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Logo ASPEN CEFPODOXIME 40 mg/5 mL (ORAL SUSPENSION)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

ASPEN CEFPODOXIME 40 mg/5 mL (ORAL SUSPENSION)
(powder for oral suspension)

COMPOSITION
Each 5 mL of reconstituted suspension contains cefpodoxime proxetil equivalent to 40 mg
cefpodoxime.
Exipients: Anhydrous citric acid, aspartame*, banana flavour, colloidal anhydrous silica, hydroxylpropyl cellulose, maize starch, microcrystalline cellulose, carboxymethylcellulose sodium, sodium benzoate, spectracol yellow iron oxide and sucrose.
Preservative: Sodium benzoate 0,2% m/v (10 mg per 5 mL of reconstituted suspension).
*CONTAINS PHENYLALANINE.
Contains sugar (sucrose 2,5 g/5 mL).

PHARMACOLOGICAL CLASSIFICATION
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Cefpodoxime proxetil is a semi synthetic beta-lactam antibiotic belonging to the third generation oral cephalosporin group. Cefpodoxime proxetil is the prodrug of the bactericidal antibiotic cefpodoxime. Cefpodoxime possesses in vitrobactericidal activity against a broad spectrum of Gram positive and Gram negative bacteria. In vitrosensitivity does not necessarily imply in vivoefficacy. Cefpodoxime is stable in the presence of the majority of beta-lactamases. The mechanism of action is bactericidal through inhibition of bacterial cell wall biosynthesis enhanced by a high affinity for proteins at the cytoplasmic membrane.
The following organisms are not sensitive: Group D streptococci, Methicillin-resistant staphylococci (S. aureusand S. epidermidis), Staphylococcus saprophyticus, Corynebacteria, groups J and K, Listeria monocytogenes, Pseudomonas aeruginosa and Pseudomonas spp., Acinetobacter baumanii, Clostridium difficile, Bacteroides fragilis and related species.
Pharmacokinetic properties
The bioavailability of cefpodoxime proxetil is increased when the product is administered with meals, or when there is a decrease in gastric pH. An increase in gastric pH results in decreased bioavailability.
Absorption:
After oral administration, cefpodoxime proxetil is absorbed in the gastrointestinal tract and rapidly hydrolysed by non-specific esterases in the gastrointestinal wall to cefpodoxime, the active acid.
Distribution:
After oral administration of a single 5 mg/kg dose (200 mg maximum) of cefpodoxime to subjects between 4 and 12 years of age, the maximum plasma concentration (Cmax) is on average 2,6 mg/L. The time taken to reach the maximum concentration (Tmax) is 2 to 4 hours. The average plasma concentrations observed 8 and 12 hours after administration (residual) are 0,39 and 0,08 mg/L respectively.
Diffusion in fluids and tissues:
Cefpodoxime proxetil diffuses well in lung parenchyma, bronchial mucosa, pleural fluid and tonsils.
Metabolism and elimination:
The main metabolite is cefpodoxime, resulting from the hydrolysis of cefpodoxime proxetil.
The elimination half-life of cefpodoxime is 2,4 hours. 80% of unchanged cefpodoxime is excreted in the urine.

INDICATIONS
ASPEN CEFPODOXIME 40 mg/5 mL is indicated for use in the short-term treatment of infections due to susceptible micro-organisms:
Upper and lower respiratory tract infections
Otitis media
Tonsillitis and pharyngitis
Pneumonia.

CONTRAINDICATIONS
Known sensitivity to cephalosporin antibiotics or to any other ingredient in ASPEN CEFPODOXIME 40 mg/5 mL (see WARNINGS)
ASPEN CEFPODOXIME 40 mg/5 mL must not be given to children with phenylketonuria, since the formulation contains aspartame (20 mg/5 mL)
Safety in pregnancy and lactation has not been established
The use of ASPEN CEFPODOXIME 40 mg/5 mL is strictly contraindicated in patients with a previous history of immediate type hypersensitivity to cephalosporins.

