Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL Powder, For Suspension, 200 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta Lactamase Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- This antibiotic is used for a range of common bacterial infections — ear infections, sinus infections, lower respiratory tract infections, skin infections, and urinary tract infect...
- What infections does amoxicillin/clavulanate actually treat?
- Taking it at the start of a meal is the best approach. Food doesn't affect amoxicillin much, but it does meaningfully improve how much clavulanate your body absorbs. More important...
- Should I take this with food or on an empty stomach?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.061 | $12.16 / 200 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0961 | $19.22 / 200 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1176 | $23.52 / 200 ml |
Where does this data come from?
🔁 Therapeutic equivalents
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00093-8675-74 You're viewing this | 200 mL in 1 BOTTLE (0093-8675-74) | $0.0608 / mL | $12.16 | 2004-09-23 | Active |
| 00093-8675-75 | 125 mL in 1 BOTTLE (0093-8675-75) | $0.0589 / mL | $7.36 | 2004-09-23 | Active |
| 00093-8675-78 | 75 mL in 1 BOTTLE (0093-8675-78) | $0.0712 / mL | $5.34 | 2004-09-23 | Active |
You're viewing the largest of 3 pack sizes for this product.
Per mL, this pack runs about 3% above the cheapest pack (125 mL, $0.0589 vs $0.0608 NADAC).
This pack accounts for about 18% of this product's recent Medicaid fills; the largest share goes to the 125 ml pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00093-8675-74?
What is the difference between NDC 00093-8675-74 and NDC 00093-8675-78?
What NDC number is used to bill for this package of Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL Powder, For Suspension?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology ( 12.4 )] .
Limitations of Use Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S . pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the beta-lactamase-producing organisms listed above.
Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors ( 1 ): Antibacterial exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance.
Limitations of Use Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the beta-lactamase-producing organisms listed above.
( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Pediatric Patients aged 3 months to 12 years weighing less than or equal to 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ( 2 )
2.1Important Administration Instructions 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.
2.2Dosage in Pediatric Patients Pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg : 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 Table 1 as a general example guideline for attainment of this dosage). This dose provides 6.4 mg/kg/day of the clavulanic acid component. Table 1: General Dosage Guidelines for Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL in Pediatric Patients 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 40 15 mL twice daily Pediatric patients weighing greater than 40 kg : Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in this group is not available.
2.3Dosage in Adult Patients 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.
2.4Dosage in Patients with Hepatic Impairment Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions ( 5.4 )].
2.5Preparation of the Oral Suspension Prepare the suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see Table 2) to be added in two parts. Add approximately 2/3 of the total amount of water for reconstitution, replace cap and shake vigorously to suspend powder.
Add remainder of the water (that had been measured), replace cap and again shake vigorously. Table 2: Volume of Water for Reconstituting 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 68 mL 125 mL 108 mL 200 mL 170 mL Each 5 mL will contain 600 mg of amoxicillin as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt. Shake oral suspension well before each use.
Suspension must be refrigerated. Discard after 10 days. Suspension is off-white at time of reconstitution; some color change is normal during the dosing period.
Flavoring Information : 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 other than the 5 flavors listed above has not been evaluated.
2.6Switching between Dosage Forms and between Strengths Amoxicillin and clavulanate potassiu…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Amoxicillin and clavulanate potassium for oral suspension, USP 600 mg/42.9 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 600 mg of amoxicillin as the trihydrate, and 42.9 mg of clavulanic acid as the potassium salt. For oral suspension: 600 mg/42.9 mg per 5 mL. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL or any other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. ( 4.2 )
4.1Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate, or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
4.2Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin and clavulanate potassium.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL if a reaction occurs and institute appropriate therapy. ( 5.1 ) Severe cutaneous adverse reactions (SCAR): Monitor closely. Discontinue if rash progresses.
( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. If this occurs, discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and institute appropriate therapy. ( 5.3 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur.
Monitor liver function tests in patients with hepatic impairment. ( 5.4 ) Clostridioides difficile -associated diarrhea (CDAD) (ranging from mild diarrhea to fatal colitis): Evaluate patients if diarrhea occurs. ( 5.5 ) Patients with mononucleosis who receive amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL develop skin rash.
Avoid amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL use in these patients. ( 5.6 )
5.1Serious Allergic Reactions, including Anaphylaxis Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
If an allergic reaction occurs, discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and institute appropriate therapy.
5.2Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL discontinued if lesions progress.
5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, [see Adverse Reactions ( 6.2 )] , with most cases occurring in pediatric patients ≤18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia.
If DIES occurs, discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and institute appropriate therapy.
5.4Hepatic Dysfunction Use amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is usually reversible. Deaths have been reported (fewer than one death reported per estimated four million prescriptions worldwide).
These have generally been cases associated with serious underlying diseases or conco…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions (SCAR) [see Warnings and Precautions ( 5.2 )] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.4 )] Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.5 )] Skin Rash in Patients with Mononucleosis [see Warnings and Precautions ( 5.6 )] The most frequently reported adverse reactions (incidence rate > 4 %) were coughing, vomiting, contact dermatitis (i.e., diaper rash), fever, upper respiratory tract infection, and diarrhea.
( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two clinical trials evaluated the safety of a 10-day treatment course of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL 90/6.4 mg/kg/day, divided every 12 hours, in pediatric patients with acute otitis media [see Clinical Studies ( 14 )] .
The first trial involved 521 pediatric patients (3 months to 50 months) and the second trial involved 450 pediatric patients (3 months to 12 years). In the intent-to-treat population of the first trial of 521 patients, the most frequently reported adverse events were vomiting (7%), fever (6%), contact dermatitis (i.e., diaper rash) (6%), upper respiratory tract infection (4%), and diarrhea (4%). 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 13% of patients.
The primary objective of the second study was to compare the safety of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL (90/6.4 mg/kg/day, divided every 12 hours) to amoxicillin and clavulanate potassium (45/6.4 mg/kg/day, divided every 12 hours) for ten days. There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events. The most frequently reported adverse reactions for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and the comparator of amoxicillin and clavulanate potassium were coughing (12% versus 7%), vomiting (7% versus 8%), contact dermatitis (i.e., diaper rash, 6% versus 5%), fever (6% versus 4%), and upper respiratory infection (3% versus 9%), respectively.
The frequencies of protocol-defined diarrhea with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL (11%) and amoxicillin and clavulanate potassium (9%) were not statistically different. Two patients in the group treated with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and one patient in the group treated with amoxicillin and clavulanate potassium were withdrawn due to diarrhea.
6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of amoxicillin and clavulanate potassium products, including amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis.
Onset o…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Coadministration with probenecid is not recommended. ( 7.1 ) Concomitant use of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL with oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Coadministration with allopurinol increases the risk of rash.
( 7.3 ) Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL may reduce efficacy of oral contraceptives. ( 7.4 )
7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL may result in increased and prolonged blood levels of amoxicillin. Coadministration of probenecid is not recommended.
7.2Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
7.3Allopurinol The concurrent administration of allopurinol and amoxicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and allopurinol administered concurrently.
7.4Oral Contraceptives Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
7.5Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of use with amoxicillin and clavulanate during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. A study in women with preterm prelabor rupture of membranes (PPROM) reported that prophylactic treatment with amoxicillin and clavulanate may be associated with an increased risk of necrotizing enterocolitis in neonates (see Data) .
Reproduction studies performed in pregnant rodents, given up to approximately 2 times the amount of amoxicillin and 15 times the amount of clavulanate in the Maximum Human Recommended Dose (MHRD) of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, revealed no evidence of harm to the fetus (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data One randomized, controlled trial included 4,826 pregnant women with premature rupture of fetal membranes who were randomly assigned to 250 mg erythromycin (n=1,197), 250 mg amoxicillin and 125 mg clavulanic acid (amoxicillin and clavulanate, n=1,212), amoxicillin and clavulanate and erythromycin (n=1,192), or placebo (n=1,225) four times daily for 10 days or until delivery.
Amoxicillin and clavulanate was associated with a significantly increased rate of proven neonatal necrotizing enterocolitis: 1.9% (n = 24) in the amoxicillin and clavulanate only group versus 0.5% (n = 6) in the placebo group (p = 0.001), and 1.8% (n = 44) in the any amoxicillin and clavulanate group versus 0.7% (n =17) in the no amoxicillin and clavulanate group (p = 0.0005). Animal Data Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate.
The amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL dose of 90/6.4 mg/kg/day. For clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL.
8.2Lactation Risk Summary Data from a published clinical lactation study report that amoxicillin is present in human milk. There are reports of diarrhea, irritability, and rash in infants exposed to amoxicillin and clavulanate through breast milk; therefore, infants exposed to amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be monitored for these symptoms. There are no data on the effects of amoxicillin and clavulanate on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and any potential adverse effects on the breastfed child from amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL or from the underlying maternal condition.
8.4Pediatric Use Acute Otitis Media The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL have been established in pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg, for the treatment of acute otitis media, and the information on this use is discu…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of use with amoxicillin and clavulanate during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. A study in women with preterm prelabor rupture of membranes (PPROM) reported that prophylactic treatment with amoxicillin and clavulanate may be associated with an increased risk of necrotizing enterocolitis in neonates (see Data) .
Reproduction studies performed in pregnant rodents, given up to approximately 2 times the amount of amoxicillin and 15 times the amount of clavulanate in the Maximum Human Recommended Dose (MHRD) of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, revealed no evidence of harm to the fetus (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data One randomized, controlled trial included 4,826 pregnant women with premature rupture of fetal membranes who were randomly assigned to 250 mg erythromycin (n=1,197), 250 mg amoxicillin and 125 mg clavulanic acid (amoxicillin and clavulanate, n=1,212), amoxicillin and clavulanate and erythromycin (n=1,192), or placebo (n=1,225) four times daily for 10 days or until delivery.
