VELOSEF

VELOSEF 

NAME OF THE MEDICINAL PRODUCT
VELOSEF Cephradlne Oral
Oral farms:
Cephradine, 250 mg, capsules
Cephrarline, 500 mg, capsules
Cephradine. 1g. tablets
Cephradine, 125 mg, powdar far oral suspension
• 250 mg powder for oral suspension
Excipleets
Cephradlee, 250 mg, 500 mg, capsales
Lactose, magsesism slearala, talc, titanium d/ocide, gelatin, aod colorants
Cephradise, tablets
Corn starch, magnesium stearate, micrscrpstalline cellulose, s/licos discide acd lactose
Cephradiee, 125 mg, 25g mg, pewder far aral saspeesios Citric acid, guar gum, melhplcallulsse, sodium citrate, sucrose, favoring agents and colorants
PHARMACEUTICAL FORM
CLINICAL INFORMATION
Capsules: light blue capsules flied mith off while grasular powder
Tablets: ott white, slightly mottled, capusle shaped with bisect bar us use side
Powder fur oral suspessios: hsmsgesous fine tree flowing powder
tsdlcatiues
Capcsteo, tablets, oral suspension
For the treatment ul:
•infectisns of the urinarp, respiratury tracts and skis and soft tissues, these lnctsde:
Etjpper mspiretury infections: pharysgitis. sisusitin, atitis media, tonsillitis, tarpngu-trsches bmnchihs.
LlLswer respiratory lnfectinns acute and chmsic bruschitis, tuhar and bmnchspneumasia.
HUr/narp tract infections: cystitis, aretritis, pyelenephr/tis. [Shin and soft tissue infections: abscess, catluhtis, furenculosis, impetigu.
Becteriutogicet studies to determine the causative organisms and their sensitivity ts caphredine should be performed. Therapp map be instituted prior to mceiving tile results of the sensitivity test
Dunage aed Admlnlslrattee
All patients, regardtesn of age evd weight
In all patients, regardless of uge and weight, doses up ta 1 gm every 6 baum map be given fur sevem or chronic infections. As with antibiotic treatment in general, therapy should be continued for a minimum of 40 to 73 huum afar the patient becomes aspmptumatic or euldence at bacterial eradication has been obtained. In infections caused by group A betu-hemutytic streptococci, a minimum of ig deyu ut treatment Is recommended to guard ugainst the rink of rheumatic fever or glomeraluneghtitin, In the treatment of chronic urinary tract infections, trequent bacteriologic and clinical appraisal is necessary during therapy and mug be necessary fur severul months aherwerds. Persistent infections may require treatment fur several weeks. Dunes smaller than those indicated above should nut be used. Duses for children should nut enceed dunes recommended for adufs
Oral cephradine maybe utilized following clinical impmvement

