Trade Name: IMACEF 1 GM IV
Generic Name: Ceftriaxone

Presentation

Imacef 250 mg IM Injection: Each vial contains Ceftriaxone 250 mg (as sterile

Ceftriaxone Sodium USP).

Imacef 500 mg IM Injection: Each vial contains Ceftriaxone 500 mg (as sterile

Ceftriaxone Sodium USP).

Imacef 1 g IV & 1 g IM Injection: Each vial contains Ceftriaxone 1 g (as sterile Ceftriaxone sodium USP).

Indications

Imacef is indicated for the treatment of the following infections when caused by susceptible organisms:

Lower Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, E. coli, Enterobacter aerogenes, Proteus mirabilis, Serratia marcescens.

Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus

influenzae (including beta-lactamase producing strains), Moraxella catarrhalis (including beta-lactamase producing strains).

Skin and Skin Structure Infections caused by Staphylococcus aureus, Staphylococcus

epidermidis, Streptococcus pyogenes, Viridans group streptococci, E. coli, Enterobacter

cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella

morganii, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus,

Bacteroides fragilis, Peptostreptococcus species.

Urinary Tract Infections (complicated and uncomplicated) caused by E. coli, Proteus

mirabilis, Proteus vulgaris, Morganella morganii, Klebsiella pneumoniae.

Uncomplicated Gonorrhea (cervical, urethral, pharyngial and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicilhnase-producing strains of

Neisseria gonorrhoeae.

Pelvic Inflammatory Disease caused by Neisseria gonorrhoeae.

Bacterial Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae. E.coli, Haemophilus influenzae, Klebsiella pneumoniae.

Bone and Joint Infections caused by Staphylococcus aureus, Streptococcus pneumoniae, E. coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobater species.

Intra-abdominal Infections caused by E. coli, Klebsiella pneumoniae, Bacteroides

fragilis, C/ostradium species, Peptostreptococcus species.

Meningitis caused by Haemophilus influenzae, Neisseria meningitidis, Streptococcus

pneumonae. Ceftriaxone has also been used successfully in a limited number of cases of

meningitis and shunt infection caused by Staphylococcus epidermidis and E. coli.

Surgical Prophylaxis: The preoperative administration of a single 1 gm dose of Ceftriaxone may reduce the incidence of postoperative infections in patients undergoing surgical

procedures classified as contaminated or potentially contaminated.

Dosage and administration

Adults

Usual daily dose is 1 to 2 g once a day (or in equally divided doses twice a day) depending on the type and severity of infection. Total daily dose should not exceed 4 g.

Uncomplicated gonococcal infections- a single dose of 250 mg IM is recommended.

Surgical prophylaxis: a single dose of 1 g IV 0.5 to 2 hour before surgery.

Children

To treat serious infections other than meningitis 50 to 75 mg/kg/day every 12 hours in divided doses is recommended. Dose should not exceed 4 g.

Meningitis-100 mg/kg/day is recommended. Dose should not exceed 4 g.

Skin & skin structure infection-50 to 75 mg/kg once daily or in equally divided doses twice daily. Dose should not exceed 2 g.

The usual duration of therapy is 4 to 14 days; in complicated infections longer therapy may be required. No dosage adjustment is required for patients with renal or hepatic impairment.

Side effects

Generally Ceftriaxone is well tolerated. However, few side effects including nausea, vomiting, diarrhea, dizziness and fever may occur.

Precautions

Ceftriaxone should be administered with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Use in Pregnancy & Lactation

Pregnancy: The safety of Ceftriaxone in the treatment of infections during pregnancy has not

been established. Ceftriaxone should only be used during pregnancy if the likely benefit outweighs the potential risk to the fetus and/or the mother.

Lactation: Ceftriaxone is excreted in breast milk at low concentrations. Therefore, caution should be exercised when Ceftriaxone is administered to a nursing mother. Contraindications

Ceftriaxone is contraindicated in patients with known allergy to ceftriaxone, other

cephalosporins or penicillins.

Drug Interactions

No drug-drug interactions have been reported.

Commercial Pack

Imacef 250 mg IM Injection: Pack of 1 vial containing 250 mg Ceftriaxone .(as sterile Ceftriaxone Sodium USP) accompanied by 1 ampoule of 2 ml Lidocaine Hydrochloride 1% USP for IM injection.

Imacef 500 mg IM Injection: Pack of 1 vial containing 500 mg Ceftriaxone ,(as sterile Ceftriaxone Sodium USP) accompanied by 1 ampoule of 2 ml Lidocaine Hydrochloride 1% USP for IM injection.

Imacef 1 gm IM Injection: Pack of 1 vial containing 1 gm Ceftriaxone (as sterile Cefuiaxone Sodium USP) accompanied by 1 ampoule of 10 ml of Water for Injection BP for Intravenous Injection and 1 ampoule of 3.5 ml lidocaine Hydrochloride 1% USP for IM injection.