Medication Paper Outline Vabomere Drug In Treating Urinary Tract Infections

Running Head: VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 1

Medication Paper Outline:

Vabomere Drug in Treating Urinary Tract Infections

NURS 570

October 2, 2017

VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 2

Abstract

Urinary tract infections are among the many that plague many people. A new drug, Vabomere,

has been introduced after successful trials. The dosage entails 4 grams taken intravenously in

every 8 hours for 14 days among persons of over 18 years. In its working chemical process, the

drug relies on the two components which are synthetic penem antibacterial drug meropenem and

cyclic boronic acid beta-lactamase inhibitor vaborbactam. Vabomere has side effects like

Hypersensitivity reactions, seizures, and Clostridium difficile-associated diarrhea. Nevertheless,

the Food and drugs administration (FDA) has accepted the drug thus offering an assurance of

safety to the users. Conversely, effectiveness has been found to be sidelined on gram-negative

bacteria like Enterobacter cloacae species complex, Escherichia coli as well as Klebsiella

pneumonia. However, for Klebsiella oxytoca, Serratia marcescens and Citrobacter freundii,

effectiveness is less.

VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 3

A. Urinary Tract Infections

UTIs ranks among the highest medical conditions affecting local and global persons

today involve Urinary tract infections. This is because although this situation has existed for a

long time now, physicians and researchers still keep trying to come up with medicine that can be

used in the treatment of even the most susceptible bacteria (Rane

&Dasgupta, 2013). A new

drug, Vabomere got approved in August 2017 after a successful trial that involved 545 adults

(FDA, 2017b). Urinary Tract Infections are prevalent and widespread in women, infract, one in

every five women develop secondary tract infections which can lead to chronic UTI. For this

reason, there is need to explore all possible treatments for this condition, (Mercer, 2014), and

since Vabomere is the latest approved drug for the disease, understanding, it might be the key to

successful treatment of UTI.

B. Treatment

1. Vabomere

Vabomere is a drug that used for the treatment of complicated Urinary Tract Infections

(cUTI) and pyelonephritis resulting from Escherichia coli, Klebsiellapneumoniae, and

Enterobacter cloacae species complex (FDA, 2017a, and Radebach, 2017). In essence,

VABOMERE is a combination product containing the chemical components meropenem and

vaborbactam. In reality, as noted by FDA (2017b), the working mechanism of Vabomere relies

on these two components which are synthetic penem antibacterial drug and cyclic boronic acid

beta-lactamase inhibitor respectively. The structural makeup of the two main components of

Vabomere, i.e., meropenem and vaborbactam are as shown below:

VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 4

Meropenem

Vaborbactam

Source: Google Images, FDA (2017b)

As part of its working mechanism, meropenem is a penem antibacterial drug vital in

inhibiting cell wall synthesis when it penetrates gram-positive as well as gram-negative bacteria.

On the other hand, vaborbactam is a non-suicidal beta-lactamase inhibitor essential in protecting

the degradation of the synthetic component meropenem from defined serine beta-lactamases.

Notably, the two components have a vital role an relies on each other for successful disease

fighting. Although Vaborbactam is a critical component of Vabomere, it does not possess

recognizable antibacterial activity and does not also inhibit the excellent performance of

meropenem in the working mechanism (FDA, 2017b). However, for maximum effectiveness, it

VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 5

is recommended that Vabomere is used in the treatment or prevention of infections that have

been proven to be the cause of susceptible bacteria.

2. Dosage

The recommended dosage for Vabomere is 4 grams, which means that the patient will be

receiving two grams of meropenem and two grams of vaborbactam after every eight hours for 14

days. As earlier on stated, this medication is administered to patients who are 18 years or older

and must have a glomerular rate of filtration that is not less than 50mL/min/1.73m2.

A person who has a renal impairment condition is most likely to have a glomerular

filtration rate of less than 50mL/min/1.73m2. This means that such patients need a different

dosage from the recommended dosage of 4 grams every eight hours. For example, a patient with

a glomerular infiltration rate of between 30 and 49 can only be administered with 2grams of

Vabomere every 8 hours while those with between 15 and 29 and less than 15 should be applied

with 2 grams and 1 gram of Vabomere every twelve hours respectively.

3. Considerations for special populations

For patients having a renal impairment, with estimated eGFR of below 50

mL/min/1.73m2, there is the need for adjusting the overall dosage (FDA, 2017a, and FDA,

2017b). Additionally, it is crucial for the daily monitoring of the person's serum creatinine

concentrations as well as the eGFR for patients having to change renal function and make

necessary alterations on dosage accordingly.

