Active ingredients: Acetoxyethylcefuroxime
Zinnat 250 mg film-coated tablets
Zinnat 500 mg film-coated tablets
Zinnat package inserts are available for pack sizes: - Zinnat 250 mg film-coated tablets, Zinnat 500 mg film-coated tablets
- Zinnat 125 mg / 5 ml granules for oral suspension, Zinnat 250 mg / 5 ml granules for oral suspension, Zinnat 250 mg granules for oral suspension
Why is Zinnat used? What is it for?
Zinnat is an antibiotic used in adults and children. It works by killing the bacteria that cause infections and belongs to a group of medicines called cephalosporins.
Zinnat is used to treat infections:
- throat
- sinuses
- of the middle ear
- of the lungs or chest
- of the urinary tract
- of the skin and soft tissues
Zinnat can also be used:
- to treat Lyme disease (a disease spread by parasites called ticks).
Your doctor can check the type of bacteria causing the infection and check if the bacteria are sensitive to Zinnat during treatment.
Contraindications When Zinnat should not be used
Do not take Zinnat:
- if you are allergic to acetoxyethylcefuroxime or to any antibiotic of the cephalosporin class or to any of the other ingredients of Zinnat (listed in section 6).
- if you have ever had a severe allergic (hypersensitivity) reaction to any of the other types of beta-lactam antibiotics (penicillins, monobactams and carbapenems).
If you think this applies to you, do not take Zinnat until you have consulted your doctor.
Precautions for use What you need to know before taking Zinnat
Talk to your doctor or pharmacist before taking Zinnat.
Children
Zinnat is not recommended in children less than 3 months of age as safety and efficacy are not known in this age group.
Look out for some symptoms such as allergic reactions, fungal infections (such as Candida) and severe diarrhea (pseudomembranous colitis) while you are taking Zinnat. This will reduce the risk of any problems.
See 'Conditions for which attention must be paid' in paragraph 4.
If you need blood tests
Zinnat can affect the results of blood sugar tests, or a blood test known as the Coombs test. If you need blood tests:
- Tell the person taking the sample that you are taking Zinnat.
Interactions Which drugs or foods can change the effect of Zinnat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines used to reduce the amount of acid in the stomach (for example antacids used to treat heartburn) can affect the way Zinnat works.
Probenecid
Oral anticoagulants
Tell your doctor or pharmacist if you are taking any of these medicines.
Contraceptive pill
Zinnat may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while being treated with Zinnat you must also use a barrier method of contraception (such as a condom). Ask your doctor for advice.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Zinnat can make you dizzy and have other side effects that make you less alert.
Don't drive or use machines if you don't feel well.
Important information about some of the ingredients of Zinnat
Zinnat tablets contain propyl and methyl parahydroxybenzoate. These excipients can cause allergic reactions (they may be delayed).
Check with your doctor that Zinnat is suitable for you.
Dose, Method and Time of Administration How to use Zinnat: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Take Zinnat after meals. This will help make the treatment more effective.
Swallow the Zinnat tablets whole with water.
Do not chew, crush or split the tablets - this can make the treatment less effective.
Recommended dose
Adults
The recommended dose of Zinnat is 250 mg to 500 mg twice a day and depends on the severity and type of infection.
Children
The recommended dose of Zinnat is 10 mg / kg (up to a maximum of 125 mg) to 15 mg / kg (up to a maximum of 250 mg) twice a day and depends on the severity and type of infection.
Zinnat is not recommended in children less than 3 months of age as safety and efficacy are not known in this age group.
Depending on the disease or how you or your child respond to treatment, the starting dose may be changed or more than one course of treatment may be required.
Patients with kidney problems
If you have kidney problems your doctor may change your dose.
Talk to your doctor if this applies to you.
If you forget to take Zinnat
Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.
If you stop taking Zinnat
Don't stop Zinnat without advice.
It is important to complete the full course of Zinnat treatment. Do not stop unless your doctor has advised you to, even if you feel better. If you do not complete the full course of treatment, the infection may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Zinnat
If you take too much Zinnat you may have neurological disorders, in particular you are more likely to have seizures.
