Amoxicillin and Clavulanate Potassium (Page 5 of 5)

14.2 Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients

One US/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., ³ 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 2‑4 days after the completion of therapy) and at the follow‑up visit (defined as 22‑28 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 In addition, the number of patients with either severe diarrhea or who were withdrawn with diarrhea was significantly lower in the every 12 hours treatment group (3% and 8% for the every 12 hours/10 day and every 8 hours/10 day, respectively). In the every 12 hours treatment group, 3 patients (1%) were withdrawn with an allergic reaction, while 1 patient in the every 8 hours group was withdrawn for this reason.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/5 mL and 400 mg/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

Tablets:

875 mg/125 mg Tablets: Each scored white capsule‑shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

NDC 72789-083-03 bottles of 3

NDC 72789-083-04 bottles of 4

NDC 72789-083-06 bottles of 6

NDC 72789-083-14 bottles of 14

NDC 72789-083-20 bottles of 20

NDC 72789-083-28 bottles of 28

Dispense in original container.

Store tablets and dry powder at or below 25°C (77°F).

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 advised to keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of Amoxicillin and Clavulanate Potassium, use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of suspension of Amoxicillin and Clavulanate Potassium may contain more liquid than required. Follow your doctor’s instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.

Patients should be aware that Amoxicillin and Clavulanate Potassium contains a penicillin class drug product that can cause allergic reactions in some individuals.

AUGMENTIN is a registered trademark of GlaxoSmithKline and is licensed to Neopharma Inc.

CLINITEST is a registered trademark of Miles, Inc.

Manufactured By:

Neopharma Tennessee LLC.

Bristol, TN 37620

Manufactured for:

Neopharma Inc.

Princeton, NJ 08540

Revised: 01/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amoxicillin and Clavulanate Potassium Tablets 875 mg/125 mg

72789083 Label
(click image for full-size original)
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin and clavulanate potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-083(NDC:72508-221)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 875 mg
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 18mm
Flavor Imprint Code AUGMENTIN;875
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-083-03 3 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:72789-083-04 4 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:72789-083-06 6 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:72789-083-14 14 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:72789-083-20 20 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:72789-083-28 28 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050720 12/12/2019 06/01/2022
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-083)

Revised: 04/2022 PD-Rx Pharmaceuticals, Inc.

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