Forta

Composition :

Each vial FORTA® contain dry powder which contain Ceftazidime Buffered with Sodium Carbonate equivalent with Ceftazidime 1 g

Each ampoule solvent contain aqua pro injection 10 ml

Pharmacology :

Various pathogenic strains and susceptible isolates in-vitro include strains that are resistant to gentamicin and other aminoglycosides.

Ceftazidime is highly stable betalactamase for clinical which produced by both gram-positive and gram-negative, therefore many ampicillin and cephalothin strains are resistant to active risk. Ceftazidime has high intrinsic activity in in-vitro and works most commonly in a narrow MIC range with slight changes in MIC at varying inoculum levels. In-vitro activity Cefftazidime and aminoglycosides in combination may increase, with evidence of synergies in some strains.

In vitro, Ceftazidime is active against the following bacteria:

AEROB

Gram negative bacteria

Pseudomonas aeroginosa, Pseudomonas spp., E. coli, Klebsiella spp (included K. pneumonia), Proteus mirabilis, Proteus vulgaris, Morganella morganii (previously Proteus morganii), Proteus rettgeri, Providencia spp., Enterobacter spp., Citrobacter spp., Serratia spp., Salmonella spp., Shigella spp., Yersinia enterocolitica., Pasteurella multocida., Acinetobacter spp., Neisseria gonorrhoeae, Neisseria meningitides, Haemophilus influenzae (included strain resisten ampisilin), Haemophilusparainfluenzae (included strain resisten ampisilin)

Gram positive bacteria

Staphylococcus aureus (Methicyllin sensitive strain , Staphylococcus epidermidis (Methicyllin sensitive strain, Micrococcus spp., Streptococcus pyogenes (Streptococci β – hemolitik Group A), Streptococcus Group B (S. agalacytiae), Streptococcus pneumonia, Streptococcus mitis, Streptococcus spp (except Streptococcus faecalis)

Anaerob abcteria

Peptococcus spp., Peptostreptococcus spp., Streptococcus spp., Propionibacterium spp., Clostridium perfringens, Fusobacterium spp., Bacteroides spp.( several strains from Bacteroides fragilis is resistant).

In vitro, Ceftazidime is not against atypical methicillin-resistant Staphylococcus, Streptococcus faecalis and other enterococcus, Lesteria monocytogenes, Camphylobacter spp. or Clostridium difficile.

Indication :

Ceftazidime is indicated for the treatment of serious infections caused by susceptible organisms.

Ceftazidime is a bactericidal antibiotic cephalosporin that is resistant to some betalactamases and Ceftazidime is active against various gram-positive and gram-negative bacteria. Because of its broad antibacterial spectrum, Ceftazidime may be used singly in the case of emergencies, depending on the results of the sensitivity test. In meningitis, it is recommended to test for sensitivity first before single Ceftazidime therapy is given.

Ceftazidime can be used for a variety of infections caused by other antibiotic resistant organisms, including aminoglycosides and some cephalosporins. Ceftazidime may be combined with other aminoglycosides or betallactam antibiotics, eg in severe neutropenia or with antibiotics that can fight anaerobic bacteria if suspected cause Bacteroides fragilis (see section Warning).

Infections which caused by sensitive bacteria, such as:

  • Common infections: septicemia, bacteremia, peritonitis, meningitis, infection in immunosuppressed patients with haematological malignancy or solid malignancy, and in ICU patients with specific problems, eg infected burns.
  • Lower respiratory tract infections: pneumonia, bronchopneumonia, pleuritis in pulmo, empyema, lung abscess, infected bronchiectasis, pulmonal abcess, pulmonal infections in patients with cystic fibrosis.
  • Urinary tract infections: acute and chronic pyelonephritis, pyelitis, prostatitis, various renal abcess.
  • Skin and soft tissue infections: eg erysipelas, cellulitis, infected wounds and burns, mastitis, skin ulcers.
  • Bone and joint infections: osteitis, osteomyelitis, septic arthritis, infected bursitis.
  • Abdominal and biliary infections: cholangitis, cholecystitis, gallbladder empyema, peritonitis, diverticulitis, pelvic inflammatory disease.
  • Dialysis: infections associated with hemodialysis and peritoneal dialysis and CAPD (continuous ambulatory peritoneal dialysis).