Don't wait. Contact your doctor or the nearest hospital emergency department immediately. Show them the pack of Zinnat if possible.
Side Effects What are the side effects of Zinnat
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions for which attention must be paid
A small number of people being treated with Zinnat experience an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:
- severe allergic reaction. The signs include raised itchy rash, swelling, sometimes on the face or mouth causing difficulty in breathing.
- skin rash with small target-like blistering formations (a dark spot in the center surrounded by a "light area with a black ring around the edge).
- widespread rash with blisters and flaking of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
Other conditions you should look out for while taking Zinnat include:
- fungal infections. Medicines such as Zinnat can cause an overgrowth of fungi (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take Zinnat for a long time.
- severe diarrhea (pseudomembranous colitis). Medicines such as Zinnat can cause inflammation of the colon (large intestine) which causes severe diarrhea usually with blood and mucus, stomach pain, fever.
- Jarisch-Herxheimer reaction. Some patients may experience a high temperature (fever), chills, headache, body aches and rash while being treated with Zinnat for Lyme disease. This is known as the Jarisch-Herxheimer reaction. Symptoms usually last a few hours or up to a day.
Contact your doctor or nurse immediately if you get any of these symptoms.
Common side effects
These may affect up to 1 in 10 patients:
- fungal infections (such as Candida)
- headache
- dizziness
- diarrhea
- nausea
- stomach pain.
Common side effects that may show up in blood tests:
- an increase in a type of white blood cell (eosinophilia)
- an increase in enzymes produced by the liver.
Uncommon side effects
These may affect up to 1 in 100 patients:
- He retched
- skin rashes.
Uncommon side effects that may show up in blood tests:
- a decrease in the number of blood platelets (cells that help blood clot)
- a decrease in the number of white blood cells
- positive Coombs test.
Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is not known:
- severe diarrhea (pseudomembranous colitis)
- allergic reactions
- skin reactions (including severe)
- high temperature (fever)
- yellowing of the whites of the eyes or skin
- inflammation of the liver (hepatitis).
Side effects that may show up in blood tests:
- too fast destruction of red blood cells (haemolytic anemia).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Zinnat contains
The active ingredient is acetoxyethylcefuroxime.
Each Zinnat 250 mg film-coated tablet contains 300.72 mg of acetoxyethylcefuroxime equivalent to 250 mg of cefuroxime.
Each Zinnat 500 mg film-coated tablet contains 601.44 mg of acetoxyethylcefuroxime equivalent to 500 mg of cefuroxime.
The other ingredients are: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica, hypromellose, propylene glycol, titanium dioxide (E171), sodium benzoate, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate.
What Zinnat looks like and contents of the pack
Zinnat 250 mg film-coated tablets: 12 x 250 mg film-coated tablets
Zinnat 500 mg film-coated tablets: 6 and 12 film-coated tablets of 500 mg
The tablets are packed in aluminum-PVC-aluminum blisters.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
ZINNAT
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Zinnat 250 mg film-coated tablets
Each Zinnat 250 mg film-coated tablet contains 300.72 mg of acetoxyethylcefuroxime equivalent to 250 mg of cefuroxime.
Zinnat 500 mg film-coated tablets
Each Zinnat 500 mg film-coated tablet contains 601.44 mg of acetoxyethylcefuroxime equivalent to 500 mg of cefuroxime.
Zinnat 125 mg / 5 ml - Granules for oral suspension
One bottle of 100 ml contains 3.00 g of acetoxyethylcefuroxime equal to 2.50 g of cefuroxime.
Zinnat 250 mg / 5 ml - Granules for oral suspension
One bottle of 50 ml contains 3.00 g of acetoxyethylcefuroxime equal to 2.50 g of cefuroxime.
Zinnat 250 mg Granules for oral suspension
One sachet contains 300.72 mg of acetoxyethylcefuroxime equal to 250 mg of cefuroxime.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
250 mg, 500 mg, film-coated tablets> film
Film-coated tablet (tablet)
125 mg / 5 ml, 250 mg / 5 ml granules for oral suspension
Granules for oral suspension
250 mg granules for oral suspension
Granules for oral suspension (sachets)
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Zinnat is indicated for the treatment of the infections listed below in adults and children from 3 months of age (see sections 4.4 and 5.1).
