

Oral ampicillin-class antibiotics are poorly absorbed during labor. It is not known whether 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 of the necessity

for an obstetrical intervention.

8.3 Nursing Mothers

Amoxicillin has been shown to be excreted in human milk. Amoxicillin and clavulanate potassium use by

nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin and

clavulanate potassium is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of amoxicillin and clavulanate potassium powder for oral suspension and

chewable tablets have been established in pediatric patients. Use of amoxicillin and clavulanate

potassium tablets in pediatric patients is supported by evidence from studies of amoxicillin and

clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate

potassium powder for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis

media [see Clinical Studies (14.2)] .

Because of incompletely developed renal function in neonates and young infants, the elimination of

amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of

amoxicillin and clavulanate potassium should be modified in pediatric patients aged <12 weeks (<3

months) [see Dosage and Administration (2.2)] .

8.5 Geriatric Use

Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium, 32%

were ≥65 years old, and 14% were ≥75 years old. No overall differences in safety or effectiveness

were observed between these subjects and younger subjects, and other reported clinical experience has

not identified differences in responses between the elderly and younger patients, but 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 adverse 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.

8.6 Dosing in Renal Impairment

Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients

with severe renal impairment (GFR <30 mL/min). See Patients with Renal Impairment (2.3) for specific

recommendations in patients with renal impairment.

10 OVERDOSAGE

In case of overdosage, discontinue medication, 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 patients after overdosage

with amoxicillin and clavulanate potassium.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and

clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid

intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium

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 and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from

circulation by hemodialysis [see Dosage and Administration (2.3)] .

11 DESCRIPTION

Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of

amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic

acid).

Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-

aminopenicillanic acid. The amoxicillin molecular formula is C

S3H

O, and the

molecular weight is 419.46. Chemically, amoxicillin is (2 S,5 R,6 R)-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 may be represented structurally as:

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam

structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by

blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C

, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z)( 2R,5R)-3-(2-

hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented

structurally as:

Each film coated tablet for oral administration contains 250 mg, 500 mg or 875 mg amoxicillin USP as

the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate

potassium tablet 250 mg/125 mg, 500 mg/125 mg or 875 mg/125 mg contains 0.63 mEq potassium.

Inactive Ingredients:

Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose

dispersion), and titanium dioxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Amoxicillin and clavulanate potassium is an antibacterial drug [see Microbiology (12.4)] .

12.3 Pharmacokinetics

Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following

administration of amoxicillin and clavulanate potassium tablets are shown in Table 3 and following

administration of amoxicillin and clavulanate potassium powder for oral suspension and chewable

tablets are shown in Table 4.

Table 3: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters

with Amoxicillin and Clavulanate Potassium Tablets

Mean (± standard deviation) values of 14 normal adults (N=15 for clavulanate potassium in the low-

dose regimens). Peak concentrations occurred approximately 1.5 hours after the dose.

Dose and Regimen

C

(mcg/mL)

AUC

(mcg*h/mL)

Amoxicillin and Clavulanate

Potassium

Amoxicillin

Clavulanate

Potassium

Amoxicillin

Clavulanate

Potassium

250 mg/125 mg every 8 hours

3.3 ± 1.12

1.5 ± 0.7

26.7 ± 4.56

12.6 ± 3.25

500 mg/125 mg every 12 hours

6.5 ± 1.41

1.8 ± 0.61

33.4 ± 6.76

8.6 ± 1.95

500 mg/125 mg every 8 hours

7.2 ± 2.26

2.4 ± 0.83

53.4 ± 8.87

15.7 ± 3.86

875 mg/125 mg every 12 hours

11.6 ± 2.78

2.2 ± 0.99

53.5 ± 12.31

10.2 ± 3.04

a,b

max

0 -24

Amoxicillin and clavulanate potassium administered at the start of a light meal.

Table 4: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters

with Amoxicillin and Clavulanate Potassium Powder for Oral Suspension and Chewable Tablets

Mean (± standard deviation) values of 28 normal adults. Peak concentrations occurred approximately 1

hour after the dose.

Amoxicillin and clavulanate potassium administered at the start of a light meal.

Dose

C

(mcg/mL)

AUC

(mcg*h/mL)

Amoxicillin and Clavulanate

Potassium

Amoxicillin

Clavulanate

Potassium

Amoxicillin

Clavulanate

Potassium

400 mg/57 mg (5 mL of suspension)

6.94 ± 1.24

1.1 ± 0.42

17.29 ± 2.28

2.34 ± 0.94

400 mg /57 mg (1 chewable tablet)

6.67 ± 1.37

1.03 ± 0.33

17.24 ± 2.64

2.17 ± 0.73

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 of 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 for clavulanic 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 were administered to normal adults. One amoxicillin

and clavulanate potassium 250 mg/62.5 mg chewable tablet or two amoxicillin and clavulanate potassium

125 mg/31.25 mg 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 concentrations of amoxicillin 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. Time above the

minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after

corresponding every 12 hour and every 8 hour dosing regimens of amoxicillin and clavulanate

potassium in adults and children.