Dosage :

Ceftazidime is used parenteral, the dose depends on the severity of the infection, the sensitivity and type of infection and the age, weight and kidney function of the patient.

Use FORTA® by intravenously or intramuscularly. Intramuscular injection is recommended in the upper outer quadrant of the gluteus maximus or lateral portion of the thigh.

FORTA® can be administered directly into a vein or inserted into a tube to regulate if the patient is administered parenteral.

Adult:

1 – 6 gram/day in two or three doses divided by injection i.v or i.m.

Urinary tract infections and less serious infections:

  • 500 mg or 1 g every 12 hours

Most infections:

  • 1 g every 8 hours or 2 g every 12 hours

Severe infection especially for immune compromised patients, including neutropenia:

  • 2 g every 8 or 12 hours

Patients with cystic fibrosis with normal renal function who have pseudomonal lung infections:

  • 100 until 150 mg/kg/day in three divided doses

In adults with normal renal function:

  • 9 gram/day still safe

When used as a prophylactic agent in prostate surgery, 1 g should be administered on induction of anesthesia. The second dose should be considered at the time of catheter removal.

Baby and child (Age more than 2 months):

30 – 100 mg / kg / day, given as divided doses (2-3 times). Doses up to 150 mg / kg / day (maximum 6 g / day) in 3 divided doses may be given to immune compromised and fibrocustic children or children with meningitis.

Neonates dan baby (0 – 2 monthsn) :

25 – 60 mg / kg / day are given as divided doses 2 times daily. Ceftazidime half-life in neonates can be 3-4 times longer than adults.

Elderly

In the elderly patients clearance ceftazidime is reduced, the daily dose should not exceed 3 g, especially in those over 80 years of age.

Dosage in patients with impaired renal function:

Ceftazidime is excreted in unchanged form through the kidneys. So the dose in patients with impaired renal function should be reduced dose.

In patients with suspected renal insufficiency, can be given Ceftazidime loading initial dose of 1 gram.

The maintenance dose should be based on creatinine clearance as listed below:

 

Recommended maintenance dose FORTA® in patients with impaired renal function:

Clearance Creatinine (ml/minute) Estimated Creatinine Serum mmol/l (mg/dl) Recommended Dose Unit FORTA® (g) Frequency Dose (jam)
>50 < 150

(< 1.7)

 The usual dose
50-31 150 – 200

(1.7 – 2.3)

 1 12
30 – 16 200 – 350

(2.3 – 4.0)

 1 24
15 – 6 350 – 500

(4.0 – 5.6)

 0.5 24
< 5 >500

(> 5.6)

 0.5 48

 

In patients with severe infection the dose should be increased 50% or the frequency of doses increased. In this patient it is recommended that serum Ceftazidime levels be monitored and serum levels should not exceed 40 mg / liter.

In children the creatinine clearance is adjusted to the area or body weight and frequency of administration as in adults.

Hemodialysis

The serum half life during haemodialysis distance from 3 to 5 hours.

Every period of hemodialysis, maintenance dosage of FORTA® is recommended according to the above table and should be repeated.

Peritoneal Dialysis

FORTA® used in peritoneal dialysis patients and Continuous ambulatory peritoneal dialysis (CAPD).

Addition to the use of I.V, FORTA® can be incorporated into the dialysis fluid (usually 125 – 250 mg for 2 liters of dialysis fluid).

Presentation and Registration Number:

FORTA® Powder Injection Box, vial @ 1 g + 1 ampoule aqua pro injeksi @ 10 ml; DKL1608023944A1

 

ON MEDICAL PRESCRIPTION ONLY                          

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