Kevork for treatment of bacterial infections such as acute sinusitis acute exacerbation of chronic bronchitis and skin and skin infections

 
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Kevork
(levofloxacin) tablets

Composition :

Kevork 500 mg :
– Each tablet contains 512.43 mg Levofloxacin Hemihydrate eq.
to 500 mg Levofloxacin .
Inactive ingredients: Hypromellose, Crospovidone , Microcrystalline cellulose PH 10 I, Magnesium stearate, Titanium dioxide. Polysorbate 80, Hydroxy propyl methyl cellulose EIS, sunset yellow
Kevork 750 mg :
– Each tablet contains 768.64 mg Levofloxacin Hemihydrate eq.
to 750 mg Levofloxacin.
Inactive ingredients: HypromelJose, Crospovidone , Microcrystalline cellulose PHIOI, Magnesium stearate, Titanium
dioxide, Polysorbate 80, Hydroxy propyl methyl cellulose EIS,
Carmosine

Properties :

Levofloxacin is a synthetic fluorquinolon antibiotic that inhibits
the bacterial topoisomerase (DNA GYRASE), an enzyme essential for DNA replication, transcription, repair and recombination.
Following administration, it binds to plasma proteins (24-38%),
rapidly and almost completely absorbed reaching tha peak plasma
concentration within 1-2 hours and a duration of action lasts
about 24 hours then penetrates well to di fferent body tissues.
It undergoes limited hepatic metabolism and it is eliminated mainly unchanged via the urine with terminal halflife about 6-8 hours.

Microbiology :

Levofloxacin has a bactericidal effect against many susceptible
Gram-positive,Gram-negative bacteria and anaerobes. In vivo and in vitro studies have been shown its activity against most strains of the following microorganisms. Aerobic Gram-positive microorganisms.e.g.: Staphylococcus aureus or Staphylococcus epidermidist Methicillin- susceptible strains),Staphylococcus
saprophyticus.Streptococcus pneumoniae,Streptococcus pyogenes.

Aerobic Gram-negative microorganisms,e.g. :

Enterobacter cloacae.Escherichia coli.Haemophilus influenzae.
Haemophilus parainjluenza,Klebsiella pneumoniae.Legionella
pneumophila, Moraxella catarrhalis, Proteus micrabilis. Pseudomonas aeruginosa.
Other microorganisms:
Chlamydia pneumonia and Mycoplasma pneumonia. There have been observed a cross-resistance only between Levofloxacin and some other fluoroquinolone but not to other antibacterials.

Indications :

Treatment of bacterial infections due to Levofloxacin
susceptible micro-organisms,e.g:
– Acute sinusitis.
– Acute exacerbation of chronic bronchitis.
– Community-Acquired pneumonia.
– Urinary tract infections and acute pyelonephritis.
– Skin and skin infections.
– Intra-abdominal infections.

Contraindications :

Hypersensitivity to the active ingredient, other
qninolones or any of the drug constituents.

Drug interactions :

Levofloxacin should not be used concomitantly (2 hours apart) with cimetidine, theophylline, cyclosporine, digoxine, probenecid, metal cations, antacias-containing multi vitamins preparations, ncn-steroida} anti- inflammatory drugs or antidiabetics.

Precautions and warnings :

– Consider the diagnosis of pseudomembraous colitis in patients who present with diarrhea subsequent to drug administration.
– Maintain adequate hydration to prevent highly concentrated urine during therapy.
– Patients with impaired hepatic, renal functions or hematopoitic disturbances.
– Patients with diabetes, arrhythmia, peripheral neuropathy and hypokalamia,
– Patients with a history ofCNS disorders e.g.epilepsy or other predisposing risk factors of convulsive seizures.
– Levofloxacin may alter alertness and coordination to such extent that the ability to drive to operate machinery may be impaired.
– Altough photo toxicity ,is rare (less than 0.1 %),e.g. skin eruption exposure to excessive sunlight or artificial U.V rays is not recommended.
– False negative results in the bacteriological diagnosis of tuberculosis may be obtained due to the inhibition of the growth of mycobacterium by Levofloxacin.
– Pregnancy and breast -feeding: due to lack of well- controlled
studies.
– Age: Pediatric patients, adolescents below the age of 18 years and
elderly due to lack of well-controlled studies .
**Exacerbation of myasthenia gravis: Fluoroquinolones have
neuromuscular blocking activity and may exacerbate muscle
weakness in persons with myasthenia gravis. Post marketing serious adverse events, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gtavis. Avoid fluoroquinolones in patients with known history of myasthenia gravis .
**Quinolones should not generally be used in patients aged less than 18 years, pregnant women, or breast-feeding mothers unless the benefits outweigh the risks.

Adverse reactions :

It is generally well-tolerated. They are usually mild. G.1.T: dry mouth .gastric or abdominal pain, dyspepsia, flatulence, anorexia, nausea, vomiting and diarrhea. Respiratory system: rhinitis and pharyngitis.
C.N.S: Peripheral neuropathy, headache. dizziness, insomnia ,
nervusness,somnolence, sleep disturbances, tremors, resilessness.v
anxiety and confusion.
Skin: allergic manifestations as pruritus, rash, urticaria, local
pain or inflammation at injection site and phototoxicity.
Musculoskeletal: pain and swelling or rupture of a tendon.
Urogenital: vaginitis, genital moniliasis or pruritus. Post marketing Experience: Exacerbation of myasthenia gravis.

Dosage and administration :

As directed by physician:
Orally: 250-750 mg once daily for the recommended course duration according to the infection and patient response. Tablets are swalled with enough water with orwithout food. Don’t double the dose if you missed a dose.

Storage :

Keep at temperature below 30°C.
Keep out of reach of children.

Pack :

Cartoon box containes one(Al! Pvc)strip of5 tablets. With inner
leaflet.

Produced by :
ORGANO PHARMACEUTICAL & CHEMICAL INDUSTRIES
(ORGANOPHARMA)

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