Acute streptococcal tonsillitis and pharyngitis.
Acute bacterial sinusitis.
Acute otitis media.
Acute flare-ups of chronic bronchitis.
Cystitis.
Pyelonephritis.
Uncomplicated skin and soft tissue infections. Treatment of early Lyme disease.
Official guidelines on the appropriate use of antibacterial agents should be considered.
04.2 Posology and method of administration -
Dosage
The normal course of therapy is seven days (it can range from five to ten days).
Table 1. Adults and children (≥ 40 kg)
Table 2. Children (
There is no experience with the use of Zinnat in children less than 3 months of age.
Acetoxyethylcefuroxime tablets and acetoxyethylcefuroxime granules for oral suspension are not bioequivalent and cannot be substituted on a milligram-for-milligram basis (see section 5.2).
125 mg / 5 ml, 250 mg / 5 ml granules for oral suspension
In infants (from 3 months of age) and children with a body mass of less than 40 kg, it may be preferable to adjust the dose based on weight or age. The dose in infants and children aged 3 months to 18 years is 10 mg / kg twice daily for most infections, up to a maximum of 250 mg per day. In otitis media or more severe infections the recommended dose is 15 mg / kg twice a day up to a maximum of 500 mg a day.
The following two tables, divided by age groups, serve as a guideline for simplified administration e.g. measuring spoons (5 ml) when using the 125 mg / 5 ml or 250 mg / 5 ml multi-dose suspension and sachets single dose of 125 mg or 250 mg.
Table 3. Dosage 10 mg / kg for most infections
Table 4. Dosage 15 mg / kg for otitis media and more severe infections
Kidney failure
The safety and efficacy of acetoxyethylcefuroxime in patients with renal insufficiency has not been established. Cefuroxime is eliminated primarily via the kidney. In patients with markedly impaired renal function it is recommended that the dose of cefuroxime be reduced to compensate for its slower excretion Cefuroxime is effectively removed by dialysis.
Table 5. Recommended doses of Zinnat in renal insufficiency
Hepatic insufficiency
There are no data available for patients with hepatic insufficiency. Since cefuroxime is primarily eliminated by the kidneys, the presence of hepatic dysfunction is expected to have no effect on the pharmacokinetics of cefuroxime.
Method of administration
250 mg, 500 mg film-coated tablets
Oral use
For optimal absorption, Zinnat tablets should be taken after meals.
Zinnat tablets should not be crushed and are therefore not suitable for the treatment of patients who cannot swallow tablets. Zinnat oral suspension can be used in children.
125 mg / 5 ml, 250 mg / 5 ml granules for oral suspension and 250 mg granules for oral suspension
Oral use
For optimal absorption, acetoxyethylcefuroxime suspension should be taken with food.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
04.3 Contraindications -
Hypersensitivity to cefuroxime or to any of the excipients listed in section 6.1.
Patients with known hypersensitivity to cephalosporin class antibiotics.
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibiotic (penicillin, monobactams and carbapenems).
04.4 Special warnings and appropriate precautions for use -
Hypersensitivity reactions
Particular attention is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics, because there is a risk of cross-sensitivity. As with all other beta-lactam antibiotics, severe and sometimes fatal hypersensitivity reactions have been reported. In the event of severe hypersensitivity reactions, treatment with cefuroxime should be discontinued immediately and appropriate emergency measures undertaken.
Before starting treatment, it should be ascertained whether the patient has a history of severe hypersensitivity reactions to cefuroxime, to other cephalosporins or to any other type of beta-lactam antibiotic. Caution should be exercised if cefuroxime is administered to patients with a "History of non-severe hypersensitivity to other beta-lactam antibiotics.
Jarisch-Herxheimer reaction
The Jarisch-Herxheimer reaction has been reported following treatment of Lyme disease with acetoxyethylcefuroxime. This derives directly from the bactericidal activity of acetoxyethylcefuroxime on the bacteria that cause Lyme disease, the spirochete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease (see section 4.8).
