Active ingredients: Ceftibuten
CEDAX 400 mg hard capsules
CEDAX 200 mg hard capsules
Cedax package inserts are available for pack sizes: - CEDAX 400 mg hard capsules, CEDAX 200 mg hard capsules
- CEDAX 36 mg / ml granules for oral suspension
- CEDAX 400 mg granules for oral suspension, CEDAX 200 mg granules for oral suspension
Why is Cedax used? What is it for?
Cedax contains the active substance ceftibuten. Ceftibuten is an antibiotic that belongs to the beta-lactam class and to a family of medicines called cephalosporins. Cedax is used against bacteria that are sensitive to the medicine.
Cedax is indicated in the treatment of:
- infections of the upper respiratory tract: of the throat (pharyngitis, tonsillitis), of the cavities near the nose (sinusitis) and of the ears (otitis media)
- infections of the lower respiratory tract: of the bronchi (bronchitis), of the lungs (primary community-acquired pneumonia) and simultaneously of the bronchi and lungs at the same time (bronchopneumonia)
- infections of the urinary tract: of the kidneys, bladder and the duct that carries urine from the bladder to the outside (acute and chronic pyelitis, cystopyelitis, cystitis, urethritis and as a second-choice drug in acute uncomplicated gonococcal urethritis).
Contraindications When Cedax should not be used
Do not use Cedax
- if you are allergic to the active substance, any other cephalosporin or any of the other ingredients of this medicine (listed in section 6)
- if you have experienced severe and sudden allergic reactions (anaphylaxis) to other antibiotics called penicillins or other antibiotics of the beta-lactam family
- if you are pregnant or suspect you are pregnant (see "Pregnancy and breastfeeding")
- if it is for a baby under six months of age (see "Warnings and precautions"). Experience in children under six months of age is insufficient to establish the safety of ceftibuten in these patients.
Precautions for use What you need to know before taking Cedax
Talk to your doctor or pharmacist before using Cedax if:
- have severe kidney damage (kidney failure) or are on dialysis, in which case your doctor will decide which dose of Cedax to use. If you are on dialysis your doctor will closely monitor your health and schedule Cedax to be administered immediately after dialysis.
- if you have stomach and bowel problems and in particular if you have chronic inflammation of the colon (chronic colitis), your doctor will use caution when prescribing the medicine.
- "Disturbance of the intestinal flora (bacteria present in the" intestine) with the onset of moderate to severe diarrhea (an "alteration of the intestinal flora, including pseudomembranous colitis due to Clostridium difficile toxins) may occur during therapy with Cedax.
- during therapy with Cedax and other antibiotics, the flora of the intestine can be altered with the appearance of antibiotic-associated diarrhea, accompanied by severe inflammation of a part of the intestine called the colon (pseudomembranous colitis), due to the toxins of a bacterium called Clostridium difficile.
- have a history of allergy or suspect an allergy to a class of antibiotics called penicillins. If you are allergic to penicillins, you may also be allergic to cephalosporins (cross reactivity) and can experience severe and sudden allergic reactions (anaphylaxis). In these cases, your doctor will stop Cedax therapy and give you appropriate therapy.
- if you experience convulsions or allergic shock while using Cedax, your doctor will immediately stop administering the medicine and initiate appropriate medical treatment promptly.
- you are taking medicines that delay blood clotting as Cedax may reduce your ability to stop bleeding. In these cases, your doctor will prescribe specific blood tests (thromboplastin time or the International Normalized Ratio - INR). When the sachets are opened, a sulfur odor may be found which does not alter the quality of the product. After reconstitution, the sulfur odor disappears.
Children
Cedax is not indicated for children under six months of age.
Interactions What medications or foods may change the effect of Cedax
Other medicines and Cedax
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Cedax does not interact with medicines that reduce stomach acidity based on aluminum-magnesium and ranitidine and medicines for asthma based on theophylline (single dose administered intravenously). Cephalosporins, including Cedax, can in rare cases interact with medicines that delay blood clotting and may reduce the ability to stop bleeding. In these cases, your doctor will prescribe specific blood tests (prothrombin time).
