INTRODUCTION:

Moxifloxacin Drug incidences and relative risk estimates (Mantel-Haenszel analysis) of patients with any adverse event (AE), adverse drug reaction (ADR), serious AE (SAE), serious ADR (SADR), treatment discontinuation due to an AE or ADR, and fatal outcomes related to an AE or ADR and patients with indications that have been approved in at (acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated pelvic inflammatory disease, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections) using the recommended daily dose (400mg) and route of administration (oral, intravenous/oral, intravenous only). The analysis included patients at risk (age ≥55 years, diabetes mellitus, renal impairment, hepatic impairment, cardiac disorders, or body mass index <18 kg/m²).

Aim:

Incidence of moxifloxacin serious adverse drug reactions in pneumococcal infections virus infected patients detected by a Pharmacovigilance program by laboratory signals in a tertiary hospital in Chhattisgarh (India)

OBJECTIVE:

1) To analyze and compare the safety profile of moxifloxacin drug in versus comparators in the entire clinical database of the manufacturer.

2) To the observation and Analysis of adverse drug reactions of moxifloxacin in primary care and profound effects on the patients.

Introduction of Pneumonia:

Pneumococcal disease is a name for any infection caused by bacteria called Streptococcus pneumonia which is also called as pneumococcal. Pneumonia is a form of acute respiratory infection that affects the lungs caused by bacteria, viruses, or fungi and common causes of viral pneumonia are influenza, respiratory syncytial virus. The lungs are made up of small sacs called alveoli, which fill with air when a healthy person breathes. It is a serious infection in lobar pneumonia affects one or more sections (lobes) of the lungs. When an individual has pneumonia, the alveoli are filled with pus and fluid, which makes breathing painful and limits oxygen intake and Symptoms typically include some combination of productive or dry cough, chest pain, fever, and difficulty breathing. The severity of the condition is variable.^1,2,3

It is of various types occurring in individuals of all ages, affecting millions of people worldwide. The condition varies from mild to severe depending on the type of organism involved, age and the underlying health of the individual. Pneumonia can be categorized as community-acquired, hospital-acquired and pneumonia occurring in Immune-compromised individuals (individuals with weakened immune system).^11,32,35

Moxifloxacin is used to treat certain bacterial infections in many different parts of the body. It may also be used for other problems as determined by your doctor. Moxifloxacin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections. Moxifloxacin is a quinolone antibiotic, prescribed for bacterial infections such as pneumonia, bronchitis, sinus, skin structure infections and others. Their trade name is Floxsafe FC/Hinemox /Moxicip FC/Staxom/Moxif /Moxilark /Moxif (100 ml)/Milflox /Remox (5ml)/Moxid.^18,21,33

Fig 1: X-Ray of Pneumococcal Disease (pneumonia) Drug using of Moxifloxacin

Moxifloxacin quickly does starts working right away since it is placed right where the infection can expect symptoms to improve within a couple days. Most people feel completely better after using moxifloxacin for 4 days. Moxifloxacin (Avelox) is not a good first choice for people who have a bacterial sinus infection. Because it does not work better than alternatives and tends to cause more side effects are nausea, vomiting, stomach pain, diarrhea, constipation, and heartburn. Moxifloxacin including ciprofloxacin, levofloxacin and Fluoroquinolones, are common broad-spectrum antibiotics most often used to treat respiratory and urogenital infections. Case reports have indicated acute kidney injury with use, and prescription labels carry a warning of kidney failure. The risk of having tendon problems may be increased if you are over 55 years of age, are using steroid medicines (e.g., dexamethasone, prednisolone, prednisone, or Medrol), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant.^31,32,34,36

· Tendon rupture warning:

This drug can increase your risk of irritating or rupturing your tendons (the cords that attach your muscles to your bones). Your risk may be higher if you’re older than 60 years, take a corticosteroid drug, or have had a kidney, heart, or lung transplant.

· Muscle weakness warning:

This drug can cause muscle weakness. If you have myasthenia gravis, this drug may make your muscle weakness worse. You should not take this medication if you have myasthenia gravis.

