Fonvicol

Fonvicol

cefazolin

Manufacturer:

Panpharma Healthcare

Distributor:

Panpharma Healthcare
Full Prescribing Info
Contents
Cefazolin sodium.
Description
Each gram of cefazolin contains sodium 48.3 mg.
Action
Cefazolin is a β-lactam antibiotic from the cephalosporin group. In vitro tests demonstrate that the bactericidal action of cefazolin results from the inhibition of cell wall synthesis.
Pharmacokinetics: Intramuscular injections produce peak serum levels within 1 hr. Protein binding is 86% but cefazolin does not penetrate the cerebrospinal fluid adequately for use during meningitis. Bile concentrations are significant and represent 3 times the simultaneous serum level. Volume of distribution is 0.14 L/kg and elimination t½ is 1.5-2.5 hrs. Hepatic metabolism is minimal, with 68-96% excreted unchanged in the urine.
Indications/Uses
Treatment of the following serious infections due to susceptible organisms: Respiratory tract infections due to S. pneumoniae, Klebsiella spp, H. influenzae, S. aureus (including penicillinase-producing strains) and group A β-hemolytic streptococci.
Genitourinary tract infections due to E. coli, P. mirabilis, Klebsiella spp and some strains of Enterobacter and enterococci.
Skin and skin structure infections due to S. aureus (including penicillinase-producing strains) and group A β-hemolytic streptococci and other strains of streptococci.
Biliary tract infections due to Escherichia coli, various strains of streptococci, Proteus mirabilis, Klebsiella spp and Staphylococcus aureus.
Bone and joint infections due to S. aureus. Septicemia due to S. pneumoniae, S. aureus (penicillin-susceptible and penicillin-resistant).
Endocarditis due to S. aureus (penicillin-susceptible and penicillin-resistant) and group A β-hemolytic streptococci.
Perioperative prophylaxis.
Because of the slight diffusion of cefazolin in the cerebrospinal fluid, this antibiotic is not indicated in the treatment of meningitis (even caused by sensitive bacilli).
Dosage/Direction for Use
Patients with Normal Kidney Function: Adults: IM from 500 mg to 1 g every 8-12 hrs. The usual maximum daily dose is 6 g, although up to 12 g has been used in severe life-threatening infections.
Children >1 month: 25-50 mg/kg body weight daily in 3 or 4 divided doses, increased in severe infections to a maximum of 100 mg/kg daily.
Surgical Prophylaxis: 1 g 30 min to 1 hr before the operation, followed by 500 mg to 1 g during surgery for lengthy procedures. A dose of 0.5-1 g is given every 6-8 hrs postoperatively for 24 hrs, or up to 5 days in certain cases.
Patients with Renal Impairment:
Severe and Very Severe Infections: See Table 1.

Click on icon to see table/diagram/image

Less Severe Infections: See Table 2.

Click on icon to see table/diagram/image

Administration: Fonvicol can be administered through IM injection, direct IV injection or IV infusion (intermittent or continuous).
IM: Dilute 1 g cefazolin with 3 mL water for injection or in a solution at 0.9% sodium chloride. In case of contraindication the solution can be reconstituted with 3 mL of 0.5% lidocaine solution. Do not inject lidocaine solution for IM route through IV route.
The obtained solutions are stable for 24 hrs at room temperature and up to 48 hrs if stored at temperature between +2°C and +8°C.
IV: Injection: Dissolve 1 g with at least 5 mL of water for injection and inject slowly 3-5 min, either directly into the vein, or into an infusion tube.
The obtained solutions are stable for 24 hrs at room temperature and up to 48 hrs if stored at temperature between +2°C and +8°C.
Infusion: Dilute 1 g in 100 mL water for injection or in 1 of the following fluids commonly used for infusion: 0.9% sodium chloride injection, 5 or 10% dextrose injection (in both cases, the obtained solutions are stable for 24 hrs at room temperature and 48 hrs at temperature between +2°C and +8°C). Or in 5% dextrose injection in lactated Ringer's solution, dextrose and sodium chloride injection (5%/0.9%, 5%/0.45%, 5%/0.2%), lactated Ringer's injection, 5 or 10% invert sugar in water for injection, Ringer's injection. These preparations must be used immediately after dilution.
Contraindications
Patients with known allergy to penicillins and cephalosporins.
Special Precautions
Because of the partial cross-allergenicity of the penicillins and the cephalosporins, cefazolin should be given cautiously in penicillin-sensitive patients. When cefazolin is administered to patients with impaired renal function, lower daily dosage is required.
Use in pregnancy & lactation: Safety for use in pregnant women and lactating mothers has not been established.
Use in children: Safety for use in prematures and infants <1 month has not been established.
Use In Pregnancy & Lactation
Safety for use in pregnant women and lactating mothers has not been established.
Adverse Reactions
Signs of Allergy: Skin rash, fever.
Hematologic Disorders: Eosinophilia, leukopenia, reversible thrombopenia.
Digestive Disorders: Nausea, vomiting, anorexia, diarrhoea.
Transient rise in SGOT, SGPT and alkaline phosphatase.
Administering high doses of β-lactams, especially in patients with renal impairment, may entail encephalopathies (confusion, abnormal movements, convulsive crises).
Drug Interactions
Incompatibilities: A false-positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution or Clinitest tablets. Positive Coombs' tests have occurred. Generally, cephalosporins are incompatible with high molecular weight molecules; therefore, they should be administered separately. Mixtures of cefazolin with other antibiotics are not recommended.
Storage
Store away from light, in a cool dry place, below 25°C.
Shelf-Life: 3 years.
MIMS Class
ATC Classification
J01DB04 - cefazolin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 1 g x 10's, 50's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in