WARNINGS
Preliminary enquiry as to an allergic diathesis and particularly hypersensitivity to beta-lactam antibiotics should precede treatment with ASPEN CEFPODOXIME 40 mg/5 mL.
ASPEN CEFPODOXIME 40 mg/5 mL should be used with extreme caution in patients sensitive to penicillin and other beta-lactam antibiotics as cross-allergy may develop. Strict medical supervision is required throughout the treatment. Hypersensitivity reactions (anaphylaxis) observed with ASPEN CEFPODOXIME 40 mg/5 mL can be serious and occasionally fatal. Treatment should be stopped immediately, should an allergic reaction occur.
Caution is also necessary in patients with a history of allergy (see CONTRAINDICATIONS).

INTERACTIONS
There is a risk of cross-sensitivity between cephalosporins and penicillins
The renal excretion of cefpodoxime as contained in ASPEN CEFPODOXIME 40 mg/5 mL is delayed by probenecid
Absorption of cefpodoxime as contained in ASPEN CEFPODOXIME 40 mg/5 mL is decreased by antacids or histamine H2-receptor antagonists such as ranitidine
There may be antagonism between ASPEN CEFPODOXIME 40 mg/5 mL and bacteriostatic antibacterials
Positive antiglobulin (AGT) test may occur during treatment with ASPEN CEFPODOXIME 40 mg/5 mL
Urinary glucose testing with non-specific reducing agents may yield a false-positive reaction in patients treated with ASPEN CEFPODOXIME 40 mg/5 mL
Concurrent use with anticoagulants, warfarin, may increase the risk of bleeding
Acute renal tubular necrosis has followed excessive dosage and has also been associated with use in older patients and those with pre-existing renal impairment, or when used with nephrotic drugs such as aminoglycosides.

PREGNANCY AND LACTATION
Safety of use in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE
The dosage depends on the weight of the child being treated. The average dose is 8 mg/kg/day administered in two doses at 12 hourly intervals. It must be taken with meals since an increase in gastric pH results in decreased bioavailability.
The following table may be used as a dosage guide:
Weight (kg)         Dose
Between 10 and 15 kg         5 mL every 12 hours
>15 kg         10 mL every 12 hours
The use of ASPEN CEFPODOXIME 40 mg/5 mL in children under one year of age is currently not indicated since insufficient clinical data is available at present.
Elderly patients:
Where renal function is normal, it is not necessary to adjust the dose.
Renal insufficiency in adults and children:
When the creatinine clearance is above 40 mL/min, it is not necessary to adjust the dose.
For values below 40 mL/min, the daily dosage regimen should be reduced by half and administered as a single daily dose for values 10 - 39 mL/min, every second day for values below 10 mL/min and after each dialysis session for haemodialysis patients.