· Peripheral neuropathy warning:

This drug may cause peripheral neuropathy (nerve damage). This condition causes changes in sensation and damage to the nerves in your arms, hands, legs, or feet. This damage may be permanent. Stop taking this drug and call your doctor right away if you have any signs of peripheral neuropathy in your arms, hands, legs, or feet. Symptoms include pain, burning, tingling, numbness, and weakness.

· Central nervous system effects warning:

This drug raises your risk of central nervous system (CNS) effects. These can include convulsions, psychosis, and increased pressure inside your head. It can also cause tremors, anxiety, agitation, confusion, delirium, and hallucinations. In addition, it can cause paranoia, depression, nightmares, and trouble sleeping. Rarely, it can cause suicidal thoughts or acts. Be sure to tell your doctor if you’re at increased risk of seizures.

· Restricted use warning:

This drug can cause serious side effects. As a result, it should only be used to treat certain conditions if no other treatment options exist. These conditions are acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis.

Adverse Drug Reaction of Moxifloxacin: -

The most common adverse events were those commonly described with moxifloxacin use and included diarrhea, dizziness, vomiting, increased lipase, increased GGT and rash. Prolonged QTc (corrected QT) occurred in 72 patients and cardiac arrest in 18.

The conditions should not take Moxifloxacin HCL is diarrhea from an infection with Clostridium difficile bacteria, diabetes, low blood sugar, low amount of potassium in the blood, a low seizure threshold, pseudo-tumor cerebra, a condition with high fluid pressure in the brain, a painful condition that affects the nerves in the legs and arms called peripheral neuropathy, myasthenia gravis, a skeletal muscle disorder, a low supply of oxygen rich blood to the heart, tirades de pointes, a type of abnormal heart rhythm, slow heartbeat, prolonged QT interval on EKG, abnormal heart rhythm, abnormal EKG with QT changes from birth, severe hardening of the arteries in the brain, hardening of the liver, damage to the liver and inflammation, kidney transplant, inflammation of a tendon, rupture of a tendon, seizures, abnormal liver function tests, high pressure within the skull, lung transplant, heart transplant, dissection of the aorta, aneurysm of aorta, Mar-fan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome.^{10,22,23,30,35}

Examples: -

Such adverse drug reactions (ADR) include rashes, vomiting, nausea, jaundice, and anemia, a decrease in the white blood cell count, kidney damage, and nerve injury that may impair vision or hearing.

Seriousness Adverse Event (AEs) of Moxifloxacin:

seriousness of Adverse Drug Reaction is any event or reaction that results in death, a life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions and adverse event or suspected adverse reaction is considered "life-threatening" if, in the view of either the investigator or sponsor, A harmful or abnormal result. An adverse effect may be caused by administration of a medication or by exposure to a chemical and be indicated by an untoward result its occurrence places the patient or subject at immediate risk of death. ^{10, 26, 27} Their seriousness adverse event (AEs) functions like:

· Death.

· Life-threatening.

· Hospitalization (initial or prolonged).

· Disability or Permanent Damage.

· Congenital Anomaly/Birth Defect.

· Paralysis difficulties.

· Required Intervention to Prevent Permanent Impairment or Damage (Devices).

· Other Serious (Important Medical Events).

Fig 2: Drug Using of Moxifloxacin (AEs v/s ADRs)

Symptoms of Pneumonia:

Symptoms can vary depending on what’s causing pneumonia, age, sex, body weight and overall health. They usually develop over several days. Common pneumonia symptoms include:

· Chest pain when you breathe or cough

· Confusion or changes in mental awareness (in adults age 55 and older)

· Cough that produces phlegm or mucus

· Fatigue and loss of appetite

· Fever, sweating, and shaking chills

· Nausea, weakness and low energy

· vomiting, and diarrhea

· Shortness of breath

· Headache and Belly pain

· Etching and Recess

· Coughing up greenish, yellow, or bloody mucus

· Lips and fingernails turning blue

Along with these symptoms, older adults and people with weak immune systems might be confused or have changes in mental awareness, or they might have a lower-than-usual body temperature. Newborns and infants may not show any signs of infection. Or they might vomiting, have a fever and a cough, and seem restless or tired.^4,13,14,28

Note: If you have a new cough, fever, or shortness of breath, call your doctor to ask about whether it could be COVID-19. Illness with the new corona virus can also lead to pneumonia.