solution or with reagent tablets such as Clieltest, tist nut with enzyme-based tents such uu Clie/sIlu or D/ant/u.
P/n/urrged sue
Au with all untibiotico, pmlovged use may result/v uvfrgruwth of non-susceptible organisms.
Hypernennd/v/ty phenomena
Hypersensitivity phenomena are more likely to occur In individuals who hove previously demonstrated hypersensitivity and thuue with a h/story of allergy, asthma, hay fever yr sd/curie (see section Adverse Reactions).
Eoc/pievfu
Tablets contain lactose. Patients with rare hereditary problems ef gatactune intolerance. fhe Leyp lactose deficiency ur glucose-galactutie malabsurptiov should rut tube thi9 medicine. Oral suspension contains sucrose, putienfo uith rare hereditary prubtemn of fructose /vtulerance, gtucoagu/actune mutabnurytion or nucrase-inumattane Insufficiency huuld not
take thin medic/ne. I teteracltees I.
Pen/c/tI/no
There is evidence of pedrul cress-allergen/city between
pen/c/Il/ne and raphalutipeden. Therafure cephradlea should be used with caution in those patients with known hypersensitivity to yen/cit/ins. There have beae instances of patients who huve tied reactions to both drag classes (including enuphytbvis) - sen section Adverse Reactions.
Leap d/srstico
Leap diuretico may increase nephratsaicity of cayhulnvpedvn. Probenecid
Prebenecid has been seen fo ruiue serum covcerrutiuea of caphred/ve, by reducing renal clearance of the ceyhatospurins. Pregeescy aed Lactaltue
FertIlity
There arena relevant data available. Pregnancy
Although animal studies have nut demonstrated any tmatagenic0g. safety/v pregnancy hen nut been established.
Therefore this antibiotic should nut be used dudng pregnancy cr lactation unless considered essential by the physician, Lactaltes
Cayhrad:ve in escreted in breast milk and should be used with caution iv lactating mothers (see also section Wen(ingn and Preceut/ovn).
Ability to perform tusks that require judgemeet, noIer or segeftive shuts
Since thin medicine may cause dizziness, petientn $hnuld he cautioned about operating hazardous machinery, inc/tiding astsmobiles.
Adverse Reactions
Feet Marketleg Data
Adveme reactions are ranked seder headings sf frequency uning the following cavvevtisv:
Very common Slit 0
Common 51/100 to vt/to
Uncommon 51/1000 lost/lao
Rare 51/f 00110 to st/boo
Very rare nl/totitto
Nut known (cannot be estimated from the available data). tsfocttsvs evd ivfontahsns
Rare: vaginitis, candidonin
Not known: psesdomembrunous cal/tin Btasd and lymphatic system disorders
Not knows: essinsph//ie, leocopenie and eestrupevia, positive
direct Coomhn tests, elevations of blood urea nitregev (BUN) IwhIII

end serum creatinine
Immune system disorders
Rare: eneyhylesin see Shin and subcutaneous tissue disorders tservsss system dinntdarn
Rare: dizziness
Respirataty, thorecic end medtast/val disorders Rare: tightness iv the chest -
ctastreivtashvel disorders
Rare: gloesitis, heartburn, nausea, vomiting, diarrhoea, abdominal pa/v
Not known: gastrn-intastivet disturbances Hapatobhary d/ssrdaco
Very rare: hepatitis, cholesraric jauvdico
Not known: elevations of alanine amivs-travnferane (ALT), anpadste amins-trevufarsen )AST), total bilirsbin and aihative phuophetase
Sb/u end subcutaneous hssua ri/sun/am
Rare: arythemu multdnrme, Stevens Jahessn Syndreme, tue/c epidermel necrulysle
Nut known: udrcarle, skin rashes
Msscstashelatal evd convective timue d/scrdars Not knows: joist pains
ctenerel dissu/ars and admiv/stretrbv site covddinvs Not knswv: sedema
Overdesage
None known
ClinIcal Pharmacotogy Phuowacedyeawtus
Pharmacntherapeuttc group
Ant/bacterial for systematic use, tr1t generabon cayhalsspodvs Mechuetsra of ActIon aed Pharwacodynumic effects
Cephrud/ne iu e breed-spectrum, becter/cidel antitastic active against both ctrem-psnit/ve and Gram-negative bacteria, It in also highly active against must sire/vs of panicitlinesa-praducieg Staphylococci.
Microbiology:
The following srgavinms have shcwn in v/tm sensitivity to ceyhradine.
Gram-punitive - Staphylococci (beth penicillin nnnnhve and resistant strains), Straylococc/, Streytococous pysgenas )hata heemutytic) avd Streylococoon pvacmuniae.
Gram-negative - Encherichie ca’, KIebsialla spy, Pretaus mirab/lis, Huamoyhilus ivfluenzae, St/gel/u spy., Salmonella syp. )/vclod/ng Salmonella typhi) end Neissada spp.
Because cephrad/va is unaffected by pen/c/It/vase, many strains of Eschedchiu coil and Staphylocsccun esraus which prodsra this enzyme are susceptible to caphrad/ne but ms/stunt ta ampicittin.
Phemraueblnettcs
Ceyhred/ne in acid stable and is rep/dIg absorbed fnllow/ng oral administration in the fasting state. Fol/awing doses of 250 mg, 500 mg, end 1 gin vsrmal adult volunteers, average peak sarem levels of epprunimutaly g, 16.5 end 24.2 pg/mI, respectively, were obtained at one hour. The presence of food in’ the gestrnintantinal tract delays the ebnsrpticv but does nut effect the Istat amount of coghradine absorbed. Measurably serum levels are gresant sin hours ahar administration. Foudy eight hours after admivislratisn of 100 mg/kg/day st caghradinn tsr treatment of ut/I/s media, average concentration of cephradiva iv middle ear esudutn wus 3.6 gg/ret. Cephrsd/na dues not pass acrnua the blood-bra/v barrier to any appreciable en/ant.
Over 90% of the dreg Is aocreted urchanged In the sr/va within 6 hours. Peak urine concentrations em ayprvnimetaly 1600 pg/mt following a 250 mg dose, 320ti pg/mI following a 500 mg

