Perix®
Ceftriaxone

COMPOSITION:
PERIX®2g IV Injection: Each Vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 2g.
PERIX®1g IV/IM Injection: Each Vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 1g.
PERIX®500mg IV/IM Injection: Each Vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 500mg.
PERIX®250mg IV/IM Injection: Each Vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 250mg.
Lidocaine solution for IM use: Each ampoule contains 2ml or 3.5ml of 1% Lidocaine Hydrochloride BP injection for reconstitution.
Water for Injection for IV use: Each ampoule contains 5ml or 10ml sterile Water for Injection BP for reconstitution.

PHARMACOLOGICAL INFORMATION:
Pharmacological Action
Ceftriaxone (PERIX®) is a semisynthetic third generation broad spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and, especially, Gram-negative organisms. The spectrum of activity includes both aerobic and some anaerobic species.
Mechanism of Action
Ceftriaxone like other cephalosporins and penicillins, kills bacteria by interfering with the synthesis of bacterial cell wall. Ceftriaxone has a higher degree of stability in the presence of beta lactamases, both penicillanases and Cephalosporinases, of gram-positive and gram-negative bacteria.
Pharmacokinetics
Ceftriaxone (PERIX®) is not absorbed after oral administration and must be given parenterally. Following IV or IM administration, Ceftriaxone is widely distributed into body tissues and fluids including gallbladder, lungs, bone, bile, prostate adenoma tissue, uterine tissue, atrial appendage, sputum, tears, and pleural, peritoneal, synovial, ascitic and blister fluids. It is eliminated mainly as drug unchanged, approximately 60% of the dose being excreted in the urine (almost exclusively by glomerular filtration) and the reminder via the biliary and intestinal tracts.

CLINICAL INFORMATION:
Therapeutic Indications:
Renal and urinary tract infections; Lower respiratory tract infections, particularly pneumonia; Gonococcal infections; Skin and soft tissue, bone and joint infections; Bacterial meningitis; Serious bacterial infections e.g. septicemia; ENT infections; Typhoid fever; Infections in cancer patients; Prevention of postoperative infection; Pre operative prophylaxis of infections associated with surgery.

Dosage & Administration
PERIX® (Ceftriaxone) can be administered either intravenously or intramuscularly.
Adults: The usual adult daily dose is 1-2g once daily, (or twice daily in equally divided doses) depending on the type and severity of infection. The daily dose may be increased, but should not exceed 4g. For preoperative use (surgical prophylaxis), a single dose of 1 gm administered intravenously 0.5-2 hours before surgery is recommended. In elderly patients, the dosages do not require modification provided that renal and hepatic functions are satisfactory. In patients with impaired renal function, there is no need to reduce the dosage of PERIX® provided liver function is intact. In patients with liver damage, there is no need for the dosage to be reduced provided renal function is intact. Gonorrhea: For the treatment of gonorrhea (penicillinase producing and non-penicillinase producing strains), a single intramuscular dose of 250mg is recommended.
Children under 12 years: The recommended total daily dose is 50 to 75mg/kg once daily (or twice daily in equally divided doses). In severe infections, up to 80mg/kg body weight daily may be given. The total daily dose should not exceed 2g. In the treatment of meningitis, the initial dose of 100mg/kg body weight (not to exceed 4g daily) once daily (or twice daily in equally divided doses), is recommended. As soon as the causative organism has been identified and its sensitivity, the doses can be reduced accordingly. The usual duration of therapy in meningitis is 7 to 14 days.

Use in children
PERIX® is contraindicated in premature infants during the first 6 weeks of life.

Contraindication
PERIX® should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics. Its safety in human pregnancy has not been established. Therefore it should not be used in pregnancy unless absolutely indicated. Only minimal amount of Ceftriaxone has excreted in breast milk, so mothers receiving PERIX® should not breast-feed.

Use in patients with impaired renal function
In severe renal impairment accompanied by hepatic insufficiency, dosage reduction is required.

Use in patients with impaired hepatic function
The stated dosage should not be exceeded. In severe renal impairment accompanied by hepatic insufficiency, dosage reduction is required.

Drug Interactions
Potentially hazardous interactions: No impairment of renal function or increased nephrotoxicity has been observed in man after simultaneous administration of Ceftriaxone with diuretics, or with aminoglycosides. A possible disulfiram-like reaction may occur with alcohol.
Other significant interactions: PERIX® doesn't interfere with the protein binding of bilirubin. Simultaneous administration of probenecid doesn't alter the elimination of Ceftriaxone.toxicity. Probenecid should not be administered concurrently with Ketorolac tromethamine because of increases in ketorolac plasma level and half-life. Potentially useful interactions: Experimentally, in vivo, Ceftriaxone has been shown to enhance bacterial killing by human neutrophils.

Use in pregnancy & lactation
PERIX® has not been associated with adverse effects on fetal on fetal development in laboratory animals, but its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Because Ceftriaxone is distributed into milk, the drug should be used with caution in nursing women.

Undesirable Effects
PERIX® is generally well tolerated. A few side-effects such as Gastrointestinal effects include diarrhea, nausea and vomiting, stomatitis and glossitis; Cutaneous reactions include rash, pruritus, urticaria, and edema & erythema multiforme; Hematological reactions include eosinophilia, thrombocytosis, leukopenia, and neutropenia; CNS reactions include headache, hyperactivity, nervousness; sleep disturbances, confusion, hypertonia, and dizziness were reported.

PHARMACEUTICAL INFORMATIONS :
Storage Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
PERIX® (Ceftriaxone) is supplied as sterile powder in glass vial.
PERIX®250mg IM injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 250mg Ceftriaxone and 1 ampoule of 2ml 1% Lidocaine Hydrochloride BP injection.
PERIX®250mg IV injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 250mg Ceftriaxone and 1 ampoule of 5ml Water for Injection BP.
PERIX®500mg IM injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 500mg Ceftriaxone and 1 ampoule of 2ml 1% Lidocaine Hydrochloride BP injection.
PERIX® 500mg IV injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 500mg Ceftriaxone and 1 ampoule of 5ml Water for Injection BP.
PERIX®1g IM injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 1g Ceftriaxone and 1 ampoule of 3.5ml 1% Lidocaine Hydrochloride BP injection.
PERIX®1g IV injection: Box containing 1 combipack and a 10ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 1g Ceftriaxone and 1 ampoule of 10ml Water for Injection BP.
PERIX®2g IV injection: Box containing 1 combipack and a 20ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 2g Ceftriaxone and 2 ampoules of 10ml Water for Injection BP.