PNEUMONIA COMPLICATIONS:

Pneumonia, it's possible for your lungs to fill with fluid. If that happens, they won't be able to transfer enough oxygen to your blood or get rid of the carbon dioxide in your blood. It's a serious condition because your organs need oxygen to work. Pneumonia can have complication^3,15,25,^,³⁴ including:

· Bacteremia, in which bacteria spread into your blood. This can cause septic shock and organ failure.

· Trouble breathing, which might mean you need to use a breathing machine while your lungs heal.

· Fluid buildup between the layers of tissue that line your lungs and chest cavity. This fluid can also become infected.

· Lung abscess, when a pocket of pus forms inside or around your lung.

Fig 3: Pneumonia Complications

Methods: Studies, Patients and Hospital analysis.

Studies: The analysis comprised all double-blind and open-label actively controlled clinical trials included in the clinical trial database of moxifloxacin 400mg once daily and performed by the manufacturer as part of the phase II-IV programs that were initiated and completed between 1996 and 2019-21, with the exception of one exploratory phase II study conducted in cirrhotic patients, most of them with Child-Pugh class C cirrhosis. All studies used the oral formulation (400mg tablets), the 400mg/250mL solution for infusion formulation, or a sequence of intravenous and oral formulations. Forty-nine oral studies enrolled patients diagnosed with streptococcal pharyngitis (n = 1), ABS (n = 10), AECB (n = 17), CAP (n = 12), uSSSIs (n = 4), uncomplicated PID (uPID; n = 3), or uncomplicated (n = 3) or complicated (n = 1) urinary tract infection (UTI). Some patients could be enrolled in the same study looking at two different indications - for example, ABS and AECB, or AECB and CAP. Fifteen intravenous/oral studies enrolled patients with CAP (n = 7), cSSSIs (n = 3), cIAIs (n = 2), nosocomial pneumonia (n = 2), or lung abscess or aspiration pneumonia (n = 1). Four intravenous-only studies enrolled patients with CAP (n = 2), cIAIs (n = 2), or AECB (n = 1; this study also enrolled patients with CAP).

Patients/Hospital Analysis: -

The studies were conducted in India, the Europe, the Americas, the Middle East, Africa, and the Pacific region (Asia). Safety-valid patients were defined as those randomized within an actively controlled clinical trial, having received at least one dose of the study drug and having had at least one observation after initial drug intake. The following subgroups of patients with pre-existing risk factors were evaluated as elderly (age ≥55 years); diabetes mellitus (blood glucose level >200 mg/dL at baseline or at least one medical history finding coded to a preferred term with a primary path in the high-level term diabetes including subtypes was renal impairment (serum creatinine ≥1.5 mg/dL for women and ≥1.8mg/dL for men, or calculated creatinine clearance ≤89mL/min and ≤59 mL/min for patients aged <55 and ≥55 years, respectively); hepatic impairment (alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal; or alkaline phosphatase >2 × ULN; or total bilirubin >2 × ULN and ALT or ALP >1 × ULN); cardiac disorders (at least one medical history finding coded to a cardiac patients in the Bayer MedDRA Query [BMQ] history of cardiac disease); and low body mass index (BMI) [<18kg/m²]. Patients with known contraindications, according to what was known or included in the labeling at the time of enrollment, were excluded from entering the study as per the study protocol design. Conversely, no patient entering a study and receiving one or more doses of moxifloxacin or a comparator was excluded from the analysis, even if found later to be among those who should have been prevented from enrollment.

Table 1. Symptoms Frequency of Pneumonia Studies, Patients and Hospital Analysis.

Symptoms Frequency of Pneumonia
Symptoms	Frequency
Cough and Cold	79-91%
Fatigue	84-90%
Fever	71-75%
shortness of breath	67-75%
Sputum	60-65%
Chest Pain	39-49%
Blue-tinged skin	10-15%

Pharmacological Investigation:

Blood tests are used to confirm an infection and try to identify the type of organism causing the infection. However, precise identification is not always possible. Chest X-ray, CT scan, pulse oximetry, urine or coughed up mucus and culture of the sputum may help the doctor diagnose pneumonia and determine the extent and location of the infection.^4,5,16,17

Reactions that may occur in anyone:

· Drug overdose— Toxic reactions linked to excess dose or impaired excretion, or to both.

