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Drugs Vercef have composition Cefaclor 125 – 250mg, indications for Lower respiratory infections,  Urinary tract infections, Skin and soft-tissue infections

ZINNAT 125 – 500MG indicated for lower, upper respiratory tract infections: pneumonia

AMLEVO 750 is indicated for the treatment of infections: Noeocomial Pneumonia …

COMPOSITION

Vercef  distab 125 mg

Each dispersible tablet contains Cefaclor USP equivalent to anhydrous Cefador 125 mg

Vercef  distab 250mg

Each dispesible tablet contains

Cefaclor USP equivalent to anhydrous Cefaclor 250 mg

Each tablet contains

Sodium Add Citrate, Aspartame, Sodium Chlonde, croscamellose Sodium, magnesium Stearate, Quinoline Yellow Lake, microcrystalline Cellulose, collordel Silicon Dioxide, Flavour Orange as inactive ingredients

Vercef Distab - Cefaclor 125 - 250 mg

DESCRIPTION

Cefaclor is a semisynthetic cephalosporin antibiotic for oral administration. It Is chemically designated as (7R)-3-Chloro-7-(a-D-phenylglycylamino)*3- cephem-4-carboxyllc acid monohydrate Its empirical formula is C.,H.,CIN,04S.H,0 and the molecular weigh! Is 385.8.

PHARMACOLOGY

Mechanism of Action

Cefaclor is a semisynthetic cephalosporin antibiotic for oral administration. In vitro tests demonstrate that foe bactericidal action of cephalosporins results from inhibition of bacterial cell-wall synthesis.

Anti-bacteriel Spectrum

Cefaclor is active against the following organisms in vitro;

Alpha and beta haemolytic streptococci

Staphylococci; Including coagulase positive, coagulase negative and penidllinase producing strains Streptococcus pneumoniae

Streptococcus pyogenes (group Abeta haemolytic streptococci)

Branhamella catanhalis (Moraxella)

Escherichia coli Proteus mirabilis Klebsiella species

Haemophilus infiuenzae, induding post beta lactamase producing ampicillin- resistant strains,

Neisseria gononhoeae (penkifinase-produdng and run-peniattnase producling strains)

Proptonibacteria senes and Bacteroides sp. (excluding BacSerotdes fragis);

Citrobacter diversus

Corynebacterium

Peptococcus&p.

Peptostreptococcus sp.

Cefaclor has no activity against Pseudomonas species or Acinetobacter spades. Methicillin-resfstanl staphylococci and most strains of enterococci (eg, Str. faecabs) are resistant to cefador. Cefaclor is not active against most strains of Enterobacter spp, Somalia spp, Morganella morgana. Proteus vulgans and Provktendarettgeri.

Pharmacokinetics

Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption Is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration achieved is 50-75% of that observed when the drug is administered to fasting subjects and generally appears from 3/4 to one hour later. Following administration of 250mg, 500mg and ig doses to fasting subjects, average peak serum levels of approximately 7,13 and 23 mg/l, respectively, were obtained within 30-60 minutes.

About 25% of cefaclor is bound to plasma proteins. Cefador is widely distributed in the body with bactericidal concentrations achieved in middle ear fluids, sinus drainage and bronchial secretions. The drug crosses the placenta and is excreted in very tow concentrations in breast milk.

Approximately 60-85% of the drug is excreted unchanged in the urine within eight hours, the greater portion being excreted within foe first two houre. During the eight hour period, peak urine concentrations following foe 250mg, 500mg and 1 g doses were approximately 600,900 and 1,900 mg/l, respectively The serum half life in normal subjects is 0.60.9 hours. In patients with reduced renal function, the serum halflite of cefaclor is sightly prolonged. In those with complete absence of renal function, the plasma half Me of foe intact molecule is 2.32.8 houre. Excretion pathways in patients wih markedly impaired renal function have not been determined. Haemodialysis shortens the half life by 25 – 30%

INDICATIONS

Vercef Distab 125/250 mg is indicated in the treatment of the following when caused by susceptible strains of the designated microorganisms

Lower respiratory infections, including pneumonia caused by S. pneumoniae, (including both empicillin-sensitive and ampicillin-resistant strains! and S pyogenes (Group A beta- haemolytic streptococci), . acute bronchitis, and acute exacerbations of chronic bronchitis. Upper respiratory infections, including pharyngitis and tonsillitis caused by S. pyogenes (Group A beta-haemolytic streptococci) and M. catarrhalis.

