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NAME OF THE MEDICINAL PRODUCT

Cefuroxime Axetil Actavis 250 mg film-coated tablets
Cefuroxime Axetil Actavis 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 250 mg cefuroxime as cefuroxime axetil
Each tablet contains 500 mg cefuroxime as cefuroxime axetil
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM

Film-coated tablet.
250 mg: Light blue-coloured film-coated, capsule shaped tablets marked “250” on one side and “P125” on
the other side.
500 mg: Light blue coloured film-coated capsule shaped tablets marked “500” on one side and “P126” on the
other side.
4.
CLINICAL PARTICULARS
Therapeutic indications
Cefuroxime Axetil Actavis is indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as: - upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis acute bronchitis, acute exacerbations of chronic bronchitis lower uncomplicated urinary tract infections: cystitis skin and soft tissue infections: furunculosis, pyoderma and impetigo treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2
Posology and method of administration
For an individual dosage, Cefuroxime Axetil Actavis 250 mg and 500 mg film-coated tablets are available. General dosage recommendations for cefuroxime depend on the sensitivity of the respective pathogen and on the site of infection. Cefuroxime Axetil Actavis tablets are coated to mask their taste: they should not be broken, crushed or chewed. The usual duration of therapy is 7 days (ranging from 5 to 10 days). In case of pharyngotonsillitis caused by Streptococcus pyogenes a therapy duration of at least 10 days is indicated. The duration of treatment of early Lyme disease should be 20 days. In order to achieve optimum absorption Cefuroxime Axetil Actavis should be taken shortly after meals. The dosage depends on the severity of the infection. For severe infections parenteral forms of cefuroxime are recommended. Where appropriate cefuroxime axetil is effective when used following initial parenteral cefuroxime sodium in the treatment of pneumonia and acute exacerbations of chronic bronchitis. Dosage schedule:
Adults and children over 12 years of age
Lower uncomplicated urinary tract infections
Children from 5 to 12 years of age
Above-mentioned indications, if relevant for this group of children Acute otitis media
*For the strength 125 mg other products containing cefuroxime axetil may be available.
Children from 5 to 12 years of age:
Children between 5 and 12 years should not receive more than a daily dose of 500 mg cefuroxime.
Children under 5 years of age:
Cefuroxime Axetil Actavis tablets are not suitable for use in children under the age of 5. For patients in this
age group it is advised to use an oral suspension. There is no experience in children under 3 months of age.

Dosage regimen in renal impairment, in dialysis patients and elderly :
No special precautions are necessary in patients with renal impairment, or in elderly patients if the daily
dosage does not exceed 1000 mg. In patients with renal impairment and creatinine clearance below 20
ml/min cefuroxime axetil should be dosed carefully. Patients undergoing haemodialysis will require a
supplementary dose of cefuroxime at the end of each dialysis treatment.
4.3
Contraindications
Hypersensitivity to cefuroxime, other cephalosporins or to any of the excipients. Previous immediate and /or severe hypersensitivity reaction to a penicillin or to any other type of beta-lactam medicinal products. Special warnings and precautions for use
If after administration of Cefuroxime Axetil Actavis sensitivity reactions occur, the use should be discontinued immediately and an appropriate treatment should be established. Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams. As with other broad spectrum antibiotics, prolonged use of cefuroxime axetil may result in the overgrowth of non-susceptible organisms (e.g., Candida, Enterococci and Clostridium diffficile, which may require interruption of treatment. In patients who develop severe diarrhoea during or after use of cefuroxime axetil, the risk of life threatening pseudomembranous colitis should be taken into account. The use of cefuroxime axetil should be discontinued and the appropriate treatment established. The use of preparations inhibiting the intestinal peristalsis is contra-indicated (see section 4.8). A 20-day treatment of Lyme disease may cause the frequency of developing diarrhoea to increase. Long term
use of cefuroxime axetil may lead to an excess of pathogens resistant to cefuroxime axetil. It is of high
importance that the patient is carefully checked. If a superinfection occurs during treatment, appropriate
measures should be taken (see section 4.8).
The use of cefuroxime axetil is not recommended in patients with severe intestinal tract disorders
accompanied by vomiting and diarrhoea, since in these situations a sufficient absorption can not be
guaranteed. Administration of a parenteral formulation of cefuroxime should be considered.
The Jarisch-Herxheimer reaction has been reported following cefuroxime axetil treatment of Lyme disease.
The reaction results directly from the bactericidal activity of cefuroxime axetil on the spirochaete Borrelia
burgdorferi
. Patients should be informed of this common and usually self-limited reaction being a
consequence of antibiotic treatment of Lyme disease.
Simultaneous use of medicines enhancing the pH of the stomach is not recommended (see section 4.5).
There is no clinical experience with the use of cefuroxime axetil in children under the age of 3 months. With
respect to the treatment of early Lyme disease there is only clinical experience with children from the age of
12 and with adults.
Either the glucose oxidase or the hexokinase methods are recommended to determine the blood and plasma
glucose levels in patients receiving cefuroxime axetil. Cefuroxime does not interfere in the alkaline picrate
assay for creatinine (see section 4.5).
During the treatment with cefuroxime sodium, some children have experienced slight to moderate hearing
loss.
4.5
Interaction with other medicinal products and other forms of interaction

