Piramal - Ceftriaxone for Injection, USP

INDICATIONS: Treatment of infecons due to suscepble strains of the designated microorganisms in the condions listed in the FPI.

DOSAGE AND ADMINISTRATION: See FPI for full details. Ceriaxone for injecon may be administered by either IV or IM routes. The recommended adult dosage of Ceriaxone for injecon is 1-2 grams once a day (or in equally divided doses twice a day) depending on the type and severity of infecon. The total daily dose should not exceed 4 grams. If Chlamydia trachomasis a suspected pathogen, appropriate anchlamydial coverage should be added, because Ceriaxone sodium has no acvity against this organism. For the treatment of uncomplicated gonococcal infecons, a single intramuscular dose of 250 mg is recommended. For preoperave use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended. Generally, Ceriaxone for injecon therapy should be connued for at least 2 days aer the signs and symptoms of infecon have disappeared. The usual duraon of therapy is 4 to 14 days; in complicated infecons, longer therapy may be required. Pediatric Paents (2 months to 16 years): The recommended daily dose is 50 -75 mg per kg of body weight administered once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 grams. Paents with Impaired Renal Funcon: No dosage adjustment is necessary for paents with impairment of renal or hepac funcon.

CONTRAINDICATIONS: Ceriaxone for injecon is contraindicated in paents who have shown immediate hypersensivity reacons to Ceriaxone or the cephalosporin class of anbiocs, penicillins or other beta-lactam anbiocs. Ceriaxone for injecon is also contraindicated in premature neonates.

COMMON SIDE EFFECTS: Local: Pain at IM injecon site, pain at IV injecon site (3%). Systemic: Rash (1.7%), diarrhea (2.7%), eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%); elevaons of aspartate aminotransferase (AST) (3.1%) or alanine aminotransferase (ALT) (3.3%). See FPI for a complete list.