Epicoflocin

Epicoflocin

For the medical profession onlyEpicoflocin® 

Ofloxacin
Scored film coated tablets 
Composition: Each scored film coated tablet contains: 
Offoxacin 200mg Properties and Mode of action: Epicoflodn is a Ituoroquinolone antibacterial with a broad spectrum of activity against Gram negative and Gram positive bacteria such as: E coil, Pseudomonas aeruginosa, Proteus mirablils and nuigaris, Kiebsiella sp. Kemophllus lnlluenzae, Moraxella catarrhalls, Salmonella op., Shigelta sp.,Campylobacter sp. Acinerobacler op., Neisseria gonorrhoeae and meningitidis, Morganella molganhi, Providentla reltgerl and stuacril, Staphylococcus aureus and epidermidis including methicillin-rnsistant and methlclllin-suscepllble strains), Staphylococcus saproptilticus, Streptococcus agalactiae,pyogenes and pneumoniae, Enterococcus faecabs, Legionella op., and Chiamydia trachomatis. It acts on the bacterial DNA gyrase enzyme and thus inhibits DNA replication. Pharmacokinetlos: Ofioxacin Is rapidly and well-absorbed from the gaslrotnientlnal tract, and Is widely distributed to most body tissues, it crosses the CSF, placenta, and is distributed through the breast milL Its bloavailability is approtomately 98% and 32% in bound to plasma protein. Ills slightly metabolized In the liver, and Is eliminated mainly by the kidneys with 70-80% recovered in urine in the active form. Plasma half life is about 5—7 hours.

Indications, Dosage and Administration: Eplcoltodn® tablets should be swatowed whole with a sufficient quantity of liquid, and it maybe taken with meals

InfectIon	Description	Unit Dose	Frequency	Duration
Urmary Tract	Cysritis due toE coil Or K. pneumoniae	oo tog	q 12 tots	3 days
Cysritis due to sitter organisms	mg	q 12 tots	7 days
omplicated tlfls	200mg	q 12 tots	10 days
l.ower  Respiratory Tract	Exacerbation of cbrs,tlr	4110 tog	q 12 hrs	tOdays
PneumonIa	400mg	q 12 tots	10 days
skin and  skin Stricture		4oomg	q12105	todays
Proolatitis		300mg	q 12 tim	6 weebs
Seoually  Transmitted  Diseases	Acxtn UsCotnptbsttrd gonorrhea	400mg	Single dose	1 day
Cernlsitis/Uretiltltis duet C. tradromatts	mg	q 12 bits  -	7 days
Cervrcltis/tirethrlss duet N. gonorrhoeae	oo mg	rg 12 tots	7 days

Renal Function Impairment Milan dosage In patients with a creatinine clearance value of 50 mi/mm. After a normal initial dose, adjust the dosing Interval as follows: - Crearinine clearance 10—80 mi/mItt, use a 24 hours interval and do not adjust the dosage. - Creatinme clearance 0 10 mI/mm, use a 24 hours interval and one — half the recommended dosage. 
CDC) Centern for Disease Control and Prevention) recommended schedules for Chlamydla, Epididlmytis, Pelvic Inflammatory Disease IPID) and Gonorrhea: 
-Chlamydia: 300mg orally 2 times/day for 7 days I alternative regimen. -Epldidbmytls: 300 mg orally 2 lImes/day for 10 days I alternatIve regtmen .PID, outpatient:400 mg orally 2 times/day for 14 days plus clindamycin or metronidozole. - Goosococcal Infections, uncomplicated: 400 tog orally in a single dose plus Missed dose: It you miss a dose, take it as soon as you can. If Iris almost time for your next dose, skip the missed dose, do not doable the dose to make up for the mtssed dose. Patients should drink sufficient quantity of water or other liquid every day. Drug interactions: - The concomitant administration of Eplcoflocin° with antacids containing calcium, aluminium, magnesium; sucralfate; drugs containing Iron; and multivltamins containing zinc results in decrease efficacy of Eplcoflocmn®, so they should sot be taker within the 2 hours period before or after administration of the drug. - Concomitant administratIon with wartarin enhances the effect of warfarin and prolongs the prothrOmbin time. - Disturbances of blood glucose may occur In patients treated concurrently with antidlabetic agents (e.g. insulin or glibenclamide (, so diabetic patients should be monitored. Precautions: Epicoflocin® should be used cautiously th: 
- Renal or hepatic Impairment. - Patients with bnown or suspected CNS disotder thai may predispose to seizures or 
lower the seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy). - Excessive sunlight or artificial ultraviolet light should be avoided. 
- Epicofiodn® may alter the reactivity to such an extent that the ability to drive 
vehicles or operate machines may be impaired. 
- Epicoflocirs® should be discontinued if the patient experiences pain, Inflammation or rupture of a tendon. Pregnancy and lactation: Eplcofbocln° Is contraindicated during pregnancy, and must be used cautiously during lactation. Contra-indications: - Hypetsensitivity in the product or to any member of the fluoroqulnolones. - Children under 18 years of age. Side effects: Nausea, vomiling, abdominal pain, diarrhea, talulenco, headache, dizziness, drowsiness, Insomnia, fatigue, rash, primlus, vaginitis, photosensitivity reactions, visual disturbances, hyperglycemia or hypoglycemia, and In rare cases elevation of liver enzytnes. Storage conditions: Store at temperature not exceeding 30’C.

Dosage GuidelInes

How supplied: 10 scored Elm coated tablets. Revision Date: July 2008.

EL P. L CO. 
lo OF RAMADAN CITY. INDUSTRIAL AREA Dl, P.O. HOSt 149 TENTH. EGYPT