ENOXABID® (Enoxacin Sesquihydrate)

   ENOXABID (Enoxacin Sesquihydrate)

ENOXABID (Enoxacin Sesquihydrate)

400mg Tablets

Description

Enoxabid is Abbott’s brand name for Enoxacin, a new broad 

spectrum antibacterial agent of the quinolone class.

Composition

Each Filmtab tablet contains:

Enoxacin sesquihydrate equivalent to Enoxacin ......... 400 mg.

Clinical Pharmacology

Enoxacin blocks DNA synthesis during bacterial replication by inhibiting the bacterial enzyme DNA gyrase.

It has a broad antibacterial spectrum against Gram-positive and Gram-negative bacteria at bioavailable concentrations achievable in body tissues and fluids. 

In vitro, it is usually bactericidal at concentrations near its MICs 

and showing high antibacterial activity against Staphylococcus aureus, Staphylococcus epidermidis and Streptococcus pyogenes as well as Campylobacter spp, Citrobacter spp. Enterobacter spp. 

Escherichia coli, Klebsiella spp, Proteus spp, Providentia spp., 

Pseudomonas aeruginosa, Pseudomonas

cepacia, Pseudomonas 

maltophilia, Serratia spp, Shigella spp, Salmonella spp, Vibrio spp, 

Haemophilus influenzae, Haemophilus ducreyi, Neisseria 

gonorrhoeae, Legionella spp, and strains of Acinobacter spp,. 

However, streptococci are less sensitive or resistant to it.

Penicillin, methicillin and/or aminoglycoside resistant isolates of 

other bacteria are as susceptible as the sensitive strains.

Enoxacin does not exhibit any significant cross-resistance with 

other antibiotics and has a low frequency of spontaneous resistant 

mutants. At subinhibitory concentrations in vitro, it has been 

shown to lower the incidence of plasmid transfer and to cause plasmid elimination (plasmid curing e ect). 

It acts synergistically with polymorphonuclear leukocytes to 

enhance intracelluar killing of bacteria.

Oral Enoxacin showed protective activity against Gram-positive 

and Gram-negative infections in systemic circulation and organ systems (i.e. lung, skin, kidney) of experimental mice. In rabbits when administered orally, it did not significantly suppress the anaerobic/streptococcal flora.

Pharmacological evaluations of Enoxacin in animals and isolated organs suggests that its preclinical potential for CNS and 

autonomous side e ects is small, especially with oral administration.

Orally administered Enoxacin is rapidly and reliably absorbed. 

After a single dose of 400 mg. peak serum levels of 2-3 mcg/ml occur at 1.5 hours on average. Meals have no significant influence 

on the rate and extent of absorption.

On multiple doses, steady state concentrations are reached within 3 days, e.g., 3.5 - 4.5 mcg/ml peaks with a 400 mg 

twice-daily schedule. The serum half-life is about 5-6 hours with plasma levels remaining above the minimal inhibitory concentrations for susceptible clinical pathogens.

Enoxacin di uses readily into most body fluids and tissues except the cerebrospinal fluid and is eliminated by both the renal and hepatic routes.

It is predominantly excreted via the kidney with 24 hour urinary 

recovery of about 60-65% and steady-state urine concentrations 10-100 times higher than the plasma levels. It is concentrated in 

the bile to mean levels up to 9 times higher than plasma levels.

It penetrates sputum, skin blister fluid, prostate and renal tissues to levels in most cases exceeding that of plasma and into middle ear fluid, tonsillar and maxillary sinus tissues at concentrations similar to corresponding plasma levels.

Enoxacin is metabolized to a very limited extent, its biotransformation occurring primarily in the piperazinyl ring to 

form mainly on oxometabolite (with 1/10th the microbiological activity of the parent compound) and 6 other minor metabolites. 

38 - 44% and at least 90% of unchanged Enoxacin are recovered, respectively, in the urine and faeces, the oxometabolite accounting in the urine for 1-13% and each of the other metabolites for less than 3% of the administered dose.

In severe renal impairment, i.e., with a creatinine clearance lower than 30 ml/minute, the elimination half-life is approximately doubled. This change in elimination kinetics should double the 

steady-state plasma concentrations.

INDICATIONS

Enoxabid is indicated in the following infections caused by 

susceptible organisms:

Upper Respiratory Tract / ENT: Pharyngitis, peritonsillar abscess, 

otitis media, sinusitis.

Lower Respiratory Tract: Acute bronchitis, acute exacerbations of chronic bronchitis, bronchiectasis with infection, pneumonia 

and lung abscess.

Skin/Skin Structures: Folliculitis, furunculosis, carbuncles, 

impetigo, cellulitis, secondary infections of wounds, burns and surgical incisions.

Urinary Tract: Acute/simple and chronic/complicated urinary 

tract infections, including cystitis, pyelonephritis and prostatitis.

Sexually Transmitted Diseases: Gonococcal urethritis.

GI Tract: Bacillary dysentery and enteritis, Typhoid (enteric 

fever).

CONTRAINDICATIONS

Enoxabid is contraindicated in patients who have known hypersensitivity to this antimicrobial agent or other quinolones.

PRECAUTIONS

Enoxabid should be carefully administered to patients with:

- severe renal dysfunction or undergoing hemodialysis.

This drug is only removed slightly by hemodialysis.

- A known history of epilepsy or other convulsive disorder as convulsions may occur (Patients must be closely monitored).

USAGE IN PREGNANT AND NURSING MOTHERS AND IN CHILDREN

- Safe use of Enoxabid during pregnancy and nursing has not been established Therefore. it should not be administed to