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Ngcef®
Rx only
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ngcef®
(Cefixime) and other antibacterial drugs, Ngcef® should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by bacteria.
Description
Ngcef® (Cefixime) is a semisynthetic, Cephalosporin antibiotic for oral administration.
Chemically, it is (6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-vinyl-5-thia-1azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-[O-(carboxymethyl) oxime] trihydrate.
Chemical formula is C16H15N5O7S2.3H2O and it has a molecular weight of 507.50 as the
trihydrate. The structural formula for Cefixime is:
Composition
Ngcef® 200 Capsule: Each capsule contains Cefixime Trihydrate BP equivalent to Cefixime 200
mg.
Ngcef® 400 Capsule: Each capsule contains Cefixime Trihydrate BP equivalent to Cefixime 400
mg.
Ngcef® Granules for Suspension: When reconstituted each 5 ml of suspension contains Cefixime
Trihydrate BP equivalent to Cefixime 100 mg.
Ngcef® DS Granules for Suspension: When reconstituted each 5 ml of suspension contains
Cefixime Trihydrate BP equivalent to Cefixime 200 mg.
Microbiology
As with other Cephalosporins, bactericidal action of Cefixime results from inhibition of cell-wall
synthesis. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many
organisms resistant to Penicillins and some Cephalosporins due to the presence of betalactamases, may be susceptible to Cefixime. Cefixime has been shown to be active against most
strains of the following organisms both in vitro and in clinical infections: Aerobic gram positive microorganisms: Streptococcus pneumoniae, Streptococcus pyogenes. Aerobic gram negative microorganisms: Haemophilus influenzae (beta-lactamase positive and negative
strains), Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase positive),
Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase- and non
penicillinase-producing strains). Note: Pseudomonas species, strains of group D streptococci
(including enterococci), Listeria onocytogenes, most strains of staphylococci (including
methicillin-resistant strains) and most strains of Enterobacter are resistant to Cefixime. In
addition, most strains of Bacteroides fragilis and Clostridia are resistant to Cefixime.
Pharmacokinetic
Cefixime, given orally, is about 40% to 50% absorbed whether administered with or without
food. Peak serum concentrations occur between 2 and 6 hours following oral administration of a
single 200 mg capsule, a single 400 mg capsule. Approximately 50% of the absorbed dose is
excreted unchanged in the urine in 24 hours. The serum half-life of Cefixime in healthy subjects
is independent of dosage from and averages 3 to 4 hours, but may range up to 9 hours in some
normal volunteers. In subjects with moderate impairment of renal function (20 to 40 ml/min
creatinine clearance), the average serum half-life of Cefixime is prolonged to 6.4 hours. In severe
renal impairment (5 to 20 ml/min creatinine clearance) the half-life increased to an average of
11.5 hours. The drug is not cleared significantly from the blood by hemodialysis. Adequate data
on CSF levels of Cefixime are not available.
Indication and Use
Cefixime is indicated in the treatment of the following infections caused by susceptible strains of
the microorganisms: Pharyngitis, Tonsillitis, Otitis media, Acute bronchitis, Acute Exacerbations
of Chronic Bronchitis, Urinary Tract Infection and Uncomplicated Gonorrhea.
Dosage and Administration
Capsule: 1 or 2 capsule as a single dose or in two divided doses daily for 7 to 14 days, according
to the severity of infection.
Suspension: 8 mg / kg daily as a single dose or in two divided doses daily for 7 to 14 days,
according to the severity of infection or for children of age ½ - 1 year : 3.75 ml or 75 mg, 1 - 4
years : 5 ml or 100 mg, 5 - 10 years : 10 ml or 200 mg, 11 - 12 years : 15 ml or 300 mg and
above 12 years : adult dose.
Direction for use
Ngcef® Granules for 50 ml Suspension: Shake the bottle well before adding water. Then add 35
ml of boiled and cool water (with the help of the provided measuring cup) to the bottle. For ease
of preparation, add water to the bottle in two portions. Then continue shaking the bottle gently
until the granules are mixed properly. Shake the bottle well before each use.
Ngcef® DS for 50 ml Suspension: Shake the bottle well before adding water. Then add 35 ml of
boiled and cool water (with the help of the provided measuring cup) to the bottle. For ease of
preparation, add water to the bottle in two portions. Then continue shaking the bottle gently until
the granules are mixed properly. Shake the bottle well before each use.
Contraindication
Cefixime is contraindicated in patients with known allergy to the Cephalosporin group of
antibiotics.
Use in Pregnancy and Lactation
Pregnancy: The safety of Cefixime in pregnancy has not been established. The drug should be
prescribed during pregnancy only if clearly needed. Lactation: Cefixime is excreted in breast
milk; caution should be exercised when Cefixime is administered to a nursing mother.
Side Effect
Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials
were mild and self-limiting in nature. Gastrointestinal: Diarrhea, loose stools, abdominal pain,
dyspepsia, nausea, and vomiting. Pseudomembranous colitis has been reported rarely.
Hypersensitivity Reactions: Skin rashes, urticaria, drug fever, and pruritus. Central Nervous
System: Headaches, dizziness, seizures. Other: Genital pruritus, vaginitis, and candidiasis.
Precaution
Cefixime, as with other broad-spectrum antibiotics, should be prescribed with caution in
individuals with a history of colitis. Dosage adjustment is only necessary in severe renal failure
(creatinine clearance < 20 ml / min). Prothrombin time should be monitored in patients at risk.
Warning
Before therapy with Cefixime is instituted, careful inquiry should be made to determine whether
the patient has had previous hypersensitivity reactions to Cephalosporins, Penicillins and other
drugs. This product should be given cautiously to penicillin hypersensitive patients. Serious
acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other
emergency measures. Pseudomembranous colitis has been reported with nearly all antibacterial
agents, including Cefixime and may range in severity from mild to life-threatening. Therefore, it
is important to consider this diagnosis in patients who develop diarrhoea subsequent to the
administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora
of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by
Clostridium difficile is one primary cause of antibiotic-associated colitis.
Drug Interaction
Carbamazepine: Elevated carbamazepine levels have been reported when Cefixime is
administered concomitantly. Warfarin and Anticoagulants: Increased prothrombin time, with or
without clinical bleeding, has been reported when Cefixime is administered concomitantly.
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.
Stability and Storage Recommendation
Capsule: Store at room temperature. Suspension: Store granules at room temperature. After
reconstitution, suspension should be stored at room temperature or under refrigeration and used
within 14 days of preparation.
Packaging Quantity
Ngcef® 200 Capsule: Box containing 2 x 3's, 2 x 6's capsules in alu-alu pack.
Ngcef® 400 Capsule: Box containing 2 x 3's capsules in alu-alu pack.
Ngcef® Granules for Suspension: Bottle containing granules to produce 50 ml of suspension
when reconstituted.
Ngcef® DS Granules for Suspension: Bottle containing granules to produce 50 ml of suspension
when reconstituted.