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Drugs ZINNAT have composition Cefuroxime, ZINNAT indicated for the treatment of lower respiratory tract infections: pneumonia, acute bronchitis, upper respiratory tract infections: ear, nose

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

Cefdinir 125 mg indicaion for acute sinusitis, hair folliculitis, paronychial inflammation, ulcer

Presentation:

ZINNAT TABLETS 125mg: White to off-white, film-coated, capsule shaped, bi-convex tablets. plain on one side and engraved ‘GXES5’ on the other. Each tablet contains 125mg Cefuroxime fas Cefuroxime axetil)

ZINNA T TABLETS 250mg: White to off-white, film-coated, capsule shaped, bi-convex tablets, plain on one side and engraved *GXES7″ on the other. Each tablet contains 250mg Cefuroxime (as Cefuroxime axetil).

ZINNAT TABLETS 500mg: White to off-white, film-coated, capsule shaped, bi-convex tablets, plain on one side and engraved ‘GXEG2’ on the other. Each tablet contains 500mg Cefuroxime (as Cefuroxime axetil).

ZINNAT TABLETS - Cefuroxime

Excipients:

Microcrystalline Cellulose; Croscarmellose Sodium type A; Sodium Lauryl Sulphate; Hydrogenated Vegetable Oil: Colloidal Silicon Dioxide; Hypromellose. Propylene Glycol: Methyl parahydroxybenzoate; Propyl parahydroxybenzoate and Opaspray M-1 -7120 J.

Pack size:

Box of 1 blister, each Mister contains 10 tablets

INDICATIONS:

ZINNAT is an oral prodrug of the bactericidal cephalosponn antibiotic cefuroxime, which is resistant to most (P)beta-toctamases and is active against a wide range of Gram-positive and Gram-negative organisms.

It is indicated for the treatment of infections caused by susceptible bacteria. Susceptibility to ZINNAT will vary with geography and time and local susceptibility data should be consulted where available (See Pharmacological properties. Pharmacodynamics).

Indications include:

– upper respiratory tract infections for example, ear, nose and throat infections, such as otitis media, sinusitis, tonsillitis and pharyngitis

– lower respiratory tract infections for example, pneumonia, acute bronchitis, and acute exacerbations of chronic bronchitis

– genito-urinary tract infections for example, pyelonephritis, cystitis and urethritis

– skin and soft tissue infections for example, furunculosis, pyoderma and impetigo

– gonorrhoea, acute uncomplicated gonococcal urethritis, and cervicitis

– treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children over 12 years old.

Cefuroxime is also available as the sodium salt (ZINACEF) for parenteral administration. This permits the use of sequential therapy with the same antibiotic, when a change from parenteral to oral therapy is clinically indicated.

Where appropriate ZINNAT is effective when used following initial parenteral ZINACEF (cefuroxime sodium) in the treatment of pneumonia and acute exacerbations of chronic bronchitis.

ZINNAT 500mg - Cefuroxime

DOSAGE AND ADMINISTRATION

The usual course of therapy is seven days (range 5 to 10 days).

ZINNAT should be taken after food for optimum absorption.

+ Adufts

Most infections 250mg twice daily
Urinary tract infections 125mgtwice daily
Mild to moderate lower respiratory tract infections e.g. bronchitis 250mg twice daily
More severe lower respiratory tract infections, or if pneumonia is suspected 500mg twice daily
Pyelonephritis 250mg twice daily
Uncomplicated gonorrhoea single dose of 1g
Lyme disease in adults and children over the age of 12 years 500mg twice daily for 20 days

Sequential therapy

Pneumonia

1.5 g ZINACEF three timesaday or twice aday (intravenous p.v.) or intramusaiaf(im)) for 48 to 72 hours, followed by ZINACEF(cefuro»me axe#) oral therapy 500 mg twice a day for 7 to 10 days

Acute exacerbations of chronic bronchitis

750mg ZINACEF three times a day or twice a day(i.v. or i.m)for 48 to 72 hours, followed by ZINNAT (celuroxirneaxe)oral therapy 500mg twce a dayfor 5 to 10 days.