Cedax with foods
Concomitant food intake may delay and decrease the absorption of Cedax oral suspension. The medicine is not contraindicated if you have celiac disease.
Warnings It is important to know that:
Pregnancy and breastfeeding
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 using this medicine.
Administration of Cedax during pregnancy and lactation should be weighed in terms of the potential risk and benefit for both the mother and the fetus.
Feeding time
Ceftibuten passes into breast milk, therefore infants may experience diarrhea such as to require a possible suspension of breastfeeding. Due to the development of a possible allergy, Cedax should only be given during breastfeeding when the benefits outweigh the risks.
Driving and using machines
Cedax has no effect on the ability to drive and use machines.
Dosage and method of use How to use Cedax: Dosage
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults is:
lower respiratory tract infections
pneumonia: 200 mg 2 times / day
bronchitis: 400 mg 1 time / day
upper respiratory tract infections
400 mg once / per day
urinary tract infections
400 mg once / day.
Cedax capsules can be taken regardless of meal times. The capsules should be swallowed with some water.
Overdose What to do if you have taken too much Cedax
If you use more Cedax than you should
No toxic manifestations have been found following an accidental overdose of Cedax. In case of accidental ingestion / intake of an overdose of Cedax notify your doctor immediately or go to the nearest hospital.
If you forget to use Cedax
Do not use a double dose to make up for a forgotten dose.
If you stop taking Cedax
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Cedax
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies, which were conducted in approximately 3,000 patients, the most frequently reported side effects were:
- nausea (3%)
- diarrhea (3%)
- headache (headache) (2%).
The following side effects have been observed:
Common (may affect up to 1 in 10 people)
- headache (headache)
- nausea
- diarrhea
Uncommon (may affect up to 1 in 100 people)
- fungal infection (oral candidiasis)
- vaginal infection
- increase in eosinophils (a type of blood cell) (eosinophilia); positive direct Coombs test * (a laboratory test)
- decrease in hemoglobin (a protein that carries oxygen in the blood) prolongation of prothrombin time (which indicates how long the blood clots)
- increase of the INR (a value that indicates the time of blood clotting)
- loss of appetite (anorexia)
- decreased sense of taste (dysgeusia)
- stuffy nose (nasal congestion)
- difficulty in breathing (dyspnoea)
- stomach inflammation (gastritis)
- He retched
- abdominal pain
- constipation
- dry mouth
- difficulty digesting (dyspepsia)
- emission of air from the anus (flatulence)
- fecal incontinence
- increase in some parameters of liver function: bilirubin and transaminases (hyperbilirubinemia *, increase in AST and ALT)
- difficulty urinating (dysuria)
- renal impairment *
- kidney damage (toxic nephropathy *)
- presence of sugars and other substances called ketone bodies in the urine (renal glycosuria * and ketonuria *)
* observed with other cephalosporins and which may occur with the use of Cedax.
Rare (may affect up to 1 in 1,000 people)
- inflammation of a part of the intestine called the colon caused by a bacterial infection (Clostridium difficile colitis)
- reduction in the number of a type of blood cell called white blood cells (leukopenia (leukopenia)
- reduction in the number of platelets (thrombocythaemia)
- reduction in the number of red blood cells (aplastic anemia, haemolytic anemia)
- bleeding disorders - reduction in the number of all types of blood cells (pancytopenia)
- reduction in the number of a type of white blood cell called neutrophils (neutropenia)
- severe reduction in the number of white blood cells (agranulocytosis)
- convulsions
- increase in blood values of some parameters of liver function (lactate dehydrogenase -LDH)
Very rare (may affect up to 1 in 10,000 people)
- impaired sensation (paraesthesia)
- drowsiness
- vertigo
- fatigue
Not known (frequency cannot be estimated from the available data)
- infections that overlap (superinfection)
- serum sickness (characterized by rash, joint pain, fever, swollen lymph nodes, decreased blood pressure and enlarged spleen)
- hypersensitivity reactions including severe and sudden reactions (anaphylactic reaction)
- contraction of the bronchial muscles (bronchospasm)
- rash
- urticaria
- sensitivity to light (photosensitivity)
- itch
- severe skin reactions (angioedema, Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis)
- mental (psychotic) disorders
- impaired speech (aphasia)
- dark stools (melena)
- liver (hepatobiliary) disorders and yellowing of the skin and eyes (jaundice).
