AMOXICILLIN AND CLAVULANATE POTASSIUM 875 mg/1
Amoxicillin and Clavulanate Potassium · TABLET, FILM COATED · Northwind Health Company, LLC
AMOXICILLIN AND CLAVULANATE POTASSIUM is a tablet, film coated containing amoxicillin and clavulanate potassium at 875 mg/1, taken oral. Manufactured by Northwind Health Company, LLC.
Key Facts
- Brand Name
- AMOXICILLIN AND CLAVULANATE POTASSIUM
- Generic Name
- Amoxicillin and Clavulanate Potassium
- NDC Code (Product)
82868-002- Manufacturer
- Northwind Health Company, LLC
- Strength
- 875 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204755
- Marketing Start
- 09/26/2023
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 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 le…
Dosage & 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 ) 2.1 Important 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. 2.2 Dosage 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 Pediatri…
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 ) 4.1 Serious 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). 4.2 Cholestatic 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.
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 ) 7.1 Probenecid 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. 7.2 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. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The c…
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 Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 clinic…
Frequently Asked Questions
What is AMOXICILLIN AND CLAVULANATE POTASSIUM used for?
AMOXICILLIN AND CLAVULANATE POTASSIUM contains Amoxicillin and Clavulanate Potassium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
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 10 other brand versions of Amoxicillin and Clavulanate Potassium.
What is the NDC code for AMOXICILLIN AND CLAVULANATE POTASSIUM 875 mg/1?
The NDC (National Drug Code) for AMOXICILLIN AND CLAVULANATE POTASSIUM 875 mg/1 is 82868-002, listed by Northwind Health Company, LLC.
Other AMOXICILLIN AND CLAVULANATE POTASSIUM Dosages
Other Amoxicillin Brands
See all →- Amoxicillin and Clavulanate Potassium500 mg/176420-455
- Amoxicillin and Clavulanate Potassium875 mg/176420-529
- Amoxicillin and Clavulanate Potassium875 mg/180425-0180
- Amoxicillin and Clavulanate Potassium875 mg/182804-177
- Amoxicillin and Clavulanate Potassium875 mg/182868-067
- Amoxicillin and Clavulanate Potassium562.5 mg/10781-1943
- Amoxicillin and Clavulanate Potassium400 mg/5mL16714-293
- Amoxicillin and Clavulanate Potassium250 mg/116714-295
- Amoxicillin and Clavulanate Potassium250 mg/116714-476
- Amoxicillin and Clavulanate Potassium875 mg/10093-2275
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)