Augmentin ES-600

Name: Augmentin ES-600

Proper Use of amoxicillin and clavulanate

This section provides information on the proper use of a number of products that contain amoxicillin and clavulanate. It may not be specific to Augmentin ES-600. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without meals. However, it is best to take this medicine at the start of a meal or snack to avoid an upset stomach.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

If you are using the chewable tablets, chew the tablet completely before swallowing.

There are certain flavors that can be mixed with the oral suspension to make it taste better. If you or your child do not like the taste of this medicine, ask your pharmacist about these flavorings.

Shake the oral liquid well before measuring the dose. Use a dosing spoon or medicine dropper to measure the dose. The average household teaspoon may not hold the right amount of liquid. Rinse the dosing spoon or dropper with water after each use.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For bacterial infections:
    • For oral dosage forms (chewable tablets or suspension):
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours.
      • Children 3 months of age and older and weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 40 mg per kg of body weight per day, divided and given every 8 hours, or 25 to 45 mg per kg of body weight per day divided and given every 12 hours.
      • Children younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 mg per kg of body weight per day, divided and given every 12 hours.
    • For oral dosage form (extended-release tablets):
      • Adults—2000 milligrams (mg) every 12 hours.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours.
      • Children weighing less than 40 kg—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the chewable tablets, regular tablets, and extended-release tablets at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral liquid in the refrigerator. Throw away any unused portion after 10 days. Keep from freezing.

Augmentin ES-600 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Hives or welts
  • itching
  • itching of the vagina or genital area
  • pain during sexual intercourse
  • redness of the skin
  • skin rash
  • thick, white vaginal discharge with no odor or with a mild odor
Rare
  • Bloody or cloudy urine
  • fever
  • greatly decreased frequency of urination or amount of urine
  • seizures
  • swelling of the feet or lower legs
Incidence not known
  • Abdominal or stomach cramps or tenderness
  • back, leg, or stomach pains
  • black, hairy tongue
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the stools
  • bloody nose
  • chest pain
  • chills
  • clay-colored stools
  • cough or hoarseness
  • cracks in the skin
  • dark urine
  • diarrhea
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • heavier menstrual periods
  • increased thirst
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • loss of heat from the body
  • lower back or side pain
  • muscle stiffness
  • nausea or vomiting
  • pain
  • pain, swelling, or redness in the joints
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • scaly skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tightness in the chest
  • troubled breathing with exertion
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight loss
  • upper right abdominal or stomach pain
  • vomiting of blood
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Abdominal or stomach pain
  • cloudy urine
  • diarrhea
  • greatly decreased frequency of urination or amount of urine
  • sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Anxiety
  • dry mouth
  • hyperventilation
  • irregular heartbeats
  • irritability
  • restlessness
  • shaking
  • sleeplessness
  • tooth discoloration
  • trouble sitting still
  • trouble with sleeping
Incidence not known
  • Burning feeling in the chest or stomach
  • indigestion
  • redness, swelling, or soreness of the tongue
  • stomach upset
  • swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Contraindications

Augmentin ES-600 Powder for Oral Suspension is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.

Augmentin ES-600 Dosage and Administration

Augmentin ES-600 Powder for Oral Suspension, does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of AUGMENTIN. Augmentin ES-600 Powder for Oral Suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of AUGMENTIN contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of AUGMENTIN should not be substituted for Augmentin ES-600 Powder for Oral Suspension as they are not interchangeable.

Dosage:

Pediatric patients 3 months and older:

Based on the amoxicillin component (600 mg/5 mL), the recommended dose of Augmentin ES-600 Powder for Oral Suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).

Body Weight (kg) Volume of Augmentin ES-600 Powder for Oral Suspension providing 90 mg/kg/day
8 3.0 mL twice daily
12 4.5 mL twice daily
16 6.0 mL twice daily
20 7.5 mL twice daily
24 9.0 mL twice daily
28 10.5 mL twice daily
32 12.0 mL twice daily
36 13.5 mL twice daily
Pediatric patients weighing 40 kg and more:

Experience with Augmentin ES-600 Powder for Oral Suspension in this group is not available.