Additional side effects in children
Uncommon (may affect up to 1 in 100 children)
- inflammation of the skin (diaper rash)
- blood in the urine (haematuria)
Very rare (may affect up to 1 in 10,000 children)
- agitation, insomnia
- excess movement (hyperkinesis)
- irritability
- cooling down
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 national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety. of this medicine.
Expiry and Retention
Do not store above 25 ° C.
Keep this medicine out of the sight and reach of children.
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.
Composition and pharmaceutical form
What Cedax contains
- The active ingredient is ceftibuten. Each capsule contains 200 mg or 400 mg of ceftibuten.
- The other ingredients are: microcrystalline cellulose, sodium amidoglycolate, magnesium stearate. Capsule components: gelatin, titanium dioxide, sodium lauryl sulfate. Sealing band components: gelatin, polysorbate 80
What Cedax looks like and contents of the pack
Cedax comes in the form of hard capsules for oral use.
It is available in the following packs:
200 mg: 6 and 12 hard capsules in blisters.
400 mg: 4 and 6 hard capsules in 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
CEDAX
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
CEDAX 200 mg hard capsules
Each hard capsule contains:
Active principle: Ceftibuten 200 mg
CEDAX 200 mg granules for oral suspension
Each sachet contains:
Active principle: Ceftibuten 200 mg.
CEDAX 400 mg hard capsules
Each hard capsule contains:
Active principle: Ceftibuten 400 mg.
CEDAX 400 mg granules for oral suspension
Each sachet contains:
Active principle: Ceftibuten 400 mg.
CEDAX 36 mg / ml granules for oral suspension - bottle
100 g of granules contain:
Active principle: Ceftibuten 14.40 g
For excipients see 6.1.
03.0 PHARMACEUTICAL FORM
Hard capsules. Granules for oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
CEDAX is indicated in the treatment of infections due to sensitive pathogens, in particular:
• Upper respiratory tract infections: pharyngitis, tonsillitis, sinusitis, otitis media.
• Lower respiratory tract infections: bronchitis, primary community acquired pneumonia, bronchopneumonia.
• Urinary tract infections: acute and chronic pyelitis, cystopyelitis, cystitis, urethritis. As a second-line drug in uncomplicated acute gonococcal urethritis.
04.2 Posology and method of administration
Adults:
Lower respiratory tract infections: Pneumonia: 200 mg twice / day; bronchitis: 400 mg once / day.
Upper respiratory tract infections: 400 mg once / day.
Urinary tract infections: 400 mg once / day.
Children over 6 months of age:
Uncomplicated lower respiratory tract infections: 9.0 mg / kg once / day.
Upper respiratory tract infections (e.g. otitis media): 9.0 mg / kg once / day.
Urinary tract infections: 9.0 mg / kg once / day.
The maximum daily dose in children should not exceed 400 mg / day.
CEDAX granules for oral suspension can be taken one to two hours before or after a meal.
CEDAX hard capsules can be taken regardless of meal times.
04.3 Contraindications
Hypersensitivity to the active substance, to any other cephalosporin, or to any of the excipients.
CEDAX should not be used in patients who have experienced known serious or acute hypersensitivity reactions (anaphylaxis) to penicillins or other beta-lactam antibiotics.
Experience in children under three months of age is insufficient to establish the safety of the active substance in this patient population.
Generally contraindicated in pregnancy (see 4.6).
04.4 Special warnings and appropriate precautions for use
Renal impairment
In patients with marked renal insufficiency or in patients undergoing dialysis the dosage of CEDAX may require adjustment. CEDAX is readily dialysable. Patients on dialysis should be closely monitored, with CEDAX being administered immediately following dialysis.
The pharmacokinetics and posology of ceftibuten are not affected by a modest impairment of renal function (creatinine clearance between 50-79 ml / min). In patients with creatinine clearance between 30-49 ml / min the daily dose should be halved. At lower creatinine clearance values, further dose adjustment is required. Dose adjustment may be necessary in patients with renal insufficiency undergoing dialysis treatment. In patients on dialysis treatment 2/3 times per week, it is recommended to administer a single 400 mg dose of CEDAX at the end of each dialysis treatment.
