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 sensitive bacteria, including upper and lower respiratory tract 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 cautioun for infants, especially for prematures 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, granulocytopenia, 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 IM 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 moderate to severe 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 other 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.

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 life-threatening infections (i.e. caused by such pathogen, as Pseudomonas aeruginosa).
It is not necessary to mix Cefamed in one bottle or a syringe with other antibiotics.

PRECAUTIONS

As with other 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.

PREGNANCY 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).

MANUFACTURED FORM

0.5 g or 1 g powder for injections in vial with a solvent in package.
10 vials 0.5 g or 1 g powder for injections in box.