Overgrowth of sensitive microorganisms
As with other antibiotics, the use of acetoxyethylcefuroxime can cause the overgrowth of the Candida. Prolonged use may result in the overgrowth of other non-sensitive microorganisms (e.g., enterococci and Clostridium difficile), which may require discontinuation of treatment (see section 4.8).
Antibiotic-associated pseudomembranous colitis has been reported with almost all antibiotics, including cefuroxime and can range in severity from mild to life-threatening. This diagnosis should be considered in patients with diarrhea during or following administration of cefuroxime (see section 4.8). The discontinuation of cefuroxime therapy and the administration of a specific treatment for the Clostridium difficile must be taken into account. Medicinal products that inhibit peristalsis should not be administered (see section 4.8).
Interference with diagnostic tests
The development of a positive Coombs test associated with the use of cefuroxime may interfere with blood compatibility tests (see section 4.8).
As a false negative result can occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood / plasma glucose levels in patients treated with acetoxyethylcefuroxime.
Important information about excipients
250 mg, 500 mg film-coated tablets
Zinnat tablets contain parabens which can cause allergic reactions (which may occur with delay).
125 mg / 5 ml, 250 mg / 5 ml granules for oral suspension and 250 mg granules for oral suspension
The sucrose content of the acetoxyethylcefuroxime oral suspension and the granules should be taken into account in the treatment of diabetic patients and appropriate advice given.
125 mg / 5 ml granules for oral suspension
Contains 3g of sucrose per 5ml serving
250 mg / 5ml granules for oral suspension
Contains 2.3g of sucrose per 5ml serving
250 mg granules for oral suspension
Contains 6.1 g of sucrose per unit dose
Acetoxyethylcefuroxime suspension contains aspartame, which is a source of phenylalanine and therefore should be used with caution in patients with phenylketonuria.
04.5 Interactions with other medicinal products and other forms of interaction -
Drugs that reduce gastric acidity can lead to a lower bioavailability of acetoxyethylcefuroxime than in the fasted state and tend to cancel the effect of greater absorption after meals.
Acetoxyethylcefuroxime can affect intestinal flora, resulting in decreased estrogen reabsorption and reduced efficacy of COCs.
Cefuroxime is excreted by glomerular filtration and tubular secretion. Concomitant use of probenecid is not recommended. Concomitant administration of probenecid significantly increases the peak concentration, the area under the serum concentration curve over time, and the elimination half-life of cefuroxime.
Concomitant use with oral anticoagulants may result in an increase in the INR (International Normalized Ratio).
04.6 Pregnancy and breastfeeding -
Pregnancy
There are limited data on the use of cefuroxime in pregnant women. Animal studies have not shown any harmful effects on pregnancy, embryonic or fetal development, parturition or postnatal development. Zinnat is to be prescribed for pregnant women. of pregnancy only if the benefit outweighs the risk.
Feeding time
Cefuroxime is excreted in breast milk in small quantities. Undesirable effects at therapeutic doses are not expected, although a risk of diarrhea and fungal mucosal infections cannot be excluded. Breastfeeding may need to be discontinued due to these effects. The possibility of sensitization should be considered. Cefuroxime should only be used during breastfeeding after a benefit / risk assessment by the treating physician.
Fertility
There are no data available on the effects of acetoxyethylcefuroxime on human fertility. Reproduction studies in animals have shown no effect on fertility.
04.7 Effects on ability to drive and use machines -
No studies on the effects on the ability to drive and use machines have been performed.
However, as this medicinal product may cause dizziness, patients should be advised to exercise caution while driving or operating machinery.
04.8 Undesirable effects -
The most common adverse reactions are overgrowth of Candida, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient elevation of liver enzymes.
The frequency categories assigned to the adverse reactions below are estimates, since for most reactions suitable data (eg from placebo-controlled studies) to calculate the incidence are not available. In addition, the incidence of the reactions adverse events associated with acetoxyethylcefuroxime may vary depending on the indication.
