Amoxicillin and Clavulanate Potassium
These highlights do not include all the information needed to use USP safely and effectively. See full prescribing information for . AMOXICILLIN and CLAVULANATE POTASSIUM powder for oral suspension Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, should be used only to treat infections that are proven or strongly suspected to be caused by bacteria (1).
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HUMAN PRESCRIPTION DRUG LABEL
Dec 29, 2019
medsource pharmaceuticals
DUNS: 833685915
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amoxicillin and Clavulanate Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
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INGREDIENTS (10)
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
2 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 suspensions of amoxicillin and clavulanate potassium.. 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:****Pediatric patients 3 months and older:**Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below). This dose provides 6.4 mg/kg/day of the clavulanic acid component.
BodyWeight (kg) |
Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Powder for Oral Suspension 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 |
**Pediatric patients weighing 40 kg and more:**Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in this group is not available.
**Adults:**Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see WARNINGS and PRECAUTIONS ( 5)].
**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.
Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Powder for Oral Suspension | |
Bottle Size |
Amount of Water Required for Reconstitution |
75 mL |
68 mL |
125 mL |
108 mL |
200 mL |
170 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 amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the five flavors listed above.
Administration: To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.
- Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ( 2)