VANCOMYCINE ELSaad
-
Chemical Name:
Vancomycin -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Glycopeptide antibiotic -
Pharmaceutical Form:
Capsules -
Composition:
Vancomycin 250 mg
VANCOMYCIN ELSaad
Capsules
Vancomycin (Hydrochloride)
Broad Spectrum Antibiotic
1-CLINICAL PHARMACOLOGY:
During multiple dosing of 250 mg every 8 hours for 7 doses, fecal concentrations of Vancomycin Hydrochloride in volunteers exceeded 100 mg/kg in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%.
Microbiology:
The bactericidal action of Vancomycin Hydrochloride results primarily from inhibition of cell-wall biosynthesis. In addition, Vancomycin Hydrochloride alters bacterial-cell membrane permeability and RNA synthesis. There is no cross-resistance between Vancomycin Hydrochloride and other antibiotics. Vancomycin Hydrochloride is active against Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains); Streptococci, including Streptococcus pyogenes, Streptococcus pneumoniae (including pencillin-resistant strains), Streptococcus agalactiae, and enterococci (e.g., Entercococcus faecalis [formerly Streptococcus faecalis]); Clostridium difficils (eg, toxigenic strains implicated in pseudomembranous enterocolitis); and diphtheroids.
Vancomycin Hydrochloride is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.
2-INDICATIONS:
VANCOMYCIN ELSaad may be administered orally for treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis caused by C. difficile. Administration of intravenous Vancomycin Hydrochloride is not effective for the above indications; therefore, Vancomycin must be given orally for these indications.
3-CONTRAINDICATIONS:
Vancomycin Hydrochloride should not be administered to subjects with a known hypersensitivity to it.
4-PRECAUTIONS:
-Vancomycin Hydrochloride should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations. Dosage of Vancomycin Hydrochloride must be adjusted for patients with renal dysfunction.
-Some patients with inflammatory disorders of the intestinal mucosa may have significant systemic absorption of Vancomycin HCl and, therefore may be at risk for the development of adverse reactions associated with the parenteral administration of Vancomycin HCl. The risk is greater if renal impairment is present.
-Ototoxicity has occurred in patients receiving Vancomycin HCl. It has been reported in patients who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as aminoglycoside. Serial tests of auditory and renal functions should be performed in these cases.
-Geriatrics: The natural decrement of glomerular filtration with increasing age may lead to elevated Vancomycin Hydrochloride serum concentrations if dosage is not adjusted. Vancomycin Hydrochloride dosage schedules should be adjusted in elderly patients.
-Pregnancy and lactation: Only if clearly needed.
5-ADVERSE REACTIONS:
Infrequently: Nausea, rashes, and drug fever.
6-DOSAGE AND ADMINISTRATION:
VANCOMYCIN ELSaad is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis.
The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dosage in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.
7-PACKAGING & COMPOSITION:
VANCOMYCIN ELSaad – Capsules: A pack of 10 capsules. Each capsule contains Vancomycin HCl equivalent to Vancomycin 250 mg.
8-STORAGE CONDITIONS:
Store VANCOMYCIN ELSaad – Capsules at temperature between (15-30)°C.
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