Loading…
AMOXICILLIN AND CLAVULANATE POTASSIUM is a brand name for Amoxicillin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's FDA label. Tap a section to expand.
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. 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.
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. 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 Adult Patients See dosing regimens of Amoxicillin and Clavulanate Potassium (based on the amoxicillin component) provided in Table 1 below.
Table 1. 5 mg per 5 mL suspension or the Amoxicillin and Clavulanate Potassium 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. 5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. 6 )] . 3 Pediatric Patients Based on the amoxicillin component, Amoxicillin and Clavulanate Potassium should be dosed as follows: Neonates and Infants Aged less than 12 weeks (less than 3 months) : See dosing regimens of Amoxicillin and Clavulanate Potassium provided in Table 2 below.
25 mg per 5 mL for oral suspension is recommended.
Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg :
See dosing regimens provided in Table 3 below. 2 )] . 5 mg and Amoxicillin and Clavulanate Potassium 400 mg/57 mg chewable tablets contain aspartame and should not be used by phenylketonurics. 7 )].
Table 3:
Dosing in Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg a Each strength of Amoxicillin and Clavulanate Potassium oral suspension is available as a chewable tablet for use by older children. b Duration of therapy studied and recommended for acute otitis media is 10 days.
4) ] The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). gov/medwatch . 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‑related adverse reactions.
The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (less than 1%) include: Abdominal discomfort, flatulence, and headache.
4 mg/kg/day (divided every 12 hours) of Amoxicillin and Clavulanate Potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of Amoxicillin and Clavulanate Potassium for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial.
Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes. 2 )] . 2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of Amoxicillin and Clavulanate Potassium.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Amoxicillin and Clavulanate Potassium.
5 WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin and Clavulanate Potassium if a reaction occurs. 1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses.
2 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. 3 ) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs.
4 ) Patients with mononucleosis who receive Amoxicillin and Clavulanate Potassium develop skin rash. Avoid Amoxicillin and Clavulanate Potassium use in these patients. 5 ) Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.
1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including Amoxicillin and Clavulanate Potassium. 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, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Amoxicillin and Clavulanate Potassium should be discontinued, and appropriate therapy instituted.
2 Severe Cutaneous Adverse Reactions Amoxicillin and Clavulanate Potassium 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 discontinued if lesions progress. 3 Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of Amoxicillin and Clavulanate Potassium.
, penicillins or cephalosporins). 1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium. , penicillins and cephalosporins). 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Amoxicillin in United States of America.
Know a brand we are missing in United States of America? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 mg per 5 mL oral suspension a Otitis media b , sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours Patients Weighing 40 kg or More : Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
5 mg chewable tablet of Amoxicillin and Clavulanate Potassium. 4 Patients with Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate (GFR) of less than 30 mL/min should NOT receive the 875 mg dose (based on the amoxicillin component) of Amoxicillin and Clavulanate Potassium.
See dosing regimens in patients with severe renal impairment provided in Table 4. Table 4. 5 Directions for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension Prepare Amoxicillin and Clavulanate Potassium for oral suspension at time of dispensing as follows: Tap bottle until all powder flows freely.
Measure a total (see Table 5 below for total amount of water for reconstitution) OF WATER. Add approximately 2/3 of the water to the powder. Replace cap and shake VIGOROUSLY. Add remaining water. Replace cap and shake VIGOROUSLY. 5 mg of clavulanic acid as the potassium salt 400 mg/57 mg per 5 mL 50 mL 75 mL 100 mL 50 mL 70 mL 90 mL 400 mg of amoxicillin and 57 mg of clavulanic acid as the potassium salt Shake oral suspension well before using.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days. Some color change is normal during dosing period. 3 )] . The 250 mg tablet of Amoxicillin and Clavulanate Potassium and the 250 mg chewable tablet of Amoxicillin and Clavulanate Potassium do not contain the same amount of clavulanic acid.
5 mg of clavulanic acid. Two Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets are NOT Substitutable with One 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet Two 250 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium should NOT be substituted for one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium.
Since both the 250 mg and 500 mg tablets of Amoxicillin and Clavulanate Potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of Amoxicillin and Clavulanate Potassium are not equivalent to one 500 mg tablet of Amoxicillin and Clavulanate Potassium.
Gastrointestinal:
Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
4 )] . 1 )] . 2 )] .
Liver:
Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with Amoxicillin and Clavulanate Potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.
The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued.
The hepatic dysfunction, which may be severe, is usually reversible. 3 )] .
Renal:
Interstitial nephritis, hematuria, and crystalluria have been reported [see Overdosage ( 10 )] .
Hemic and Lymphatic Systems:
Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Thrombocytosis was noted in less than 1% of the patients treated with Amoxicillin and Clavulanate Potassium. 2 )] .
Central Nervous System:
Agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.
Miscellaneous:
Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment. 4 Clostridioides difficile Associated Diarrhea (CDAD) Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amoxicillin and Clavulanate Potassium, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5 Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, Amoxicillin and Clavulanate Potassium should not be administered to patients with mononucleosis.
6 Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin and clavulanate potassium should be discontinued and appropriate therapy instituted.
7 Phenylketonurics Amoxicillin and Clavulanate Potassium Chewable tablets and Amoxicillin and Clavulanate Potassium for Oral Suspension contain aspartame which contains phenylalanine. 2 mg phenylalanine; each 5 mL of either the 200 mg/5 mL or 400 mg/5 mL oral suspension contains 7 mg phenylalanine.
The other formulations of Amoxicillin and Clavulanate Potassium do not contain phenylalanine. 8 Development of Drug-Resistant Bacteria Prescribing Amoxicillin and Clavulanate Potassium in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug‑resistant bacteria.