Simultaneous use of medicines enhancing the pH of the stomach decreases the bioavailability of cefuroxime
axetil. It is recommended to avoid this combination (see section 4.4).
Since bacteriostatic drugs may interfere with the bactericidal action of cephalosporins, it is advisable to avoid
giving tetracyclines, macrolides, or chloramphenicol in conjunction with cefuroxime axetil.
The concomitant administration of probenicid can produce higher and sustained concentrations of cefuroxime in
the serum and in the bile.
Cefuroxime may interfere with the determination of glucose in urine with copper containing reagentia (Benedict-
or Fehling-solution, Clinitest). For the determination of blood- and plasma sugar levels in patients receiving
cefuroxime axetil, the glucose-oxidase- or hexokinase method is recommended (see section 4.4).
The use of cefuroxime axetil may be accompanied by a false positive Coombs test. This may interfere with the
performance of cross matching tests with blood (see section 4.8).
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics,
aminoglycosides, or amphotericin as these combinations increases the risk of nephrotoxicity.
During therapy with oral antibiotics, reduced absorption of steroid metabolites (lower oestrogen re-absorption)
from combined oral contraceptives may occur, due to possible disturbance of intestinal flora. Therefore, due to
possibly reduced efficacy, additional contraceptive measures are advisable.
4.6
Pregnancy and lactation

Pregnancy:
There are not sufficient data on the use of cefuroxime axetil during pregnancy to assess its possible harmfulness. So
far, animal tests have not yielded evidence of harmfulness. Cefuroxime crosses the placenta. Cefuroxime Axetil
Actavis should not be used during pregnancy unless considered essential by the physician.
Lactation:
Cefuroxime is excreted to a small degree into human breast milk and lactation should therefore be avoided
during treatment.
4.7
Effects on ability to drive and use machines

Since this medicinal product may cause dizziness, patients should be warned to be cautious when driving a
vehicle or operating machinery.
4.8
Undesirable effects
Within each frequency class, undesirable effects are specified in order of decreasing severity. The frequency is defined using the following conventions: Common (≥ 1/100, < 1/10) Rare (≥ 1/10,000, < 1/1,000)
Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Infections and infestations
Rare

As with other antibiotics prolonged use may lead to secondary superinfections caused by insusceptible
organisms, e.g. Candida, Enterococci and Clostridium difficile (see section 4.4).