Gastrointestinal
CEDAX should be prescribed with caution in individuals with a history of complicated gastrointestinal conditions, particularly chronic colitis.
Clostridium difficile
During therapy with CEDAX and other broad spectrum antibiotics, an "alteration of the intestinal flora with the onset of antibiotic-associated diarrhea" including pseudomembranous colitis due to toxins may occur. Clostridium difficile. Patients may present with moderate to severe or fatal diarrhea, with or without dehydration, both during and after treatment with the associated antibiotic. It is important to keep this diagnosis in mind for any patient who presents with persistent diarrhea during or until two months after administration of CEDAX or another broad spectrum antibiotic. Mild forms of pseudomembranous colitis typically respond favorably to simply stopping the drug. In moderate or severe forms, treatment should include sigmoidoscopy, appropriate bacteriological research, and the administration of fluids, electrolytes and proteins. In cases where colitis does not improve after drug withdrawal and in severe cases, oral vancomycin is the treatment of choice for pseudomembranous colitis. Clostridium difficile induced by antibiotics. Other causes of colitis must be excluded.
Hypersensitivity
Cephalosporin antibiotics should be administered with extreme caution to patients with known or suspected allergy to penicillins. Approximately 5% of patients with documented penicillin allergy cross-react to cephalosporin antibiotics. Severe acute hypersensitivity reactions (anaphylaxis) have also been observed in individuals receiving penicillins or cephalosporins, and cross-reactivity with anaphylaxis may be observed. If an allergic reaction is observed with CEDAX it is recommended to discontinue its use and administer appropriate therapy. Severe anaphylaxis requires appropriate emergency treatment as clinically indicated (adrenaline, intravenous fluid infusion, administration of oxygen, antihistamines, corticosteroids, other pressor amines). Extreme caution should also be exercised when administering CEDAX to patients with reactions allergic of any kind (eg hay fever or bronchial asthma), as these patients are at an increased risk of severe hypersensitivity reactions.
If convulsions or allergic shock occur during use of CEDAX, administration of CEDAX should be discontinued immediately and appropriate medical treatment initiated promptly.
Hematology
Cephalosporins, including ceftibuten, may in rare cases decrease prothrombin activity leading to prolongation of thromboplastin time, especially in patients previously stabilized on oral anticoagulant therapy. Thromboplastin time or the International Normalized Ratio (INR) should be monitored. If indicated, vitamin K should be administered to these patients.
General
CEDAX granules for oral suspension should be taken on an empty stomach. CEDAX capsules can be taken with or without meals.
Excipients
The granules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose / galactose malabsorption syndrome or sucrase-isomaltase deficiency should not take this medicine.
Upon opening the bottle or sachets, a sulphurous odor may be detected which does not alter the quality of the product. After reconstitution, the sulphurous odor disappears.
Pediatric use:
See section 4.3 "Contraindications".
04.5 Interactions with other medicinal products and other forms of interaction
Interaction studies have been conducted between CEDAX and each of the following substances: antacids with a high content of aluminum-magnesium hydroxide, ranitidine and theophylline in a single dose administered intravenously. No significant interactions occurred. The effects of CEDAX on plasma levels and pharmacokinetics of orally administered theophylline are unknown.
Cephalosporins, including ceftibuten, may in rare cases decrease prothrombin activity leading to prolonged prothrombin time, especially in patients previously stabilized on oral anticoagulant therapy. Prothrombin time should be monitored in patients at risk, by administering vitamin if necessary. K.
No significant interactions with other drugs have been reported to date. No chemical interactions or laboratory tests have been observed with CEDAX. A false positive in direct Coombs test has been reported with the use of other cephalosporins. However, the results of tests using erythrocytes from healthy volunteers to evaluate the ability of CEDAX to cause reactions "in vitro" in the of direct Coombs, did not show positive reactions even up to concentrations of 40 mcg / ml.
Concomitant food intake does not interfere with the efficacy of CEDAX capsules, while it may delay and decrease the absorption of CEDAX suspension.
