Mix one tablet in a small amount of water [approximately 2 teaspoonfuls]. Drink the entire mixture. Rinse the container with an additional small amount of water and drink the contents to assure the whole dose is taken. Do not chew or swallow the tablets. The tablets will not rapidly dissolve in your mouth.

The tablet is not recommended to be mixed with any liquid other than water, as studies have only been conducted using water.

ALL RECOMMENDED DOSAGES FOR Augmentin 400 mg/57 mg/5 m ARE INCLUDED IN THIS SECTION FOR INFORMATIONAL PURPOSES ONLY. THE 200 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 200 mg DOSE. THE 400 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 400 mg DOSE. THE 600 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 600 mg DOSE.

Neonates and infants aged ≤ 12 weeks (≤ 3 months):

Due to incompletely developed renal function affecting elimination of Augmentin 400 mg/57 mg/5 m in this age group, the recommended upper dose of Augmentin 400 mg/57 mg/5 m is 30 mg/kg/day divided q12h.

Adults and pediatric patients > 3 months

Infection	Severity‡	Usual Adult Dose	Usual Dose for Children > 3 months§
Ear/Nose/Throat	Mild/Moderate	500 mg every 12 hours or 250 mg every 8 hours	25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
	Severe	875 mg every 12 hours or 500 mg every 8 hours	45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract	Mild/Moderate or Severe	875 mg every 12 hours or 500 mg every 8 hours	45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Skin/Skin Structure	Mild/Moderate	500 mg every 12 hours or 250 mg every 8 hours	25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
	Severe	875 mg every 12 hours or 500 mg every 8 hours	45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Genitourinary Tract	Mild/Moderate	500 mg every12 hours or 250 mg every 8 hours	25 mg/kg/day in divided doses every 12 hours or20 mg/kg/day in divided doses every 8 hours
	Severe	875 mg every 12 hours or 500 mg every 8 hours	45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, Uncomplicated		3 grams as single oral dose	Prepubertal children: 50 mg/kg Augmentin 400 mg/57 mg/5 m, combined with
ano-genital and urethral infections in males and females			25 mg/kg probenecid as a single dose. NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

§ The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

All patients with gonorrhea should be evaluated for syphilis.

Larger doses may be required for stubborn or severe infections.

General:

It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

H. pylori eradication to reduce the risk of duodenal ulcer recurrence:

Triple Therapy:

Augmentin 400 mg/57 mg/5 m/clarithromycin/lansoprazole

The recommended adult oral dose is 1 gram Augmentin 400 mg/57 mg/5 m, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days.

Dual Therapy:

Augmentin 400 mg/57 mg/5 m/lansoprazole

The recommended adult oral dose is 1 gram Augmentin 400 mg/57 mg/5 m and 30 mg lansoprazole, each given three times daily (q8h) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

Dosing recommendations for adults with impaired renal function:

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

There are currently no dosing recommendations for pediatric patients with impaired renal function.

More about Augmentin 400 mg/57 mg/5 m (Augmentin 400 mg/57 mg/5 m)

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What other drugs will affect Augmentin 400 mg/57 mg/5 m?

Tell your doctor about all other medicines you use, especially:

probenecid (Benemid);
a blood thinner such as warfarin (Coumadin, Jantoven);
an antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);
sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or
a tetracycline antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap), and others.

This list is not complete and other drugs may interact with Augmentin 400 mg/57 mg/5 m. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Augmentin 400 mg/57 mg/5 m interactions

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Probenecid decreases the renal tubular secretion of Augmentin 400 mg/57 mg/5 m. Concurrent use of Augmentin 400 mg/57 mg/5 m and probenecid may result in increased and prolonged blood levels of Augmentin 400 mg/57 mg/5 m.

Chloramphenicol, macrolides, sulfonamides, and tetracy-clines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

Drug/Laboratory Test Interactions: High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST^®, Benedictís Solution, or Fehlingís Solution. Since this effect may also occur with Augmentin 400 mg/57 mg/5 m, it is recommended that glucose tests based on enzymatic glucose oxi-dase reactions (such as CLINISTIX^®) be used.

Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with Augmentin 400 mg/57 mg/5 m.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of Augmentin 400 mg/57 mg/5 m alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of Augmentin 400 mg/57 mg/5 m and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m²).

Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Augmentin 400 mg/57 mg/5 m. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery:

Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of Augmentin 400 mg/57 mg/5 m in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers: Penicillins have been shown to be excreted in human milk. Augmentin 400 mg/57 mg/5 m use by nursing mothers may lead to sensitization of infants. Caution should be exercised when Augmentin 400 mg/57 mg/5 m is administered to a nursing woman.

Pediatric Use: Because of incompletely developed renal function in neonates and young infants, the elimination of Augmentin 400 mg/57 mg/5 m may be delayed. Dosing of AMOXIL should be modified in pediatric patients 12 weeks or younger (£3 months). (See DOSAGE AND ADMINISTRATIONñNeonates and infants.)

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References

DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
FDA/SPL Indexing Data. "9EM05410Q9: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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