Amoxicillin and clavulanate was associated with a significantly increased rate of proven neonatal necrotizing enterocolitis: 1.9% (n = 24) in the amoxicillin and clavulanate only group versus 0.5% (n = 6) in the placebo group (p = 0.001), and 1.8% (n = 44) in the any amoxicillin and clavulanate group versus 0.7% (n =17) in the no amoxicillin and clavulanate group (p = 0.0005). Animal Data Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate.
The amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL dose of 90/6.4 mg/kg/day. For clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL.
🆘 Overdosage ▾
10 OVERDOSAGE Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In the case of overdosage, discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, treat symptomatically, and institute supportive measures as required.
If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying. 1 Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration.
High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis [see Dosage and Administration ( 2 )].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is an antibacterial drug [see Microbiology ( 12.4 )].
12.3Pharmacokinetics The pharmacokinetics of amoxicillin and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL at an amoxicillin dose of 45 mg/kg q12h with a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in Table 3. Table 3.
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 C max (mcg/mL) 15.7 ± 7.7 1.7 ±
0.9T max (hr) 2.0 (1.0 to 4.0) 1.1 (1.0 to 4.0) AUC 0-T (mcg*hr/mL) 59.8 ± 20.0 4.0 ±
1.9T 1/2 (hr) 1.4 ± 0.3 1.1 ±
0.3CL/F (L/hr/kg) 0.9 ± 0.4 1.1 ± 1.1 * Arithmetic mean ± standard deviation, except T max values which are medians (ranges). The effect of food on the oral absorption of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL has not been studied. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of amoxicillin and clavulanate potassium, 250 mg/62.5 mg per 5 mL suspension.
Neither component in amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Oral administration of a single dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL at 45 mg/kg (based on the amoxicillin component) to pediatric patients, 9 months to 8 years, yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF): Table 4.
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 14.0 (n = 5) 3.2 3.5 0.2 to 5.5 (n = 4) 2 hour mean median range 15.7 13.0 11.0 to 25.0 (n = 7) 3.3 2.4 1.9 to 6 (n = 5) 3 hour mean median range 13.0 12.0 5.5 to 21.0 (n = 5) 5.8 6.5 3.9 to 7.4 (n = 5) *Dose administered immediately prior to eating.
Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues. Drug Interaction Studies Clinical Studies Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.
12.4Microbiology Mechanism of Action Amoxicillin is a semisynthetic antibacterial with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by beta-lactamases, and therefore, its spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a beta-lactam, structurally related to penicillin, which possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins.
In particular, it has good activity against the clinically important plasmid-mediated beta-lactamases frequently found responsible for transferred drug resistance. The clavulanic acid component of amoxicillin and clavulanate potassium for oral su…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is an antibacterial drug [see Microbiology ( 12.4 )].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied The color of the dry powder for Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is white to off-white powder. Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt. It is available in bottles of 75 mL (NDC 0093-8675-78), 125 mL (NDC 0093-8675-75), and 200 mL (NDC 0093-8675-74).
Storage Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original container. Keep tightly closed.
Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep this and all medications out of the reach of children.
📋 Description ▾
11 DESCRIPTION Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2 S ,5 R, 6 R )-6-[( R )-(-)-2-amino-2-( p -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as: C 16 H 19 N 3 O 5 S • 3H 2 O M.W.
419.46 Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.
Chemically, clavulanate potassium is potassium ( Z )-(2 R ,5 R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as: C 8 H 8 KNO 5 M.W. 237.25 Following constitution, each 5 mL of oral suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid (equivalent to 51.1 mg of clavulanate potassium). Inactive Ingredients: aspartame, citric acid, colloidal silicon dioxide, mannitol, hypromellose, PB82 spray dried orange 739 flavor, sodium citrate, sodium saccharin, and xanthan gum [see Warnings and Precautions ( 5.8 )] .
Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium). The potassium content per 5 mL is 0.23 mEq. Structural formula for amoxicillin structural formula for clavulanic acid
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients to take amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL every 12 hours with a meal or snack to reduce the possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, they should call their doctor [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.5 )]. Allergic Reactions Counsel patients that amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, contains a penicillin class drug product that can cause allergic reactions in some individuals [see Warnings and Precautions ( 5.1 , 5.3 )] .
Severe Cutaneous Adverse Reactions (SCAR ) Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions ( 5.2 )]. Diarrhea Counsel patients that diarrhea is a common problem caused by antibacterial drugs, including, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, which usually ends when the antibacterial is discontinued.
Sometimes after starting treatment with antibacterial drugs, 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 antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions ( 5.5 )] . Phenylketonuria Counsel patients with phenylketonuria: Each 5 mL of the amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 1.4 mg phenylalanine [see Warnings and Precautions ( 5.8 )] .
Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, should only be used to treat bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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 for oral suspension, 600 mg/42.9 mg per 5 mL or other antibacterial drugs in the future [see Warnings and Precautions ( 5.9 )] . Storage Instructions Keep suspension refrigerated. Shake well before using.
When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, 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 for oral suspension, 600 mg/42.9 mg per 5 mL 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. Brands listed are the trademarks of their respective owners.
Manufactured In Canada By: Teva Canada Limited Toronto, Canada M1B 2K9 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. N 12/2024