Ceporex is a bactericidal antibiotic

Ceporex
 
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Ceporex
Cephalexin

CEPOREX” Cephelexin
Ceporex 250 mg film coated tablet
Cepcrex 500mg film coated tablet
Ceporex 1 9 film coated tablet
CeporexsyrUp125mg/5mlgranulesfororalsuspension
Ceporexsyrup 250 mg/5ml granules for oral suspension

COMPOSITION :

film coated Tablets contain either 250,500 mg or 1 g of cepbatexln.
– Granules for oral suspension: when reconstituted each 5 ml containst39.5 mg Cephalexin monohydrate equivalent to 125mg Cephalexin anhydrous or 279.5 mg CephaJexin monohydrate s250 mg Cephalexin anhydrous
Tablet: Magnesiun Stearate, Microcrystalline Cellulose, Opadry Pink, Opadry OY-S-6927, Macrogol ~OO, water purified. Granules for oral suspension: sodium calcium Edetate-Acaria powder- Citric acid anhydrous- Soduim citrete anhydrous- Sunset yellow- Orange-bramble flavour polvaromas- Sucrose powder

PHARMACEUTICAL FORM :

film coated tablets and granules for oral suspension

Indications :

CEPOREX is a bactericidal antibiotic which is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for treatment of the following conditions. when caused bysusceptibJebacteria.

 Oral formulations:

Respiralorytractinfections:acuteandchronicbronchitisand infected bronchiectasis.
Ear. nose and throat infections: otitis media, mastoiditis, sin esitls. follicular tonsillitis and pharyngitis. Urinary tract infections: acute and chronicpyelonephritis,cy stitis and prostatitis. Prophylaxis of recurrent urinary tract infec tion. Gynaecological and obstetric infections. Skin, soft-tissue and bone infections. Gonorrhoea (when Penicillin is unsuitable). Dental procedures: treatment of dental infections. As prophylaxis treatment for patients with heart disease undergoing dental treatment as an alternative to penicillin.

Dosage and Administration :

Ora/formulations:
Duration of treatment:
for most acute infections, treatment should continue for at lea si two days after signs have returned to normal and symptoms have subsided,butinchronic, recurrent or complicated urinar y tract infections, treatment for two weeks (giving 500 mg four times dailyl isrecommended.Forgonorrhoea,asingledoseof3g with 1 9 probenecidformalesor2gwithO.5gprobenecidforfemalesis usually effective. Concurrent administration of probenecid del ays excretion ofcephalexinand raises the strum revels by 50 to 100% .
• Adults
Many infections in adults will respond to oral dosage of 1 9 to 2 g per day in divided doses; however, for most infections, the simpl e scheme of 500mg three times daily will be found satisfactory.
– for prophylaxis of recurrent urinary tract infections in adult s, a dose of 125 mg each night ls reccmmendec and rnaybr continued for several months.
Children
Idratty, dosage should be’ calculated on a body-weight basis, particularly in infants.ThefoUowing dosage recommendations f or children are deriV(‘d from a normal dosag( of 25 to 60 mg/kg/day. For chronic.severe or deep-seated infections, this should be Incr eased to 100 mg/kgfday {maximum 4 g/day).
0 to 1 vear:     25to60mg/kg/day.

1 year to 2 years:     62.5 to 125 mg four times daily or 12510 250 mg twice daily.
3 to s vears:     125 to 250 mg four times daily or 250 to 500 mg twice daily.
7 to 12 yurs:     25010 SOamg four times daily or SOOmg to 19 twice daily.
• Eldtrly
In elderly patients, the possibility of renal impairment should be considered (see Renal impairment below)
• Renal impairment
Cephalexin has not been shown to have a tcdc effect on the kidney, but as with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is below about half of normal. Clinical practice indicates that in view of the wide therapeutic window of CEPOREX, the standard recommended doses should be halved onlyin those patients with sevm renal impairment (creatinine de:aranttkssthanl0ml/min}. The maximum recommended dosages (Le. adults 6 g/day, children 4 g/day) should be reduced by 50% in mild. 75% in moderate and 87.5C!b in severe renal failure. AduJt patients receiving intermittent dialysis should be given an additional SOO mg CEPOR£X after each dialysis. i.e. a total dosage et upto 19 on that day. Children should receive an additional amg/kg.