04.6 Pregnancy and lactation
There are no adequate and controlled studies on the use of the drug in pregnant women or during labor or delivery. Since there is currently no clinical experience in the use of ceftibuten during pregnancy, the product should only be administered when really necessary, under the direct supervision of the physician. Since reproductive studies in animals are not always predictive for humans, administration of CEDAX during pregnancy and lactation should be evaluated in terms of the potential risk and benefit for both the mother and the the fetus.
Ceftibuten is excreted in breast milk, therefore infants may experience changes in the intestinal flora with diarrhea and colonization of yeasts, such as to require the eventual suspension of breastfeeding.
Due to the development of possible sensitization, CEDAX should only be administered during lactation when the benefits outweigh the risks.
04.7 Effects on ability to drive and use machines
CEDAX has no effect on the ability to drive and use machines.
04.8 Undesirable effects
Summary of the safety profile
In clinical studies, which were conducted in approximately 3,000 patients, the most frequently reported adverse effects were nausea (3%), diarrhea (3%) (see section 4.4) and headache (2%).
Table of adverse reactions
Within the system organ classification, adverse events are listed using the following frequency categories: common (≥1 / 100,
Within each frequency group, undesirable effects are presented in order of decreasing severity.
* observed with other cephalosporins and which may occur with the use of CEDAX.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency, website web http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No toxic manifestations were found following an accidental overdose of CEDAX.
Gastric lavage may be indicated, there is no specific antidote. High amounts of CEDAX can be removed from the bloodstream by hemodialysis. The actual removal by peritoneal dialysis has not been determined.
In adult healthy volunteers who received single doses of up to two grams of CEDAX, no serious adverse reactions were observed and all laboratory and clinical tests showed normal values.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Beta ≥lactam antibacterials. Cephalosporins.
ATC code: J01DD14
CEDAX is a semi-synthetic cephalosporin antibiotic. Ceftibuten has a broad spectrum of bactericidal activity against Gram-negative and Gram-positive bacteria. Ceftibuten has been shown to have high activity (low MIC) against E. coli, Klebsiella sp., Proteus, Salmonella spp. ., Haemophilus influenzae and Streptococcus pyogenes. It is also active against Citrobacter sp., Moraxella (Branhamella) catarrhalis, Morganella morganii, Enterobacter spp., Serratia spp. and Streptococcus pneumoniae. Susceptible microorganisms include species frequently involved in upper and lower respiratory tract infections and acute and complicated urinary tract infections. It is not active against Staphylococci, Enterococci or Pseudomonas spp. However, these organisms are not commonly implicated in the proposed indications for ceftibuten.
Antibacterial activity and mechanism of action. As with most beta-lactam antibiotics, the bactericidal activity of ceftibuten derives from the inhibition of cell wall synthesis. Thanks to its chemical structure, ceftibuten is highly stable against beta- Lactamase. Many beta-lactamase-producing microorganisms resistant to penicillins or other cephalosporins can be inhibited by ceftibuten. Ceftibuten is highly stable against chromosomal cephalosporinases and plasmid-mediated penicillinases, except for the beta-lactamases produced by B.fragilis . Ceftibuten essentially binds to the PBP-3 of E. coli, giving rise to doses equal to 1 / 4-1 / 2 of the minimum inhibitory concentration (MIC), to the formation of filamentous forms, while lysis is observed at doses equal to 2 times the MIC The minimum bactericidal concentration (CMB) for E. coli sensitive and resistant to ampicillin is almost equal to the MIC. A high bioavailability in extracellular fluids allows ceftibuten to act on only moderately sensitive pathogens "in vitro" (see pharmacokinetics).
Sensitivity test: Diffusion technique: laboratory results obtained using single discs containing 30 mcg of ceftibuten, must be interpreted according to the following criteria: zone diameter ≥21 mm indicates sensitivity; 18-20 mm moderate sensitivity; ≤17 mm resistance. For Haemophilus a zone> 28 mm indicates sensitivity. Isolates of Pneumococcus with an oxacillin zone greater than 20 mm are sensitive to ceftibuten.
Standard procedures require the use of laboratory control organisms.
