Zenith
Pharmaceuticals Ltd.
Bangladesh
Quality for life









Zenicef

Cefixime Trihydrate USP

Presentation
Zenicef Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg.
Zenicef Powder for Suspension: After reconstitution according to direction, each 5 ml suspension contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg.


Description
Cefixime is a semi-synthetic, broad-spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. Cefixime is highly stable in the presence of beta-lactamase enzymes. Cefixime has marked in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including beta lactamase producers.
Clinical efficacy of Cefixime has been demonstrated in infections caused by commonly occurring pathogens including Gram-positive organism Streptococcus pneumoniae, Streptococcus pyogenes, Gram-negative organism Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), Salmonella typhi and Enterobacter species.
Indications and Uses
Zenicef is indicated in the following infectious diseases -

Respiratory Tract Infections:
Pneumonia
Sinusitis
Pharyngitis and Tonsillitis
Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis (AECB)
Otitis Media
Typhoid
Urinary Tract Infections
Uncomplicated gonorrhea (cervical/urethral)
Contraindications
Patients with known hypersensitivity to Cefixime or cephalosporin group of drugs.
Dosage And Administration
The usual treatment of Emixef is 7 days. This may be continued for up to 14 days according to the severity of infection.

Age Zenicef Capsule
Adult and child over 10 years 200 or 400 mg daily as a single dose or in two divided doses
Zenicef Suspension
Child over 6 months 8 mg/kg daily as a single dose or in 2 divided doses
Child 6 months - 1 year 3.75 ml or 75 mg daily
1-4 Years 5 ml or 100 mg daily
4-10 Years 10 ml or 200 mg daily
10-12 Years 15 ml or 300 mg daily
Above 12 years 10 ml or 20 ml or 200-400 mg daily
Precautions
Cefixime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)
Side Effects
Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self-limiting in nature.
Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, and flatulence have been reported.
CNS disturbances: Headache, dizziness.
Others: Hypersensitivity reactions, which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.
Use in pregnancy & lactation
Pregnancy: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.
Use in elderly
No special precautions are necessary. No dosage adjustment is required for elderly.
Overdosage
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 up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
Commercial Pack
Zenicef Capsule: Box containing 1 Alu-Alu blister strip of 4 capsules.
Zenicef Suspension: Bottle containing powder for the preparation of 50 ml suspension

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