Amoxicillin and Clavulanate Potassium (Page 6 of 7)
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., ≥ 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 In addition, the number of patients with either severe diarrhea or who were withdrawn with diarrhea was significantly lower in the every 12 hours treatment group (3% and 8% for the every 12 hours/10 day and every 8 hours/10 day, respectively). In the every 12 hours treatment group, 3 patients (1%) were withdrawn with an allergic reaction, while 1 patient in the every 8 hours group was withdrawn for this reason.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.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 8th ed. CLSI Document M7-A9. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087, 2012.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standard for Antimicrobial Disk Susceptibility Tests;Approved Standard – 11th ed. CLSI Document M2-A11. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087, 2012.
4. CLSI. Performance Standards for Antimicrobial Susceptibility Testing: 22nd Informational Supplement. CLSI document M100-S22. CLSI, Wayne, PA, 2012.
16 HOW SUPPLIED/STORAGE AND HANDLING
Tablets:
250‑mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt.
NDC 43598-218-30 bottles of 30
NDC 43598-218-78 Unit Dose (10×10) 100 tablets
500‑mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt.
NDC 43598-206-14 bottles of 20
NDC 43598-206-78 Unit Dose (10×10) 100 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 875mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt.
NDC 43598-221-14 bottles of 20
NDC 43598-221-78 Unit Dose (10×10) 100 tablets
Powder for Oral Suspension:
125 mg/31.25 mg per 5 mL: Banana-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt).
NDC 43598-212-51 75 mL bottle
NDC 43598-212-52 100 mL bottle
NDC 43598-212-53 150 mL bottle
200 mg/28.5 mg per 5 mL: Orange-favored powder for oral suspension (each 5 mL of reconstituted suspension contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt).
NDC 43598-213-50 50 mL bottle
NDC 43598-213-51 75 mL bottle
NDC 43598-213-52 100 mL bottle
250 mg/62.5 mg per 5 mL: Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt).
NDC 43598-204-51 75 mL bottle
NDC 43598-204-52 100 mL bottle
NDC 43598-204-53 150 mL bottle
400 mg/57 mg per 5 mL: Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt).
NDC 43598-208-50 50 mL bottle
NDC 43598-208-51 75 mL bottle
NDC 43598-208-52 100 mL bottle
Chewable Tablets:
125-mg/31.25-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 189, contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt.
NDC 43598-214-31 carton of 30 tablets
200-mg/28.5 mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with PL over C20, contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.
NDC 43598-215-14 carton of 20 tablets
250-mg/62.5-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190, contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt.
NDC 43598-216-31 carton of 30 tablets
400-mg/57-mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with PL over C40, contains 400 mg amoxicillin and 57.0 mg clavulanic acid as the potassium salt.
NDC 43598-217-14 carton of 20 tablets
Dispense in original container.
Store tablets and dry powder at or below 25°C (77°F).
Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.
Keep out of the reach of children.
17 PATIENT COUNSELING INFORMATIO N
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 Clavulante Potassium, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Amoxicillin and Clavulante 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 Clavulante 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 Clavulante 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 Clavulante 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 Clavulante 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 Dr. Reddy’s Laboratories Inc.
CLINITEST is a registered trademark of Miles, Inc.
Manufactured by:
Dr. Reddy’s Laboratories Tennessee LLC,
Bristol, TN 37620
Issued: 02/2014
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