Cefixime Powder for Suspension

Cefixime Powder for Suspension is used for: Uncomplicated Urinary Tract Infections, Otitis Media, Pharyngitis, Tonsillitis, Acute Exacerbations of Chronic Bronchitis, Uncomplicated Gonorrhea (cervical/urethral), Pneumonia, Typhoid fever, Susceptible infections, Sinusitis, Soft tissue infections, Respiratory tract infections, Gonococcal urethritis, Acute bronchitis

Oral Adult: Acute Bronchitis & Acute Exacerbations of Chronic Bronchitis, Otitis Media, Pharyngitis/Tonsillitis, Uncomplicated Urinary Tract Infections 200 or 400 mg daily as a single dose or in two divided doses 12 hourly Uncomplicated Gonorrhea: Alternative treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea if ceftriaxone unavailable 400 mg as a single dose plus azithromycin 1 g PO once Typhoid fever: 20 mg/kg body weight daily in two divided doses. The usual treatment is 7 days. This may be continued for up to 14 days according to the severity of the infection. In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

Oral Child: 8 mg/kg/day if <50 kg taken as a single dose (24 hourly) or divided into two doses (12 hourly) For convalescent oral therapy of serious infections, up to 20 mg/kg/day Child over 12 years: Capsule: 200 or 400 mg daily as a single dose or in two divided doses Powder for Suspension & DS Powder for Suspension & Paediatric Drops: Children above 6 months: 8 mg/kg daily in 1-2 divided doses or Child 6–11 months: 75 mg daily Child 1–4 years: 100 mg daily Child 5–9 years: 200 mg daily Child 10–17 years: 200–400 mg daily, alternatively 100–200 mg twice daily Typhoid Fever 15-20 mg/kg/day PO divided q12hr for 7-14 days; not to exceed 400 mg/day <6 months: Safety and efficacy not established

Renal impairment CrCl >60 mL/min: No dosage adjustment necessary CrCl 21-60 mL/min: 260 mg/day PO CrCl <20 mL/min or continuous peritoneal dialysis : 200 mg/day PO

May be taken with or without food. May be taken w/ food or milk to reduce GI discomfort.

Hypersensitivity to cephalosporin.

Limited activity against anaerobes Dosage must be adjusted in severe renal insufficiency (high doses may cause CNS toxicity, including seizures); superinfections and promotion of nonsusceptible organisms may occur with prolonged use or repeated therapy Use with caution in patients with history of penicillin allergy Bacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapy Immune-mediated hemolytic anemia reported; monitor hematologic parameters during and for 2 to 3 weeks after therapy; discontinue therapy if hemolytic anemia occurs during treatment Phenylalanine can be harmful to patients with phenylketonuria (PKU); chewable tablets contain aspartame, a source of phenylalanine; before prescribing, consider combined daily amount of phenylalanine from all sources, including chewable tablets Use caution in patients with history of gastrointestinal disease Clostridium difficile associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, discontinue ongoing antibacterial drug use not directed against C. difficile; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation as clinically indicated Immune-mediated hemolytic anemia reported; monitor hematologic parameters during and for 2 to 3 weeks after therapy; discontinue therapy if hemolytic anemia occurs during treatment Cephalosporins may be associated with a fall in prothrombin activity; patients with renal or hepatic impairment, or poor nutritional state, patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy; monitor prothrombin time in patients at risk and exogenous vitamin K administered as indicated May cause acute renal failure including tubulointerstitial nephritis; discontinue therapy if renal failure occurs and initiate supportive therapy Severe cutaneous reactions, including Stevens-Johnson syndrome, epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS) reported; discontinue therapy and implement supportive therapy if reaction occurs

Pregnancy Available data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes; perinatal transmission of gonorrhea to offspring can result in infant blindness, joint infections, and bloodstream infections Animal data Reproduction studies have been performed in mice and rats at doses equivalent to 40 and 80 times, respectively, adult human recommended dose and have revealed no evidence of harm to the fetus due to cefixime Lactation There are no available data on presence of drug in human milk, effects on breastfed infant, or on milk production; drug is present in animal milk; when a drug is present in animal milk, it is likely the drug will be present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from mother’s underlying condition

Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants. Potentially Fatal: May increase prothrombin time with anticoagulants. Contraindicated (0) Serious (4) BCG vaccine live cholera vaccine microbiota oral typhoid vaccine live

Side effects of Cefixime : >10% Diarrhea (16%) Frequency Not Defined Abdominal pain,Candidiasis,Dizziness,Dyspepsia,Elevated transaminases,Eosinophilia,Erythema multiforme,Fever,Flatulence,Headache,Increased blood urea nitrogen (BUN),Increased creatinine,Leukopenia,Nausea,Prolonged prothrombin time (PT),Pruritus,Pseudomembranous colitis,Rash,Serum sickness-like reaction,Stevens-Johnson syndrome,Thrombocytopenia,Urticaria,Vaginitis,Vomiting Potentially Fatal: Pseudomembranous colitis.

Cefixime 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.

Cefixime 100mg/5ml Powder for Suspension manufactured by Apollo Pharmaceutical Laboratories Ltd.. Its generic name is Cefixime. Cefixime is availble in Bangladesh. Farmaco BD drug index information on Cefixime Powder for Suspension is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.