Contraindications :

– Hypersensitivity to any ingredient of the preparation.
– Patients with known hypersensitivity to cephalosporin antibiotics.

Warnings and Precautions :

Special care is indicated in patients who have experienced an allergic reaction to penlclluns or other beta-tactams. As with other broad-spectrum antibiotics, prolonged use may result in the overqrowth of non-susceptible organisms (e.g.
Candida, enterococci, Clostridium diffidlel. which may require interrupticn ot treatment. Pseudomembranous colitis has been reported with the use of
broad-spectrum antibiotics. therefore, it is important to ccnsld er its diagnosis in patients who develop severe diarrhoea during or
after antibiotic use. CEPOREX can interfere with the determination of the alkaline
picrateassayforcreatinine,givingafalsehighreading,although Ihis is unlikely to be of clinical importance. In patients receiving CEPOREX, a false-positive reaction for
glucose in the urine maybe given, with Benedict’s or Fehling’s solution or with ‘Clinitest’ tablets. but not with enzyme-based tests. As with other antibiotics that are excreted mainly by the kidntys, when renal function is poor, dosagt of CEPOR£X should be suitably reduced (set Dosoge ond Administration).
Interactions :

Concurrent trutment with high doses of cephalosporins and nephrotoxic drugs such as aminoglycosides or potent diuretics ( e.g. frusemide.ethacrvnic acid and pirelanidel may adverstly effect renalfunclion.Clinicaltxperiencehasshownlhatlhisisnotlikely
10 be a problem with CEPOREX at the recommended dosaqe levels. In common with other antibiotics, cephalexin may affect the gUI flora, leading to lower oestrogen reabsorption and reduced efflca cy otccmblnec oralcontraceptives.

Pregnancy and lactation :

There is no experimental or clinical evidence of teratogenic eff ects attributable to cephalexln. but CEPOREX should be administered with caution during the early months of pregnancy. Cephaledn s excreted in human milk in low concentrations and
should be used with caution in nursing mothers.

Adverse Reactions :

lnfections andlnfestatlons
Common: Prolonged use can result in the overqrowth of Candida causingvulvo-vaginitis.
Blood and lymphatic system disorders
Common: Positive Coombs’ test
Rare: Reversible neutropenia
Very rare: Haemolytic anaemia.
Cephalosporinsasaclasstend tobe adsorbed onto the surface of red cell membranes. If antibodies directed against the drug are also present, this may result in reports of positive Cocmbs’ test (which can interfere with cross-matching of blood) and very rarely haemolvtlc anaemla.

Immune system disorders

Hypersensitivityreaclionsincluding:
Rare: AnaphylalCis
Very rare: Angioedema
Gastrointestinaldisorders
Common:     Gastrcintestinal symptoms including nausea. diarrhoea
Uncommon: Vomiting
Very rare: Pseudomembranous colitis.
Skin and subcutaneous tissue disorders
Common:     Drug rashes-both urticarial and maculopapular
Very rare:     Severe skin reactions including toxic epidermal necrolysis (elCanthematic:necrolysis) ,StevensJohnson syndrome.
Renal and urinary disorders
Very rare:     Reversible interstitial nephritis.
Overdose
Serum levels ot ceptelexln can be reduced by haemodialysis or by peritoneal dialysis.