Directions and reconstitution of the suspension
Remove the screw-cap by simultaneously pushing and turning it. Remove the foilseal and discard. A total of 27 mL water is required to make up 50 mL of the suspension in the 75 mL bottle and a total of 54 mL water is required to make up 100 mL of the suspension in the 150 mL bottle. Add water and shake vigorously to disperse all granules.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
Infections and infestations
Frequent: Multiplication of non-sensitive micro-organisms, oral and vaginal candidiasis, super infection
Blood and lymphatic system disorders
Less frequent: Hypoprothrombinaemia, haemolytic anaemia
Frequency unknown: Agranulocytosis, eosinophilia, leucopenia, neutropenia, reduction in haemoglobin, thrombocytosis, thrombocytopenia
Immune system disorders
Less frequent:Anaphylactic reactions, e.g. angioedema, bronchospasm, malaise, serum sickness-like reactions
Nervous system disorders
Frequent: Headache
Less frequent: Seizures
Frequency unknown
: Asthenia, dizziness and paraesthesia
Ear and labyrinth disorders
Less frequent: Hearing loss
Frequency unknown: Tinnitus
Gastrointestinal disorders
Frequent: Abdominal pains, diarrhoea, flatulence, vomiting
Hepatobiliary disorders
Less frequent: Cholestatic jaundice, hepatitis
Skin and subcutaneous tissue disorders
Less frequent: Bullous eruptions, cutaneous eruptions, erythema multiforme, Stevens-Johnson syndrome, skin rashes, pruritus, purpura, urticaria
Renal and urinary disorders
Less frequent: Renal dysfunction
Investigations
Frequency unknown: Increase of ASAT, ALAT, alkaline phosphatase, blood urea, creatinine
Special precautions
Diarrhoea, particularly if severe and/or persistent, occurring during treatment or initial weeks following treatment with ASPEN CEFPODOXIME 40 mg/5 mL may be symptomatic of Clostridium difficile associated disease, the most severe form of which is pseudomembranous colitis. The diagnosis of this rare but possibly fatal condition should be confirmed by colonoscopy and/or histology. This occurrence requires immediate cessation of administration and treatment with appropriate specific antibiotic therapy such as vancomycin given orally when the colitis does not improve or when it is severe. Treatment should be discontinued if symptoms suggestive of pseudomembranous colitis arise. Mild cases of pseudomembranous colitis may respond to discontinuance of ASPEN CEFPODOXIME 40 mg/5 mL. Pseudomembranous colitis may occur even after ASPEN CEFPODOXIME 40 mg/5 mL is discontinued.
Cephalosporins, such as ASPEN CEFPODOXIME 40 mg/5 mL, in high doses frequently give a positive response to the antiglobulin (AGT) test although haemolytic anaemia occurs less frequently.
Convulsions and other CNS toxicity have been associated with high doses, especially in patients with severe renal impairment.
ASPEN CEFPODOXIME 40 mg/5 mL should be given with caution to patients with renal impairment as it may result in increased blood levels and toxicity. Dosage reduction may be necessary. Renal and haematological status should be monitored especially during prolonged high dose therapy.
ASPEN CEFPODOXIME 40 mg/5 mL may interfere with Jaffè method of measuring creatinine concentrations and may produce falsely high values.
ASPEN CEFPODOXIME 40 mg/5 mL contains aspartame, excessive use of aspartame should be avoided by patients with phenylketonuria since one of its metabolic products is phenylalanine (see CONTRAINDICATIONS).
ASPEN CEFPODOXIME 40 mg/5 mL contains 2,5 mg sucrose per 5 mL. This should be taken in account in patients with diabetes mellitus.
Effects on ability to drive and use machines
Dizziness has been reported during treatment with cefpodoxime and may affect the ability to drive and use machines (see Side effects).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
(See SIDE EFFECTS AND SPECIAL PRECAUTIONS).
Treatment should be symptomatic and supportive.
In cases of overdosage, particularly in patients with renal insufficiency, there is a risk of reversible encephalopathy for several cephalosporins.

IDENTIFICATION
An almost white to pale yellow coloured powder for reconstitution. The reconstituted suspension is off-white to pale yellow with a fruity odour.

PRESENTATION
Powder for 50 mL suspension: Packed in a 75 mL translucent HDPE bottle, foil-sealed and with a white child-resistant screw-on cap.
Powder for 100 mL suspension: Packed in a 150 mL translucent HDPE bottle, foil-sealed and with a white child-resistant screw-on cap.
Not all packs and pack sizes are necessarily marketed.

STORAGE INSTRUCTIONS
Before reconstitution
Store at or below 25ºC.
Protect from light and moisture.
After reconstitution
Use within 10 days.
Store in a refrigerator (2 to 8ºC).
Shake before use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
42/20.1.1/0387

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THE PACKAGE INSERT
19 April 2013

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start giving ASPEN CEFPODOXIME 40 mg/5 mL.
•        Keep this leaflet. You may need to read it again.
•        If you have further questions, please ask your doctor or pharmacist.
•        ASPEN CEFPODOXIME has been prescribed for the child personally and you should not share this medicine with other people. It may harm them, even if their symptoms are the same as the child’s.

SCHEDULING STATUS S4
ASPEN CEFPODOXIME 40 mg/5 mL (ORAL SUSPENSION)
(powder for oral suspension)
Cefpodoxime proxetil
.

WHAT ASPEN CEFPODOXIME 40 mg/5 mL CONTAINS
Each 5 mL of reconstituted suspension contains cefpodoxime proxetil equivalent to 40 mg cefpodoxime.
The other ingredients are Anhydrous citric acid, aspartame*, banana flavor, colloidal anhydrous silica, hydroxylpropyl cellulose, maize starch, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, spectracol yellow iron oxide and sucrose.
Each 5 mL of reconstituted suspension contains 10 mg of preservative, sodium benzoate.
*CONTAINS PHENYLALANINE.
Contains sugar (sucrose 2,5 g/5 mL).

WHAT ASPEN CEFPODOXIME 40 mg/5 mL IS USED FOR
ASPEN CEFPODOXIME 40 mg/5 mL is an antibiotic and kills germs.
It is used in treating infections of the:
Upper and lower airway system
Middle ear
The tonsils and throat
Lungs.

