CEFIXIME-ELSaad (susp)
-
Chemical Name:
Cefixime -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Cephalosporin (Third Generation) -
Pharmaceutical Form:
Dry powder for suspension -
Composition:
Cefixime 100mg/5ml
CEFIXIME ElSaad
Cefixime
F.C.Tablets
Dry Powder for Oral Suspension
Cefixime
F.C.Tablets
Dry Powder for Oral Suspension
1. PHARMACOLOGY:
Cefixime is a third-generation cephalosporin antibiotic, it has bactericidal action and acts by inhibiting the synthesis of the bacterial cell wall.
It is highly stable to hydrolysis by most beta-lactamases. Cefixime is active against most strains of gram-negative and gram-positive organisms and has greater activity against gram-negative bacteria than first or second-generation cephalosporins. Many organisms are resistant to penicillin and some cephalosporins, due to the presence of beta lactamases, may be susceptible to cefixime.
2. INDICATIONS:
CEFIXIME ELSaad is used in the treatment of susceptible infections including:
- Otitis media.
- Pharyngitis.
- Lower respiratory-tract infections (bronchitis).
- Urinary-tract infections.
- Gonorrhea.
3. CONTRAINDICATION:
Hypersensitivity to cefixime or to other cephalosporins.
4. SIDE EFFECTS:
The most common side effects are gastro-intestinal disturbances especially diarrhea, and hypersensitivity reactions including skin rashes and urticaria.
5. PRECAUTIONS:
- Careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs. If an allergic reaction to the drug occurs, discontinue the drug.
- Cefixime should be used with caution in patients with renal impairment.
- Cefixime should be discontinued in case of pseudomembranous colitis and severe diarrhea.
6. PREGNANCY & LACTATION:
Pregnancy Category B. The drug should be used in pregnancy only if clearly needed.
Consideration should be given to discontinuing nursing temporarily during treatment with this drug.
7. DRUG INTERACTIONS:
- The concomitant use of a nephrotoxic drugs such as the aminoglycoside antibiotics and furosemide may increase the risk of kidney damage.
- Plasma concentrations are enhanced if probenecid is given concomitantly.
8. DOSAGE & ADMINISTRATION:
Adults:
400 mg (1 tablet) daily as a single dose or in two divided doses (each 12 hours).
For gonorrhea: 400 mg (1 tablet) as a single dose.
Children:
Children under 50 kgs: 8 mg per 1 kg of body weight daily as an oral suspension, or 4 mg per 1 kg of body weight each 12 hours.
Children weighing more than 50 kg or older than 12 years: should be treated with the recommended adult dose.
- The tablet should not be substituted for the suspension in the treatment of otitis media.
- Doses should be reduced in patients with moderate to severe renal impairment.
9. PACKAGING & COMPOSITION:
- CEFIXIME ElSaad 200 - F.C.Tablets: A pack of 6 or 10 f.c.tablets. Each film-coated tablet contains Cefixime 200 mg.
- CEFIXIME ElSaad 400 - F.C.Tablets: A pack of 6 or 10 f.c.tablets. Each film-coated tablet contains Cefixime 400 mg.
- CEFIXIME ElSaad 100 - Dry Powder for Oral Suspension: A pack of glass bottle of 60 mL. After reconstitution, each 5 mL suspension contains Cefixime 100 mg.
10. STORAGE CONDITIONS:
Store CEFIXIME ElSaad - F.C.Tablets and Dry Powder for Oral Suspension at temperature between (15-30)°C.
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