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Augmentin 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 AUGMENTIN 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…
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 AUGMENTIN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when AUGMENTIN is administered at the start of a meal.
To minimize the potential for gastrointestinal intolerance, AUGMENTIN should be taken at the start of a meal. 2 Adult Patients See dosing regimens of AUGMENTIN (based on the amoxicillin component) provided in Table 1 below. Table 1. 5 mg per 5 mL suspension or the AUGMENTIN 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, AUGMENTIN should be dosed as follows: Neonates and Infants Aged less than 12 weeks (less than 3 months) : See dosing regimens of AUGMENTIN 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. 8)].
Table 3:
Dosing in Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg Table 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 AUGMENTIN.
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 AUGMENTIN.
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 AUGMENTIN.
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 AUGMENTIN if a reaction occurs. 1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses. 2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with use of Amoxicillin, A componet of Augmentin.
3 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. 4 ) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs.
5 ) Patients with mononucleosis who receive AUGMENTIN develop skin rash. Avoid AUGMENTIN use in these patients. 6 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 AUGMENTIN.
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 AUGMENTIN, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
If an allergic reaction occurs, AUGMENTIN should be discontinued, and appropriate therapy instituted. 2 Severe Cutaneous Adverse Reactions AUGMENTIN 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 AUGMENTIN discontinued if lesions progress. 2)], with most cases occurring in pediatric patients < 18 years of age. DIES is a non IgE mediated hypersensitivity reaction characterized by protracted vomiting occuring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms.
, penicillins or cephalosporins). 1 ) History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. , penicillins and cephalosporins). 2 Cholestatic Jaundice/Hepatic Dysfunction AUGMENTIN is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 AUGMENTIN 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 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 AUGMENTIN and the 250 mg chewable tablet of AUGMENTIN do not contain the same amount of clavulanic acid.
5 mg of clavulanic acid. Two AUGMENTIN 250 mg/125 mg Tablets are NOT Substitutable with One 500 mg/125 mg AUGMENTIN Tablet Two 250 mg/125 mg tablets of AUGMENTIN should NOT be substituted for one 500 mg/125 mg tablet of AUGMENTIN. Since both the 250 mg and 500 mg tablets of AUGMNTIN contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of AUGMENTIN are not equivalent to one 500 mg tablet of AUGMENTIN.
Gastrointestinal:
Drug-induced enterocolitis syndrome (DIES), 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.
5 ] . 1 )] .
Skin and Appendages:
Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis , and linear IgA dermatosis.
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. 4 )] .
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 AUGMENTIN. 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.
DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours of ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue AUGMENTIN and institute appropriate therapy. 4 Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of AUGMENTIN.
Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment. 5 Clostridioides difficile Associated Diarrhea (CDAD) Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AUGMENTIN, 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.
6 Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, AUGMENTIN should not be administered to patients with mononucleosis. 7 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. 8 Phenylketonurics AUGMENTIN Chewable tablets and AUGMENTIN 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 AUGMENTIN do not contain phenylalanine. 9 Development of Drug-Resistant Bacteria Prescribing AUGMENTIN 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.