Dicephin IV Injection

Dicephin IV Injection is used for: Pneumonia, Meningitis, Acute otitis media, Lyme disease, Typhoid fever, Otitis media, Pelvic inflammatory disease, Septicemia, Skin and Skin-Structure Infections, Gonorrhea, Respiratory tract infections, Urinary tract infections, Bone and Joint Infections, Chlamydia infection, Surgical Prophylaxis

Susceptible infections IV/IM 1-2 g/day, up to 4 g/day for severe infections. Acute Bacterial Otitis Media 50 mg/kg IM once Persistent or treatment failures: 50 mg/kg IV/IM for 3 days Intra-abdominal Infections Complicated, mild-to-moderate, community-acquired: 1-2 g/day IV in single daily dose or divided 12 hourly for 4-7 days, in combination with metronidazole Meningitis 2 g IV every 12 hours for 7-14 days Acute Uncomplicated Pyelonephritis 1-2 g IV once daily Typhoid fever 2 g IV once daily for 14 days. Surgical Prophylaxis Prophylaxis of surgical infection 1 g IV 0.5-2 hours before the procedure Uncomplicated Gonococcal Infections Indicated for uncomplicated gonococcal infection of pharynx, cervix, urethra, or rectum Weight <150 kg: Ceftriaxone 500 mg IM once Weight >150 kg: Ceftriaxone 1,000 mg IM once If chlamydial infection has not been excluded, add doxycycline 100 mg BID x 7 days, or if pregnant give azithromycin 1,000 mg Pelvic Inflammatory Disease 250 mg IM as single dose with doxycycline, with or without metonidazole for 14 days

Children: IV, IM: 50–75 mg/kg/day, max 2 g/day every 24 hours Acute Bacterial Otitis Media 50 mg/kg IM in single dose; not to exceed 1 g Meningitis 100 mg/kg/day IV/IM in single daily dose or divided every 12 hours for 7-14 days; not to exceed 4 g/day Serious Infections Other Than Meningitis 50-75 mg/kg/day IV/IM divided every 12 hours for 7-14 days Skin/Skin Structure Infections >12 years: 1-2 g/day IV/IM in single daily dose or divided every 12 hours for 7-14 days, depending on type and severity of infection Gonococcal Infections Neonates Ophthalmia neonatorum: 25-50 mg/kg IV/IM once; not to exceed 125 mg Disseminated gonococcal infections and gonococcal scalp abscesses: 25-50 mg/kg/day IV/IM in single daily dose for 7 days; if meningitis is documented, treat for 10-14 days Prophylaxis for infants of mothers with gonococcal infection: 25-50 mg/kg IV/IM once; not to exceed 125 mg Children <45 kg with uncomplicated gonococcal vulvovaginitis, cervicitis, urethritis, pharyngitis, or proctitis: 125 mg IM once <45 kg with bacteremia or arthritis: 50 mg/kg/day IM/IV in single daily dose for 7 days; daily dose not to exceed 1 g >45 kg with bacteremia or arthritis: 50 mg/kg/day IM/IV in single daily dose for 7 days >45 kg: 1-2 g IV every 12 hours

Renal impairment: CrCl (ml/min) <10 Max: 2 g daily.

IV/IM Preparation Dilutions are stable for 24 hours at room temperature IV Reconstitute to ~100 mg/mL, then dilute further to 10-40 mg/mL 10 g bulk package: not for direct IV infusion; reconstitute in 95 mL, then use appropriate portions for further dilution 10-g bulk package not for direct IV injection; reconstitute in 95 mL, then use appropriate portions for further dilution IM Dilute with compatible fluid (eg, SWI, NS, D5W) to 250-350 mg/mL IV/IM Administration IV: Infuse intermittently over 30 minutes IM: Inject deep into large muscle mass

Hypersensitivity to cephalosporins; hyperbilirubinemia neonates. Do not use calcium or calcium-containing solutions or products with or within 48 hr of ceftriaxone administration due to risk of calcium-ceftriaxone precipitate formation. Documented hypersensitivity; hyperbilirubinemic neonates, particularly those who are premature; neonates <28 days if they receive calcium-containing IV products Intravenous administration of ceftriaxone solutions containing lidocaine Lidocaine contraindications if lidocaine solution used as solvent with ceftriaxone for intramuscular injection

