Actions of Auro-Amoxicillin in details
Auro-Amoxicillin Pharmaniaga is an antibiotic of group semisynthetic penicillins a wide spectrum of action. It is a 4-hydroxyl analog of ampicillin. It has bactericidal action. Auro-Amoxicillin is active against aerobic gram-positive bacteria: Staphylococcus spp. (except strains producing penicillinase), Streptococcus spp; aerobic gram-negative bacteria: Neisseria Gonorrhoeae, Neisseria Meningitidis, Escherichia Coli, Shigella spp., Salmonella spp., Klebsiella spp.
Microorganisms producing penicillinase is resistant to Auro-Amoxicillin.
In combination with metronidazole Auro-Amoxicillin Pharmaniaga is active against Helicobacter Pylori. It is believed that inhibits the development of Auro-Amoxicillin resistance of Helicobacter pylori to metronidazole.
There is a cross-resistance between Auro-Amoxicillin and ampicillin.
The spectrum of antibacterial action while expanding the application of Auro-Amoxicillin and beta-lactamase inhibitor clavulanic acid. This combination increased the activity of Auro-Amoxicillin against Bacteroides spp., Legionella spp., Nocardia spp., Pseudomonas (Burkholderia) Pseudomallei. However, Pseudomonas Aeruginosa, Serratia Marcescens, and many other gram-bacteria are resistant.
How should I take Auro-Amoxicillin?
Take Auro-Amoxicillin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
The recommended dose of Auro-Amoxicillin is one 775 mg tabet taken once daily with food. The tablet should be taken within one hour of finishing a meal.
Take Auro-Amoxicillin around the same time every day for 10 days. Complete the full 10-day course of therapy for effective treatment. Do not skip any doses or stop taking Auro-Amoxicillin until you finish your prescribed treatment, unless you have a serious allergic reaction or your doctor tells you to stop.
Do not crush, chew, or break a Auro-Amoxicillin extended-release tablet. Swallow it whole. Breaking the tablet may cause too much of the Auro-Amoxicillin to be released at one time.
While using this medicine, you may need frequent blood tests. Your kidney and liver function may also need to be checked.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Auro-Amoxicillin will not treat a viral infection such as the flu or a common cold.
Do not share this medicine with another person, even if they have the same symptoms you have.
This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Auro-Amoxicillin.
Store at room temperature away from moisture, heat, and light.
Auro-Amoxicillin administration
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
You may take Auro-Amoxicillin with or without food.
Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
You may place the liquid directly on the tongue, or you may mix it with water, milk, baby formula, fruit juice, or ginger ale. Drink all of the mixture right away. Do not save any for later use.
The chewable tablet should be chewed before you swallow it.
Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.
If you are being treated for gonorrhea, your doctor may also have you tested for syphilis, another sexually transmitted disease.
If you are taking Auro-Amoxicillin with clarithromycin and/or lansoprazole to treat stomach ulcer, use all of your medications as directed. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Auro-Amoxicillin will not treat a viral infection such as the common cold or flu.
Do not share this medication with another person, even if they have the same symptoms you have.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Auro-Amoxicillin.
Store at room temperature away from moisture, heat, and light.
You may store liquid Auro-Amoxicillin in a refrigerator but do not allow it to freeze. Throw away any liquid Auro-Amoxicillin that is not used within 14 days after it was mixed at the pharmacy.
Auro-Amoxicillin pharmacology
Mechanism of Action
Auro-Amoxicillin is an antibacterial drug.
Pharmacokinetics
Auro-Amoxicillin is an extended-release formulation of Auro-Amoxicillin intended to provide once-daily dosing. Following the administration of Auro-Amoxicillin with a low-fat meal in healthy subjects, mean Auro-Amoxicillin AUC0-∞, Cmax, and Tmax values were 29.8 μg•h/mL, 6.6 μg/mL and 3.1 hours, respectively. The mean plasma concentration-time curve is shown below in Figure 1.
