1.

PRODUCT DESCRIPTION

SR Brand Name Manufacturer Dosage Strength Pack Size Price/Unit

No Form

1 Mediceena injection 500mg vial 666 PKR

Lyphocin phrama (PVT)
LTD

2 VANCOMYCIN Pharmaceutical capsule 250mg 2x

associates,inc,
HYDROCHLORIDE 10 capsule
CAPSULES USP

3 Vanlid Cipla capsule 250mg 1 x 10 6.6 USD

Pharmaceuticals
capsule

4 Venjec inj Bosh injection 1g vial 1043 PKR

5 Pharmaceutics injection 500mg vial 666 PKR
V ANCOLON JULPHAR P
AKISTAN
 How to store this drug (instructions for patients): Store at room
temperature away from heat and light. Do not store in the bathroom.
Keep all medications away from children and pets .Do not flush
medications down the toilet or pour them into a drain unless instructed
to do so. Properly discard this product when it is expired or no longer
needed. Consult your pharmacist or local waste disposal company.

2. CHEMISTRY OF DRUG

Chemical Class ; glycopeptide antibiotic.

 Physical Properties:
 Average mass:1449.254 Da
 Monoisotopic mass:1447.430176 Da
 Vancomycin Hydrochloride is a white to tan lyophilized powder.
 3. PHARMACOKINETICS

1) ABSORPTION:
Poorly absorbed from gastrointestinal tract, however systemic absorption (up to 60%) may
occur following intraperitoneal administration

2) DISTRIBUTION
Bio-Availability Protein Placen Blood Secre Volume Time For Onset
Binding tal Brain ted In Of Of Action
(%) Barrie Barrier Milk Distribut
r ion

-Oral vancomycin has Can Don’t Drug -The onset of

a bioavailability of less than Approxi cross redeaily Secre The action of oral
10%. mately placen cross t volume of Vancomycin Is
- 50% tal blood in distributi currently
Systemic absorption of vanco serum barrie r brain breas on, as unknown
mycin following intraperitoneal protein barrier t discusse d -Vancomycin has a
administration is 54–65% of a bound milk in the rapid onset of
given dose in 6 hours and results literatur action with a
in adequate serum e, varies serum peak
concentrations between concentration
0.4-1 immediately
L/kg following the
completion of the
intravenous i
nfusion
 3). ELIMINATION
Half LIFE Site Of Metabolism Active Route Of
Metabolite Excretion
(if any)

 Following intravenous
Half-life in normal administration, In the first 24
renal patients is vancomycin is hours, about
approximately 6 poorly metabolized and is 75-80% of an
hours (range 4 to mainly excreted unchanged administered
11 hours). In in urine. dose of
anephric patients, Total body clearance is thus vancomycin is
the average half- dependent on the kidney, excreted in
life of elimination and is correlated with urine by
is glomerular filtration rate glomerular
7.5 days and creatinine clearance filtration
 . Vancomycin is
not metabolized by the
body and is excreted
unchanged in the urine by
glomerular filtration
4. CLINICAL PHARMACOLOGY
Pharmacological Class gylcopeptide

Therapeutic Class antibiotic

Mechanism Of Action The bactericidal action of vancomycin results
primarily from inhibition of cell-wall biosynthesis.
Specifically, vancomycin prevents incorporation of N-
acetylmuramic acid (NAM)- and N-acetylglucosamine

(NAG)-peptide subunits from being incorporated into

the peptidoglycan matrix, which forms the major
structural component of Gram-positive cell walls.
Vancomycin forms hydrogen bonds with the terminal D-
alanyl-D-alanine moieties of the NAM/NAG- peptides,
preventing the incorporation of the NAM/NAG-peptide
subunits into the peptidoglycan matrix. In addition,
vancomycin alters bacterial-cell- membrane permeability
and RNA synthesis. There is no cross-resistance between
vancomycin and other antibiotics. Vancomycin is not active
in vitro against gram-negative bacilli, mycobacteria, or fungi
 Spectrum Listeria monocytogenes, Streptococcus
(in case of antibiotic) pyogenes, Streptococcus pneumoniae (including
penicillin-resistant strains), Streptococcus agalactiae,
Actinomyces species,
and Lactobacillus species. The combination of
vancomycin and an aminoglycoside acts synergistically
in vitro against many strains of Staphylococcus aureus,
Streptococcus bovis, enterococci, and the viridans group
streptococci

