Retracef PFS Cefixime
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100mg/5mL Powder for Suspension



Each 5mL (1 teaspoonful) contains Cefixime (as trihydrate)…..100mg


Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. Cefixime is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. Cefixime is also highly stable in the presence of beta-Iactamase enzyme. As a result, many organisms resistant to penicillin and some cephalosporin due to the presence of beta- lactamases, may be susceptible to Cefixime. Cefixime exhibits very good activity against most of the Enterobacteriaceae, Haemophilus influenzae and Neisseria gonorrhoeae (including ß-Iactamase producing strains ), ß-hemolytic streptococci of groups A and B and Streptococcus pneumoniae. Absorption is about 40% to 50% whether administered with or without food.


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) - 200mg to 400mg daily in two divided doses.
6 months to 1 year - 3.75mL or 75mg daily
1 to 4 years old - 5mL or 100mg
5 to 10 years - 200mg daily - 10mL or 200mg
11 to 12 years old - 15mL or 300mg
Adult or children weighing <30kg - 200mg to 400mg (1 – 2 capsules) or as prescribed by physician.


Cefixime 100 mg/5 mL Powder for Suspension:
37.5 mL - To reconstitute, add 22.5 mL of water
50mL – To reconstitute, add 30mL of water
Discard unused portion after 7 days.

Caution in Use:

Cefixime Granules should not be stored suspended in milk, juice, etc.


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.


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, if 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)

Adverse Reactions:

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.

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.


1. Antibacterial Activity:

a. Ceflxime 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.

b. lt is extremely stable to ß-Iactamase produced by many organisms, and has good activity against ß-Iactamase producing organisms.

2. 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.

Retracef - Cefixime




1. 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 1.95mcg/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 3.97mcg/mL, respectively. The serum half-life was 3.2-3.7 hours.

2. Diffusion and tissue penetration:

Penetration into sputum, tonsils, maxillary sinus, mucosal tissue, otorrhea, biliary fluid and gallbladder tissue is good.

3. Metabolism

No antibacterially active metabolites are found in the human serum or urine.

4. 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%.


FOODS, DRUGS, DEVICES AND COSMETICS ACT prohibits dispensing without prescription.


Cefixime 100mg/5mL: Store in a dry place at temperatures not exceeding 30OC; protect from light. After reconstitution, always keep container tightly closed.


* 37.5mL Cefixime 100mg/5mL Powder for Suspension in 60mL amber bottle



Manufactured by:

The ACME Laboratories LTD.

Dhulvita, Dhamrai

Dhaka, Bangladesh


Imported by:

EUROGENERICS International Philippines Inc.

Suites D & E, 11th Floor Burgundy Corporate Tower
252 Sen. Gil Puyat Avenue, Brgy. San Lorenzo
Makati City, Philippines


Exclusively Distributed by:

Remed Pharmaceuticals, Inc. 1113 11F AIC Burgundy Empire Tower ADB Ave. corner Sapphire & Garnet Sts., Ortigas Center, Pasig City 1605