Onefix 200 mg Cap


Description

Composition
Onefix 200 Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg.
Onefix-400 Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 400 mg.
Onefix 30 ml PFS: After reconstitution according to direction, each 5 ml suspension contains Cefixime
Trihydrate USP equivalent to Cefixime 100 mg.
Onefix 50 ml PFS: After reconstitution according to direction, each 5 ml suspension contains Cefixime
Trihydrate USP equivalent to Cefixime 100 mg.
Pharmacology
Onefix (Cefixime) is a broad spectrum antibiotic of 3rd generation Cephalosporin group. Cefixime has
a longer duration of action than the other Cephalosporins that are active by mouth. It is a bactericidal
antibiotic and is stable to many beta-lactamases. Cefixime kills bacteria by interfering in the synthesis
of the bacterial cell wall. Peak plasma concentration attained within 2-6 hrs, plasma half-life usually 3-4
hrs and about 65% is bound to plasma protein.
Indication
Onefix (Cefixime) is indicated for the treatment of following infections: Upper and lower respiratory tract
infections: acute bronchitis and acute exacerbation of chronic bronchitis, acute sinusitis, pneumonia
caused by Streptococcus pneumoniae and Haemophilus influenzae. Otitis media caused by
Haemophilus influenzae, Moraxella catarrhalis & S. pyogenes Pharyngitis & Tonsillitis caused by S.
pyogenes Uncomplicated urinary tract infections caused by Escherichia coli & Proteus mirabilis
Uncomplicated cervical and rectal infections Uncomplicated gonorrhea (Cervical & Urethral) caused by
Neisseria gonorrhea
Multi-Drug Resistant (MDR) enteric fever
Dose and Administration
Route of administration: Oral
Community Acquired Pneumonia (CAP): Children (6 months to 12 years of age): 8 mg/kg once daily or
4 mg/kg every 12 hours for 10-14 days. Adult: 400 mg once daily or 200 mg every 12 hours for 10-14
days Acute Otitis Media (AOM): Children (6 months to 12 years of age): 8 mg/kg once daily or 4 mg/kg
every 12 hours for 10-14 days Adult: 400 mg once daily or 200 mg every 12 hours for 10-14 days
Pharyngitis and Tonsillitis: Children (6 months to 12 years of age): 8 mg/kg once daily or 4 mg/kg every
12 hours for 10-14 days Adult: 400 mg once daily or 200 mg every 12 hours for 10 days Acute
Exacerbations of Chronic Bronchitis (AECB): Children (6 months to 12 years of age): 8 mg/kg once
daily or 4 mg/kg every 12 hours for 10-14 days Adult: 400 mg once daily or 200 mg every 12 hours for
10-14 days Acute Bacterial Sinusitis: 8 mg/kg once daily or 4 mg/kg every 12 hours for 10-14 days.
Uncomplicated Urethral, Endocervical or Rectal Gonorrhea: Children weighing < 45 kg: 8 mg/kg (upto
400 mg) as single dose Typhoid Fever: 20 mg/kg once daily or 10 mg/kg every 12 hours for 14 days.
Children beyond neonatal period: 8 mg/kg daily in 1 or 2 equally divided doses for treatment of mild or
moderate infections. In renal impairment: Dose should be adjusted according to Creatinine Clearance
(CC). CC 20-60 ml/min: 75% of standard dose and CC<20 ml/min: 50% of standard dose.
Contraindication
Onefix (Cefixime) is contraindicated in known hypersensitivity to Cefixime or other antibiotics of
Cephalosporin group.
Warning & Precaution
Onefix (Cefixime) should be administered with caution in renal impairment, a history of colitis and on
anticoagulant therapy. Like other antibiotics, pseudomembranous colitis has been reported with
Cefixime.
Side-effects
Common: Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical
trials were mild and self-limiting in nature. Gastrointestinal disturbances: Diarrhea, abdominal pain,
dyspepsia, nausea and vomiting. Hypersensitivity Reactions: Skin rashes, urticaria, pruritus,
angioedema and facial edema.
Rare: Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.
Use in Pregnancy and Lactation
Pregnancy: Pregnancy category B. Although the use of Cefixime in pregnancy not known to be
harmful, this drug should be used during pregnancy only if clearly needed.
Lactation: Since Cefixime is excreted in breast milk in low concentration, caution should be exercised
when Cefixime is administered to a nursing woman.
Direction for Reconstitution of Onefix Suspension
Shake the bottle to loosen powder. Add 20 ml boiled and cooled water for 30 ml suspension & add 30
ml boiled and cooled water for 50 ml suspension. For ease of preparation, add water to the bottle in two
proportions. Shake well after each addition until all the powder is in suspension. The reconstituted
suspension should be used within 7 days if kept in room temperature or within 14 days if refrigerated.
Drug Interaction
With Medicine: Carbamazepine: Elevates Carbamazepine blood level. Warfarin: Increased
prothrombin-time.
With Food & Others: Onefix (Cefixime) usually taken with or without food.
Overdose
Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in
significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in
small numbers of healthy adult volunteers receiving single doses upto 2 g of cefixime did not differ from
the profile seen in patients treated at the recommended doses.
Storage
Store below 30° C temperature. Keep in dry place, away from light & moisture. Keep out of reach of
children.
Packing
Onefix 200 Capsule: Each box contains 2 x 7’s capsules in Alu-Alu blister pack.
Onefix 400 Capsule: Each box contains 1 x 7’s capsules in Alu-Alu blister pack.
Onefix 30 ml PFS: Each bottle contains dry powder to make 30 ml suspension with a measuring cup.
Onefix 50 ml PFS: Each bottle contains dry powder to make 50 ml suspension with a measuring cup.