The 30 mcg disc should give an area with a diameter of 29-35 mm for E. Coli ATCC 25922 and 29-35 mm for H. influenzae ATCC 9247.
Ceftibuten 30 mcg discs should be used for all tests in vitro of the blocks. The class of discs (cephalothin) used to test for sensitivity to cephalosporin is not appropriate due to differences in the spectrum with ceftibuten.
Dilution technique: Microorganisms can be considered sensitive to ceftibuten if the MIC is ≤ 8 mcg / ml and resistant if the MIC is> 32 mcg / ml. Organisms with an MIC of 16 mcg / ml are moderately sensitive.
Like standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard ceftibuten powder gives MIC values between 0.125 and 0.5 mcg / mL for 1 "E. Coli ATCC 25922,> 32 mcg / mL for S. aureus ATCC 29213, and 0.25-1.0 mcg / mL for H. influenzae ATCC 49247.
"In vitro" antibacterial activity: ceftibuten shows a marked bactericidal activity; the number of live bacterial cells declines sharply at concentrations equal to 50% or more of the MIC; at concentrations equal to 2 times the MIC mortality is 99.9% with no regrowth observed in 24 hours.
In healthy volunteers treated with doses up to 2 g of CEDAX, no serious side effects were observed and all laboratory parameters remained within normal limits.
05.2 "Pharmacokinetic properties
Doses administered orally are well absorbed, reaching maximum plasma concentration in 2-3 hours. The mean plasma peak after oral administration of a single 200 mg dose is 9.9 mcg / ml (range: 7.7-11.9 mcg / ml); while after administration of a single oral dose of 400 mg the mean plasma peak is about 17.0 mcg / ml (range: 9.5-29.9). When administered in the absence of food, absorption is around 90% of the dose, assessed on the basis of urinary recovery.
Oral administration of 400 mg of CEDAX capsules with a high-calorie (800-calorie), lipid-rich meal slows down but does not decrease the absorption of ceftibuten, while, as some studies have shown, it slows and decreases the absorption of CEDAX. Suspension.
Ceftibuten easily penetrates interstitial fluids, reaching concentrations similar to those in serum, which are maintained longer. The main metabolite, trans-ceftibuten, which has an antibiotic activity 8 times lower than ceftibuten, represents 7.2-9.2% of the total amount of drug excreted. Ceftibuten is excreted via the kidney and 62-68% of the administered dose is excreted unchanged in the urine. Renal clearance is nearly identical to total clearance, indicating that ceftibuten is eliminated primarily via the kidney. The half-life of ceftibuten in healthy subjects is approximately 2-2.3 hours. In subjects with modest renal impairment (creatinine clearance 30 to 49 ml / min) the mean plasma half-life is prolonged to 7.1 hours. The drug can be dialyzed with both hemodialysis and peritoneal dialysis in an amount equal to 65% of the dose.
05.3 Preclinical safety data
Ceftibuten exhibits very low toxicity when administered to laboratory animals at doses 250 to 1,000 times higher than the dose used in humans. Unlike other cephalosporins, ceftibuten does not exhibit nephrotoxicity when administered iv at doses of 1,000 mg / kg to rabbits. . Ceftibuten has a protein binding of about 80% in monkeys, about 30% in rats, about 17% in mice and about 65% in humans. Ceftibuten does not exhibit relevant antigenic potential. Ceftibuten does not show no "disulfiram-like" effect in rats, while showing very low acute and chronic toxicity in rats and dogs at the doses studied (acute toxicity: rat 5000-10,000 mg / kg - dog 2,500-5,000 mg / kg; chronic toxicity: rat 100-1,000 mg / kg - dog 150-600 mg / kg). Ceftibuten does not alter the sexual cycle and reproductive capacity of both rats and their offspring. Ceftibuten does not show any teratogenic effect in rats up to 4,000 mg / kg / day and in rabbits up to 40 mg / kg / day as well as does not induce mutagenic effects in all the tests examined.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
CEDAX 200 mg hard capsules
Microcrystalline cellulose, Sodium amidoglycolate, Magnesium stearate. Capsule components: Gelatin, Titanium dioxide, Sodium lauryl sulfate. Sealing band components: Gelatin, Polysorbate 80.