BEFORE YOU GIVE ASPEN CEFPODOXIME 40 mg/5 mL
Do not give ASPEN CEFPODOXIME 40 mg/5 mL:
If the child is allergic to cefpodoxime proxetil, the active ingredient in ASPEN CEFPODOXIME 40 mg/5 mL or any of the other ingredients of ASPEN CEFPODOXIME 40 mg/5 mL
If the child has a history of allergic reactions to cephalosporins (a group of antibiotics), as serious allergic reactions can be fatal
If the child has phenylketonuria
In patients who are pregnant or breastfeeding.

Take special care with ASPEN CEFPODOXIME 40 mg/5 mL:
Tell your doctor or pharmacist if your child:
Is sensitive to penicillin and other beta-lactam antibiotics (e.g. amoxicillin, ampicillin) as cross-allergy may develop
Had a history of any allergic reactions
Requires any tests such as Jaffè test (measure creatinine in blood), Coombs test also called antiglobilin test (AGT) (blood test for low red blood cells), or glucose tests in urine as these test may show a false positive result
Has kidney problems as a high dose can cause convulsions and other toxic effects in the brain and spinal cord
Develops diarrhoea, it may be a symptom of another disease called Clostridium difficile and can lead to pseudomembranous colitis, a severe inflammation of the colon, often resulting from eradication of the normal gut flora by antibiotics.

Taking ASPEN CEFPODOXIME 40 mg/5 mL with food and drink:
Give this medicine with meals, never on an empty stomach
Give this medicine to your child by mouth
Use a 5 mL measuring spoon to give the medicine.

Pregnancy and breastfeeding:
The safety of ASPEN CEFPODOXIME 40 mg/5 mL in pregnancy and lactation has not been established.
If the child is pregnant or breastfeeding while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Driving and using machinery:
Dizziness has been reported during treatment with cefpodoxime and may affect the ability to drive and use machines.

Important information about some of the ingredients of ASPEN CEFPODOXIME 40 mg/5 mL:
ASPEN CEFPODOXIME 40 mg/5 mL contains aspartame as a sweetener. Aspartame must not be given to children with phenylketonuria (an inherited defect of protein metabolism).
ASPEN CEFPODOXIME 40 mg/5 mL contains 2,5 mg/5 mL sugar, it must not be given if your child cannot tolerate or digest some sugars, and it should be taken in account if your child is a diabetic patient.

Giving other medicines with ASPEN CEFPODOXIME 40 mg/5 mL:
If you are giving other medicines on a regular basis, including complementary or traditional medicines, the use of ASPEN CEFPODOXIME 40 mg/5 mL with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice.
If you feel the effect of ASPEN CEFPODOXIME 40 mg/5 mL is too weak or to strong, do not change the dose yourself, but ask your child’s doctor.

Tell your child’s doctor if you are giving any of the following to your child:
There is a risk if your child is sensitive or allergic to other cephalosporins or penicillins that they may be allergic to ASPEN CEFPODOXIME 40 mg/5 mL
Antacids (used to treat indigestion)
Medicines for treating ulcers (such as ranitidine)
ASPEN CEFPODOXIME 40 mg/5 mL may reduce the effectiveness of bacteriostatic antibacterials (used to treat infections) such as sulphonamides, tetracyclines, chloramphenicol, erythromycin, trimethoprim
Aminoglycoside antibiotics (used to treat infections) such as amikacin, gentamicin or neomycin
Probenecid (a medicine used to increase urine acid excretion) as it increases the blood levels of ASPEN CEFPODOXIME 40 mg/5 mL and may increase the chances of side effects
Warfarin (used to thin the blood) as ASPEN CEFPODOXIME 40 mg/5 mL may increase the risk of bleeding
If your child has diabetes, as ASPEN CEFPODOXIME 40 mg/5 mL may cause false test results with some urine sugar tests.