Duration of both parenteral and oral therapy is determined by the seventy of the infaction and the clinical status of the patient

+ Children

Most infections 125 mg (1 x 125 mg tablet) twice daily, to a maximum of 250 mg daily.
Chidren aged two years or older with otits media or, where appropriate, with more severe erfecbons 250 mg (1 x 250 mg tablet or 2 x 125 mg tablets) twice daily, to a maximum of 500 mg daily.

ZINNAT tablets should not be crushed and are therefore insubtable for treatment of patents, sush as younger children, who cannot swallow tablets, in children ZINNAT oral may be used.

There is no experience of using ZINNAT  in children under the age of 3 months

+ Renal impairment

Cefuroxime is primarily excreted by the kidneys in patients with renal fonction it commended that the dosage of cefuroxime be reduced to compensate for its slower excretion ( see the table below )

creatinine clearance

 

T – (hours) Recommended Dosage
>= 30 mL/min

 

14-24 No dose adjustment necessary standard dose of 125 mg to 500mg given twice daily)
10-29 rnl/min 46 Standard individual dose given every 24hovs
<10ml/min 16.8 Standard individual dose given every 48 hours
Durung haemodialysis

 

2-4 A Singe additional standard individual dose should be given at the end of each dialysis

CONTRAINDICATIONS

Patients with known hypersensitivity to cephalosporin antibiotics

WARNINGS AND PRECAUTIONS

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

As with other antibiotics, use of ZINNA T may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible organisms (e.g enterococci and Clostridium difficile), which may reqrnre interruption of treatment

Pseudomembranous colitis has been reported with the use of antibiotics, and may range in severity from mild to life- threatening Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further

The Jarisch-Herxheimer reaction has been seen following ZINNAT treatment of Lyme disease. It results directly from the bactericidal activity of ZINNAT on the causative organism of Lyme disease, the spirochaete Brrelle burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.

With a sequential therapy regime the timing of change to oral therapy is determined by severity of the infection, clinical status of the patient and susceptibility of the pathogens involved If there is no clinical improvement within 72 hours, then the parenteral course of treatment must be continued.

Please referto the relevantprescribing information for cefuroxime sodium before initiating sequential therapy.

INTERACTIONS

Drugs which reduce gastric acidity may result in a tower bioavailability of ZINNAT compared with that of the fasting state and tend to cancel the effect of enhanced post-prandial absorption.

In common with other antibiotics, ZINNAT may affect the gut flora, leading to tower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

As a false negative result may occur in the fenicyanide test it is recommended that either the glucose oxidase or hexokinase methods are used to determine btood/plasma glucose levels in patients receiving ZINNAT. This antibiotic does not interfere in the alkaline picrate assay for creatinine.

PREGNANCY AND LACTATION

There is no experimental evidence of embryopafoic or teratogenic effects attributable to ZINNATbut, as with all drags, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in human milk, and consequently caution should be exercised when ZINNAT\$ administered toanureing mother.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

As this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

ADVERSE REACTIONS

Adverse drug reactions to ZINNAT are generally mild and transient in nature.

The frequency categories assigned to foe adverse reactions below are estimates, as for most reactions suitable data (for example from placebo-controlled studies) for calculating incidence were not available. In addition the incidence of adverse reactions associated with ZINNAT my vary according to foe indication.

Data from large dimcal studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/1000) were mainly determined using post-marketing data and refer to a reporting rate rather than tree frequency. Placebo-controlled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drag-related (investigator assessed) data.

The following convention has been used for the classification of frequency:

very common       >=1/10

common      > =1/100 to < 1/10

uncommon  >=l/1000to<1/100

rare   >=1/10,000to<1/1000

very rare     <1/10,000

Infections and Infestations

Common-   Over growth of CandkJa

Blood and lymphatic system disorders

Common;    Eosinophilia

Uncommon:         Positive Coombs’ test, thrombocytopenia, leukopenia (sometimes profound)

Veryrare:    Haemotyticanaerma

Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed aganst the drag to produce a positive Coombs test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia.

Immune system disorders

Hypersensitivity reactions including

Uncommon:         Skin rashes

Rare: Urticaria, pruritus

Very rare:   Drug fever, serum sickness, anaphylaxis

Nervous system disorders

Common:    Headache, dizziness

Gastrointestinal disorders

Common:    Gastrointesttoai disturbances including diarrhoea. nausea, abdominal pain

Uncommon:         Vomiting

Rare: Pseudomembranous colitis (See Warnings and Precautions)

Hepatobiliary disorders

Common:    Transient increases of hepatic enzyme levels, [ALT (SGPT), AST (SGOT), LDH)

Very rare:   Jaundice (predominantly cholestatic), hepatitis

Skin and subcutaneous tissue disorders

Very rare:   Erythema multiforme, SlevensUohnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis)

See also Immune system disorders.