Adults:

Experience with Augmentin ES-600 Powder for Oral Suspension in adults is not available and adults who have difficulty swallowing should not be given Augmentin ES-600 Powder for Oral Suspension in place of the 500-mg or 875-mg tablet of AUGMENTIN.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)

Directions for Mixing Oral Suspension:

Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

Augmentin ES-600 Powder for Oral Suspension
Bottle Size Amount of Water
Required for Reconstitution
75 mL 70 mL
125 mL 110 mL
200 mL 180 mL

Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Information for the Pharmacist:

For patients who wish to alter the taste of Augmentin ES-600 Powder for Oral Suspension, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Augmentin ES-600 Powder for Oral Suspension. The resulting suspension is stable for 10 days under refrigeration. Stability of Augmentin ES-600 Powder for Oral Suspension when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the 5 flavors listed above.

Administration:

To minimize the potential for gastrointestinal intolerance, Augmentin ES-600 Powder for Oral Suspension should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Augmentin ES-600 Powder for Oral Suspension is administered at the start of a meal.

Description of Clinical Studies

Two clinical studies were conducted in pediatric patients with acute otitis media.

A non-comparative, open-label study assessed the bacteriologic and clinical efficacy of Augmentin ES-600 Powder for Oral Suspension (90/6.4 mg/kg/day, divided every 12 hours) for 10 days in 521 pediatric patients (3 to 50 months) with acute otitis media. The primary objective was to assess bacteriological response in children with acute otitis media due to S. pneumoniae with amoxicillin/clavulanic acid MICs of 4 mcg/mL. The study sought the enrollment of patients with the following risk factors: Failure of antibiotic therapy for acute otitis media in the previous 3 months, history of recurrent episodes of acute otitis media, ≤ 2 years, or daycare attendance. Prior to receiving Augmentin ES-600 Powder for Oral Suspension, all patients had tympanocentesis to obtain middle ear fluid for bacteriological evaluation. Patients from whom S. pneumoniae (alone or in combination with other bacteria) was isolated had a second tympanocentesis 4 to 6 days after the start of therapy. Clinical assessments were planned for all patients during treatment (4-6 days after starting therapy), as well as 2-4 days post-treatment and 15-18 days post-treatment. Bacteriological success was defined as the absence of the pretreatment pathogen from the on-therapy tympanocentesis specimen. Clinical success was defined as improvement or resolution of signs and symptoms. Clinical failure was defined as lack of improvement or worsening of signs and/or symptoms at any time following at least 72 hours of Augmentin ES-600 Powder for Oral Suspension; patients who received an additional systemic antibacterial drug for otitis media after 3 days of therapy were considered clinical failures. Bacteriological eradication on therapy (day 4-6 visit) in the per protocol population is summarized in the following table:

Table 5. Bacteriologic Eradication Rates in the Per Protocol Population
Bacteriologic Eradication on Therapy
* CI = confidence intervals; 95% CIs are not adjusted for multiple comparisons.
Pathogen n/N % 95% CI*
All S. pneumoniae 121/123 98.4 (94.3, 99.8)
S. pneumoniae with penicillin
MIC = 2 mcg/mL
19/19 100 (82.4, 100.0)
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, 100.0)

Clinical assessments were made in the per protocol population 2-4 days post-therapy and 15-18 days post-therapy. Patients who responded to therapy 2-4 days post-therapy were followed for 15-18 days post-therapy to assess them for acute otitis media. Nonresponders at 2-4 days post-therapy were considered failures at the latter timepoint.

