The following Structured Product Label (SPL) was submitted to the FDA by Unit Dose Services for the product Amoxicillin (NDC 50436-5101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1.1 infections of the ear, nose, and throat, 1.2 infections of the genitourinary tract, 1.3 infections of the skin and skin structure, 1.4 infections of the lower respiratory tract, 1.5 helicobacter pylori infection, 1.6 usage, 2.1 dosing for adult and pediatric patients > 3 months of age, 2.2 dosing in neonates and infants aged ≤ 12 weeks (≤ 3 months), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of species. (α- and β-hemolytic isolates only), , spp., or . StreptococcusStreptococcus pneumoniaeStaphylococcusHaemophilus influenzae
Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of , or . Escherichia coli, Proteus mirabilisEnterococcus faecalis
Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of spp. (α- and β-hemolytic isolates only), spp., or . StreptococcusStaphylococcusE. coli
Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of spp. (α- and β-hemolytic isolates only), spp., or . StreptococcusS. pneumoniae, StaphylococcusH. influenzae
Triple therapy for with clarithromycin and lansoprazole: Helicobacter pylori
Amoxicillin for oral suspension, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate . Eradication of has been shown to reduce the risk of duodenal ulcer recurrence. H. pyloriH. pyloriH. pylori
Amoxicillin for oral suspension, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) . (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for with lansoprazole: H. pyloriH. pyloriwho are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspectedH. pylori
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension and other antibacterial drugs, amoxicillin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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 to prevent the occurrence of acute rheumatic fever. In some 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. Streptococcus pyogenes
| Infection | Severity a | Usual Adult Dose | Usual Dose for Children > 3 Months b |
|---|---|---|---|
| Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin 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.
a b | |||
| Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract
| Mild/Moderate
| 500 mg every 12 hours or 250 mg every 8 hours
| 25 mg/kg/day in divided doses every 12 hours 20 mg/kg/day in divided doses every 8 hours
or |
| Severe
| 875 mg every 12 hours or 500 mg every 8 hours
| 45 mg/kg/day in divided doses every 12 hours 40 mg/kg/day in divided doses every 8 hours
or | |
| 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 40 mg/kg/day in divided doses every 8 hours
or |
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 to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin for oral suspension is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. Streptococcus pyogenes
The recommended adult oral dose is 1 gram amoxicillin for oral suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. The recommended adult oral dose is 1 gram amoxicillin for oral suspension and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.
Triple therapy:
Dual therapy:
Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.
| Strength | Bottle Size | Amount of Water Required for Reconstitution |
|---|---|---|
| Oral Suspension 200 mg/5 mL
| 50 mL
| 35 mL
|
| 75 mL
| 52 mL
| |
| 100 mL
| 69 mL
| |
| Oral Suspension 400 mg/5 mL
| 50 mL
| 35 mL
|
| 75 mL
| 52 mL
| |
| 100 mL
| 69 mL
|
After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.
NOTE:
200 mg/5 mL, and 400 mg/5 mL. Each 5 mL of reconstituted bubble-gum-flavored pink suspension contains 200 mg, and 400 mg amoxicillin as the trihydrate. Powder for Oral Suspension:
Amoxicillin for oral suspension is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin for oral suspension or to other β-lactam antibiotics (e.g., penicillins and cephalosporins).
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted.
associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, 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 Clostridium difficileC. difficile.
produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of 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. C. difficileC. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated. C. difficileC. difficile
Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus amoxicillin should not be administered to patients with mononucleosis.
The oral suspension of amoxicillin do not contain phenylalanine and can be used by phenylketonurics.
The following are discussed in more detail in other sections of the labeling:
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 common adverse reactions (> 1%) observed in clinical trials of amoxicillin for oral suspension were diarrhea, rash, vomiting, and nausea. The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%). The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.
Triple therapy:
Dual therapy:
In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. 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.
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
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.
The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated ; however, the clinical significance of this interaction is not well documented. in vitro
High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ) be used. Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
®®
Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. Teratogenic Effects:
Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.
Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months). [See .] Dosage and Administration (2.2)
An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See for specific recommendations in patients with renal impairment. Dosing in Renal Impairment (2.4)
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin . Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.
1
Formulation of amoxicillin for oral suspension, USP contains amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 ,5 ,6 )-6-[( )-(-)-2-amino-2-( -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: SRRRp
Structure (Amoxicillin Str)
The amoxicillin molecular formula is C H N O S•3H O, and the molecular weight is 419.45. 1619352
Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 200 mg or 400 mg anhydrous amoxicillin. Each 5 mL of the 200 mg and 400 mg reconstituted suspension contains 0.16 mEq (3.61 mg) of sodium; Inactive ingredients: sucrose, sodium citrate, sodium benzoate, edetate disodium, FD&C Red No. 3, xanthan gum, bubble-gum flavor, and colloidal silicon dioxide.
Amoxicillin is an antibacterial drug [see]. Microbiology (12.4)
Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. Absorption:
Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.
Mean amoxicillin pharmacokinetic parameters from an open, , single-dose study in 27 adults showed that the 875 mg tablet of amoxicillin produces an AUC of 35.4 ± 8.1 mcg•hr/mL and a C of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast. two-partcrossover bioequivalencecomparing 875 mg of amoxicillin with 875 mg of amoxicillin/clavulanate potassium0-∞max
Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.
Oral administration of single doses of 400 mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data:
| * Administered at the start of a light meal. Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
† | ||
| Dose* | •
AUC (mcg
0-∞hr/mL) | C (mcg/mL)†
max |
| Amoxicillin
| Amoxicillin (±S.D.)
| Amoxicillin (±S.D.)
|
| 400 mg (5 mL of suspension)
| 17.1 (3.1)
| 5.92 (1.62)
|
| 400 mg (1 chewable tablet)
| 17.9 (2.4)
| 5.18 (1.64)
|
Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. Following a 1 gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Distribution:
The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid . Metabolism and Excretion:[see ] Drug Interactions (7.1)
Mechanism of Action
Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.