Data from large clinical trials were used to determine the frequency of very common to rare side effects. The frequencies assigned to all other undesirable effects (such as those occurring at
Treatment related adverse reactions, of all grades, are listed below by MedRA system organ class, frequency and severity level. The following convention was used for frequency classification: very common 1/10; common 1/100 a
Description of selected adverse reactions
Cephalosporins as a class tend to be absorbed on the surface of erythrocyte membranes and react against antibodies directed against the drug to produce a positive Coombs test (which can interfere with blood compatibility tests) and very rarely haemolytic anemia.
Transient elevations of liver enzymes in serum have been observed which generally are reversible.
Pediatric population
The safety profile for acetoxyethylcefuroxime in children is the same as the safety profile in adults.
04.9 Overdose -
Overdose can lead to neurological consequences including encephalopathy, seizures and coma. Symptoms of overdose may occur if the dose is not reduced appropriately in patients with renal insufficiency (see sections 4.2 and 4.4).
Serum levels of cefuroxime can be reduced by hemodialysis or peritoneal dialysis.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: antibacterials for systemic use, second generation cephalosporins.
ATC code: J01DC02.
Mechanism of action
Acetoxyethylcefuroxime is hydrolyzed by esterase enzymes in the active antibiotic cefuroxime.
Cefuroxime inhibits bacterial cell wall synthesis following adhesion to penicillin-binding proteins (penicillin binding proteins - PBP). This involves disruption of cell wall biosynthesis (peptidoglycan) which leads to bacterial cell lysis and death.
Resistance mechanism
Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms: hydrolysis by beta-lactamases including (but not limited to) broad-spectrum beta-lactamases (extended-spectrum beta-lactamases-ESBLs) and Amp-C enzymes which can be induced or stably depressed in some species of aerobic Gram-negative bacteria; reduced affinity of penicillin-binding proteins for cefuroxime; impermeability of the outer membrane that limits the access of cefuroxime to the penicillin-binding proteins in Gram-negative bacteria; bacterial efflux pumps.
Organisms that have acquired resistance to other injectable cephalosporins are expected to be resistant to cefuroxime.
Based on the resistance mechanism, organisms with resistance to penicillins may demonstrate reduced susceptibility or resistance to cefuroxime.
Breakpoints of acetoxyethylcefuroxime
The breakpoints of the Minimum Inhibitory Concentration (MIC) established by the European Committee on Antibacterial Sensitivity Tests (European Committee on Antimicrobial Susceptibility Testing - EUCAST) are the following:
1 cephalosporin breakpoints for Enterobacteriaceae will determine all clinically important resistance mechanisms (including ESBLs and plasmid-mediated AmpCs). Some beta-lactamase producing strains are susceptible or intermediate susceptibility to 3rd or 4th generation cephalosporins with these breakpoints and should be reported as found, i.e. the presence or absence of an ESBL does not in itself influence the categorization of susceptibility. In many areas, detection and characterization of ESBLs is recommended or mandatory for infection control purposes.
2 Uncomplicated urinary tract infections (cystitis) only (see section 4.1).
3 Susceptibility of staphylococci to cephalosporins is inferred from susceptibility to methicillin except for ceftazidime, cefixime and ceftibuten, which have no breakpoints and should not be used for staphylococcal infections.
4 The sensitivity to beta-lactams of beta-haemolytic streptococci of groups A, B, C and G is inferred from the sensitivity to penicillin.
5 There is "insufficient evidence that the species in question are a good target for drug therapy."
A MIC with a comment but without an S or R categorization accompaniment can be reported.
S = Sensitive, R = Resistant.
Microbiological sensitivity
The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, especially when treating severe infections. As necessary, expert advice should be sought if the local prevalence of resistance is such that doubts are raised as to the usefulness of acetoxyethylcefuroxime in at least some types of infections.
Cefuroxime is generally active against the following microorganisms in vitro.
* All sorts of S. aureus resistant methicillin are resistant to cefuroxime.
05.2 "Pharmacokinetic properties -
Absorption
After oral administration acetoxyethylcefuroxime is absorbed from the gastrointestinal tract and rapidly hydrolyzed in the intestinal mucosa and blood to release cefuroxime into the circulation. Optimal absorption is achieved when administered immediately after a meal.