HOW TO GIVE ASPEN CEFPODOXIME 40 mg/5 mL
Do not share medicines prescribed for your child with any other person.
Always give ASPEN CEFPODOXIME 40 mg/5 mL exactly as your doctor has instructed you.
You should check with your doctor or pharmacist if you are unsure.
The doctor will tell you how long your child’s treatment with ASPEN CEFPODOXIME 40 mg/5 mL will last. Do not stop treatment early because the success of the treatment depends on finishing the course.
The usual dose is one or two medicine measures every 12 hours. The dose depends on the weight of the child being treated. If the child has kidney problems, your doctor may tell you to give half the dose.
Instructions for use:
Give the medicine 12 hours apart, in the morning and in the evening, with food
Shake well before use
Keep in the fridge
Finish the course.
If you give more ASPEN CEFPODOXIME 40 mg/5 mL than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.
If you forget to give ASPEN CEFPODOXIME 40 mg/5 mL:
If you miss a dose of ASPEN CEFPODOXIME 40 mg/5 mL, give it as soon as you remember and then continue as before. Do not give a double dose to make up for forgotten individual doses.

Effects when treatment with ASPEN CEFPODOXIME 40 mg/5 mL is stopped:
If you stop giving ASPEN CEFPODOXIME 40 mg/5 mL before the course is finished, the treatment may fail.

POSSIBLE SIDE EFFECTS
ASPEN CEFPODOXIME 40 mg/5 mL can have side effects.
Not all side effects reported for ASPEN CEFPODOXIME 40 mg/5 mL are included in this leaflet. Should the child’s general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happen, stop giving ASPEN CEFPODOXIME 40 mg/5 mL and contact your doctor immediately or go to the casualty department at your nearest hospital:
- Swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
- Skin rash, itching or redness.
- Diarrhoea, which can result as a complication of antibiotic therapy. The child must immediately stop taking ASPEN CEFPODOXIME 40 mg/5 mL if this happens. This is a serious side effect and the child may need urgent medical attention. These serious side effects usually occur less frequently.
The following has been reported frequently:
Black tarry stools, chest pain, chills, cough, fever, headaches, diarrhoea, flatulence, oral and vaginal candida (yeast) infections, painful or difficulty to urinate, shortness of breath, sore throat, sores, stomach pains, ulcers or white spots on lips or in mouth, swollen glands, unusual bleeding or bruising, unusual tiredness or weakness, vomiting.
The following has been reported less frequently:
Severe abdominal or stomach cramps and pain, abdominal tenderness, diarrhoea (watery and severe, which may also be bloody), hives or wheals, hypoprothrombinaemia (a blood disorder results in impaired blood clotting), jaundice (yellowing of the whites of the eyes, skin, and mucous membrane), low red blood cell count, itching, redness of skin, or skin rash, peeling of skin; seizures.
Note:
Some of these side effects may also occur up to several weeks after the child stopped taking ASPEN CEFPODOXIME 40 mg/5 mL.

After the child stopped taking ASPEN CEFPODOXIME 40 mg/5 mL, it may still produce side effects that need attention.
Contact your doctor immediately if you notice any of the following side effects:
Blistering, peeling or loosening of skin; decrease in urine output; joint pain; hearing loss; loss of appetite; nausea or vomiting; red or irritated eyes; trouble in breathing; yellowing of the eyes and skin, severe diarrhoea.
Tell your doctor if any of the following side effects continue or are bothersome:
Mild diarrhoea; headache; sore mouth or tongue; mild stomach cramps; vaginal itching or discharge.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

STORING AND DISPOSING OF ASPEN CEFPODOXIME 40 mg/5 mL
Before reconstitution:
Store at or below 25ºC.
Protect from light and moisture.
After reconstitution:
Use within 10 days.
Store in a refrigerator (2 to 8ºC).
Shake before use.
KEEP OUT OF REACH OF CHILDREN.

PRESENTATION OF ASPEN CEFPODOXIME 40 mg/5 mL
Powder for 50 mL suspension: Packed in a 75 mL translucent HDPE bottle, foil-sealed and with a white child-resistant screw-on cap.
Powder for 100 mL suspension: Packed in a 150 mL translucent HDPE bottle, foil-sealed and with a white child-resistant screw-on cap.
Not all packs and pack sizes are necessarily marketed.

IDENTIFICATION OF ASPEN CEFPODOXIME 40 mg/5 mL
The suspension is off-white to pale yellow with a fruity odour.

REGISTRATION NUMBER
42/20.1.1/0387

NAME AND ADDRESS OF REGISTRATION HOLDER
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION
19 April 2013

New addition to this site: October 2014
Source: Pharmaceutical Industry

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