Mechanism of Resistance
Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive.
Amoxicillin has been shown to be active against most isolates of the bacteria listed below, both and in clinical infections as described in the section. in vitroINDICATIONS AND USAGE
Gram-Positive Bacteria
spp. spp. (alpha and beta-hemolytic)
Enterococcus faecalis
Staphylococcus
Streptococcus pneumoniae
Streptococcus
Gram-Negative Bacteria
Escherichia coli
Haemophilus influenzae
Helicobacter pylori
Proteus mirabilis
Susceptibility Test Methods:
When available, the clinical microbiology laboratory should provide cumulative susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial. in vitro
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method -(broth or agar) . The MIC values should be interpreted according to the criteria in Table 4. Dilution Techniques:2,4
Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds . The zone size should be determined using a standardized test method . Diffusion Techniques:3,43
Susceptibility to amoxicillin of spp Enterobacteriaceae, and , may be inferred by testing ampicillin . Susceptibility to amoxicillin of spp., and beta-hemolytic spp., may be inferred by testing penicillin . The majority of isolates of spp. that are resistant to ampicillin or amoxicillin produce a TEM-type beta-lactamase. A beta-lactamase test can provide a rapid means of determining resistance to ampicillin and amoxicillin . Enterococcus.,H. influenzae4StaphylococcusStreptococcus4Enterococcus4
Susceptibility to amoxicillin of (non-meningitis isolates) may be inferred by testing penicillin or oxacillin . The interpretive criteria for . to amoxicillin are provided in Table 4 . Streptococcus pneumoniae4Spneumoniae4
| should be tested using a 1 mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of with oxacillin zone sizes of ≤19 mm .
* S. pneumoniaeS. pneumoniae4 | ||||||
| Minimum Inhibitory Concentration (mcg/mL) | Disk Diffusion (zone diameter in mm) | |||||
| Susceptible | Intermediate | Resistant | Susceptible | Intermediate | Resistant | |
| (non-meningitis isolates)*
Streptococcus pneumoniae | ≤ 2
| 4
| ≥ 8
| -
| -
| -
|
A report of “Susceptible” indicates the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches a concentration at the infection site necessary to inhibit growth of the pathogen. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration usually achievable at the infection site; other therapy should be selected.
Susceptibility Testing for Helicobacter pylori
Amoxicillin susceptibility testing methods for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing . Specimens for and clarithromycin susceptibility test results should be obtained on isolates from patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used. in vitroH. pyloriH. pylori
Quality Control:
Standardized susceptibility test procedures require use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test control. Standard amoxicillin powder should provide the following range of MIC values provided in Table 5 . For the diffusion technique the criteria provided in Table 5 should be achieved. 2,3,44
| QC limits for testing 35218 when tested on Haemophilus Test Medium (HTM) are ≥ 256 mcg/mL for amoxicillin; testing amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase . ATCC = American Type Culture Collection
aE. coli4 b | ||
| Quality Control Microorganism | Minimum Inhibitory Concentrations (mcg/mL) | Disc Diffusion Zone Diameter (mm) |
| ATCC 49619
Streptococcus pneumoniaeb | 0.03 to 0.12
| ---
|
| ATCC 700603
Klebsiella pneumoniae | >128
| ---
|
Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and clavulanic acid mixture was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and clavulanic acid mixture 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. Amoxicillin and clavulanic acid mixture 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 2 times the 3 g human dose based on body surface area).
Randomized, double-blind clinical studies performed in the United States in patients with and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily ( ). Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily ( ). All treatments were for 14 days. eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of has been shown to reduce the risk of duodenal ulcer recurrence.
H. pyloriH. pylori
Triple Therapy:see Table 6
Dual Therapy:
see Table 7H. pyloriH. pylori
| Study | Triple Therapy | Triple Therapy |
|---|---|---|
| Evaluable Analysis [95% Confidence Interval] (number of patients)
a | Intent-to-Treat Analysis [95% Confidence Interval] (number of patients)
b | |
| This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest , histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. Patients were included in the analysis if they had documented infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
aH. pylori® bH. pylori | ||
| Study 1
| 92 [80 to 97.7] (n = 48)
| 86 [73.3 to 93.5] (n = 55)
|
| Study 2
| 86 [75.7 to 93.6] (n = 66)
| 83 [72 to 90.8] (n = 70)
|
| Study | Dual Therapy | Dual Therapy |
|---|---|---|
| Evaluable Analysis [95% Confidence Interval] (number of patients)
a | Intent-to-Treat Analysis [95% Confidence Interval] (number of patients)
b | |
| This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest , histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. Patients were included in the analysis if they had documented infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
aH. pylori® bH. pylori | ||
| Study 1
| 77 [62.5 to 87.2] (n = 51)
| 70 [56.8 to 81.2] (n = 60)
|
| Study 2
| 66 [51.9 to 77.5] (n = 58)
| 61 [48.5 to 72.9] (n = 67)
|
NDC:50436-5101-0 in a BOTTLE of 100 POWDER, FOR SUSPENSIONS
Information for Patients
CLINITEST is a registered trademark of Siemens Medical Solutions Diagnostics, and Ames Company, Inc. ®
CLINISTIX is a registered trademark of Bayer Healthcare Llc, and Ames Company, Inc. ®
CLOtest is a registered trademark of Kimberly-Clark Worldwide, Inc. ®
Manufactured for:
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Aurobindo Pharma USA, Inc.
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Revised: 01/2016
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