Immune-mediated hemolytic anemia reported; if patient develops anemia while on ceftriaxone, stop antibiotic until etiology determined; severe hemolytic anemia, including fatalities, reported in both adults and children May increase INR, especially in nutritionally deficient patients, hepatic or renal disease or prolonged treatment Dosage must be adjusted in severe renal insufficiency (high dosages may cause CNS toxicity) Superinfections and promotion of nonsusceptible organisms may occur with prolonged use or repeated therapy Use with caution in patients with history of penicillin allergy Use with caution in patients with history of GI disease, especially colitis Use with caution in breast-feeding women; drug may displace bilirubin from albumin-binding sites, increasing risk of kernicterus Abnormal gallbladder sonograms reported, possibly the result of ceftriaxone-calcium precipitates; discontinue if signs or symptoms of gallbladder disease occur Ceftriaxone-calcium precipitates in urinary tract observed in patients receiving ceftriaxone; may be detected as sonographic abnormalities; patients may be asymptomatic or may develop symptoms of urolithiasis, and ureteral obstruction and post-renal acute renal failure; appears to be reversible upon discontinuation of therapy and institution of appropriate management; ensure adequate hydration; discontinue therapy in patients who develop signs and symptoms suggestive of urolithiasis, oliguria or renal failure and/or the sonographic findings Clostridium difficile-associated diarrhea (CDAD reported with use of nearly all antibacterial agents, including ceftriaxone; If CDAD suspected or confirmed, may consider discontinuing ongoing antibacterial use not directed against C. difficile; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation Pancreatitis secondary to biliary obstruction reported rarely; use with caution in patients with gallbladder, biliary tract, liver, or pancreatic disease and patients with history of penicillin hypersensitivity Use with caution in patients with history of GI disease (eg, colitis) Serious neurological adverse reactions reported during postmarketing surveillance with ceftriaxone use; reactions include encephalopathy (disturbance of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and non-convulsive status epilepticus MONITORING PARAMETERS Advises to monitor full blood count regularly during prolonged treatment.

Pregnancy Available data from published prospective cohort studies, case series, and case reports over several decades in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes The estimated background risk of major birth defects and miscarriage for the indicated population is unknown; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes Animal data In animal reproduction studies, no adverse developmental effects were observed when ceftriaxone was administered to pregnant rats at doses up to approximately 2.8 times clinical dose of 2 g/day Lactation Data from published literature report that ceftriaxone is present in human milk; there are no data on effects of drug on breastfed child or on milk production The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and dextrose injection and any potential adverse effects on breastfed child from antibiotic for Injection and dextrose injection or from mother’s underlying condition

May increase nephrotoxicity of aminoglycosides. May diminish therapeutic effect of BCG, typhoid vaccine, Na picosulfate. May increase anticoagulant effect of vit K antagonists (e.g. warfarin). May increase serum level w/ probenecid. Potentially Fatal: Admin w/ Ca-containing IV soln may cause precipitation of a crystalline material in the lungs and kidneys. Contraindicated (5) calcium acetate calcium carbonate calcium chloride calcium citrate calcium gluconate Serious (4) BCG vaccine live cholera vaccine microbiota oral typhoid vaccine live

Side effects of Ceftriaxone : >10% Induration after IM injection (5-17%) 1-10% Eosinophilia (6%),Thrombocytosis (5%),Diarrhea (3%),Elevated hepatic transaminases (3%),Leukopenia (2%),Rash (2%),Increased blood urea nitrogen (BUN) (1%),Induration at IV site (1%),Pain (1%) <1% Agranulocytosis,Anaphylaxis,Anemia,Basophilia,Bronchospasm,Candidiasis,Chills,Diaphoresis,Dizziness,Dysgeusia,Flushing,Gallstones,Glycosuria,Headache,Hematuria,Hemolytic anemia,Increased alkaline phosphatase or bilirubin,Increased creatinine,Jaundice,Leukocytosis,Lymphocytosis,Lymphopenia,Monocytosis,Nausea,Neutropenia,Phlebitis,Prolonged or decreased prothrombin time (PT),Pruritus,Renal stones,Serum sickness,Thrombocytopenia,Urinary casts,Vaginitis,Vomiting

Ceftriaxone binds to one or more of the penicillin-binding proteins (PBPs) which inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

Dicephin 250mg/vial IV Injection manufactured by Drug International Ltd.. Its generic name is Ceftriaxone. Dicephin is availble in Bangladesh. Farmaco BD drug index information on Dicephin IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.