Obtis media caused by S. pneumoniae. H. influenzae (including both ampicillin- sensitve and ampicillin-resistant strains) staphylococci, and S. pyogenes (Group A beta-haemolytic streptococci), and M. catarrhalis.

Skin and soft-tissue infections caused by Staphylococcus aureus (including p- lactam.jse producing strains), S. pyogenes (Group A beta-haemolytic streptococci) and Sfaphy/ococcus epidermidis (including p-lactamase producing strains).

Urinary tract infections, including pyelonephritis and cystitis caused by e coli.. Ktebsre/te sp.. and coagulase-negative staphylococci.

Cefaclor has been found to be effective in both acute and chronic urinary tract infectious: sinusitis: gonococcal urethritis.

Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available. Bacteriological studies to determine the causative organism and its susceptibility to cefaclor should be performed. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

DOSAGE AND ADMINISTRATION

Disperse the tablet in one teaspoonful of water (5 ml) before administration. Adults

The usual adult dosage is 250 mg every 8 to 12 hours.

For bronchitis and pneumonia, the dosage is 250 mg administered 3 times daily. A dosage of 250 mg administered 3 times daily for 10 days is recommended for sinusitis.

For more severe infections, such as pneumonia, or those caused by less susceptible organisms doses may be doubled.

For mild to moderate infections of the urinary tract, skin and soft tissues, and upper respiratory tract, a dosage of 250 mg administered 2 times daily may be sufficient.

Doses of 4 g/day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount.

For the treatment of acute gonococcal urethritis in males and females, a single doseof3g combined with probenecid 1 g, is given,

Patients with Renal Impairment: Cefaclor may be administered in the presence of impaired renal infections. In case of severe renal impairment, following dosage adjustment is required:

– Creatinine clearance: 10-50ml/min.dosage is a half of usual dosage

– Creatinine clearance: < 10ml/min, dosage is 25% of usual dosage

Patients undergoing ftaemodia/ysis: Haemodialysis shortens serum half life by 25 • 30%. In patients undergoing regular haemodialysis, a loading dose of 250 mg-1 g administered prior to dialysis and a therapeutic dose of250 mg – 500 mg every six to eight hours maintained during interdialytic periods is recommended.

Elderly: Same as for adults.

Children

The usual recommended daily dosage for children is 20mg/kg/day in divided doses, every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses, administered 3 times daily. For otitis and pharyngitis, the total daily dosage may be divided and administered every 12 hours.

Safety and efficacy have not been established for use in infants aged less than one month.

Age Dose
Under 1 year (9 kg) 62.5 mg tid daily
1-5 years (9-18 kg) 125 mg tid daily
over 5 years 250 mg tid daily

PRECAUTIONS

General

Vercef ( Cefaclor )  should be administered with caution in the presence of maikedly impaired renal function Since the half-life of cefador in anunc patients is 2.3 to 2.8 hours (compared to 0.6-0 9 hours in normal subjects), dosage adjustments for patients with moderate or severe renal impairment are not usually required Clinical experience with cefador under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made, Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastro-mtestinal disease, particularly colitis Prolonged use of cefador may result in the overgrowth of non-suscaptible organisms. If superinfection occurs during therapy, appropnate measures should be taken.

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. In haematological studies or in transfusion crossmatching procedures, when anti-globulin tests are performed on the minor side or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised foal a positive Coombs’ test may be due to the drug.