· Drug side effect— Undesirable pharmacological effect at recommended doses.

· Drug interaction— Action of a drug on the effectiveness or toxicity of another drug.

Reactions that occur only in susceptible subjects:

· Drug intolerance— A low threshold to the normal pharmacological action of a drug.

· Drug idiosyncrasy— A genetically determined, qualitatively abnormal reaction to a drug related to a metabolic or enzyme deficiency.

· Drug allergy— An immunologically mediated reaction, characterized by specificity, transferability by antibodies or lymphocytes, and recurrence on re-exposure.

· Pseudo allergic reaction— A reaction with the same clinical manifestations as an allergic reaction (eg, as a result of histamine release) but lacking immunological specificity.

· Expected reactions:

· Extensions of therapeutic effect.

· Undesirable side-effects.

· Interactions with other drugs.

· Unexpected reactions:

· Anaphylaxis.

· Allergic reactions.

· Prescription error.

· Administration errors.

· Idiosyncratic metabolism reactions, leading to increased or decreased clearance.

· Interaction with the critical care environment.

Prevention:

In medicine, action taken to decrease the chance of getting a disease or condition. For example, pneumonia prevention includes avoiding risk factors such as smoking, obesity, lack of exercise, and radiation exposure and increasing protective factors such as getting regular physical activity, staying at a healthy weight, and having a healthy diet. Generally, practicing personal hygiene, like regularly washing your hands, is the best way to prevent respiratory infections.^3,6,8

Vaccinations are also recommended for people who have an increased risk of pneumonia or its complications. For example, children can be vaccinated against the Haemophilus influenza bacteria and pneumococcal. Flu and pneumococcal vaccinations are also suitable for people over 55 years of age.^36,37

Herbal medicines and dietary supplements such as vitamin products are often said to strengthen the immune system. But there are no studies that prove that such substances are worth it - except for people who have a diagnosed vitamin deficiency. That usually only occurs in Germany or similar countries as a result of a very imbalanced diet.^32,35,36

· Prevent Pneumonia From Virus:

· Get the pneumococcal vaccine.

· Practice good hygiene.

· Don't smoke and air pollution.

· Practice a healthy lifestyle.

· Avoid sick people.

· Try not to touch your face, mouth, or eyes until you've washed your hands.

· Improve lung health and vital organs.

· Always drink warm lemon water.

Treatment:

Pneumonia should be treated with antibiotics. The antibiotic of choice for first line treatment for pneumonia in adults is macrolide antibiotics, like azithromycin or erythromycin and amoxicillin dispersible tablets. Most cases of pneumonia require oral antibiotics, which are often prescribed at a health centre. These cases can also be diagnosed and treated with inexpensive oral antibiotics at the community level by trained community health workers. Hospitalization is recommended only for severe cases of pneumonia.^7,11

Treatment lasts about 5 to 7 days. Mild pneumonia can usually be treated at home with rest, antibiotics and drinking plenty of fluids. The antibiotic can be taken as a tablet or syrup. Depending on the severity of the illness and the risk of complications, treatment in a hospital may sometimes be needed. The antibiotic is usually given as an infusion there. Some people with severe pneumonia are also given a steroid injection. Inhalation of oxygen using a mask is sometimes necessary; artificial respiration is less commonly needed. If the pneumonia was caused by viruses, other drugs are needed, like a virostatic against flu viruses. Cough medicines from the pharmacy, special breathing exercises or physiotherapy are not recommended for treating pneumonia.^9,10,12

Example: Dicloxacillin is penicillin-like antibiotic, prescribed for certain types of bacterial infections such as pneumonia, infections of the ear, urinary tract, bone, blood and skin.

Name of Pneumonia Treatment using Drug:

· Gemifloxacin/Fluoroquinolones. Delafloxacin (Baxdela).

