Amoxicillin and Clavulanate Potassium description, usages, side effects, indications, overdosage, supplying and lots more!

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Amoxicillin and Clavulanate Potassium

Northstar Rx LLC
Aurobindo Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


AMOXICILLIN AND CLAVULANATE POTASSIUM DESCRIPTION


SRRRp
Amoxicillin and Clavulanate Potassium

Streptomyces clavuligerus-ZRR

Amoxicillin and Clavulanate Potassium



Inactive Ingredients:

PRECAUTIONS, Information for the Patient, Phenylketonurics

CLINICAL PHARMACOLOGY


Table 1. Mean (±SD) Plasma Amoxicillin and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Every 12 Hours to Pediatric Patients
Parameter* Amoxicillin Clavulanate
*Arithmetic mean ± standard deviation, except Tmax values which are medians (ranges).
   Cmax (mcg/mL)
15.7 ± 7.7
 1.7 ± 0.9
   Tmax (hr)
2 (1 to 4)
 1.1 (1 to 4)
   AUC0-t (mcg•hr/mL)
 59.8 ± 20
 4 ± 1.9
   T½ (hr)
1.4 ± 0.3
 1.1 ± 0.3
   CL/F (L/hr/kg)
0.9 ± 0.4
 1.1 ± 1.1











Table 2. Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL to Pediatric Patients
Timepoint Amoxicillin concentration
in plasma (mcg/mL)		 Amoxicillin concentration
in MEF (mcg/mL)
   1 hour
mean
median
range
 7.7
9.3
1.5 to 14
(n = 5)
 3.2
3.5
0.2 to 5.5
(n = 4)
   2 hour
mean
median
range
 15.7
13
11 to 25
(n = 7)
 3.3
2.4
1.9 to 6
(n = 5)
   3 hour
mean
median
range
 13
12
5.5 to 21
(n = 5)
 5.8
6.5
3.9 to 7.4
(n = 5)



Microbiology






in vitro INDICATIONS AND USAGE



Streptococcus pneumoniae



Haemophilus influenzae
Moraxella catarrhalis

in vitro but their clinical significance is unknown.

in vitro



Staphylococcus aureus

NOTE:

Streptococcus pyogenes

NOTE: S. pyogenesS. pyogenes

Susceptibility Test Methods

in vitro



1,2 S. pneumoniaeH. influenzae

Table 3



2,3Table 3
Table 3. Susceptibility Test Result Interpretive Criteria for Amoxicillin/Clavulanate Potassium
Pathogen Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion
(Zone Diameter in mm)
S I R S I R
   Streptococcus pneumoniae (non-meningitis isolates)
 ≤ 2/1
 4/2
 ≥ 8/4
 Not applicable (NA)
   Haemophilus influenzae
≤ 4/2
 NA
 ≥ 8/4
 ≥ 20
 NA
 ≤ 19

NOTE:S. pneumoniaeS. pneumoniae

NOTE: H. influenzae



1-3Table 4.Table 4
Table 4. Acceptable Quality Control Ranges for Amoxicillin/Clavulanate Potassium
Quality Control Organism Minimum Inhibitory Concentration Range (mcg/mL) Disk Diffusion (Zone Diameter Range in mm)
*ATCC is a trademark of the American Type Culture Collection.
† When using Haemophilus Test Medium (HTM).
   Escherichia coli ATCC®* 35218†
   (H. influenzae quality control)
4/2 to 16/8
 17 to 22
   Haemophilus influenzae ATCC 49247
2/1 to 16/8
 15 to 23
   Streptococcus pneumoniae ATCC 49619
0.03/0.016 to 0.12/0.06
 NA

AMOXICILLIN AND CLAVULANATE POTASSIUM INDICATIONS AND USAGE


S. pneumoniaeH. influenzae M. catarrhalis
  • antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: 
    • age ≤ 2 years
    • daycare attendance

 


CLINICAL PHARMACOLOGY, Microbiology

NOTE:S. pneumoniae S. pneumoniae

S. pneumoniae

AMOXICILLIN AND CLAVULANATE POTASSIUM CONTRAINDICATIONS


WARNINGS


SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Clostridium difficileC. difficile

C. difficile C. difficile

C. difficileC. difficile

CONTRAINDICATIONS ADVERSE REACTIONS, Liver

PRECAUTIONS

General






PseudomonasCandida

Information for Patients




Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.





Phenylketonurics

Drug Interactions








Drug/Laboratory Test Interactions


®®

Carcinogenesis, Mutagenesis, Impairment of Fertility


in vitroin vivoin vitro
Teratogenic Effects



Labor and Delivery


Nursing Mothers


Pediatric Use


DESCRIPTION OF CLINICAL STUDIES

CLINICAL PHARMACOLOGY

AMOXICILLIN AND CLAVULANATE POTASSIUM ADVERSE REACTIONS






Gastrointestinal
 
 WARNINGS

Hypersensitivity Reactions

WARNINGS

Liver

CONTRAINDICATIONS

Renal

OVERDOSAGE

Hemic and Lymphatic Systems



Central Nervous System



Miscellaneous

OVERDOSAGE




4





AMOXICILLIN AND CLAVULANATE POTASSIUM DOSAGE AND ADMINISTRATION


Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other amoxicillin and clavulanate potassium suspensions. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as they are not interchangeable.

