amoxicillin and clavulanate potassium 400 mg/5mL
amoxicillin and clavulanate potassium · POWDER, FOR SUSPENSION · Proficient Rx LP
Amoxicillin and clavulanate potassium is an antibiotic combination used to treat bacterial infections by working together to fight bacteria that may be resistant to amoxicillin alone. This oral suspension form is typically prescribed for infections such as ear infections, urinary tract infections, and respiratory infections.
Key Facts
- Brand Name
- amoxicillin and clavulanate potassium
- Generic Name
- amoxicillin and clavulanate potassium
- NDC Code (Product)
63187-320- Manufacturer
- Proficient Rx LP
- Strength
- 400 mg/5mL
- Dosage Form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- NDA050725
- Drug Class
- Penicillin-class Antibacterial [EPC]; Penicillins [CS]
- Marketing Start
- 10/22/1990
Recall History
Teva Pharmaceuticals USA, Inc
Subpotent drug; Clavulanate Potassium component
AuroMedics Pharma LLC
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Morton Grove Pharmaceuticals, Inc.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Sandoz Inc
Subpotent Drug; Clavulanic Acid
Teva Pharmaceuticals USA, Inc
Subpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species. Amoxicillin and Clavulanate Potassium is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta‑lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure i…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on the amoxicillin component. ( 2.2 , 2.3 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. ( 2.3 ) Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended. ( 2.3 ) 2.1 Important Administration Instructions Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal. 2.2 Adult Patients See dosing regimens of Amoxicillin and Clavulanate Potassium (based on the amoxicillin component) provided in Table 1 below. Table 1. Dosing Regimens of Amoxicillin and Clavulanate Potassium in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF Amoxicillin…
Contraindications
4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium or to other beta‑lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium. ( 4.2 ) 4.1 Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium 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). 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and Clavulanate Potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium.
Drug Interactions
7 DRUG INTERACTIONS Co‑administration with probenecid is not recommended. ( 7.1 ) Concomitant use of Amoxicillin and Clavulanate Potassium and oral anticoagulants may increase the prolongation of prothrombin time.( 7.2 ) Co-administration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin and Clavulanate Potassium may reduce efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with Amoxicillin and Clavulanate Potassium may result in increased and prolonged blood concentrations of amoxicillin. Co-administration of probenecid is not recommended. 7.2 Oral 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 with Amoxicillin and Clavulanate Potassium. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopuri…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug‑rela…
Frequently Asked Questions
What is amoxicillin and clavulanate potassium used for?
Amoxicillin and clavulanate potassium is an antibiotic combination used to treat bacterial infections by working together to fight bacteria that may be resistant to amoxicillin alone. This oral suspension form is typically prescribed for infections such as ear infections, urinary tract infections, and respiratory infections.
Is amoxicillin and clavulanate potassium a controlled substance?
amoxicillin and clavulanate potassium is not classified as a controlled substance by the DEA.
What is the generic name for amoxicillin and clavulanate potassium?
The generic name for amoxicillin and clavulanate potassium is amoxicillin and clavulanate potassium. There are 11 other brand versions of amoxicillin and clavulanate potassium.
What is the NDC code for amoxicillin and clavulanate potassium 400 mg/5mL?
The NDC (National Drug Code) for amoxicillin and clavulanate potassium 400 mg/5mL is 63187-320, listed by Proficient Rx LP.
Other Amoxicillin Brands
See all →- Amoxicillin and Clavulanate Potassium250 mg/116714-295
- Amoxicillin and Clavulanate Potassium200 mg/5mL16714-292
- Amoxicillin and Clavulanate Potassium500 mg/172162-2210
- Amoxicillin and Clavulanate Potassium400 mg/5mL16714-293
- Amoxicillin and Clavulanate Potassium875 mg/172162-2211
- Amoxicillin and Clavulanate Potassium600 mg/5mL16714-294
- Amoxicillin and Clavulanate Potassium875 mg/172789-456
- Amoxicillin and Clavulanate Potassium875 mg/168071-4967
- Amoxicillin and Clavulanate Potassium400 mg/5mL68071-1619
- Amoxicillin and Clavulanate Potassium600 mg/5mL67296-2234
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)