· Macrolides. Azithromycin (Zithromax).

· Monobactams. Aztreonam (Azactam).

· Antibiotics, Lincosamide. Clindamycin (Cleocin).

· Tetracyclines. Doxycycline (Bio-Tab, Doryx, Doxy, Periostat, Vibramycin, Vibra-Tabs).

· Carbapenems. Ertapenem (Invanz).

· Oxazolidinones. Linezolid (Zyvox).

· Balofloxacin is a quinolone antibiotic (Baloforce).

· Cephalosporin / Cefotaxime antibiotic (Distaclor).

· Minocycline is a broad spectrum tetracycline antibiotic (Nidcyclin)

· Aminoglycosides. Etc….

Data Collection:

All patients admitted to participating hospitals during the 2-3 Month were included in the study and followed until discharge. Patients were excluded if they were discharged within 24 hours and had been transferred from other hospitals or other wards within the study hospitals. Data collected included sociodemographic characteristics, previous medical history, admission and discharge diagnoses, length of stay, laboratory tests, instrumental procedures, therapies administered (before admission and during hospital stay), medications prescribed at discharge, as well as information on the dosage, frequency, route, and indication of use of drugs. Data collected were entered into a computerized database developed. Based on the collected data, all patients were classified into three different groups depending on whether they have developed at least one ADR (patients with ADR occurring during hospitalization and patients with ADRs that caused hospitalization) or not (patients without ADRs).

All identified cases of ADRs were reviewed by a research team consisting of clinical pharmacologists, working at the Regional Pharmacovigilance Centre sited at Hospital of India, ward physicians and monitors. The team analyzed each case of suspected Moxifloxacin ADR, to make a final causality assessment between a drug and an adverse reaction applying. Only ADR reports with a certain, probable, or possible causality assessment were included. In accordance with the Italian healthcare system, all collected ADRs were reported to the Indian Pharmacovigilance System. Additionally, for each ADR, customized information, to update the reporters about risks related to a drug’s use.Adverse drug reactions were codified as detailed by the Medical Dictionary for regulatory Activities and organized according to the system organ class (SOC) classification and preferred term (PT). Moxifloxacin was considered serious when it was fatal, life-threatening, required or prolonged hospitalization, caused serious or permanent disability, or congenital birth defect. The diagnosis of admission and discharge at the hospital ward and concurrent diseases were coded according to the International Classification of Diseases, ninth edition, Clinical Modification. Co morbidities were assessed by the Charlson score.

The LOS was evaluated as the number of days between the date of admission and the date of discharge or determines the rate of ADRs occurring during hospital stay, the number of inpatients who experienced an ADR divided by the total number of patients admitted to the hospital wards was considered. The prevalence of ADRs present upon admission was calculated as the ratio between the number of patients admitted for ADRs and the total number of admissions in Internal Medicine departments.^{19,20,24,28,31,35}

RESULTS:

The incidence of adverse drug reaction reported in the studies ranged between 16% and up to 85-90% in cases. "Pneumonia can be incredibly taxing and there's no one-size-fits-all to recovery. Some people feel better in about six weeks, but it can take several months for others to feel better after severe pneumonia," Overall incidence rates of AEs were globally similar in the moxifloxacin and comparator groups. By filtering the data for differences in disfavor of moxifloxacin at ≥2.5-3% for events with an incidence ≥2.5-3% or at ≥2-fold for events with an incidence <2.5-3% in one or both groups and affecting ≥10 patients in either group, we observed slightly more as AEs in double-blind intravenous-only and open-label oral studies, SAEs in double-blind intravenous-only studies, ADRs and SADRs in open-label oral studies, SADRs in open-label intravenous/oral studies, and premature discontinuation due to AEs in open-label intravenous-only studies. The actual numbers of SADRs (in all studies) were small, with clinically relevant differences noted only in intravenous/oral studies and mainly driven by ‘gastrointestinal disorders’ (16 versus 8 patients) and ‘changes observed during investigations’ 24 versus 8 patients (asymptomatic QT prolongation: 12 versus 5 patients in double-blind studies). Analysis by comparator (including another fluoroquinolone) did not reveal medically relevant differences, even in patients at risk. Incidence rates of hepatic disorders, tendon disorders, and clinical surrogates of QT prolongation, serious cutaneous reactions, and Clostridium difficile-associated diarrhea were similar with moxifloxacin and comparators.