Dosage





Body Weight
(kg)		 Volume of Amoxicillin and Clavulanate
Potassium for Oral Suspension,
600 mg/42.9 mg per 5 mL providing
90 mg/kg/day
8
 3 mL twice daily
12
 4.5 mL twice daily
16
 6 mL twice daily
20
 7.5 mL twice daily
24
 9 mL twice daily
28
 10.5 mL twice daily
32
 12 mL twice daily
36
 13.5 mL twice daily









WARNINGS




Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL
Bottle Size Amount of Water
Required for Reconstitution
75 mL
 71 mL
125 mL
 112 mL
200 mL
 176 mL



NOTE:

Administration


HOW SUPPLIED


Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL





STORAGE

DESCRIPTION OF CLINICAL STUDIES




S. pneumoniaeS. pneumoniaeTable 5


Table 5. Bacteriologic Eradication Rates in the Per Protocol Population
Bacteriologic Eradication on Therapy
Pathogen n/N % 95% CI*
* CI = confidence intervals; 95% CIs are not adjusted for multiple comparisons.
   All S. pneumoniae
121/123
 98.4
 (94.3, 99.8)
   S. pneumoniae with penicillin MIC = 2 mcg/mL
19/19
 100
 (82.4, 100)
   S. pneumoniae with penicillin MIC = 4 mcg/mL
12/14
 85.7
 (57.2, 98.2)
   H. influenzae
75/81
 92.6
 (84.6, 97.2)
   M. catarrhalis
11/11
 100
 (71.5, 100)



Table 6. Clinical Assessments in the Per Protocol Population (Includes S. pneumoniae Patients With Penicillin MICs = 2 or 4 mcg/mL*)
2 to 4 Days Post-Therapy
(Primary Endpoint)
Pathogen n/N % 95% CI†
* S. pneumoniae strains with penicillin MICs of 2 or 4 mcg/mL are considered resistant to penicillin.
† CI = confidence intervals; 95% CIs are not adjusted for multiple comparisons.
‡ Clinical assessments at 15 to 18 days post-therapy may have been confounded by viral infections and new episodes of acute otitis media with time elapsed post-treatment.
   All S. pneumoniae
122/137
 89.1
(82.6, 93.7)
   S. pneumoniae with penicillin MIC = 2 mcg/mL
17/20
 85
(62.1, 96.8)
   S. pneumoniae with penicillin MIC = 4 mcg/mL
11/14
 78.6
(49.2, 95.3)
   H. influenzae
141/162
 87
(80.9, 91.8)
   M. catarrhalis
22/26
 84.6
(65.1, 95.6)
 
 15 to 18 Days Post-Therapy‡
(Secondary Endpoint)
Pathogen
n/N
%
95% CI†
   All S. pneumoniae
95/136
 69.9
(61.4, 77.4)
   S. pneumoniae with penicillin MIC = 2 mcg/mL
11/20
 55
(31.5, 76.9)
   S. pneumoniae with penicillin MIC = 4 mcg/mL
5/14
 35.7
(12.8, 64.9)
   H. influenzae
106/156
 67.9
(60, 75.2)
   M. catarrhalis
14/25
 56
(34.9, 75.6)

S. pneumoniae



REFERENCES

  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing – 21st Informational Supplement. CLSI Document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011.
  • Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Approved Standard 7th ed. CLSI Document M11-A7. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2007.
  • Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – 8th ed. CLSI Document M07-A8. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2009.
  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Test; Approved Standard – 10th ed. CLSI Document M02-A10. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2009.
  • 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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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/42.9 mg per 5 mL (125 mL Bottle)


Rx only
NDC 16714-294-02
Amoxicillin and
Clavulanate Potassium
for Oral Suspension, USP
600 mg/42.9 mg* per 5 mL
125 mL when reconstituted
Northstar Rx LLC
Amoxicillin and Clavulanate Potassium

Amoxicillin and Clavulanate Potassium

Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-294
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AMOXICILLIN amoxicillin anhydrous 600 mg
CLAVULANATE POTASSIUM clavulanic acid 42.9 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
COLLOIDAL SILICON DIOXIDE
HYPROMELLOSE 2910 (50 MPA.S)
SILICON DIOXIDE
SUCCINIC ACID
XANTHAN GUM
Strawberry

Product Characteristics

Color
WHITE (White to Off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-294-01 75 in 1 BOTTLE
2 NDC:16714-294-02 125 in 1 BOTTLE
3 NDC:16714-294-03 200 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201091 2011-12-20


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