Peak serum levels after administration of acetoxyethylcefuroxime tablets (2.9 mcg / ml for a dose of 125 mg, 4.4 mcg / ml for a dose of 250 mg, 7.7 mcg / ml for a dose of 500 mg and 13.6 mcg / ml for a dose of 1000 mg) are established approximately after about 2.4 hours from administration, if it occurs concomitantly with food intake. The rate of absorption of cefuroxime from the suspension is lower than in tablets resulting in later and lower serum peaks and reduced systemic bioavailability (4 to 17% lower) Acetoxyethylcefuroxime oral suspension was not bioequivalent to acetoxyethylcefuroxime tablets when tested in healthy adult volunteers and therefore is not substitutable on a milligram-for-milligram basis (see section 4.2) The pharmacokinetics of cefuroxime are linear over the oral dose range of 125 to 1000 mg. No accumulation of cefuroxime occurred after repeated oral doses of 250 to 500 mg .
Distribution
Protein binding has been reported from 33 to 50% and depends on the methodology used. Following a single dose of a 500 mg acetoxyethylcefuroxime tablet to 12 healthy volunteers, the apparent volume of distribution was 50 L (% CV = 28%). Concentrations of cefuroxime above the minimum levels of inhibition for common pathogens can be reached in the tonsils, sinus tissues, bronchial mucosa, bone, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile , in the sputum and in the aqueous humor. Cefuroxime passes the blood-brain barrier when the meninges are inflamed.
Biotransformation
Cefuroxime is not metabolised.
Elimination
The serum half-life is between 1 and 1.5 hours. Cefuroxime is excreted by glomerular filtration and tubular secretion. Renal clearance ranges from 125 to 148 ml / min / 1.73 m².
Special patient populations
Sex
There was no difference in the pharmacokinetics of cefuroxime between males and females.
Senior citizens
No special precautions are necessary in elderly patients with normal renal function at doses up to a maximum of 1 g per day. Elderly patients are more likely to have reduced renal function, therefore the dose should be adjusted according to renal function in the elderly (see section 4.2).
Pediatric population
In older infants (> 3 months of age) and children, the pharmacokinetics of cefuroxin are similar to that seen in adults.
There are no clinical data available on the use of acetoxyethylcefuroxime in children less than 3 months of age.
Kidney failure
The safety and efficacy of acetoxyethylcefuroxime in patients with> renal insufficiency have not been established. Cefuroxime is primarily excreted by the kidneys. Therefore, as with all these antibiotics, in patients with markedly impaired renal function (ie C1cr
Hepatic insufficiency
There are no data available in patients with hepatic insufficiency. Since cefuroxime is mainly excreted by the kidneys, hepatic dysfunction is not expected to have any effect on the pharmacokinetics of cefuroxime.
Pharmacokinetic / pharmacodynamic relationship
For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlated with efficacy in vivo has been shown to be the percentage of time within the dose range (% T) during which the non-protein bound drug concentration remains above the minimum inhibitory concentration (MIC) of cefuroxime for individual target bacterial species ( i.e.% T MIC).
05.3 Preclinical safety data -
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, reproductive and developmental toxicity. Carcinogenicity studies have not been conducted, however there is no evidence to suggest a carcinogenic potential.
The activity of gamma-glutamyl transpeptidase in rat urine is inhibited by various cephalosporins, however the level of inhibition is lower with cefuroxime. This may have significance in the interference in clinical laboratory tests in humans.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Tablets
Microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica, hypromellose, propylene glycol, titanium dioxide (E171), sodium benzoate, methyl parahydroxybenzoate, propyl para-hydroxybenzoate.
Granules for oral suspension in bottle or sachet
Stearic acid, sucrose, all fruit flavor, povidone k30, acesulfame potassium, aspartame, xanthan gum.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
Tablets: 3 years.
Granules for oral suspension: 2 years.
Granules for oral suspension
Once prepared with the indicated volume of water, the suspension can be stored in the refrigerator for 10 days at a temperature between 2 ° C and 8 ° C.
06.4 Special precautions for storage -
Do not store above 30 ° C.
The reconstituted suspensions (125 mg / 5 ml and 250 mg / 5 ml) should be stored immediately in the refrigerator at 2 ° C to 8 ° C.