On the other hand, there is the unique consideration vital in using Vabomere concerning

fetal malformations. As noted by FDA (2017), although in laboratory tests in rabbits treated

with vaborbactam-treated rabbits showed abnormalities, it is vital for pregnant women to be

aware of the likely risks to the fetus. Never less, as of 2017, no significant data exists on the

VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 6

significant defects as well as miscarriages reported in women with a pregnancy. Moreover, on a

statistical scale, the FDA (2017) notes that in the U.S. population, the estimated risk of

significant congenital disabilities is 2-4% and 15-20% for miscarriage pregnancies (FDA,

2017b).

Conversely, FDA (2017), notes that meropenem excretion in human milk has gotten

reported although no information exists on the discharge of vaborbactam in milk. Moreover,

although the FDA has approved the drug, no info significant data exists on meropenem and

vaborbactam important effects on the production of milk. Likewise, for patients below 18 years,

no studies have taken place.

4. Side effects

Like any other drug, Vabomere has contraindications and should, therefore, be handled

with care. It is known to have contraindications in patients that are hypersensitive to its

components, meropenem, and vaborbactam (FDA, 2017b). It is essential to understand any

hypersensitivity history due to reaction with beta-lactam medications. Diarrhea is a common side

effect associated with antibacterial drugs such as Vabomere. Vabomere was recently approved

by the United States Food and drug administration for the treatment of cUTI and also kidney

infections caused by bacteria (Satoskar&Nadasdy, 2017).

Although the drug has the mentioned side effects including severe headaches and the risk

of seizure, it has attained successful testing and approved to for use for treatment of a qualified

infectious disease product (QIDP). This is only a title that gets given to medication used in the

treatment of severe conditions under the generating Antibiotic Incentives Now (GAIN) title of

the FDA Safety and Innovation Act (Satoskar & Nadasdy, 2017).

VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 7

As an FDA approved the drug, VABOMERE is vital in treating complicated UTIs and a

kidney infection pyelonephritis among the adult patients (FDA, 2017a). However, there is the

need for better investigation and research on the excretion of vaborbactam in milk as well as the

effects on mothers. Additionally, as a recommendation, since no studies exist on the drug used

for the under 18-year patients, there is the need for research for better understanding of the

essentiality and application of the drug.

C: CONCLUSION

With the high cases of UTIs affecting people, the approval of the FDA for the use of

Vabomere is an assurance of the drug’s effectiveness in the treatment of UTIs and consent that

the benefits of the medication surpass any contraindications that may get associated with its use.

However, despite the positive reviews, it is recommended that overdose situations, one should

discontinue the usage of VABOMERE and focus on other measures like general supportive

treatment.

Vabomere is a vital drug addressing drug-resistant bacteria as well as the reduction in the

risks emanating from secondary infections because of weak or compromised immune system of

the patient (Radebach, 2017). The drug has been found to be highly effective in vitro and clinical

infections for gram-negative bacteria like Enterobacter cloacae species complex, Escherichia

coli as well as Klebsiella pneumonia.

However, the efficacy level in dealing with other infection-causing bacteria is inadequate.

These include Klebsiella oxytoca, Serratia marcescens, Citrobacter freundii, Morganella

morganii as well as Citrobacter koseri and others. And as noted by the FDA (2017), maximum

effectiveness of Vabomere requires its usage for treating as well as prevention of infections

proved as the cause of susceptible bacteria.

VABOMERE DRUG IN TREATING URINARY TRACT INFECTIONS 8

References

FDA (2017a). FDA approves new antibacterial drug. U.S. Food & Drug Administration (FDA).

Retrieved from

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573955.htm

FDA (2017b). Vabomere; Highlights Of Prescribing Information. U.S. Food & Drug

Administration (FDA). Retrieved from

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf

Mercer, A. (2014). Infections, Chronic Disease, and the Epidemiological Transition: A new

perspective. Rochester, NY: University of Rochester Press.

Radebach, M. (2017). From Cut-Off to Connected: HHS and the U.S. Army Work together to

protect health in Utuado, Puerto Rico following a landslide. ASPR. Retrieved from

https://www.phe.gov/ASPRBlog/default_old1.aspx

Rane

, A., &Dasgupta, R. (2013). Urinary Tract Infection: Clinical perspectives on urinary tract

infection. London: Springer.

Satoskar, A. A., &Nadasdy, T. (2017). Bacterial Infections and the Kidney. Cham, Switzerland:

Springer.

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