Augprime Tab Actions

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Actions of Augprime Tab in details

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Augprime Tab 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. Augprime Tab 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 Augprime Tab.

In combination with metronidazole Augprime Tab Pharmaniaga is active against Helicobacter Pylori. It is believed that inhibits the development of Augprime Tab resistance of Helicobacter pylori to metronidazole.

There is a cross-resistance between Augprime Tab and ampicillin.

The spectrum of antibacterial action while expanding the application of Augprime Tab and beta-lactamase inhibitor clavulanic acid. This combination increased the activity of Augprime Tab 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 Augprime Tab?

Take Augprime Tab 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 Augprime Tab is one 775 mg tabet taken once daily with food. The tablet should be taken within one hour of finishing a meal.

Take Augprime Tab 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 Augprime Tab 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 Augprime Tab extended-release tablet. Swallow it whole. Breaking the tablet may cause too much of the Augprime Tab 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. Augprime Tab 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 Augprime Tab.

Store at room temperature away from moisture, heat, and light.

Augprime Tab administration

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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 Augprime Tab 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 Augprime Tab 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. Augprime Tab 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 Augprime Tab.

Store at room temperature away from moisture, heat, and light.

You may store liquid Augprime Tab in a refrigerator but do not allow it to freeze. Throw away any liquid Augprime Tab that is not used within 14 days after it was mixed at the pharmacy.

Augprime Tab pharmacology

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Mechanism of Action

Augprime Tab is an antibacterial drug.

Pharmacokinetics

Augprime Tab is an extended-release formulation of Augprime Tab intended to provide once-daily dosing. Following the administration of Augprime Tab with a low-fat meal in healthy subjects, mean Augprime Tab 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 Augprime Tab Plasma Concentrations Following a Single

Oral Dose of Augprime Tab With a Low-Fat Meal in Healthy Subjects (N=20)

Administration of Augprime Tab with food decreases the rate, but not the extent of Augprime Tab absorption. Compared to immediate-release Augprime Tab suspension, the rate of Augprime Tab absorption following administration of Augprime Tab was slower, resulting in a lower Cmax and longer Tmax. Total Augprime Tab exposure (AUC) achieved with Augprime Tab is similar to that observed after oral administration of a comparable dose of immediate-release Augprime Tab suspension.

Augprime Tab diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. Augprime Tab is approximately 20% protein bound in human serum.

Augprime Tab is primarily cleared by renal excretion. Approximately 60% of an oral dose of immediate-release Augprime Tab is eliminated unchanged in urine. The half-life of Augprime Tab after oral administration of Augprime Tab is approximately 1.5 hours, similar to that of immediate-release Augprime Tab. No accumulation of Augprime Tab was observed after once-daily dosing of 775 mg of Augprime Tab for 7 days.

Drug Interactions

In a study of healthy adult subjects, Augprime Tab AUC was similar whereas Cmax increased approximately 35% following the administration of lansoprazole with Augprime Tab given with food.

Probenecid decreases the renal tubular secretion of Augprime Tab. Concurrent use of Augprime Tab and probenecid may result in increased and prolonged blood levels of Augprime Tab. The clinical relevance of this finding has not been evaluated.

Microbiology

Mechanism of Action

Augprime Tab 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 Augprime Tab in Streptococcus pyogenes.

Augprime Tab 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 Augprime Tab (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 Augprime Tab may be inferred by testing penicillin. An organism that is susceptible to penicillin can be considered susceptible to Augprime Tab 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 Augprime Tab 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.

Table 2. Acceptable Quality Control Ranges for Amoxicillina
aQC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are greater than 256 mcg/mL for Augprime Tab; testing Augprime Tab 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

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Klebsiella pneumoniae

ATCC 700603

>128

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References

  1. 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).
  2. 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).
  3. NCIt. "Clavulanic Acid: 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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