Zinnat 250 mg Granules for oral suspension Sachets: the suspension should be taken immediately after preparation.
06.5 Nature of the immediate packaging and contents of the package -
The tablets are packed in aluminum-PVC-aluminum blisters.
Zinnat 250 mg - Film-coated tablets: 12 x 250 mg film-coated tablets (as cefuroxime).
Zinnat 500 mg - Film-coated tablets: 6 and 12 film-coated tablets of 500 mg (as cefuroxime).
The granulate for suspension is packaged in amber type III glass bottles. The dilution cup and spoon are made of polyethylene.
Zinnat 125 mg / 5 ml Granules for oral suspension: bottle of 100 ml (125 mg / 5 ml as cefuroxime).
Zinnat 250 mg / 5 ml Granules for oral suspension: bottle of 50 ml (250 mg / 5 ml as cefuroxime).
The sachets consist of a laminate of paper, polyethylene, aluminum and ethylene-methacrylic acid ionomer.
Zinnat 250 mg Granules for oral suspension Sachets -12 sachets of 250 mg (as cefuroxime).
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with current legislation.
125 mg / 5 ml, 250 mg / 5 ml granules for oral suspension
Instructions for reconstitution / administration
The bottle should be shaken vigorously before withdrawing the medicine.
The reconstituted suspension, if refrigerated at 2 ° C to 8 ° C, can be kept for up to 10 days.
If desired, the Zinnat suspension in multidose bottles can be further diluted in cold fruit juices, or milk based drinks and should be taken immediately.
Instructions for reconstitution of the suspension in multidose bottles
1. Shake the bottle to disperse the granules. Remove the cap and heat-sealed membrane. If the latter is damaged or not present, the product must be returned to the pharmacist.
2. Add the total amount of water to the bottle as indicated on the label or as indicated in the cup (if present in the package). Close with the cap.
3. Invert the bottle and shake vigorously (for at least 15 seconds).
4. Turn the bottle upright and shake vigorously.
5. Refrigerate immediately at 2 to 8 ° C.
6. If using a dosing syringe, allow the reconstituted suspension to be prepared at least one hour before taking the first dose.
Instructions for use of the dosing syringe (if present in the package)
1. Remove the bottle cap and insert the collar syringe adapter into the bottle neck.
Press it fully down until the collar fits securely into the neck. Turn the bottle and syringe upside down.
2. Pull the plunger up from the barrel until the rim of the barrel is aligned with the notch on the plunger corresponding to the required dose.
3. Turn the bottle and syringe upright. While holding the syringe and plunger up to make sure the plunger does not move, remove the syringe from the bottle, leaving the plastic collar in the bottle neck.
4. With the patient sitting upright, place the tip of the syringe just inside the patient's mouth, towards the inside of the cheek.
5. Push the plunger of the syringe slowly to expel the medicine without causing choking.
DO NOT spray the drug in a stream.
6. After administering the dose, replace the bottle cap without removing the plastic collar.
Disassemble the syringe and wash it thoroughly with fresh drinking water. Leave the plunger and barrel to dry naturally.
250 mg granules for oral suspension
Instructions for reconstitution of the suspension from the sachets
1. Pour the granules from the sachet into a glass
2. Add a small amount of water
3. Shake well and drink immediately
The reconstituted suspension or granules must not be mixed with hot drinks.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona.
Dealer for sale: Biofutura Pharma S.p.A. - Pomezia (Rome)
08.0 MARKETING AUTHORIZATION NUMBER -
250 mg Film-coated tablets - 12 tablets A.I.C .: 026915025
500 mg Film-coated tablets - 6 tablets A.I.C .: 026915037
500 mg Film-coated tablets - 12 tablets A.I.C .: 026915102
125 mg / 5 ml Granules for oral suspension - bottle of 100 ml A.I.C .: 026915049
250 mg / 5 ml Granules for oral suspension - bottle of 50 ml A.I.C .: 026915076
250 mg Granules for oral suspension - 12 sachets A.I.C .: 026915052
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Film-coated tablets: November 20, 1990 / January 2009
Granules for oral suspension: February 27, 1991 / January 2009
10.0 DATE OF REVISION OF THE TEXT -
August 2013