OVERDOSE Signs and symptoms

Overdosage of cephatosponns can cause cerebral irritation leading to convulsions.

Treatment

Seram levels of cefuroxime can be reduced by haemodialysis and peritoneal dialysis.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

The prevalence of acquired resistance is geographically and time dependent and for select species may be very high. Local information on resistance is desirable, particularly when (reatmo severe infections.

In vitro suscuptibillty of micro-organisms to Cefuroxime

Where clinical efficacy ofcefuroxime axetil has been demonstrated in dinicai trials this is indicated with an asterisk (*) Commonly Susceptible Species

Gram-PositiveAerobes. Streptococcus pyogenes” Beta-hemoMic streptococci

Gram-Negative Aerobes:

Haemophilus influenzae’ induding ampicillin resistant strains Haemophilus parainfluenzae*

Moiaxella catarrhaiis*

Neisseria gonofrhoea*includinq penicillinase and non-penitiliina producing strains Gram-Positive Anaerobes:

Pepfostreptococcus spp.

Proobnibacterium spp.

Borrelia burgdorferi*

Organisms for which acquired resistance may be a problem Gram-PositiveAerobes:

Staphylococcus spp. including S. aureus (methicillin-susceptible isolates only)* Streptococcus pneumoniae

Gram-PositiveAnaerobes:

Closfridrum spp. not includina C. difficile

Gram-Negative Anaerobes: Bacferoides spp. not including 8. fragilis Fusobaeteriums spp.

Inherently resistant organisms

Gram-PositiveAerobes-

Enterococcus spp. including E faecalis and E. faecium Listeria monocvfoaems

Gram-Negative Aerobes:

Citrobacterspp. not including C. freundii Enterobacterspp. not including E. aerogenesandE cloacae Escherichia coli*

Klebsiella spp. including Klebsiella pneumoniae*

Proteus mtrabilis

Proteus spp. not including P. penneriand P. vulgaris

Acmetobacterspp.

Burkholderia cepacia Campylobacterspp.

Citrobacter freundii Enterobacteraerogenes Enterobacter cloacae Morganelia morgana Proteus penned Proteus vulgaris

Pseudomonas spp. including Pseudomonas aeruginosa Serratiaspp.

Stenotroohomonas maftoohilia

Gram-Positive Anaerobes:

Bactemidesfraaitis

Others:

Chlamydiaspecies Mycoplasma species Legionella species

Pharmacokinetics

Absorption

Afteroral administration ZINNAT is slowly absorbed from the gasb-ointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefurosume into the circulation. Optimum absorption occurs when it is administered shortly aftera meal.

Following administration of ZINNAT tablets peak serum levels (2.9 mg/l fora 125 mg dose, 44 mg/l for a 250 mg dose, 7.7 mg/l for a 500 mg dose and 13.6 mg/l for a 1 g dose) occur approximately 2.4 hours after dosing when taken with food.

Distribution

Protein binding has been variously stated as33 to 50% depending on the methodology used,

Metabolism

Cefuroxime is not metabolised.

Elimination

The serum half life is between 1 and 1.5 hours.

Ceturoxlme is excreted by glomerular filtration and tubular secretion. Concurrent administration of probenecid increases the area under the mean serum concentrations time curve by 50%.

Renal imairment:

Cefuroxime pharmacokinetics have been investigated in patients with various degrees of renal impairment Cefuroxime elimination halt-life increases with decrease in renal function which serves as the basis for dosage adjustment recommendations in this group of patents (See Dosage and administration). In patients undergoing haemodialysis, at least 60% of the total amount of cefuroxime present in the body at the start of dialysis will be removed during a 4-hour dialysis period. Therefore, an additional single dose of cefuroxime should be administered following the completion of haemodialysis.

Pre-clinical Safety Data

Animal toxicity studies indicated that cefuroxime axetil isoflow toxicity with no significant findings.

SHELFLIFE: 36 months from manufacturing date

STORAGE:  below 300 C

 

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