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Sporetik Sporetik DS Division:
Brand
Sub Division :
Antibiotics & Chemotherapeutics
Therapeutic Class
:Beta-Lactams Cephalosporins
DOSAGE FORM COMPOSITION PRESENTATION
CapsuleCefixime 50 mgBox of 3 strips @ 10 capsules
CapsuleCefixime 100 mgBox of 3 strips @ 10 capsules
Dry SyrupCefixime trihydrate 100 mg/5 mlBottle 30 ml

SPORETIK®

Cefixime

Capsule, Dry Syrup


COMPOSITIONS
Capsule : Each capsule contains : Cefixime Trihydrate equivalent to 50/100 mg of Cefixime.
Dry Syrup : Each 5 ml contains : Cefixime Trihydrate equivalent to 100 mg of Cefixime.

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 and negative strains)
  • Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase positive)
  • Escherichia coli
  • Proteus mirabilis
  • Neisseria gonorrhoeae (including penicillinase- and non-penicillinase- producing strains)

SPORETIK® has been shown to be active in vitro against most strains of the following organisms :
Gram-positive organisms :
  • Streptococcus agalactiae
Gram-negative organisms :
  • Haemophilus parainfluenzae (beta-lactamase positive and negative strains)
  • Proteus vulgaris
  • Pasteurella multocida
  • Providencia sp.
  • Salmonella sp.
  • Shigella sp.
  • Citrobacter amalonaticus
  • Serratia marcescens
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
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).

CONTRA-INDICATIONS
Patients with known hypersensitivity to cephalosporin antibiotics.

ADVERSE REACTIONS
SPORETIK® is generally well tolerated.
The majority of adverse reactions were mild and self-limiting in nature.
  • Gastrointestinal disturbances :
    The most frequent adverse reactions are diarrhoea, abdominal pain, nausea, vomiting, dyspepsia, flatulence, pseudomembraneous colitis, anorexia, heart-burn, 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.

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 poor oral nutrition, 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.

DOSAGES
  • 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.
  • 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.
  • 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.

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.

ON MEDICAL PRESCRIPTION ONLY

PRESENTATIONS
SPORETIK® 50 Capsule : Box of 3 strips @ 10 capsules
Reg. No.: DKL9522216501A1
SPORETIK® 100 Capsule : Box of 3 strips @ 10 capsules
Reg. No.: DKL9522216501B1
SPORETIK® 50 Dry Syrup : Bottle containing dry syrup to be dispensed with drinking water up to 30 ml.
Reg. No.: DKL9522216438A1

STORAGE
Keep in a cool (15° - 25° C) and dry place, away from light.
 
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