Refix

Refix

cefixime

Manufacturer:

Medhaus

Distributor:

Medhaus
Concise Prescribing Info
Contents
Cefixime trihydrate
Indications/Uses
Cap: Acute bronchitis, acute exacerbations of chronic bronchitis, bronchiectasis w/ infection, secondary infections in chronic resp tract diseases, pneumonia; UTI including pyelonephritis, cystitis & cystourethritis; uncomplicated gonorrhea (cervical/urethral); cholecystitis, cholangitis; scarlet fever; sinusitis, tonsillitis, pharyngitis, otitis media; typhoid fever (enteric fever) including multi-drug resistant typhoid fever. Granules for oral susp: Gonorrhea, otitis media, pharyngitis, lower resp tract infections (eg, bronchitis) & UTI.
Dosage/Direction for Use
Cap Max: 400 mg daily. Duration: Most infection: 7-14 days; infections due to Strep pyogenes: At least 10 days. Adult 200 mg every 12 hr. Uncomplicated UTI 200 mg once daily for 7-14 days. Uncomplicated cystitis 200 mg every 12 hr for 3 days. Uncomplicated acute pyelonephritis 200 mg every 12 hr for 14 days. Typhoid fever 200 mg every 12 hr for 7-14 days. Renal impairment: CrCl 20-40 mL/min 75% of standard dose (ie, 300 mg daily at usual dosing interval), <20 mL/min & those maintained on chronic ambulatory peritoneal dialysis or hemodialysis 50% of standard dose (ie, 200 mg daily at usual dosing interval). Childn >12 yr or >50 kg 200 mg every 12 hr, 7-12 yr 200 mg once daily. Granules for oral susp Childn >6 mth & <50 kg 8 mg/kg daily as a single dose or in 2 divided doses.
Administration
May be taken with or without food: Granules for oral susp: May be taken w/ food or milk to reduce GI discomfort.
Contraindications
Hypersensitivity to cefixime, other cephalosporins or penicillins.
Special Precautions
Penicillin-sensitive patients. Pregnancy & lactation. Cap: Discontinue use in case of allergic reaction or renal failure; if severe cutaneous adverse reactions or seizures occur; in diagnosis of cephalosporin-associated anemia. Not to be used in patients w/ history of cephalosporin-associated hemolytic anemia. Clostridium difficile-associated diarrhea. Patients w/ history of colitis; GI malabsorption. Long term or repeated use may result in overgrowth of non-susceptible organisms including fungi. Monitor prothrombin time in patients at risk of fall in prothrombin activity. Granules for oral susp: History of allergy.
Adverse Reactions
Cap: Abdominal pain, anorexia, diarrhea, dry mouth, dyspepsia, flatulence, loose or frequent stools/stool changes, nausea, vomiting, pseudomembranous colitis, pruritus ani; anaphylactic/anaphylactoid reactions (including shock & fatalities), angioedema, arthralgia, drug fever, erythema multiforme, facial edema, pruritus, skin rashes, serum sickness-like reactions, SJS, TEN, DRESS, urticaria; transient elevation of ALT, AST, alkaline phosphatase, bilirubin & LDH; hepatitis, jaundice (cholestatic &/or hepatocellular); transient elevations in BUN & serum creatinine levels; acute renal failure including tubulointerstitial nephritis; dysuria, pyuria, genital pruritus, vaginitis, vag candidiasis; dizziness, headache, fatigue, insomnia, malaise, nervousness, seizures, somnolence; transient thrombocytopenia, thrombocytosis, leucopenia, leukocytosis, neutropenia, agranulocytosis, eosinophilia & hypereosinophilia; immune hemolytic anemia; prolonged prothrombin time & partial thromboplastin time, decreased Hb conc & hematocrit; hyperbilirubinemia; increased serum amylase conc; dyspnea, resp distress. Granules for oral susp: Skin rashes, urticaria, eosinophilia, fever, serum sickness-like reactions & anaphylaxis; +ve Coombs' test. Hypoprothrombinaemia &/or platelet dysfunction.
Drug Interactions
May increase prothrombin time w/ anticoagulants. Cap: Elevated levels of carbamazepine. Antagonism w/ chloramphenicol. Increased oral bioavailability w/ nifedipine. Increased Cmax & AUC w/ probenecid. Cmax & AUC may be decreased w/ salicylates.
MIMS Class
Cephalosporins
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Refix cap 200 mg
Packing/Price
30's
Form
Refix granules for oral susp 100 mg/5 mL
Packing/Price
60 mL x 1's (P310/bottle)
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