Tablets (Film Coated) – Dry Mix(Oral Suspension)
Each dosage unit contains :
Tablet: amoxycillin as trihydrate 250 mg ,500 mg ,875 mg Suspension 5ml :amoxycillin 125 mg, 200 mg, 250 mg, 400 mg
Tablet:clavulanic acid as potassum salt :125 mg Suspension 5ml clavulanic acid : 31.25 mg,28.5 mg,62.5 mg,57 mg
E.MOXCLAV Is a combination of amoxyotnn. a broad-spectrum penlctllin, and clavutamc acid. a competitive inhibitor ofbeta-tacremese enzymes. Clavulanic acid protects amoxyclllln from
destrucuon, and subsequent loss of acnvny, caused by thebera-Iectamase enzymes produced by many bacteria. Consecuenuy It Widens the spectrum or errnxycnun’s activity 10 Include bactena nonnally resistant 10 amoxyalhn and other beta-tactam antibiotics E-MOXCLA\ICI is active agaltlSl a wide range of gram-pcsltrve and gram·negauve aerobic and anaerobic baoena such as Sl:aphylococd tbela-lactamase and non-beta-lactamase producmgllnduding S aureus, S epidertmdis; Strepeccocct Including S pneemoruae. 5 pyogenes. S vindans, and S faecahs; Bacillus anthraces, Llsrena monocytogenes: beta-tecamase and non-beta-Iactamase prodUCing
seams of Heemoptulus Inn nzae. Moraxt”l~ catarmaus. Netsseza gonorrhoeae. Escher.chia coli Proteus rrurabths, Proteus vulgans, Klebsiella sp.. Salmonella Shlgella sp and Yerstnta enterccohnca. Bcrdereua pertussis. Brucella sp Neisseria meningitidis. Cernpytobacrer jejuru,
Vibrio cncrerae, Pasteurella reuttocrda. Gardnerella vaginalls: coriebactenum sp, Clostridium sp . Peptococcus sp., PeplostleplQCoccus sp., betalactamase and oco-ceia-lacramase producing strams of Bacteroides sp. Including Bacteroides fragllls
E-MOXCLV tamoxyoUU’l .md davutaruc acid! is well absorbed from the gastrointestinal tractafter oral administration Dol,bhng me dose can double the ccncereaucn. Approxunately 20 % of amoxyclllln and .approxlITlafely 25 % of ctavulamc add are bound 10 plasma proteins, respectively Plasma ~Irhves of 1,0 – 1.5 hours have been reported. E-MOXCLAVII’ls readily distributed IOta most body ussoes and fluids. Amoxyolhn IS metabolized to a limited extent to
perucillorc acid which IS excreted in the unne. About 60 % of the “arocxycunn and about 25 – 40 % of the ctavutantc acid are excreted unchanged in the urine In 6 hours by glomerular filtration and tubular secretion
– Ear. nose and throat infections;eq otitis media, Sinusitis , tonsillitis
– Lower respiratory tract Infections: eg acute and chronic orcncmus pneurnonia.
– genito urinary tract Infections; eg cystitis,a pyelonephritis ,urethritis, gonorrhoea
– Skin and soft tissue Infections: e.g Boils, abscesses, cellulitis, wound infecttons
– Bone and jctnr infections: e 9- osteomyelitis
– gastro -intestinal tract infections: e.g. emenus. typhoid and paratyphoid fevers.
– Other Infections
– Perucnms. post-operative Infections, endocarditis, septicaemia, blhary tract Infections, and chancroid
– Septic abortion, pelvic or puerperal sepsis, Intra-abdominal sepsis
– Animal bites, severe denial abscess with spreading cellulrus
Dosage and Administration:
E-MOXCLA Tablets and Oral Suspension may be gIven Without regard to meals.