Pharmacodynamics :

Bacteriology
Cephalexin is a bactericidal antibiotic: of the cephalosporin gro up which is active against a wide range of Gram-positive and Gram-negative organisms.
Gram-positive organisms Cephalexin is stable to staphvioccccel penicillinase and so is active against penicillin-resistant Staphylococcusaureusand other staphylococcal species (exciuding methiciltin-resistant isolat esl Streptococcus pyogenes, Streptococcus pneumonior:, Streptococcus ogoloctiae(Graup Bl.cther beta-haemolytic streptococci and most viridans group streptococci are also highly susceptible to
cephalexin. Grom-negotive organisms Cephaledn has in vitro activity against E. coli, K/ebsiel/aspecies, Protr:us mirobilis, Corynebocterium diphtheriar:. Solmonel/o and
Shigella species. Neisseria gonorrhor:ar: and N. mr:ningitidis are also susceptible.

Pharmacokinetics

Absorption
Oralcephalexin is almost completely absorbed in the upper portions of the gastrointestinal tract. Following oral administr atlon, absorption is rapid and peak serum levels (4.5 micrograms/ml for a 125 mg dose, 9 microgramsfml f0l’25O mg dose. 18 micrograms/ml for a 500 mg dose and 32 micrograms/ml for a 1000 mg dose) are usually reached at 1 h. In patients with normal renal function, serum levels
Absorption isd(lay(d whencephalexln isgiv(n with or shortly afte r
food, but the total amount absor~ is not altered. Absorption of CfPOREXis not adV(rSt/y affw(d by coeliac esease, partial gastr(ttomy, achlorhydria, jaundic( or diV(rticulosis (duod(nal orjtjunal).
Distribution
lhe dnq-protein binding is w(ak and rMrsibl(varying from Oto 3()qb according to the method otdeterminatton. C(phal(xin lswldelvdtstrfbuted in body tissues and high
ccncenuatlcns arefcund in all organs. particular/yth(liv(rand kidn(yS. Cephaluin ruches therapeutic lMIs in the blood. urine. blte. synovial fluid, pus, tonsillar tissue. amniotic fluid, cord blood and fOf:tal blood.
Metabolism
Cephakxin is not m(tabolis(d in the body.
Elimination
Ihe serum half-lirels ncrmallvabout t h.but is longer in the newborn (Re Dosag( and Administration). C(phaluin is eliminated by glom(rular filtration and tubular
Rmtionr(achingth(urineinanactiv(<lndunchang(dform. Urinary rttOVtfy erte- 6 h is aboYt 8MIt of the administ(red dose, Cephalexin is excreted in human milk in low concentrations. Ccncenent administration of probenecid detavs excreticn of
cephalexin and raises the serum levels by 50 to 100Clb. (set Dosage and Administration). Special Patient Popu/ations In patients with impaired renal function, an Increase in serum half-life of ttphalexin occurs. Clinical practice indicates that in vitw of the wide therapeutic window of CEPOREX, the standard recommended doses should be halved only in these patients with severe rmal impairment (creatinine clearance less than 10 mlfmin). Incompatibiliti(s CfPOREX granules for oral suspension should not be diluted with syrup (see Spttial Prtcautions for Storage).
Special Precautions for Storage
For storage: see ecter pact, f« granules for oral suspension: to be stored at tempreture not exceeding 30’C, after reconstitution it retains their potency for 7 days when stored at (2-S’C). lhe qranules fcr cral suspension maybe diluted with water (not
Syrup 8Pl, after which tnev shculd be used within seven days.
Nature and Contents of Container
CfPOREXfilm coated Tablet 250 & 500 mg: Carton box contains 2 strips PVC/At each of 6 tOilbkts and infltl” leaflet. CfPOREXfilm coated Tablet 1 g: Carton box contains 2 strips PVCJAI pp tamper white closure withPVDC faced wad tiner& inner leaflet
[toform60mt)
Instrudions for Use/HOiIndling
tEPOREX syrups (grOilnules for oral suspensionl are prepared by: fill the measu,;ng cup to theline with water then add water to the )ottle in one go OiInd replace the cap, shOilke the bottle well to mix nedlcine properly to form Oral suspension containing

Manufactured by :

GIOiIxoSmithKline S.A.E. El Salam city-Cairo-Egypt
under license from Glaxo Wellcome – UK limited T/A Glaxo beratenes

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