Sporetik

Sporetik

cefixime

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Cefixime Trihydrate.
Description
SPORETIK 50 Capsule: Each capsule contains: Cefixime Trihydrate equivalent to 50 mg of Cefixime.
SPORETIK 100 Capsule: Each capsule contains: Cefixime Trihydrate equivalent to 100 mg of Cefixime.
SPORETIK 200 Film-coated caplet: Each film-coated caplet contains: Cefixime Trihydrate equivalent to 200 mg of Cefixime.
SPORETIK Dry syrup: After reconstitution, each 5 mL contains: Cefixime Trihydrate equivalent to 100 mg of Cefixime.
Action
Pharmacology: SPORETIK contains Cefixime, a semisynthetic third generation cephalosporin antibiotic for oral administration.
The bactericidal action of SPORETIK results from inhibition of cell-wall synthesis.
SPORETIK is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to SPORETIK.
SPORETIK has been shown to be active against most of the following organisms both in vitro and in clinical infections: Gram-positive organisms: Streptococcus pneumoniae; Streptococcus pyogenes.
Gram-negative organisms: Haemophilus influenzae (beta-lactamase positive); Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase positive); Escherichia coli; Proteus mirabilis.
SPORETIK has been shown to be active in vitro against most strains of the following organisms: Gram-positive organisms: Streptococcus agalactiae.
Gram-negative organisms: Neisseria gonorrhoeae (beta-lactamase positive and negative strains); Haemophilus parainfluenzae (beta-lactamase positive and negative strains); Proteus vulgaris; Pasteurella multocida; Providencia sp.; Serratia marcescens; Salmonella sp.; Shigella sp.; Citrobacter amalonaticus.
The average serum half-life of Cefixime in healthy subjects is 3 to 4 hours. In subjects with moderate impairment of renal function the average serum half-life of Cefixime is prolonged to 6.4 hours and in severe renal impairment the half-life increased to an average of 11.5 hours.
Indications/Uses
SPORETIK is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Uncomplicated urinary-tract infections caused by Escherichia coli and Proteus mirabilis, e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.
Upper respiratory-tract infections: Otitis media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase positive) and Streptococcus pyogenes; Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Lower respiratory-tract infections, e.g. acute bronchitis and acute exacerbations of chronic bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains).
Dosage/Direction for Use
Adults and children weighing ≥30 kg or over 12 years: 50-100 mg twice daily.
Dosage should be adjusted according to the age, bodyweight and condition of the patients.
For more severe or intractable infections, the dosage may be increased up to 200 mg, twice daily.
For uncomplicated gonorrhoeae, a single dose of 400 mg of Cefixime may be given.
Children weighing <30 kg: 1.5-3 mg/kg body-weight/day administered in divided doses, twice daily.
Dosage should be adjusted according to the age, bodyweight and condition of the patients.
For more severe or intractable infections, the dosage may be increased up to 6 mg/kg bodyweight, twice daily.
In the children, otitis media should be treated with SPORETIK Suspension and should not be substituted by SPORETIK Capsule. The clinical testing of otitis media shows that drug assay in the blood is higher for suspension rather than tablet in the same dose.
Patients with impaired renal function require modification of dosage depending on the degree of impairment.
Patients with creatinine clearances >60 mL/minute: Standard dosage.
Patients with creatinine clearances between 21-60 mL/minute: 75% of the standard dosage.
Patients with creatinine clearances <20 mL/minute: 50% of standard dosage.
Contraindications
Patients with known hypersensitivity to cephalosporin antibiotics.
Special Precautions
The dose should be adjusted in patients with impaired renal function.
It should be used in pregnant and nursing women only if clearly needed.
Safety and effectiveness of drug in children aged less than 6 months old have not been established.
It should be given with caution to penicillin-sensitive patients.
It should be carefully administered to patients with a personal or familial history of some forms of allergies such as bronchial asthma, rash or urticaria.
It should be carefully administered to patients with nutrition deficiency, patients receiving parenteral nutrition, elderly patients or patients in a debilitated state.
It should be used with caution in patients with a history of gastrointestinal disease, particularly colitis.
Prolonged treatment may result in overgrowth of resistant organisms. If superinfection occurs, treatment should be discontinued.
Use In Pregnancy & Lactation
It should be used in pregnant and nursing women only if clearly needed.
Adverse Reactions
SPORETIK is generally well tolerated.
The majority of adverse reactions were mild and self-limiting in nature.
Gastrointestinal disturbances: Gastrointestinal disturbance is the most frequent adverse reactions which occured, such as diarrhoea, abdominal pain, nausea, vomiting, dyspepsia, flatulence, pseudomembraneous colitis, anorexia, heartburn, constipation.
Hypersensitivity reactions: Skin rash, urticaria, erythema, pruritus.
Hepatic: Transient elevations in SGPT, SGOT and alkaline phosphatase.
Haematologic: Transient thrombocytopenia, leukopenia and eosinophilia may occasionally occur.
Central nervous system: Headache, dizziness.
Others: Shock, genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction, haemorrhage and colitis.
Abnormal laboratory tests: Positive direct Coombs test, neutropenia, agranulocytosis, elevated bilirubin and LDH.
Caution For Usage
Directions for reconstitution: Pour 10 mL of drinking water, shake for 30 seconds, pour further 10 mL of drinking water, shake again to make homogenous suspension. After reconstitution the suspension may be used within 7 days and stored at room temperature (25°-30°C) or in refrigerator (2°-8°C). Discard any unused suspension after 7 days. Shake well before used.
Storage
Store below 30°C.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Cap 50 mg x 3 x 10's. 100 mg x 3 x 10's. FC caplet 200 mg x 1 x 10's. Dry syr 100 mg/5 mL x 30 mL x 1's.
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