Adverse Events (AES):

Rates of treatment-emergent AEs based on study design are presented in Reported AEs with ≥5% incidence for patients in the double-blind studies included wound infections (moxifloxacin 11.8% versus comparator 7.5%, intravenous; corresponding mainly to patients treated for cIAIs and cSSSI); diarrhea (moxifloxacin 6.3% versus comparator 5.1%, oral, moxifloxacin 8.2% versus comparator 7.8%, intravenous/oral, moxifloxacin 6.4% versus comparator 4.5%, intravenous); nausea (moxifloxacin 7.8% versus comparator 6.1%, oral, moxifloxacin 7.4% versus comparator 6.4%, intravenous/oral, moxifloxacin 5.5% versus comparator 3.6%, intravenous); headache (moxifloxacin 5.7% versus comparator 5.8%, intravenous/oral); constipation (moxifloxacin 7.8% versus comparator 6.2%, intravenous/oral); hypokalemia (moxifloxacin 5.2% versus comparator 5.1%, intravenous/oral); and insomnia (moxifloxacin 7.3% versus comparator 7.3%, intravenous/oral). Reported AEs with ≥5% incidence for patients enrolled in open-label studies included diarrhea (moxifloxacin 3.7% versus comparator 7.5%, oral, moxifloxacin 6.2% versus comparator 6.6% and intravenous/oral) and nausea (moxifloxacin 5.2% versus comparator 2.5%, oral).

Again limiting the description to situations there was a 2-fold difference between treatment arms for events with an incidence <2.5-3% in either of the treatment groups or a ≥2.5-3% difference between treatments for events with an incidence ≥2.5-3% in both groups, and the number of patients experiencing an event was ≥10 in either treatment group, the following differences were noted in disfavor of moxifloxacin in the double-blind studies for patients treated with oral therapy (moxifloxacin 8823 v/s comparator 8644) hyperhidrosis (37 [0.5%] v/s 17 [0.3%]), tremor (36 [0.5%] v/s 16 [0.3%]), atrial fibrillation (17 [0.3%] v/s 4 [<0.2%]), and pleural effusion (13 [0.2%] v/s 6 [<0.2%]); for patients treated with intravenous/oral therapy (moxifloxacin 1890 versus comparator 1857) incision site pain (22 [1.2%] v/s 12 [0.6%]), erythema (20 [1.1%] v/s 7[0.4%]), hypophosphatemia (17 [0.9%] v/s 4 [0.3%]), depression (16 [0.9 %] v/s 5[0.3%]), increase in white blood cell (WBC) count (12[0.7%] v/s 6 [0.4%]), and increase in lactate dehydrogenase (LDH; 11[0.6%] v/s 5[0.3%]); and patients treated by the intravenous route (moxifloxacin 589 versus comparator 572) insomnia (12 [1.9%] v/s 4 [0.6%]) and abdominal pain (11[1.8%] v/s 2 [0.2%]). Conversely, and with the same double filter, the following AEs were more frequently reported in the comparator in oral studies dysgeusia (moxifloxacin 76 [0.9%] v/s comparator 179[2.2%]), increase in gammaglutamyl transferase (GGT; moxifloxacin 21 [0.3%] v/s comparator 42[0.6%]), muscle spasms (moxifloxacin 13[0.2%] v/s comparator 26[0.4%]), and myocardial infarction (moxifloxacin 3[<0.2%] v/s comparator 13[0.2%]); and intravenous/oral studies: cough (moxifloxacin 8[0.5%] v/s comparator 16[0.9%]), myocardial infarction (moxifloxacin 6[0.4%] v/s comparator 11[0.6%]), musculoskeletal pain (moxifloxacin 4[0.3%] v/s comparator 11 [0.6%]), and leukocytosis (moxifloxacin 3[0.2%] v/s comparator 11 [0.6%]).