Blood and lymphatic system disorders
Common:

thrombocytopenia; leukopenia and/or neutropenia
Immune system disorders
Common
Jarisch-Herxheimer reaction following cefuroxime axetil treatment of Lyme disease (see section 4.4)
Psychiatric disorders
Very rare:


Nervous system disorders
Common:


Gastrointestinal disorders
Common:

gastrointestinal diseases including diarrhoea, nausea and vomiting. The frequency of diarrhoea is related to the administered dose and may rate up to 10% with tablets. The incidence is even higher (approx. 13%) at prolonged treatment of 20 days of early Lyme disease.
Hepatobiliary disorders
Very rare:


Skin and subcutaneous tissue disorders
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Renal and urinary disorders
Common:

increased levels of creatinine and urea in serum, especially in patients with impaired renal function
General disorders and administration site conditions
Rare


Investigation
Common:

temporary increase of liver enzymes (AST, ALT, LDH) and billirubin
Depending on the method, false-positive or false-negative results may be observed in glucose testing of the
blood or urine. This can be prevented by using enzymatic methods. During cephalosporin treatment, results
of Coombs-testing may be false-positive. The alkaline Pikrad assay (Jaffé method) should be used for
creatinine assessment.
4.9
Overdose

Overdose of cephalosporins may cause cerebral irritancy leading to convulsions. In case of overdose
cefuroxime serum levels can be reduced by haemodialysis and peritoneal dialysis.
5.
PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Second-generation cephalosporins, ATC-code: J01DC02
Mode of action
Cefuroxime axetil owes its in vivo bactericidal activity to the parent compound cefuroxime.
All cephalosporins (β-lactam antibiotics) inhibit cell wall production and are selective inhibitors of
peptidoglycan synthesis. The initial step in drug action consists of binding of the drug to cell receptors,
called Penicillin-Binding Proteins. After a β-lactam antibiotic has bound to these receptors, the
transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is the end result.
Mechanism of resistance
Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms:

hydrolysis by beta-lactamases. Cefuroxime may be efficiently hydrolysed by certain of the extended-spectrum beta-lactamases (ESBLs) and by the chromosomally-encoded (AmpC) enzyme that may be induced or stably derepressed in certain aerobic gram-negative bacterial species reduced affinity of penicillin-binding proteins for cefuroxime outer membrane impermeability, which restricts access of cefuroxime to penicillin binding proteins in gram-negative organisms Methicillin-resistant staphylococci (MRS) are resistant to al currently available β-lactam antibiotics including cefuroxime. Penicillin-resistant Streptococcus pneumoniae are cross-resistant to cephalosporins such as cefuroxime through alteration of penicillin binding proteins. Beta-lactamase negative, ampicillin resistant (BLNAR) strains of H. influenzae should be considered resistant to cefuroxime despite apparent in vitro susceptibility. Strains of Enterobacteriaceae, in particular Klebsiella spp. and Escherichia coli that produce ESBLs (extended spectrum β-lactamase) may be clinically resistant to therapy with cephalosporins despite apparent in vitro susceptibility and should be considered as resistant.
Breakpoints:
According to the EUCAST (European Society of Clinical Microbiology and infectious diseases) 2009-02-16
the following tentative breakpoints have been defined for cefuroxime axetil:
Susceptible
Resistant
1The cephalosporin breakpoints for Enterobacteriaceae will detect reduced susceptibility mediated by
most clinically important beta-lactamases in Enterobacteriaceae. Occasional ESBL-producing strains will be
reported susceptible. For purposes of infection control, epidemiology and surveillance, laboratories may wish
to use specific tests to screen for and confirm ESBL-production.
2 For uncomplicated urinary tract infections only.
3 Susceptibility of staphylococci to cephalosporins is inferred from the methicillin susceptibility.
4 The susceptibility of streptococcus groups A, B, C and G can be inferred from their susceptibility to
benzylpenicillin

Susceptibility:
The prevalence of resistance may vary geographically and with time for selected species and local
information on resistance is desirable, particularly when treating severe infections. As necessary, expert
advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least
some types of infections is questionable.
Commonly susceptible species
Aerobes, Gram positive:
Staphylococcus aureus (methicillin-susceptible)
Coagulase-negative staphylococci (methicillinsusceptible)
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes

Aerobes, Gram negative:
Escherichia coli
Haemophilus influenzae
Klebsiella
species
Moraxella catarrhalis
Proteus mirabilis
Proteus rettgeri

