1. Name Of The Medicinal Product
Baxan Capsules 500mg
Baxan Suspension 125mg/5ml, 250mg/5ml and 500mg/5ml
2. Qualitative And Quantitative Composition
Baxan Capsules: contain Cefadroxil Monohydrate equivalent to 500mg cefadroxil activity.
Baxan Suspension: contains Cefadroxil Monohydrate equivalent to 125mg, 250mg or 500mg cefadroxil activity per 5ml.
3. Pharmaceutical Form
Capsule.
Oral suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
Baxan is indicated in the treatment of the following infections when due to susceptible micro-organisms:
Respiratory tract infections:
Tonsillitis, pharyngitis, lobar and bronchopneumonia, acute and chronic bronchitis, pulmonary abscess, empyema, pleurisy, sinusitis, laryngitis, otitis media.
Skin and soft-tissue infections:
Lymphadenitis, abscesses, cellulitis, decubitus ulcers, mastitis, furunculosis, erysipelas.
Genitourinary tract infections:
Pyelonephritis, cystitis, urethritis, gynaecological infections.
Other infections:
Osteomyelitis, septic arthritis.
4.2 Posology And Method Of Administration
The bioavailability and consequent chemotherapeutic effects of cefadroxil are unaffected by food. It may, therefore, be taken with meals or on an empty stomach.
Adults and Children Weighing More Than 40kg (88lbs):
500mg to 1g twice a day, depending upon the severity of infection.
Alternatively, in skin and soft tissue and uncomplicated urinary tract infections, 1g once a day.
In the treatment of beta-haemolytic streptococcal infections, Baxan should be administered for at least 10 days.
Children Weighing Less Than 40kg (88lbs):
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Elderly:
No specific dosage recommendations or precautions for use in the elderly except to monitor those patients with impaired renal function.
The bioavailability and consequent chemotherapeutic effects of cefadroxil are unaffected by food. It may, therefore, be taken with meals or on an empty stomach.
Renal Impairment:
In patients with renal impairment, the dosage should be adjusted according to creatinine clearance rates to prevent drug accumulation and serum levels should be monitored.
The following schedule is suggested. In adults, the initial dose of 1g of Baxan and the maintenance dose (based on the creatinine clearance rate) is 500mg at the time intervals listed below:
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Patients with creatinine clearance rates over 50 mL/min/1.73m2 may be treated as if they were patients having normal function
4.3 Contraindications
Baxan is contra-indicated in patients with a history of hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
In patients with a history of penicillin allergy, Baxan should be used with caution. There is evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Should an allergic reaction to Baxan occur, the drug should be discontinued and the patient treated with the usual agents (pressor amines, corticosteroids and/or antihistamines), depending on the severity of the reaction.
As experience in premature infants and neonates is limited, the use of Baxan in these patients should only be undertaken with caution.
As with all antibiotics, prolonged use may result in overgrowth of non-susceptible organisms.
As with other broad spectrum antibiotics, pseudomembranous colitis has been reported. It is important to consider its diagnosis in patients who develop diarrhoea in association with Baxan therapy.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There are not sufficient data available to indicate whether the concurrent use of Baxan and potential nephrotoxic agents such as aminoglycosides causes any alteration in their nephrotoxic effects.
A false-positive Coombs' reaction may occur in some patients receiving Baxan.
Urine from patients treated with Baxan may give a false-positive glycosuria reaction when tested with Benedict's or Fehling's solutions. This does not occur with enzyme based tests.
4.6 Pregnancy And Lactation
Although animal studies and clinical experience have not shown any evidence of teratogenicity, the safe use of Baxan during pregnancy has not been established. Baxan is excreted in breast milk and should be used with caution in lactating mothers.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
The most commonly reported side-effects are gastrointestinal disturbances and hypersensitivity phenomena. Rash, pruritus, urticaria, angioneurotic oedema have been observed infrequently. Serum sickness, erythema multiforme and anaphylaxis have been reported rarely. Side-effects, including nausea, vomiting, diarrhoea, dyspepsia, abdominal discomfort, fever, dizziness, headache, arthralgia and genital moniliasis may also occur. Reversible neutropenia may occur rarely, as may leucopenia, thrombocytopenia, agranulocytosis and minor elevations in serum transaminase and Stevens-Johnson syndrome. Colitis, including rare instances of pseudo-membraneous colitis, has been reported.
During postmarketing experience, hepatic dysfunction, including cholestasis has been reported and rare reports of idiosyncratic hepatic failure has been received
4.9 Overdose
Ingestion of < 250 mg/kg in children under six years of age was not associated with significant outcomes. The patient should be observed and treated symptomatically. For amounts > 250 mg/kg gastric lavage or stimulation of vomiting is appropriate.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Baxan is a cephalosporin antibiotic, bactericidal in vitro against a wide range of Gram-positive and Gram-negative micro-organisms. Baxan inhibits mucopeptide synthesis in the bacterial cell wall, making it defective and osmotically unstable. The action in vivo is usually bactericidal, depending on organism susceptibility, dose, tissue concentrations and the rate at which organisms are multiplying. It is more effective against rapidly growing organisms forming cell walls. In vitro, Baxan is bactericidal against a wide range of organisms. Sensitive Gram-positive organisms include: penicillinase and non-penicillinase-producing Staphylococci, beta-haemolytic Streptococci, Streptococcus pneumoniae and Streptococcus pyogenes. Sensitive Gram-negative organisms include Escherichia coli, Klebsiella species, Proteus mirabilis, Moraxella (Branhamella) catarrhalis and Bacteroides spp. (excluding Bacteroides fragilis) and some strains of Haemophilus influenzae.
5.2 Pharmacokinetic Properties
Baxan is rapidly absorbed after oral administration. The bioavailability is unaffected by food. Following single doses of 500 and 1,000mg, average peak serum levels were approximately 16 and 28 µg/ml, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1,800 µg/ml after a 500mg dose. Increases in dose generally produce a proportionate increase in Baxan urinary concentration. Oral dosing produces effective tissue penetration in lungs, tonsils, liver, gall bladder, bile duct, prostate, bone, muscle and synovial capsule as well as saliva, sputum, pleural exudate, bile and synovial fluid. The half-life is approximately 80-120 minutes and protein binding is approximately 20%. In addition, Baxan is soluble in lipids (0.19 mg/ml ether) and in water (12.79 mg/ml).
5.3 Preclinical Safety Data
No additional relevant data.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Baxan Capsules:
Colloidal silicon dioxide, lactose, magnesium stearate; gelatin capsules contain gelatin and titanium dioxide.
Baxan Suspensions:
Flavours, polysorbate 40, sodium benzoate, sucrose, titanium dioxide and xanthan gum.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Capsules and Suspensions:
36 months
6.4 Special Precautions For Storage
Baxan Capsules:
Store below 30°C.
Baxan Suspensions:
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6.5 Nature And Contents Of Container
Baxan Capsules:
Blister packs consisting of PVC/PVDC laminate and aluminium foil containing 20 capsules.
Baxan Suspensions:
HDPE bottles with polyethylene closures containing 60ml.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Bristol-Myers Squibb Holdings Limited
t/a Bristol-Myers Pharmaceuticals
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex
UB8 1DH
8. Marketing Authorisation Number(S)
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9. Date Of First Authorisation/Renewal Of The Authorisation
Baxan Capsules:
2nd November 1979 / 9th July 2001
Baxan Suspensions:
11th December 1979 / 8th July 2001
10. Date Of Revision Of The Text
Baxan Capsules:
19th August 2009
Baxan Suspensions:
19th August 2009
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