In the open-label studies, the most common AEs in disfavor of moxifloxacin were nausea (in oral studies: moxifloxacin 92[5.2%] v/s comparator 51[2.5%]) and dizziness (in oral studies: moxifloxacin 45[2.5%] v/s comparator 9[0.4%]; in intravenous/oral studies: moxifloxacin 27[1.8%] v/s comparator 14[0.9%]), and the most common AE in disfavor of the comparator was diarrhea (in oral studies: moxifloxacin 66[3.7%] v/s comparator 153[7.5%]).

Adverse Drug Reactions (ADRS):

ADRs occurring in at least 0.6% of patients in either treatment group In the oral population enrolled in double-blind studies, the most common ADRs were nausea (moxifloxacin 603[6.9%] v/s comparator 458 [5.4%]), diarrhea (moxifloxacin 433[5.0%] v/s comparator 335[4.1%]), dizziness (moxifloxacin 248 [2.9%] v/s comparator 199[2.4%]), headache (moxifloxacin 166[2.0%] v/s comparator 178[2.1%]), and vomiting (moxifloxacin 163[1.9%] v/s comparator 151[1.8%]). Only dysgeusia (moxifloxacin 67 [0.8%] v/s comparator 172[2.1%]) and increased GGT (moxifloxacin 12[0.2%] v/s comparator 31[0.4%]) met the criteria set by the double filter In the double-blind intravenous/oral population, diarrhea was the most common ADR (moxifloxacin 97 [5.2%] v/s comparator 96[5.2%]). Differences affected fewer than 10 patients in each treatment group, except for vomiting (moxifloxacin 14 [0.8%] v/s comparator 27[1.5 %]). In the double-blind intravenous population, increased lipase (moxifloxacin 15[2.5%] v/s comparator 19[3.3%]) and increased GGT (moxifloxacin 14 [2.3%] v/s comparator 19[3.3%]) were the most common ADRs, and only nausea showed a difference in disfavor of moxifloxacin v/s comparator (13[2.1%] v/s 4 [0.6%], respectively) according to the double filter. In the open-label oral studies, nausea (moxifloxacin 78[4.4%] v/s comparator 45[2.3%]) and diarrhea (moxifloxacin 55 [3.1%] v/s comparator 142[7.0%]) were again the most common ADRs across therapy arms, followed by dizziness (moxifloxacin 31[1.8%] v/s comparator 5[0.3%]), upper abdominal pain (moxifloxacin 24[1.4%] v/s comparator 21[1.1%]), and vomiting (moxifloxacin 21[1.2%] v/s comparator 15[0.8%]), all experienced by >1.2% of patients in the moxifloxacin arm. Application of the double filter to the open-label oral population showed that diarrhea was more frequent with comparators (moxifloxacin 55[3.1%] v/s comparator 142[7.0%]), whereas dizziness (moxifloxacin 31[1.8%] v/s comparator 5[0.3%]), rash (moxifloxacin 17[1.1%] v/s comparator 9[0.6%]), dysgeusia (moxifloxacin 14 [0.8%] v/s comparator 3[<0.2%]), and somnolence (moxifloxacin 11[0.7%] v/s comparator 3[<0.2%]) were more frequent with moxifloxacin. In the open-label intravenous/oral population, diarrhea was the most common ADR for both moxifloxacin and comparator (62[4.1%] and 61[3.9%], respectively). Differences in disfavor of moxifloxacin v/s comparator that met the double filter criteria concerned QT prolongation (moxifloxacin 20[1.3%] v/s comparator 4 [0.3%]) and dizziness (moxifloxacin 11[0.7%] v/s comparator 3 [0.2%]). For patients treated with intravenous therapy in the open-label population, all ADRs occurred in <11 patients in both treatment groups at low incidence rates, i.e. nausea (moxifloxacin 6[1.5%] v/s comparator 3 [0.7%]), dizziness (moxifloxacin 7[1.8%] v/s comparator 7[1.8%]), increased ALT (moxifloxacin 10[2.7%] v/s comparator 9[2.4%]), and rash (moxifloxacin 9[2.4%] v/s comparator 4[1.1%]).