A false positive reaction for glucose in foe urine may occur with Benedict’s or Fehling’s solutions or with copper sulphate test tablets Effect on driving / Machine operating ability

Vercef is presumed to be safe or unlikely to produce an effect on the ability to drive or use machinery,

Warnings

Before instituting therapy with cefador, every effort should be made to determine whether foe patient has had previous hypersensitivity reactions to cefador. cephalosporins, penicillins or other drugs. Cefador should be given cautiously to penicillin-sensitive patients, because cross-hypersensitivity, induding anaphylaxis, among beta-lactam antibiotics has been dearly documented

If an allergic reaction to cefaclor occurs, foe drug should be discontinued and the patient treated with the appropriate agents e.g. pressor amines, antihistamines or corticosteroids.

Pseudomembranous colitis has been reported with virtualy all broad-spectrum antibiotics, including macrolides, semi-synthetic penicillins and cephalosporins It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such cotitis may range in severity from mild to life-threatening. Mild cases usually respond to drug discontinuance alone. In moderate to severe cases, appropnate measures should be taken.

Contraindication

Vercef Distab 125/250 mg is contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics or to any of the ingredients of the formulation.

Pregnancy

Animal studies have shown no evidence of impaired fertility or teratogenicity However, since there are no adequate or well-controlled studies in pregnant women, caution should be exercised when prescribing for the pregnant patient

Lactation

Small amounts of cefador have been detected in breast milk folovong administration of single 500mg doses. Average levels of about 02 micrograms/ml or less were detected up to 5 hours later, Trace amounts were detected at one hour, As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to a nursing woman.

Carcinogenicity/ mutagenicity / Impairment of fertility

Studies in animals have not been performed to evaluate foe caronogenc or mutagenic potential for cefador. Reproduction studies of other cefador products have revealed no evidence of impaired fertility.

Neonates

Safety and efficacy have not been established for use in infants aged less than one month.

Drug Interactions

Warfarin; There have been rare reports of increased prothrombin time, wtih or without clinical bleeding, m patients receiving cefador and werfenn concomitantly. It is recommended that in such patients, regular mentoring of prothrombin time should be considered, with adjustment of dosage i necessary.

probenecid: The renal excretion of cefador is inhibited by probeneod

Adverse Effects

Gastrointestinal : The most frequent side effect has been diarrhoea, it is rarefy severe enough to warrant cessation of therapy. Colitis, induding rare instances of pseudomembranous colitis, has been reported. Nausea and vomiting have also occurred.

Hypersensitivity : Allergic reactions such as morbilliform eruptions, pruritus and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions (erythema multiforme minor, rashes or other skin manifestations accompanied by arthritis/arthraJgia, with or without fever) have been reported. Lymphadenopathy and proteinuria are infrequent; there are no circulating immune complexes and no evidence of – sequelae. Occasionally, solitary symptoms may occur, but do not represent a serum sickness like reaction. Serum sickness like reactions are apparently due to hypersensitivity and have usually occurred during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and usually subside within a few days of cessation of therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome. No serious sequelae have been reported.

There are rare reports of erythema multiforme major (Stevens Johnson syndrome), toxic epidermal necrolysis, and anaphylaxis. Anaphylaxis may be more common in patients with a history of penicillin allergy. Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, or vasodilatation.

Rarely, hypersensitivity symptoms may persist for several months. Haematological: Eosinophilia, positive Coombs’ tests and, rarely, thrombocytopenia. Transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance

Hepatic: Transient hepatitis and cholestatic jaundice have been reported rarely, slight elevations in AST, ALT or alkaline phosphatase values have also been reported.

Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis have been reported. Central nervous system: Reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Miscellaneous: Genital pruritus, vaginitis and vaginal moniliasis have been reported.

INFORM TO YOUR DOCTOR ALL UNDESIRABLE EFFECTS UPON DRUG ADMINISTRATION.

OVERDOSE AND TREATMENT

Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary.

General management may consist of supportive therapy.

STORAGE: Store below 25°C, protected from moisture.

KEEP ALLMEDICINES OUT OF REACH OF CHILDREN.

SUPPLY: Aluminium strip of6’s. Box of 1 strip.

SHELF LIFE: 24 months from the manufacturing date.

DO NOT USE OVER EXPIRY DATE.

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