Absorption: 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.

Distribution: Neither component in amoxicillin and clavulanate potassium is highly protein-bound;

clavulanic acid is 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.

Two hours after oral administration of a single 35 mg/kg dose of suspension of amoxicillin and

clavulanate potassium to fasting children, average concentrations of 3 mcg/mL of amoxicillin and 0.5

mcg/mL of clavulanic acid were detected in middle ear effusions.

a,b

max

0-24

Metabolism and Excretion: 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 hour.

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 a single amoxicillin and

clavulanate potassium tablet 250 mg/125 mg or 500 mg/125 mg.

12.4 Microbiology

Amoxicillin is a semisynthetic antibiotic with in vitro bactericidal activity against Gram-positive and

Gram-negative bacteria. Amoxicillin is, however, susceptible to degradation by beta-lactamases, and

therefore, the spectrum of activity does not include organisms which produce these enzymes.

Clavulanic acid is a beta-lactam, structurally related to the penicillins, which possesses the ability to

inactivate some beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and

cephalosporins. In particular, it has good activity against the clinically important plasmid-mediated beta-

lactamases frequently responsible for transferred drug resistance.

The formulation of amoxicillin and clavulanic acid in amoxicillin and clavulanate potassium protects

amoxicillin from degradation by some beta-lactamase enzymes and extends the antibiotic spectrum of

amoxicillin to include many bacteria normally resistant to amoxicillin.

Amoxicillin and clavulanic acid has been shown to be active against most isolates of the following

bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE

section.

Gram-positive Bacteria

Staphylococcus aureus

Gram-negative Bacteria

Enterobacter species

Escherichia coli

Haemophilus influenzae

Klebsiella species

Moraxella catarrhalis

The following in vitro data are available, but their clinical significance is unknown. At least 90

percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or

equal to the susceptible breakpoint for amoxicillin and clavulanic acid. However, the efficacy of

amoxicillin and clavulanic acid in treating clinical infections due to these bacteria has not been

established in adequate and well-controlled clinical trials.

Gram-positive Bacteria

Enterococcus faecalis

Staphylococcus epidermidis

Staphylococcus saprophyticus

Streptococcus pneumoniae

Streptococcus pyogenes

Viridans group Streptococcus

Gram-negative Bacteria

Eikenella corrodens

Proteus mirabilis

Anaerobic Bacteria

Bacteroides species including Bacteroides fragilis

Fusobacterium species

Peptostreptococcus species

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.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Amoxicillin and clavulanate potassium (4:1 ratio formulation of amoxicillin:clavulanate) was non-

mutagenic 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.

Amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of

up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats.

Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum

recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is

approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8

hours), also based on body surface area.

14 CLINICAL STUDIES

14.1 Lower Respiratory Tract and Complicated Urinary Tract Infections

Data from 2 pivotal trials in 1,191 patients treated for either lower respiratory tract infections or

complicated urinary tract infections compared a regimen of 875 mg/125 mg tablets of amoxicillin and

clavulanate potassium every 12 hours to 500 mg/125 mg tablets of amoxicillin and clavulanate potassium

dosed every 8 hours (584 and 607 patients, respectively). Comparable efficacy was demonstrated

between the every 12 hours and every 8 hours dosing regimens. There was no significant difference in

the percentage of adverse events in each group. The most frequently reported adverse event was

diarrhea; incidence rates were similar for the 875 mg/125 mg every 12 hours and 500 mg/125 mg every

8 hours dosing regimens (15% and 14%, respectively); however, there was a statistically significant

difference (p < 0.05) in rates of severe diarrhea or withdrawals with diarrhea between the regimens:

1% for 875 mg/125 mg every 12 hours regimen versus 2% for the 500 mg/125 mg every 8 hours

regimen.

In one of these pivotal trials, patients with either pyelonephritis (n = 361) or a complicated urinary tract

infection (i.e., patients with abnormalities of the urinary tract that predispose to relapse of bacteriuria

following eradication, n = 268) were randomized (1:1) to receive either 875 mg/125 mg tablets of

amoxicillin and clavulanate potassium every 12 hours (n=308) or 500 mg/125 mg tablets of amoxicillin

and clavulanate potassium every 8 hours (n=321).

The number of bacteriologically evaluable patients was comparable between the two dosing regimens.

Amoxicillin and clavulanate potassium produced comparable bacteriological success rates in patients

assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were

comparable at one of the follow-up visits (5 to 9 days post-therapy) and at a late post-therapy visit (in

the majority of cases, this was 2 to 4 weeks post-therapy), as seen in Table 7.