CEDAX 200 mg granules for oral suspension
Polysorbate 80, Simethicone, Xanthan gum, Anhydrous colloidal silica, Cherry flavor, Titanium dioxide, Sodium benzoate (E211), Sucrose.
CEDAX 400 mg hard capsules
Microcrystalline cellulose, Sodium amidoglycolate, Magnesium stearate. Capsule components: Gelatin, Titanium dioxide, Sodium lauryl sulfate. Sealing band components: Gelatin, Polysorbate 80.
CEDAX 400 mg granules for oral suspension
Polysorbate 80, Simethicone, Xanthan gum, Anhydrous colloidal silica, Cherry flavor, Titanium dioxide, Sodium benzoate (E211), Sucrose.
CEDAX 36 mg / ml granules for oral suspension, bottle
Polysorbate 80, Simethicone, Xanthan gum, Anhydrous colloidal silica, Cherry flavor, Titanium dioxide, Sodium benzoate (E211), Sucrose.
06.2 Incompatibility
None known.
06.3 Period of validity
With intact packaging
CEDAX 200 mg hard capsules: 2 years
CEDAX 200 mg granules for oral suspension: 18 months
CEDAX 400 mg hard capsules: 2 years
CEDAX 400 mg granules for oral suspension: 18 months
CEDAX 36 mg / ml granules for oral suspension, bottle: 18 months
After reconstitution
Reconstituted suspension: 14 days.
06.4 Special precautions for storage
To be kept at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
CEDAX 200 mg hard capsules - 6 hard capsules in blister (non-marketed pack)
CEDAX 200 mg hard capsules ≥ 12 hard capsules in blister (non-marketed pack)
CEDAX 200 mg granules for oral suspension ≥ 6 sachets (non-marketed pack)
CEDAX 200 mg granules for oral suspension ≥ 12 sachets (non-marketed pack)
CEDAX 400 mg hard capsules - 4 hard capsules in blister (non-marketed pack)
CEDAX 400 mg hard capsules - 6 hard capsules
CEDAX 400 mg granules for oral suspension - 4 sachets (non-marketed pack)
CEDAX 400 mg granules for oral suspension - 6 sachets (non-marketed pack)
CEDAX 36 mg / ml granules for oral suspension ≥ 1 bottle
06.6 Instructions for use and handling
Capsules: the capsules should be swallowed with a little water.
Sachets: the contents of the sachets must be dispersed in a small amount of water and drunk immediately.
Preparation of the oral suspension: Shake the bottle before adding the water to facilitate the dispersion of the granulate. Fill the attached meter with water up to the "water level" mark engraved on it. Add half of this water to the bottle, close it, turn it upside down and shake it vigorously. the water left in the meter in the bottle, close and shake vigorously until a complete dispersion of the granulate is obtained. After reconstitution, the suspension is stable for 14 days. Shake the suspension before each administration.
15 g of granules, dispersed in the expected quantity of water, provide 60 ml of suspension containing 36 mg / ml of ceftibuten.
After reconstitution of the suspension, proceed as follows:
1) Remove the colored protective cap of the dispenser;
2) Insert the dispenser all the way into the bottle;
3) Aspirate the suspension by pulling only the graduated piston until reaching the notch corresponding to the weight of the child.
07.0 MARKETING AUTHORIZATION HOLDER
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
08.0 MARKETING AUTHORIZATION NUMBER
CEDAX 200 mg hard capsules - 6 hard capsules 027849064
CEDAX 200 mg hard capsules ≥ 12 hard capsules 027849165
CEDAX 200 mg granules for oral suspension ≥ 6 sachets 027849088
CEDAX 200 mg granules for oral suspension ≥ 12 sachets 027849177
CEDAX 400 mg hard capsules - 4 hard capsules 027849076
CEDAX 400 mg hard capsules - 6 hard capsules 027849140
CEDAX 400 mg granules for oral suspension - 4 sachets 027849090
CEDAX 400 mg granules for oral suspension - 6 sachets 027849153
CEDAX 36 mg / ml granules for oral suspension ≥ 1 bottle 027849102
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
February 17, 1992 / March 2007
10.0 DATE OF REVISION OF THE TEXT
September 2013
