OMNICLOR 250 (cap)
-
Chemical Name:
Cefaclor -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Cephalosporin(Second Generation)) -
Pharmaceutical Form:
Capsules -
Composition:
Cefaclor 250mg
OMNICLOR
Capsules, Dry Powder for Oral Suspension
Cefaclor Monohydrate
Broad Spectrum Antibiotic
1. PHARMACOLOGY:
OMNICLOR is a second generation cephalosporin antibiotic. It acts as bactericidal and inhibits synthesis of bacterial wall. It has antimicrobial activity similar to that of cephalexin. It acts against Gram-negative and Gram-positive bacteria, but it is more active against Gram-negative bacteria including: Escherichia coli, Klebsiella, Neisseria gonorrhea, Proteus mirabilis and especially against Haemophilus influenza.
2. INDICATIONS:
OMNICLOR is used in the treatment of infections caused by susceptible organisms including:
- Upper and lower respiratory infections, pharyngitis, tonsillitis and pneumonia.
- Otitis media.
- Skin and soft tissue infections.
- Urinary-tract infections: pyelonephritis and cystitis.
3. CONTRAINDICATIONS:
Hypersensitivity to Cefaclor or to other cephalosporins.
4. PRECAUTIONS:
- If hypersensitivity reaction occurs Cefaclor should be discontinued.
- Care is necessary with known history of allergy.
- Cefaclor should be given with caution in patients with renal impairment.
- Renal and hematological status should be monitored especially during prolonged and high doses therapy.
- Cefaclor should be given with caution in pregnancy and lactation.
5. SIDE EFFECTS:
The most common side effects are hypersensitivity reactions: Skin rashes, urticaria, eosinophilia, reaction resembling serum sickness, gastro-intestinal disturbances, hepatitis, pseudomembranous colitis have been reported.
6. DRUG INTERACTIONS:
- The concomitant use of nephrotoxic drugs such as aminoglycosides (Gentamycin) with Cefaclor may increase the risk of kidney damage.
- Probenecid inhibits the excretion of Cefaclor.
7. DOSAGE & ADMINISTRATION:
Adults: 250-500 mg three times daily. Up to 4 g daily.
Children: 20 mg/kg/day in divided doses increased in serious infections and otitis media to 1g/day maximally.
- Reconstitution directions for oral suspension:
Shake the bottle to loosen the powder. Add 40 ml of water to the bottle, invert and shake. Keep the bottle tightly closed. Shake well before use. Reconstituted OMNICLOR is stable for 14 days stored in refrigerator.
8. PACKAGING & COMPOSITION:
- OMNICLOR 250 – Capsules: A pack of 10 capsules. Each capsule contains Cefaclor Monohydrate equivalent to 250 mg Cefaclor.
- OMNICLOR 500 – Capsules: A pack of 10 capsules. Each capsule contains Cefaclor Monohydrate equivalent to 500 mg Cefaclor.
- OMNICLOR 125 – Dry Powder for Oral Suspension: A pack of glass bottle of 60mL. After reconstitution each 5 mL of the suspension contains Cefaclor Monohydrate equivalent to 125mg Cefaclor.
- OMNICLOR 250 – Dry Powder for Oral Suspension: A pack of glass bottle of 60mL. After reconstitution each 5 mL of the suspension contains Cefaclor Monohydrate equivalent to 250mg Cefaclor.
9. STORAGE CONDITIONS:
Store OMNICLOR – Capsules and Dry Powder for Oral Suspension at temperature between (15-30)°C.
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