Edicin

Edicin

vancomycin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Vancomycin HCl
Indications/Uses
Severe infections caused by gm +ve microorganisms resistant to other antimicrobial drugs eg, endocarditis, sepsis, osteomyelitis, CNS, lower resp tract (pneumonia) & skin & soft tissue infections, & for patients w/ known allergy to penicillins & cephalosporins.
Dosage/Direction for Use
Usual IV infusion dose & for Adult 500 mg every 6 hr or 1g every 12 hr administered slowly at rate not exceeding 10 mg/min over a period of at least 60 min or longer. Infant >1 mth 40 mg/kg daily, divided to individual doses given every 6 or 12 hr. Neonate up to 1 mth Initially 15 mg/kg followed by 10 mg/kg every 8 hr, up to 7 days 15mg/kg followed by 10 mg/kg every 12 hr. Impaired renal function Initially 15 mg/kg, CrCl 100 mL/min 1,545 mg every 24 hr, 90 mL/min 1,390 mg every 24 hr, 80 mL/min 1,235 mg every 24 hr, 70 mL/min 1,080 mg every 24 hr, 60 mL/min 925 mg every 24 hr, 50 mL/min 770 mg every 24 hr, 40 mL/min 620 mg every 24 hr, 30 mL/min 465 mg every 24 hr, 20 mL/min 310 mg every 24 hr, 10 mL/min 155 mg every 24 hr.
Contraindications
Hypersensitivity. Not to be administered IM.
Special Precautions
Discontinue in case of hypersensitivity reactions; if symptoms or signs of SJS (eg, progressive skin rash often w/ blisters or mucosal lesions) are present. Not suitable as a single agent for treatment of some types of infections. Not for intrathecal, intralumbar & intraventricular routes of administration. Cross hypersensitivity, including fatal anaphylactic shock in patients w/ allergic reactions to teicoplanin. Infusion-related reactions; pain & thrombophlebitis; anaesth induced myocardial depression; Pseudomembranous enterocolitis. Overgrowth of non-susceptible organisms during prolonged use. Avoid in patients w/ previous hearing loss. May cause neutropenia or agranulocytosis over a longer-term period or concurrently w/ other medications. Transitory or permanent ototoxicity in patients w/ prior deafness, who have received excessive IV doses, or receiving concomitant treatment w/ another ototoxic active substance eg, aminoglycoside. May cause erythema & histamine-like flushing in childn in concomitant use w/ anaesth agents. Increased risk of nephrotoxicity in concomitant use w/ nephrotoxic agents eg, aminoglycosides, NSAIDs (eg, ibuprofen for closure of patent ductus arteriosus) or amphotericin B. Monitor leukocyte count at regular intervals. Perform periodic haematologic studies, urine analysis, LFT & renal function tests during treatment. Periodically determine blood levels & test auditory function. Regularly monitor blood levels in high dose therapy & longer-term use, in patients w/ renal dysfunction or impaired faculty of hearing as well as in concurrent administration of nephrotoxic or ototoxic substances. Carefully monitor blood conc in childn. Monitor vestibular & auditory function in elderly during & after treatment. Frequently monitor serum levels & renal function. Avoid concurrent or sequential use of other ototoxic substances. Concomitant administration of anaesth agents. Not to be given w/ antidiarrhoeic medicinal products in severe persistent diarrhoea. May affect ability to drive & use machines. Renal insufficiency, including anuria. Pregnancy & lactation. Premature neonates & young infants. Elevated serum conc in elderly.
Adverse Reactions
Decreased BP; dyspnoea, stridor; flushing of upper body (red man syndrome), exanthema & mucosal inflammation, pruritus, urticaria; renal insufficiency manifested primarily by increased serum creatinine & urea; phlebitis, redness of upper body & face. SJS.
Drug Interactions
Concomitant administration w/ anaesth agents. Concurrent or sequential systemic or topical use of other potentially ototoxic, neurotoxic, or nephrotoxic medicinal products eg, amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin or cisplatin. Increased potential of neuromuscular blockade w/ neuromuscular blocking agents.
MIMS Class
Other Antibiotics
ATC Classification
J01XA01 - vancomycin ; Belongs to the class of glycopeptide antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Form
Edicin powd for soln for infusion 500 mg
Packing/Price
((0.5 g)) 10 × 1's
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