Nucef

NUCEF

Composition

Each NUCEF® capsule contains Cefixime trihydrate equivalent to Cefixime 100 mg

Each NUCEF® film-coated caplet contains Cefixime trihydrate equivalent to Cefixime 200 mg

Each 5 ml of NUCEF® syrup contains Cefixime trihydrate equivalent to Cefixime 100 mg

 

Pharmacology

Cefixime is an antibiotic with a broad spectrum of action against gram-positive and gram-negative microorganisms.

In particular, when compared to other cephalosporins, it has potent activity against gram-positive bacteria such as Streptococcus sp, Streptococcus pneumoniae, and gram-negative bacteria such as Branhamella catarrhalis, Escherichia coli, Proteus sp, Haemophilus influenza, Neisseria gonorrhoeae.

Cefixime has a bactericidal action. Cefixime is very stable against -lactamase produced by many organisms and has good activity against -lactamase-producing organisms.

The way Cefixime works is to inhibit the synthesis of bacterial cell walls. Cefixime has a high affinity for Penicillin Binding Protein (PBP) 1 (1a, 1b, and 1c) and 3, with the site of action varying depending on the organism.

 

Indication

Cefixime is indicated for the treatment of infections caused by the following microorganisms:

  • Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
  • Otitis media caused by Haemophillus influenzae (β-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (especially -lactamase positive strains) and Streptococcus pyogenes.
  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes
  • Acute bronchitis and acute exacerbation of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase positive and negative strains).
  • Treatment of typhoid fever in children with multi-resistant to standard treatment.
  • Uncomplicated gonorrhea (cervical or urethral) caused by Neisseria gonorrhoeae (penicillinase-producing and non-penicillinase-producing strains).

 

Dose

  • NUCEF® Membrane-Coated Capsules and Caplets: Adults and children weighing 30 kg: the recommended daily dose is 50-100 mg given 2 times a day. Dosage should be adjusted based on the age, weight and condition of the patient. In severe infections, the dose may be increased to 200 mg given twice daily.
  • NUCEF® dry syrup: daily dose for children is 1.5 – 3 mg (potency)/kgBW given orally 2 times a day. The dose should be adjusted according to the patient’s condition. For more severe infections, the dose may be increased to 6 mg (potency)/kg body weight given orally 2 times a day.
  • Otitis media in children should be treated with suspension. Clinical studies of otitis media have shown that administration of the suspension achieves higher peak plasma levels than the administration of tablets at the same dose.
  • Typhoid fever in children: 10-15 mg/kg BW/day for 2 weeks
  • Patients with impaired renal function require dose adjustment depending on the severity. If the creatinine clearance is between 21 – 60 mL/min or the patient is receiving hemodialysis, the recommended dose is 75% of the standard dose (eg 300 mg daily). If the creatinine clearance is less than 20 mL/min or the patient is on continuous outpatient peritoneal dialysis (CAPD), the recommended dose is 50% of the standard dose (eg 200 mg daily).
  • For uncomplicated gonorrhea (cervical or urethral), a single dose of 400 mg is recommended.

 

How to Dissolve the Syrup:

Add 20 ml of boiled water, shake for 60 seconds. After reconstitution, the suspension can be stored for 7 days after reconstitution at 15 – 25ºC, without significant loss of potency. Keep it tightly closed. Do not use more than 7 days after reconstitution.

 

Storage

Store at temperatures below 30ºC

 

Packaging

NUCEF® Capsule                       Box, 3 strips @ 10 capsules                      Reg Number. : DKL0808014601A1

NUCEF® Dry Syrup                   Box, bottle @ 30 ml                                  Reg Number. : DKL0808014938A1

NUCEF® Film Coated Caplet       Box, 1 strip @ 10 film-coated caplets         Reg Number. : DKL1908026509A1

 

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