Figure 1. Mean Auro-Amoxicillin Plasma Concentrations Following a Single
Oral Dose of Auro-Amoxicillin With a Low-Fat Meal in Healthy Subjects (N=20)
Administration of Auro-Amoxicillin with food decreases the rate, but not the extent of Auro-Amoxicillin absorption. Compared to immediate-release Auro-Amoxicillin suspension, the rate of Auro-Amoxicillin absorption following administration of Auro-Amoxicillin was slower, resulting in a lower Cmax and longer Tmax. Total Auro-Amoxicillin exposure (AUC) achieved with Auro-Amoxicillin is similar to that observed after oral administration of a comparable dose of immediate-release Auro-Amoxicillin suspension.
Auro-Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. Auro-Amoxicillin is approximately 20% protein bound in human serum.
Auro-Amoxicillin is primarily cleared by renal excretion. Approximately 60% of an oral dose of immediate-release Auro-Amoxicillin is eliminated unchanged in urine. The half-life of Auro-Amoxicillin after oral administration of Auro-Amoxicillin is approximately 1.5 hours, similar to that of immediate-release Auro-Amoxicillin. No accumulation of Auro-Amoxicillin was observed after once-daily dosing of 775 mg of Auro-Amoxicillin for 7 days.
Drug Interactions
In a study of healthy adult subjects, Auro-Amoxicillin AUC was similar whereas Cmax increased approximately 35% following the administration of lansoprazole with Auro-Amoxicillin given with food.
Probenecid decreases the renal tubular secretion of Auro-Amoxicillin. Concurrent use of Auro-Amoxicillin and probenecid may result in increased and prolonged blood levels of Auro-Amoxicillin. The clinical relevance of this finding has not been evaluated.
Microbiology
Mechanism of Action
Auro-Amoxicillin is similar to penicillin in its bacterial action against susceptible organisms 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
To date there are no known mechanisms of resistance to penicillin or Auro-Amoxicillin in Streptococcus pyogenes.
Auro-Amoxicillin has been shown to be active in vitro against isolates of the microorganism S. pyogenes and in clinical infections as described in the INDICATIONS AND USAGE section.
Gram-Positive Bacteria:
Streptococcus pyogenes
The following in vitro data are available, but their clinical significance is unknown. At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptibility breakpoint of Auro-Amoxicillin (as determined by susceptibility tests using the class representative agents penicillin or ampicillin).
Gram-Positive Bacteria:
Streptococcus spp. (Group B, C, and G; Beta-hemolytic)
Susceptibility Test Methods:
When available, the clinical microbiology laboratory should provide cumulative in vitro 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.
Dilution Techniques
Quantitative methods are used to determine antimicrobial MICs. These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized method (broth or agar)1,2.
Susceptibility of beta-hemolytic streptococcal isolates to Auro-Amoxicillin may be inferred by testing penicillin. An organism that is susceptible to penicillin can be considered susceptible to Auro-Amoxicillin when used for approved indications2. If testing is performed, any beta hemolytic streptococcal isolate found to be nonsusceptible should be reidentified, retested, and if confirmed, submitted to a public health laboratory.
Quality Control
Standardized susceptibility test procedures1,2 require the 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. Standard Auro-Amoxicillin powder should provide the following range of MIC values provided in Table 2. For the disk diffusion technique, the criteria in Table 2 should be achieved.
| aQC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are greater than 256 mcg/mL for Auro-Amoxicillin; testing Auro-Amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase2. | ||
| bATCC = American Type Culture Collection | ||
| Quality Control Organism | Minimum Inhibitory Concentrations (mcg/mL) | Disk Diffusion Zone Diameters (mm) |
| Streptococcus pneumoniae ATCCb 49619 | 0.03–0.12 | --- |
| Klebsiella pneumoniae ATCC 700603 | >128 | --- |
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).
- NCIt. "Amoxicillin Anhydrous: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- EPA DSStox. "Amoxicillin: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
