Yellow coloured suspension having a characteristic odour when reconstituted with 2.25 mL of water.
Each 5 mL (1 teaspoonful) contains: Cefixime (as trihydrate) USP 100 mg.
Pharmacology: Pharmacodynamics: Antibacterial Activity: Cefixime has a broad-spectrum activity against Gram-positive and Gram-negative microorganisms. In comparison with the other oral cephalosporins, this product has a particular potent activity against such gram-positive organisms as Streptococcus sp., Streptococcus pneumoniae, and such gram-negatives as Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella sp., Serratia sp., Proteus sp., and Haemophilus influenzae. Its mechanism of action is bactericidal.
lt is extremely stable to β-lactamase produced by many organisms, and has good activity against β-lactamase producing organisms.
Mechanism of Action: Cefixime acts by inhibiting the cell wall synthesis. It has high affinity for penicillin binding proteins (PBP)1 (1a, 1b, and 1c) and 3, with the site of activity varying according to organism.
Pharmacokinetics: Serum concentration: Following a single-oral dose of 50, 100 or 200 mg (potency) of Cefixime in healthy, fasted adults, maximum serum concentrations at 4 hours were 0.69, 1.13, and 1.95 mcg/mL, respectively. The serum half-life was 2.3-2.5 hours. Following a single oral dose of 1.5, 3.0 or 6.0 mg (potency)/Kg of Cefixime in pediatric patients with normal renal function, maximum serum concentrations at 3-4 hours were 1.14, 2.01, and 3.97 mcg/mL, respectively. The serum half-life was 3.2-3.7 hours.
Diffusion and tissue penetration: Penetration into sputum, tonsils, maxillary sinus, mucosal tissue, otorrhea, biliary fluid and gallbladder tissue is good.
Metabolism: No antibacterially active metabolites are found in the human serum or urine.
Excretion: Cefixime is primarily and renally excreted. The extent of urinary excretion (up to 12 hours) after oral administration of 50, 100 or 200 mg (potency) in healthy, fasted adults was about 20-25%. Maximum urine concentrations were 42.9, 62.2, and 82.7 mcg/mL at 4-6 hours. The extent of urinary excretion (up to 12 hours) after oral administration of 1.5, 3.0, or 6.0 mg (potency)/Kg in pediatric patients with normal renal function was about 13-20%.
For the following infections caused by Cefixime-susceptible strains of Streptococcus sp., Streptococcus pneumoniae, Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella sp., Serratia sp., Proteus sp., Haemophilus inlfuenzae: Bronchitis, bronchiectasis with infection, secondary infections of chronic respiratory tract diseases, pneumonia; Pyelonephritis, cystitis, gonococcal urethritis; Cholecystitis, cholangitis; Scarlet fever; Otitis media; Sinusitis.
Adult and children (over 10 years): 200 mg to 400 mg daily in two divided doses.
6 months to 1 year: 3.75 mL or 75 mg daily.
1 to 4 years old: 5 mL or 100 mg.
5 to 10 years: 10 mL or 200 mg daily.
11 to 12 years old: 15 mL or 300 mg.
Adult or children weighing <30 kg: 200 mg to 400 mg or as prescribed by physician.
Patients with a history of shock due to any ingredient of this product or other cephalosporin antibiotics.
As a general rule, this product is contraindicated in the following patients, although if necessary, it should be administered with caution: Patients with a history of hypersensitivity to penicillins; Patients with a personal or familial history of some form of allergy such as bronchial asthma, rash, and urticaria; Patients with serious renal function disorder; Patients with poor oral nutrition, those receiving parenteral nutrition, elderly patients or those in a debilitated state.
(Careful observation is essential in these patients as vitamin K deficiency symptoms may develop).
To avoid the unnecessary emergence of resistant bacteria, sensitivity testing is recommended prior to antibiotic administration. In addition, it is important to consider minimizing length of treatment while maintaining treatment objectives.
General Precautions: Careful inquiry about any form of hypersensitivity should be made, since reactions such as shock may occur.
Use during pregnancy: The safety of this product in pregnant women has not been established. Therefore, the product should be used in pregnant women and women suspected of being pregnant only when treatment benefits outweigh the possible risks.
Use in Newborns/Prematures: Safety in newborns and prematures has not been established.
The drug is generally well tolerated. The most frequent side effects observed are diarrhea and stool changes; that has been more commonly associated with higher doses. The drug should be discontinued if marked diarrhea occurs. Other side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon discontinuation of therapy.
Directions for use/mixing/reconstitution: Cefixime 100 mg/5 mL Powder for Suspension: 37.5 mL: To reconstitute, add 22.5 mL of water.
Discard unused portion after 7 days.
Caution in Use: Cefixime Granules should not be stored suspended in milk, juice, etc.
Special precautions for disposal and other handing: Any antibiotic residual solution as well as all materials that have been used for administration should be disposed of in accordance with local waste management center, discard any unused portion after 7 days.
Store in a dry place at temperatures not exceeding 30°C. Protect from light. After reconstitution, always keep container tightly closed.
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Retracef powd for oral susp 100 mg/5 mL
37.5 mL x 1's
Sign Out
Continue with Google
Sign up with email
Already a member?
Sign in