Table 7: Bacteriologic efficacy rates for Amoxicillin and Clavulanate Potassium

Time Post Therapy

875 mg/125 mg every

12 hours

% (n)

500 mg/125 mg every

8 hours

% (n)

2 to 4 days

81% (58)

80% (54)

5 to 9 days

58% (41)

52% (52)

2 to 4 weeks

52% (101)

55% (104)

As noted before, though there was no significant difference in the percentage of adverse events in each

group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with

diarrhea between the regimens.

14.2 Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients

One U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12

hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8

hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media. Only

the suspension formulations were used in this trial. A total of 575 pediatric patients (aged 2 months to 12

years) were enrolled, with an even distribution among the 2 treatment groups and a comparable number

of patients were evaluable (i.e., ≥ 84%) per treatment group. Otitis media-specific criteria were

required for eligibility and a strong correlation was found at the end of therapy and follow-up between

these criteria and physician assessment of clinical response. The clinical efficacy rates at the end of

therapy visit (defined as 2 to 4 days after the completion of therapy) and at the follow-up visit (defined

as 22 to 28 days post-completion of therapy) were comparable for the 2 treatment groups, with the

following cure rates obtained for the evaluable patients: At end of therapy, 87% (n = 265) and 82% (n =

260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively. At follow-up,

67% (n = 249) and 69% (n = 243) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours,

respectively.

Diarrhea was defined as either: (a) 3 or more watery or 4 or more loose/watery stools in 1 day; OR (b)

2 watery stools per day or 3 loose/watery stools per day for 2 consecutive days. The incidence of

diarrhea was significantly lower in patients who received the every 12 hours regimen compared to

patients who received the every 8 hours regimen (14% and 34%, respectively). In addition, the number

of patients with either severe diarrhea or who were withdrawn with diarrhea was significantly lower in

the every 12 hours treatment group (3% and 8% for the every 12 hours/10 day and every 8 hours/10 day,

respectively). In the every 12 hours treatment group, 3 patients (1%) were withdrawn with an allergic

reaction, while 1 patient in the every 8 hours group was withdrawn for this reason. The number of

patients with a candidal infection of the diaper area was 4% and 6% for the every 12 hours and every 8

hours groups, respectively.

It is not known if the finding of a statistically significant reduction in diarrhea with the oral suspensions

dosed every 12 hours, versus suspensions dosed every 8 hours, can be extrapolated to the chewable

tablets. The presence of mannitol in the chewable tablets may contribute to a different diarrhea profile.

The every 12 hour oral suspensions (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) are

sweetened with aspartame.

15 REFERENCES

1. 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white,

capsule shaped, film-coated tablets, debossed with X on one side and score line in between 3 and 2 on

the other side.

NDC 68071-5065-3 BOTTLES OF 3

Dispense in a tight container [see USP].

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

Patients should be informed that amoxicillin and clavulanate potassium may be taken every 8 hours or

every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to

reduce the possibility of gastrointestinal upset.

Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium,

should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common

cold). When amoxicillin and clavulanate potassium 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 or other

antibacterial drugs in the future.

Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when

the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can

develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more

months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or

3 days, patients should contact their physician.

Patients should be aware that amoxicillin and clavulanate potassium contains a penicillin class drug

product that can cause allergic reactions in some individuals.

CLINITEST is a registered trademark of Miles, Inc.

Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 038, India

Revised: 07/2018

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -

AMOXICILLIN AND CLAVULANATE POTASSIUM

amoxicillin and clavulanate potassium tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 71-50 6 5(NDC:6 58 6 2-50 3)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMO XICILLIN (UNII: 8 0 48 26 J2HU) (AMOXICILLIN ANHYDROUS - UNII:9 EM0 5410 Q9 )

AMOXICILLIN

ANHYDROUS

8 75 mg

CLAVULANATE PO TASSIUM (UNII: Q42OMW3AT8 ) (CLAVULANIC ACID -

UNII:23521W1S24)

CLAVULANIC ACID

125 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

HYPRO MELLO SE 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

HYPRO MELLO SE 2 9 10 ( 150 0 0 MPA.S) (UNII: 28 8 VBX44JC)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L 4 0 0 0 (UNII: 4R4HFI6 D9 5)

PO LYETHYLENE GLYCO L 6 0 0 0 (UNII: 30 IQX730 WE)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

ETHYLCELLULO SE, UNSPECIFIED (UNII: 7Z8 S9 VYZ4B)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white (White to Off-white)

S core

2 pieces

S hap e

CAPSULE

S iz e

22mm

Flavor

Imprint Code

X;3;2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-50 6 5-3

3 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 156 9

0 1/20 /20 12

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

NuCare Pharmaceuticals,Inc.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re pa c k(6 8 0 71-50 6 5)

Revised: 9/2019

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