AUGMENTIN - GENERIC

Eur J Obstet Gynecol Reprod Biol. 2005 Mar 1;119(1):21-6.
Effect of amoxicillin sulbactam in threatened preterm labour with intact membranes: a randomised controlled trial.
Keuchkerian SE, Sosa CG, Fernandez A, Alonso JG, Laborde A, Cuadro JC.
Department of Obstetrics and Gynecology, Pereira Rossell Hospital, School of Medicine, University of Uruguay, Montevideo, Uruguay.

Objective: To determine whether treatment with amoxicillin-sulbactam in women with threatened idiopathic preterm labour will prolong the gestation and reduce preterm birth rates in a Latin-American population. Methods: A double-blind, placebo-controlled, randomized trial was conducted in 96 women who were hospitalized for preterm labour between 24 and 34 weeks of gestation at the Pereira Rossell Hospital, in Montevideo, Uruguay. The primary outcome measure was prematurity. The sample size was calculated a priori based on the hospital database. Statistical analyses were performed using the t-test, chi square, weighted mean difference (WMD) and relative risk (RR) with their confidence intervals (95% CI). Analysis by intention-to-treat. Results: Out of 47 patients assigned for antibiotics, 43 completed the treatment. There were no significant statistical differences between antibiotics and placebo group in prematurity (RR:1.04, 95% CI: 0.59, 1.84), prolongation of pregnancy (WMD:0.23, 95% CI: -0.96, 1.42) and other perinatal outcomes. Conclusion: Antibiotics did not prove to have benefits in improving perinatal outcomes in this Latin American population.

JAMA. 2005 Feb 23;293(8):949-55.
Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women: a randomized trial.
Hooton TM, Scholes D, Gupta K, Stapleton AE, Roberts PL, Stamm WE.
Department of Medicine, School of Medicine, University of Washington, Seattle, USA. hooton@u.washington.edu.

CONTEXT: The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied. OBJECTIVE: To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure. DESIGN, SETTING, AND PATIENTS: Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 10(2) colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization. INTERVENTIONS: Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months. MAIN OUTCOME MEASURES: The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E coli colonization at the 2-week follow-up visit. RESULTS: Clinical cure was observed in 93 (58%) of 160 women treated with amoxicillin-clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60%] of 109 women in the amoxicillin-clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group; P = .004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin-clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45% of women in the amoxicillin-clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli (P<.001). CONCLUSIONS: A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.

GENERIC NAME: amoxicillin
BRAND NAME: Augmentin, Amoxil, Polymox, Trimox

DRUG CLASS AND MECHANISM: Amoxicillin is an antibiotic that belongs to a class of antibiotics called penicillins. Other members of this class include ampicillin (Unasyn), piperacillin (Pipracil), ticarcillin (Ticar) and a several others. These antibiotics are very similar to penicillin. They stop bacteria from growing and multiplying by preventing the bacterial cells from forming the wall that surrounds them. The cell wall protects bacteria from their environment and keeps the contents of the bacterial cell together. Bacteria cannot survive without a cell wall. Amoxicillin is effective against many different bacteria including H. influenzae, N. gonorrhoea, E. coli, Pneumococci, Streptococci, and certain strains of Staphylococci.

PREPARATIONS: Capsules: 250 and 500 mg. Tablets: 500 and 875 mg. Chewable tablets: 125, 200, 250, and 400 mg. Powder for Suspension: 50 , 125 , 200, 250, and 400 mg/5 ml.

STORAGE: Tablets, capsules and dry powder can be stored at room temperature, 15-30°C (59-86°F). Powder that has been mixed with water should be refrigerated.

PRESCRIBED FOR: Amoxicillin is used to treat infections due to organisms that are susceptible to the effects amoxicillin. Common infections that amoxicillin is used for include infections of the middle ear, tonsils, throat, larynx (laryngitis), bronchi (bronchitis), lungs (pneumonia), urinary tract, and skin. It also is used to treat gonorrhea.

DOSING: For most infections in adults the dosing regimens for amoxicillin are 250 mg every 8 hours, 500 mg every 12 hours or 875 mg every 12 hours depending on the type of infection. For the treatment of adults with gonorrhea the dose is 3 g given as one dose. For most infections, children older than 3 months but less than 40 kg are treated with either 40 mg/kg/day in divided doses every 8 hours or 45 mg/kg/day in divided doses every 12 hours.

Amoxicillin can be taken with or without food.

DRUG INTERACTIONS: Amoxicillin is rarely associated with important drug interactions.

PREGNANCY: There are no adequate studies of amoxicillin in pregnant women.

NURSING MOTHERS: Small amounts of amoxicillin may be excreted in breast milk and may cause diarrhea or allergic responses in nursing infants.

SIDE EFFECTS: Side effects due to amoxicillin include diarrhea, dizziness, heartburn, insomnia, nausea, itching, vomiting, confusion, abdominal pain, easy bruising, bleeding, rash and allergic reactions.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.