Table 6. Clinical Assessments in the Per Protocol Population (Includes S. pneumoniae Patients With Penicillin MICs = 2 or 4 mcg/mL*)
2-4 Days Post-Therapy (Primary Endpoint)
* 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 15-18 days post-therapy may have been confounded by viral infections and new episodes of acute otitis media with time elapsed post-treatment.
Pathogen n/N % 95% CI†
All S. pneumoniae 122/137 89.1 (82.6, 93.7)
S. pneumoniae with penicillin
MIC = 2 mcg/mL
17/20 85.0 (62.1, 96.8)
S. pneumoniae with penicillin
MIC = 4 mcg/mL
11/14 78.6 (49.2, 95.3)
H. influenzae 141/162 87.0 (80.9, 91.8)
M. catarrhalis 22/26 84.6 (65.1, 95.6)
15-18 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 55.0 (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 (60.0, 75.2)
M. catarrhalis 14/25 56.0 (34.9, 75.6)

In the intent-to-treat analysis, overall clinical outcomes at 2-4 days and 15-18 days post-treatment in patients with S. pneumoniae with penicillin MIC = 2 mcg/mL and 4 mcg/mL were 29/41 (71%) and 17/41 (41.5%), respectively.

In the intent-to-treat population of 521 patients, the most frequently reported adverse events were vomiting (6.9%), fever (6.1%), contact dermatitis (i.e., diaper rash) (6.1%), upper respiratory tract infection (4.0%), and diarrhea (3.8%). Protocol-defined diarrhea (i.e., 3 or more watery stools in one day or 2 watery stools per day for 2 consecutive days as recorded on diary cards) occurred in 12.9% of patients.

A double-blind, randomized, clinical study compared Augmentin ES-600 Powder for Oral Suspension (90/6.4 mg/kg/day, divided every 12 hours) to AUGMENTIN (45/6.4 mg/kg/day, divided every 12 hours) for 10 days in 450 pediatric patients (3 months to 12 years) with acute otitis media. The primary objective of the study was to compare the safety of Augmentin ES-600 Powder for Oral Suspension to AUGMENTIN. There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events. The most frequently reported adverse events for Augmentin ES-600 Powder for Oral Suspension and the comparator of AUGMENTIN were coughing (11.9% versus 6.8%), vomiting (6.5% versus 7.7%), contact dermatitis (i.e., diaper rash, 6.0% versus 4.8%), fever (5.5% versus 3.9%), and upper respiratory infection (3.0% versus 9.2%), respectively. The frequencies of protocol-defined diarrhea with Augmentin ES-600 Powder for Oral Suspension(11.1%) and AUGMENTIN (9.4%) were similar (95% confidence interval on difference: –4.2% to 7.7%). Only 2 patients in the group treated with Augmentin ES-600 Powder for Oral Suspension and 1 patient in the group treated with AUGMENTIN were withdrawn due to diarrhea.

References

  1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing – 21st Informational Supplement. CSLI Document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011.
  2. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Approved Standard 7th ed. CSLI Document M11-A7. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2007.
  3. 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.
  4. 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.
  5. 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.

Augmentin ES-600 is a registered trademark of GlaxoSmithKline and is licensed

to Dr. Reddy's Laboratories Inc.

CLINITEST is a registered trademark of Miles, Inc.

CLINISTIX is a registered trademark of Bayer Corporation.

AUGMENTIN XR is a registered trademark of GlaxoSmithKline and is licensed to

Dr. Reddy's Laboratories Inc.

FLAVORx is a trademark of FLAVORx. Inc.



Dist.by: Dr. Reddy's Laboratories Inc.,

Bridgewater, NJ 08807


What should I discuss with my healthcare provider before taking Augmentin ES-600 (amoxicillin and clavulanate potassium)?

You should not use this medicine if you are allergic to it, or if:

  • you have severe kidney disease (or if you are on dialysis);

  • you have had liver problems or jaundice while taking amoxicillin and clavulanate potassium; or

  • you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Levaquin, Moxatag, Omnicef, and others.

To make sure amoxicillin and clavulanate potassium is safe for you, tell your doctor if you have ever had:

  • liver disease (hepatitis or jaundice);

  • kidney disease; or

  • mononucleosis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amoxicillin and clavulanate potassium can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Amoxicillin and clavulanate potassium can pass into breast milk and may affect the nursing baby. Tell your doctor if you are breast-feeding.

Do not give this medicine to a child without medical advice.

The liquid or chewable tablet may contain phenylalanine. Talk to your doctor before using these forms of this medicine if you have phenylketonuria (PKU).

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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