Usual Dose For Mild – Moderate Jntecttons:
One E-MOXQ.A 375 mg Tablet every 8 hours
For Severe Infections and For Respiratory Tract Infections:
One E-MOXCLA~ 625 mg Tablet every e hours or One E-MOXCLAV«> 1 gm Tablet every 12 hours
Renal function Impairment:
Renal functton impairment generally does not require a dose reduction unless impairment is severe. In mUd renal impairment (creaunine clearance> 30 mllmlnutel. no dosage adjustment
is necessary. E-MOXQ.A\4 1 gm Tablets should only be used In patients with mild Impairment wlthOUl change In dosage. It should not be used In moderate or severe renal irnpasrment
In moderate- renal Impairment /creallOlne clearance 10 – 30 ml/minute), the adult dose Is One
E-MOXCLAV* 375 mg Tablet or One E-MOXCLAV.t:I 625 mg Tablet every 12 hours, more than One E-MOXCLAV@375 mg Tablet or One &MOXCLAV@ 625 mg Tablet every hours, depending on the severity of Infection.
In haemodialysis patients:
One E-MOXCLA V@ 375 mg Tablet or One E-MOXCLA V@ 625 mg Tablet every 24 hours, an additional dose during and at the end of dialysis.
Children 7 -]2 years: 1 teaspoonsfut E-MOXCLA~ 312 mg Oral Suspension every 8 ho or 2 teaspoonfuls E-MOXCLAV@ 156 mg Oral Suspension every B hours; or 1 teaspoon
E-MOXCLA~ 457 mg Oral Suspension every 12 hours; or 2 teaspoonfuls E-MOXCU
22B.5 mg Oral Suspension every 12 hOUTS.
Children 2 – 7 years: 1 teaspoonful E-MOXCLA~ 156 mg Oral Suspension every 8 hour 1 teaspoonful E-MOXCLAvt!> 228.5 mg Oral Suspension every 12 hours. Children 9 months – 2 years: ‘h teaspoonful E-MOXCLAV@ 156 mg Oral Suspension el
B hours or ~ teaspoonful E-MOXCLA v@ 228.5 mg Oral Suspension every 12 hours. In severe infections, these dosages may be doubled.
Another method of calculating children’s dose based on amoxycillin content is as follows:
Children < 3 months of age: 30 mg/kg/day divided every 12 hours. based on the amoxyc content. Use of E-MOXCLA~156 mg / 5 ml Oral Suspension is recommended.
Children 3 months of age or older: E-MOXCLAV«> 156 mg/5 ml or 312 mg/5 ml suspension: 20 – 40 mg/kg/day divided every 8 hours.
E-MOXCLA~ 228.5 mg/5 rnl or 457 m9/5 mt oral suspension: 25-45 mg/kg/day divi every 12 hours.
Children 40 kg: Dose according to adult recommendations.
Reconstitution of E-MOXCLA\’«l Dry Mix: To make up, first shake the bottle to loosen pow then add water, to the content crborne and shake wett. Pill up to line and allow to stand for runutes 10 ensure full dispersion. Shake well before use
After reconstitution, E-MOXCLA\4! Oral Suspension should be stored in a refrigerator used only within 10 days
Co-administration of probenecid may result in increased and prolonged blood levels amoxycillin
-E-MOXCLAY@should be discontinued if a skin rash occurs.
-E-MOXCLA~ dosage in renal irnparrment: Refer to Dosage and Adrmntstraticn section.
-tn pauems with hepatic function tmpaiment the drug should be dosed with caution and bep function should be monitored.
Pregnancy and lactation:
E-MOXCLAV@ should be used with caution, and only If clearly needed. in pregnancy lactation
A known hypersensitivity to penkilllns or cephalosporins.
-As with other penicillins, side-effects are usually mild and transient including dlarrh. indigestion and skin rashes
-Hepattns and chotestauc jaundice have been reported rarely.
-Occasional cases of erythema mulliforme, Stevens-Johnson syndrome, toxic epider necrolysis, and exfoliative dermatitis have also been reponed.
Store at temperature not exceeding 250 C, and protect from light and moisture.
– E-MOXCLAV@3750r625mgor] gm Tablets: A box of 10 tablets.
– E-MOXCLA~ 156 mg/5 ml Oral Suspension: A bottle of 60 or 100 ml after reconsttrunon
– E-MOXCLAv!’ 228_5 mg/5 ml Oral Suspension: A bottle of 75 ml after reconstitution
– E-MOXCLAV’!l312 mg/5 ml Oral Suspenslon: A bottle of 60 or 100 ml after reconstitution
– E-MOXCLA~ 457 mg/5 ml Oral Suspension: A bottle of 70 ml after reconstitution.
produced by :
EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
Oth OF RAMADAN CITY, INDUSTRIAL AREA EGYPT