Yafix Actions

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Actions of Yafix in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacotherapeutic Group: Antimicrobial (chemotherapeutic) agents, broad and medium spectrum antibiotics.

Pharmacology: Pharmacodynamics: Yafix is an orally-active cephalosporin antibiotic which has in vitro bactericidal activity against a wide variety of gram-positive and gram-negative organisms including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella sp, Haemophilus influenzae (positive and negative β-lacatamases), Moxarella (Branhamella) catarrhalis (positive and negative β-lacatamases). Yafix is stable in the presence of β-lactamase enzymes.

Most strains of enterococci (Streptococcus faecalis, group D streptococci) and staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to Yafix. In addition, most strains of Enterobacter and Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to Yafix.

Pharmacokinetics: Yafix, given orally, is about 40-50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hrs when administered with food. A single Yafix 200 mg tablet produces an average peak serum concentration (Cmax) of approximately 2 mcg/mL (range 1-4 mcg/mL); a single Yafix 100 mg dispersible tablet produces an average Cmax of approximately 1 mcg/mL (range 0.5-2 mcg/mL). Peak serum concentrations occur between 2 and 6 hrs following oral administration of a single 200 mg tablet or a single 100 mg tablet of Yafix.

Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hrs. In animal studies, it was noted that Yafix is also excreted in the bile in excess of 10% of the administered dose. Serum protein-binding is concentration-independent with a bound fraction of approximately 65%.

The serum half-life (t½) of Yafix in healthy subjects is independent of dosage form and averages from 3-4 hrs but may range up to 9 hrs in some normal volunteers. Average area under time curve (AUC) at steady state in elderly patients are approximately 40% higher than average AUC in other healthy adults.

In subjects with moderate renal impairment [creatinine clearance (CrCl) 20-40 mL/min], the average serum t½ of Yafix is prolonged to 6.4 hrs. In severe renal impairment (CrCl 5-20 mL/min), the t½ increased to an average of 11.5 hrs. Yafix is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar profiles as subjects with CrCl 21-60 mL/min. There is no evidence of metabolism of Yafix in vivo.

How should I take Yafix?

Take Yafix only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Keep using Yafix for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of Yafix will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Yafix. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Yafix, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the oral liquid either at room temperature or in the refrigerator. Throw away any unused medicine after 14 days.

Store the tablets in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Yafix administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Yafix works best if you take it with a meal or within 30 minutes of a meal.

The Yafix chewable tablet must be chewed before you swallow it.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked 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.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Yafix.

Take Yafix for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Yafix will not treat a viral infection such as the common cold or flu.

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

Store the oral liquid in the refrigerator. Throw away any unused medication after 14 days.

Yafix pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Mechanism of Action

Yafix is a semisynthetic cephalosporin antibacterial drug.

Pharmacokinetics

Yafix tablets and suspension, given orally, are about 40% to 50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when administered with food. A single 200 mg tablet of Yafix produces an average peak serum concentration of approximately 2 mcg/mL (range 1 to 4 mcg/mL); a single 400 mg tablet produces an average peak concentration of approximately 3.7 mcg/mL (range 1.3 to 7.7 mcg/mL). The oral suspension produces average peak concentrations approximately 25% to 50% higher than the tablets, when tested in normal adult volunteers. Two hundred and 400 mg doses of oral suspension produce average peak concentrations of 3 mcg/mL (range 1 to 4.5 mcg/mL) and 4.6 mcg/mL (range 1.9 to 7.7 mcg/mL), respectively, when tested in normal adult volunteers. The area under the time versus concentration curve (AUC) is greater by approximately 10% to 25% with the oral suspension than with the tablet after doses of 100 to 400 mg, when tested in normal adult volunteers. This increased absorption should be taken into consideration if the oral suspension is to be substituted for the tablet. Crossover studies of tablet versus suspension have not been performed in children.

The 400 mg capsule is bioequivalent to the 400 mg tablet under fasting conditions. However, food reduces the absorption following administration of the capsule by approximately 15% based on AUC and 25% based on Cmax.

Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg tablet or 400 mg of Yafix suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of suspension. Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg capsule.

Distribution

Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the tablet or suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Adequate data on CSF levels of Yafix are not available.

Metabolism and Excretion

There is no evidence of metabolism of Yafix in vivo. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. In animal studies, it was noted that Yafix is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of Yafix in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers.

Special Populations

Geriatrics: Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults. Differences in the pharmacokinetic parameters between 12 young and 12 elderly subjects who received 400 mg of Yafix once daily for 5 days are summarized as follows:

Pharmacokinetic Parameters (mean ± SD) for Yafix in Both Young & Elderly Subjects

Pharmacokinetic parameter

Young

Elderly

Cmax (mg/L)

4.74 ± 1.43

5.68 ± 1.83

Tmax (h)*

3.9 ± 0.3

4.3 ± 0.6

AUC (mg.h/L)*

34.9 ± 12.2

49.5 ± 19.1

T½ (h)*

3.5 ± 0.6

4.2 ± 0.4

Cave (mg/L)*

1.42 ±0.50

1.99 ± 0.75

*Difference between age groups was significant. (p<0.05)

However, these increases were not clinically significant.

Renal Impairment: In subjects with moderate impairment of renal function (20 to 40 mL/min creatinine clearance), the average serum half-life of Yafix is prolonged to 6.4 hours. In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours. The drug is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar blood profiles as subjects with creatinine clearances of 21 to 60 mL/min.

Microbiology

Mechanism of Action

As with other cephalosporins, the bactericidal action of Yafix results from inhibition of cell wall synthesis. Yafix is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to Yafix.

Resistance

Resistance to Yafix in isolates of Haemophilus influenzae and Neisseria gonorrhoeae is most often associated with alterations in penicillin-binding proteins (PBPs). Yafix may have limited activity against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). Pseudomonas species, Enterococcus species, strains of Group D streptococci, Listeria monocytogenes, most strains of staphylococci (including methicillin-resistant strains), most strains of Enterobacter species, most strains of Bacteroides fragilis, and most strains of Clostridium species are resistant to Yafix.

Antimicrobial Activity

Yafix has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications And Usage (1).

Gram-positive Bacteria

Streptococcus pneumoniae

Streptococcus pyogenes

Gram-negative Bacteria

Escherichia coli

Haemophilus influenzae

Moraxella catarrhalis

Neisseria gonorrhoeae

Proteus mirabilis

The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for Yafix against isolates of similar genus or organism group. However, the efficacy of Yafix in treating clinical infections caused by to these bacteria has not been established in adequate and well-controlled clinical trials.

Gram-positive Bacteria

Streptococcus agalactiae

Gram-negative Bacteria

Citrobacter amalonaticus

Citrobacter diversus

Haemophilus parainfluenzae

Klebsiella oxytoca

Klebsiella pneumoniae

Pasteurella multocida

Proteus vulgaris

Providencia species

Salmonella species

Serratia marcescens

Shigella species

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.



References

  1. DailyMed. "CEFIXIME: 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. "Cefixime: 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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