DISCUSSION AND CONCLUSION:

The safety of moxifloxacin is essentially comparable to that of standard therapies for patients receiving the currently registered dosage and for whom contra indications and precautions of use (as in the product label) are taken into account. Incidence rates of AEs were globally similar in the moxifloxacin and comparator groups. Analysis by comparator (including another fluoroquinolone) did not reveal medically relevant differences, even in patients at risk. Incidence rates of hepatic disorders, tendon disorders, and clinical surrogates of QT prolongation, serious coetaneous reactions, and Clostridium difficile-associated diarrhea were similar with moxifloxacin and comparators.

The strongest antibiotic for pneumonia drug is Macrolides. The best initial antibiotic choice is thought to be a macrolide. Macrolides provide the best coverage for the most likely organisms in community-acquired bacterial pneumonia (CAP). Macrolides have effective coverage for gram-positive, Legionella, and Mycoplasma organisms and Ceftazidime injection is used to treat certain infections caused by bacteria including pneumonia and other lower respiratory tract (lung) infections; meningitis (infection of the membranes that surround the brain and spinal cord) and other brain and spinal cord infections; and abdominal (stomach area), skin and blood.

Complications of pneumonia in Kidney, Liver and Heart Damage For older adults, more commonly those with underlying chronic health conditions, pneumonia can cause severe shortness of breath and other respiratory complications that restrict oxygen to the lungs. Risk factors for pneumonia Lung diseases, such as asthma, bronchiectasis, cystic fibrosis, or COPD, also increase your pneumonia risk. Other serious conditions, such as malnutrition, diabetes, heart failure, sickle cell disease, or liver or kidney disease, are additional risk factors.

History of Pneumococcal Infection:

Symptoms of pneumonia were first described by the Greek physician Hippocrates around 460 BC. Although it carried many names and was often identified as a sickness, in the 19th century it was demonstrated that immunization of rabbits with killed pneumococcal protected them against subsequent challenge with viable pneumococcal. Serum from immunized rabbits or from humans who had recovered from pneumococcal pneumonia also conferred protection. In the 20th century, the efficacy of immunization was demonstrated in South African miners.

It was discovered that the pneumococcus's capsule made it resistant to phagocytosis, and in the 1920s it was shown that an antibody specific for capsular polysaccharide aided the killing of S. pneumonia. In 1936, a pneumococcal capsular polysaccharide vaccine was used to abort an epidemic of pneumococcal pneumonia. In the 1940s, experiments on capsular transformation by pneumococcal first identified DNA as the material that carries genetic information.

In 1900 it was recognized that different servers of pneumococcal exist and that immunization with a given server did not protect against infection with other servers. Since then over ninety servers have been discovered each with a unique polysaccharide capsule that can be identified by the quelling reaction. Because some of these servers cause disease more commonly than others it is possible to provide reasonable protection by immunizing with less than 90 servers; current vaccines contain up to "23-valent".

Viral pneumonia was first described by Hobart Reimann in 1938. Reimann, Chairman of the Department of Medicine at Jefferson Medical College, had established the practice of routinely typing the pneumococcal organism in cases where pneumonia presented. Out of this work, the distinction between viral and bacterial strains was noticed. The servers are numbered according to two systems: the American system, which numbers them in the order in which they were discovered, and the Danish system, which groups them according to antigenic similarities.

ACKNOWLEDGEMENT:

I am very thankful to Principal (Dr Amit Roy), and Columbia Institute of pharmacy tekari Raipur Chhattisgarh and my teachers for their valuable guidance. I would like to thank all monitors who participated in data collection for this study and structures involved into the project: Saraswati Sahu, Dr. Trilochan Sathpathy (HOD- Pharmacology), Dr. Ram Sahu.

I am also thankful to my friends, school teacher and colleagues for their time to time support. Especially thanks to my family and also grateful to the Hospital staff for informatics support and help for collecting of adverse drugs reaction (ADRs) reports at hospitalized patients and their dedication to patient safety, even when the system was overwhelmed by the pneumonia.

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Received on 03.06.2022 Modified on 13.08.2022

Res. J. Pharmacology and Pharmacodynamics.2022;14(4):237-245.

DOI: 10.52711/2321-5836.2022.00041