A

I II I’ achieved with parenierul therapy for the csetleuatiun uf therapy

fur persistent or severe infections where prolonged therapy in

indicated.

Capsules, tablets, oral suspension

Cephradiee maybe given without regard ta meals.

Adults

Cupsutes, tablets, mat ssuyevu/un

Respiratory tract infections (other than lubur pneumonia) and

shin and suti tissue ictect/sno - The usual dose is 250 mg every

6 hours or 500 mg every 12 houre. Severe wfectiuns may

require lurger doses.

Luhar pneumonia - The usual dose instill mg every 6 hours or I

gm esery f2 hours.

Uncomplicated urinary tract infectiunu - The usual dune for

uncomplicated infections is 500 mg every t2 hours. Fur mum

neduus infectiuns including prustafitin, 500 rng every 6 houru or 1 gm enery 12 hournfr recommended. Chlldree

Cepsuteu, tablets, urpi suspension

In mild to muderatet severe infections the usual doily dose is from 25 to 50mg/kg 4dministered in equally divided dnseti every 6url2huum. For slit/n media due H. iefuevzue, deity doses from 75 to loll mg/hg administered i equally divided dunes every Our 12 hours

in recommended. Tho maulmum dune nheuld nut eucoed 4g per

day.

Reset impairmeel

Nut on Dialysis: Thç following dosage schedule honed on

dosage of Still m O6H and on creetinine clearance Is suggested us a gug/eline. Fudher modification in the dosage schedule may tie requrad because of the dosage selected and

individual variation.

Creel/nine clearance Dune Time internal

o 20 mI/mm 500 mg 6 houm

5-20 mI/mm 250mg 6 houm

vS mtimin 250mg 12 houm

On Chronic, Intermittent Hemodiulynin:

250mg ntart.

250mg at 12 houre.

250mg 30- dO hosts (after start).

Children may require dosage mndif cation prepurtlunel tu their

weight end severity ut infectiun.

Elderly

There are no apec/td dosage recommendations or precautIons

for usa iv the eldedy aucept, us m/th steer dregs, fo munitar

those patients with irrpalred revel or hepetic fonctisn.

Hepatlu Impairmeet

There era no relevant data available.

Ceetraiedleatieen

Cephradlee iu cuntcaifdicated in: •Hypereeenlhsity to the cephaluoporin antihiotico or any

component ul the furmulutiue

Wamtegs end Precautions

Revel tmpe/rmevf

Dosage: Une of this antibiotic in patients with renal dyafoechun

should be monitored ‘utensively. A modified dosage schedule in

palleeto with decreased muat functiun in necessary (see section

Dosage and Administration).

Fatse pouit/ve react/us for gtacuue

After treatment with ephradine, a false positive react/un fur glucose in the urine ntyy scour with Benedict’s or Fehlivg’n