Cefamed (Ceftriaxone)
Pharmaceutical Form
Powder for injections.
COMPOSITION
Each vial contains:
Ceftriaxone (as sodium salt) 0.5 g or 1.0 g
Solvent: Lidocaine hydrochloride 20 mg or 35 mg;
THERAPEUTIC INDICATIONS
Cefamed is effective against infections caused
by bacteria strains sensitive to Cefamed, including upper and lower
respiratory diseases (including pneumonia, lungs abscess, pleural empyema);
infections of abdominal cavity organs (including cholangitis, gallbladder
empyema, inflammatory diseases of gastrointestinal tract, biliary tracts,
peritonitis); bone and joint infections; infections of skin and soft tissues;
urinary tracts infections (including pyelonephritis); infections transmitted
by genital tracts (including, gonorrhea); infected wounds and burns;
inflammation of meningeal membranes, sepsis.
Prophylaxis of postoperative infection.
CONTRAINDICATIONS
Hypersensitivity to cephalosporin and
penicillins.
The first trimester of pregnancy.
The drug should be prescribed with cautious for infants, especially for
premature due to high risk of development of hyperbilirubinemia.
ADVERSE EFFECTS
Cefamed is generally well tolerated. As a rule
adverse effects are reversible and
disappear after discontinuation of the drug.
Possible: loose stools or diarrhoea, nausea,
vomiting, stomatitis, glossitis, eosinophilia, leukopenia, granulopenia,
hemolytic anemia, thrombocytopenia, exanthema, allergic dermatitis, pruritus,
urticaria, anaphylactic shock, erythema multiforme.
Rarely: headache and vertigo, increase in liver
enzymes, oliguria, and increase in serum creatinine.
Very rarely: pseudomembranous colitis,
coagulation disorders, tenderness in the
site of IV introduction, and phlebitis.
INSTRUCTIONS FOR CONSTITUTION AND
INTRODUCTION
For intramuscular introduction: Dilute 0.5 g or
1 g of the powder in 2 or 3.5 ml of 1% lidocaine solution, respectively and
inject deeply into gluteal muscle. Use the drug solution immediately after
preparation!
DOSAGE AND ADMINISTRATION
Cefamed is IM injected.
The usual dose for adults and children at the
age of 12 and older is 1-2 g once daily. The dosage interval is 24 hours. The
daily dose may be increased to 4 g in severe or moderate infections.
The daily dose for infants (under 2 weeks) is
20-50 mg/kg of body weight once daily. The dose cannot be increased because of
unformed enzyme system in infants.
The daily dose for infants and children under 12
is 20-80 mg/kg of body weight once daily. The usual doses for adults are used
in children with body weight of 50 kg or more.
The duration of therapy depends on kind and
severity of disease. As with others antibiotics, introduction of Cefamed is
recommended to continue within not less than 3 days following normalization of
body temperature.
The initial dose for children and infants with
bacterial meningitis is 100 mg/kg of body weight once daily. The maximum
daily dose is 4 kg. The dose may be decreased after identification of pathogen.
The recommended dose for patients with
gonococcal infection of lower parts of urogenital system without complications
is 250 mg IM as a single dosing.
Patients with gonococcal infection of lower
parts of urogenital system with complications, infection of upper parts and
small pelvis organs should be treated in hospital. (Therapeutic management
depends on clinical course of gonorrhea. Thus it is necessary to apply
appropriate pathogenetic, physical, and surgical treatment methods in abscess
formation paraurethral and main vestibular glands along with antimicrobial
agents effective against N. gonorrhoeae,). Etiological treatment of
complicated gonococcal infection of urogenital system and small pelvis organs:
1.0 g of Cefamed IM every 24 hours.
It is not necessary to reduce the dose in
patients with impaired renal function and normal hepatic function and in
patients with impaired hepatic function and normal renal function. The dose of
Cefamed should not be exceeded 2 g daily in case of apparent renal impairment
(creatinine clearance <10 ml/min).
Ceftriaxone serum concentrations must be
constantly monitored in patients with simultaneous impaired renal and hepatic
function and also in hemodialysis patients.
Single introduction of 1-2 g of Cefamed 30-90 minutes before operation is
recommended for prophylaxis of postoperative infections.
OVERDOSAGE
Date on overdosage is not available.
DRUG INTERACTIONS
Co-administration with loop diuretic (i.e.
furosemide) does not cause renal dysfunction.
Cefamed and aminoglycosides have synergistic
action against the most of gram-negative bacteria. The similar combination is
proved in treatment of severe and threatening to life infections (i.e. caused
by such pathogen, as Pseudomonas aeroginosa).
It is not necessary to mix Cefamed in one bottle
or a syringe with other antibiotics.
PRECAUTIONS
As with others cephalosporins, the possible
development of anaphylactic reactions in Cefamed therapy must be considered.
The long-term therapy requires constant monitoring of peripheral blood picture.
In rare cases, shadows suggesting sludge have been detected by sonograms of
the gallbladder. This condition was reversible on discontinuation of the drug.
If this condition is associated with pains in right hypochondrium, drug
administration is recommended to continue with symptomatic treatment.
PRAGNANCY AND LACTATION
The drug should be prescribed during pregnancy
only if treatment efficacy justifies potential risk for fetus (ceftriaxone
crosses the placenta).
The breast-feeding should be ceased during
treatment (ceftriaxone penetrates in the human milk).
PHARMACEUTICAL FORM
0.5g or 1g powder for injections in vial
complete with a solvent (2 ml or 3.5 ml of 1% solution of lidocaine
hydrochloride in a glass ampoule) in a strip in a carton box with an
annotation-insert.
SALES TERMS
Sold under a prescription.
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