Triocef Tablet

CEFIXIME

100 mg Dispersible Tablet
200 mg Film-Coated Tablet
400 mg Film-Coated Tablet

ANTIBACTERIAL

Category:

Description

FORMULATION

Each uncoated tablet contains:

Cefixime (as trihydrate)

Equivalent to anhydrous cefixime ………………………… 100 mg

PHARMACOLOGY

Cefixime is a semi-synthetic third-generation cephalosporin beta-lactam antibiotic for oral administration. It is highly stable in the presence of beta-lactamase enzymes. Cefixime acts by binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, resulting in the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to cefixime.

Cefixime is orally active antibiotic which has in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including Streptococcus pneumonia, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species. Haemophilus influenza (beta-lactamase positive and negative), Moraxella (Branhamella) catarrhalis (beta-lactamase positive and negative).

PHARMACOKINETICS

Only 40 to 50% of an oral dose is absorbed from the gastrointestinal tract, whether taken before or after meals. The rate of absorption may be decreased in the presence of food. Cefixime is better absorbed from oral suspension than from tablets. Absorption is fairly slow; peak plasma concentrations of 2 to 3 micrograms per mL and 3.7 to 4.6 micrograms per mL have been reported between 2 and 6 hours after single doses of 200 and 400 mg, respectively. The plasma half-life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% of cefixime is bound to plasma proteins.

Information of the distribution in body tissues and fluids is limited. It crosses the placenta. Relatively high concentrations may be achieved in the bile and urine. About 20% of an oral dose (or 50% of an absorbed dose) is excreted unchanged in the urine within 24 hours. Up to 60% may be eliminated by nonrenal mechanisms; there is no evidence of metabolism but some are probably excreted in the feces from bile. It is not substantially removed via hemodialysis.

INDICATIONS         

Cefixime is indicated for the treatment of the following infections when caused by susceptible microorganisms.

  • Upper respiratory infections: e.g. bacterial pharyngitis, tonsillitis, otitis media, sinusitis.
  • Lower respiratory tract infections: e.g. bronchitis.
  • Urinary Tract Infections: e.g. acute cystitis
  • Uncomplicated gonorrhea

DOSAGE AND DIRECTIONS FOR USE            

Absorption of cefixime is not significantly modified in the presence of food. The usual course of treatment is 5-14 days.

Adults and children over 12 years

The recommended dose of Cefixime is 100 – 400 mg daily given either as a single dose or divided doses. In lower respiratory tract infections, 400 mg once daily is recommended. For upper respiratory tract infections and uncomplicated urinary tract infections, 100 mg once daily is usually effective. For sinusitis, the therapeutic dosage must be administered for 10 to 14 days.

For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.

Or as recommended by the physician.

CONTRAINDICATIONS

Allergy to cephalosporins. Cefixime is contraindicated with renal impairment with a creatinine clearance below 60 mL/min.

WARNINGS

Cefixime should be given with caution to patients who have shown hypersensitivity to other medicines. Cephalosporins should be given with caution to penicillin-sensitive patients as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient should be treated with appropriate agents if necessary.

Cefixime should be administered with caution in patients with markedly impaired renal function. Prolonged use of Cefixime may result in the overgrowth of non-susceptible organisms. Cefixime has been shown to alter the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate a toxin(s) produced by Clostridium difficile is the primary cause of antibiotic associated pseudomembranous colitis. The product should be discontinued if diarrhea occurs.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

A false positive reaction for glucose in the urine may occur with Benedict’s of Fehling’s solution or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions. A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore, it should be recognized that a positive Coombs test may be due to the medicine.

Gastrointestinal Disturbances: The most frequent side effects seen with cefixime are diarrhea and stool changes. Moderate to severe diarrhea has been reported. Other gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting, and flatulence. Pseudomembranous colitis has been reported.

Central Nervous System: Headache and dizziness.

Hypersensitivity Reactions: Allergy in the form of rash, pruritus, urticaria, drug fever and arthralgia have been observed. These reactions usually subsides upon the discontinuation of therapy.

Hematological and Clinical Chemistry: thrombocytopenia, leukopenia, and eosinophilia have been reported. These reactions were infrequent and reversible. Changes in liver and renal function tests have been observed.

Miscellaneous: Other possible reactions include genital pruritus and vaginitis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

No specific antidote exists. Cefixime is not removed from the circulation in significant quantities by dialysis. Treatment shall be symptomatic and supportive.

DRUG INTERACTIONS

Care should be exercised in patients receiving anticoagulants and cefixime due to the possibility that cefixime may increase prothrombin time.

PREGNANCY

The safety of cefixime in the treatment of infection in pregnant women has not been established. Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefixime. Because animal production studies are not always predictive of human response, this drug should be used during pregnancy only if the likely benefits outweigh the potential risk to the fetus and/or the mother.

STORAGE

Store at temperatures not exceeding 30°C.

Keep out of reach of children.

AVAILABILITY

Alu/Alu Blister Pack of 10’s (Box of 30’s).

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