Anaerobes,
Peptococcus species
Peptostreptococcus species
Other organisms:
Borrelia burgdorferi
Species for which resistance may be a problem
Acinetobacter species
Citrobacter species
Enterobacter species
Morganella morganii
Resistant
Bacteroides fragilis
Clostridium difficile
Enterococci
Listeria monocytogenes
Proteus vulgaris
Pseudomonas
species
Serratia species
5.2
Pharmacokinetic properties

Absorption: After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and
rapidly hydrolysed in the intestinal mucosa and blood causing the release of the active compound cefuroxime
into the circulation. Optimum absorption occurs when cefuroxime axetil is taken shortly after a meal (50-
60%). Under these circumstances maximum serum concentration is achieved after 2-3 hours.
Distribution: Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial
fluid, and aqueous humour, but only achieves therapeutic concentrations in the CSF when the meninges are
inflamed. About 50% of cefuroxime in the circulation is bound to plasma proteins. It diffuses across the
placenta and has been detected in breast milk.
Metabolism: Cefuroxime is not metabolised.

Elimination:
Most of the dose of cefuroxime is excreted unchanged. About 50% is excreted by glomerular
filtration and about 50% through renal tubular secretion within 24 hours, with the majority being eliminated
within 6 hours; high concentrations are achieved in the urine. Small amounts of cefuroxime are excreted in
bile.
Probenecid competes with cefuroxime for renal tubular secretion resulting in higher and more prolonged
plasma concentrations of cefuroxime.
The plasma half-life ranges between 60 and 90 minutes and is prolonged in patients with renal impairment
and in neonates.
Dialysis causes the decrease of cefuroxime serum levels.
5.3
Preclinical safety data

Studies on chronic toxicity indicated no significant pathological changes in rats and dogs after administration
of high doses over a period of 6 months.
Reproduction toxicology studies in rats have shown no evidence of undesirable effects with regard to fertility
and peri- and postnatal development. Mice showed no signs of embryonic or foetal toxicity.
Mutagenicity and carcinogenicity studies did not show any clinically significant mutagenic or carcinogenic
potential.
6.
PHARMACEUTICAL PARTICULARS
List of excipients
Core: Pregelatinised starch, Croscarmellose sodium, Sodium lauril sulfate, Microcrystalline cellulose, Silica colloidal anhydrous, Hydrogenated vegetable oil. Coating: Opadry blue: Hydroxypropyl methylcellulose (E 464),
Titanium dioxide (E 171),
Propylene glycol,
Brilliant Blue aluminium coating (E133),
Indigo Carmine aluminium coating (E132).
6.2
Incompatibilities

Not applicable.
6.3
Shelf life

2 years

6.4

Special precautions for storage

This medicinal product does not require any special storage conditions
6.5
Nature and contents of container

The film-coated tablets are packed in a PVC/Aclar-blister and tablet container (HDPE) with child-resistant
plastic cap (PE) with pulp and heat seal liner (aluminium).
Pack sizes:
Blisters: 10, 12, 14, 16, 20 and 50 film-coated tablets
Tablet containers: 20 and 60 film-coated tablets
Not all pack sizes may be marketed.
6.6
Special precautions for disposal and other handling

No special requirements
7.
MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf
Rejkyavikurvegur 76-78
220 Hafnarfjordur
Iceland
8.
MARKETING AUTHORISATION NUMBER(S)

Cefuroxime Axetil Actavis 250 mg film-coated tablets: MA628/05201
Cefuroxime Axetil Actavis 500 mg film-coated tablets: MA628/05202

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

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<[To be completed nationally]>
10.
DATE OF REVISION OF THE TEXT

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<[To be completed nationally]>
Detailed information on this medicinal product is available on the website of the Malta Medicines Authority.


Source: http://www.actavis.com.mt/NR/rdonlyres/F98484BE-B221-42FF-8E83-852FA647EA09/20204/Cefuroximespc.pdf

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