Contradictions It should be contraindicated in

Conditions:

 systemic mastocytosis
 low levels of a type of white blood cell called
neutrophils
 hearing loss
 kidney disease with likely reduction in kidney
Precautions function
Use cautiously in patients older than age 60; patients
with impaired renal or hepatic function, hearing loss, or
Allergies:
allergies to other antibiotics; and patients receiving other
neurotoxic, nephrotoxic, or ototoxic drugs.
 Vancomycin Analogue
 Clinically Monitoring Parameters

Patients receiving vancomycin therapy require monitoring to ensure the safety and efficacy
of the medication. Periodic renal function tests and complete blood cell counts can help to
monitor the patient’s response to the drug.
Assessment of vancomycin trough concentrations is a strong recommendation in the
following patients receiving intravenous vancomycin injection:
 A severe or invasive infection
 Critical illness
 Impaired or unstable renal function
 Morbid obesity (body mass index greater than or equal to 40 kg/m)
 Advanced age
 Inadequate response to therapy after three to five days
 Concomitant use of nephrotoxic agents (i.e., aminoglycosides, piperacillin- tazobactam,
amphotericin B, cyclosporine, loop diuretics, nonsteroidal anti- inflammatory drugs,
contrast dye).
Monitoring vancomycin trough concentrations in stable patients with normal renal
function is also recommended to assess satisfactory clinical response.
Obtaining vancomycin serum trough concentrations allows healthcare professionals to
evaluate the efficacy of the vancomycin dosing regimen and clearance of the drug by the
individual patient. The target therapeutic serum trough concentration varies depending on
the indication and typically ranges between 10 mcg/mL to 20 mcg/mL.
Serum trough concentrations should ideally be drawn immediately (30 minutes or less)
before administration of a dose at steady-state conditions. Typically, steady state occurs
after the third dose of vancomycin.
Unlike intravenous vancomycin injection, oral vancomycin typically does not require serum
concentration monitoring due to a lack of systemic absorption.
 5. DOSAGE SCHEDULE
Indications Route Of Recommended Dosage Duration Of
Administration Therapy (if any)

parental 15 mg/kg IV
Infective Endocarditis every 12 hours (Adults)

Endocarditis parental 500 mg IV

-Native Valve
every 6 hours OR 1 g IV
every 12 hours (adults) Endocarditis: At least 4
weeks
-Prosthetic Valve
Endocarditis: At least 6
weeks
For treatment oral 125 milligrams 10 days
of C. difficile- (mg) 4 times
associated diarrhea (adults)
 6. ADJUSTMENT OF DOSAGE (if required) HEPATIC/RENAL

IMPAIRMENT: For patients with renal failure, adjust dosage based on degree of
renal impairment, severity of infection, and susceptibility of causative organism.
Base dosage on serum levels of drug.
Recommended initial dose is 15 mg/kg. Subsequent doses should be adjusted,
p.r.n. Some clinicians use the following schedule.

Creatinine clearance Adult

(ml/min) dosage
< 1.5 1 g q 12 hr
1.5-5 1 g q 3-6 days
>5 1 g q 10-14 days
 7. SIDE EFFECTS
 Oral:
 Vomiting (9%)
 Diarrhea (9%)
 Pyrexia (9%)
 Flatulence (8%)
 Urinary tract infection (8%)
 Headache (7%)
 Peripheral edema (6%)
 Back pain (6%)
 Fatigue (5%)
 Nephrotoxicity (5%)
 IV
 Hypersensitivity reactions (eg, anaphylaxis, “red man syndrome”)

 Renal and urinary disorders: Acute kidney injury and interstitial nephritis
 Ear and labyrinth disorders: Tinnitus, hearing loss, vertigo
 Blood and lymphatic system disorders: Agranulocytosis, neutropenia,
pancytopenia, leukopenia, thrombocytopenia, eosinophilia
 General disorders and administration site conditions: General discomfort,
fever, chills, phlebitis, injection site irritation, injection site pain and necrosis
following intramuscular injection, chemical peritonitis following
intraperitoneal administration
 8. ADMINISTRATION GUIDELINES
1) FOR ORAL USE
How to take this drug: vancomycin comes as a capsule to take by mouth ,take it
around the same times every day
Can you break or crush tablets: Swallow the capsule whole. Do not crush, open,
or chew

 Counseling about the drug:

 If your symptoms or health problems do not get better or if they
become worse, call your doctor.
 Do not share your drugs with others and do not take anyone else's drugs.
 Some drugs may have another patient information leaflet. Check with your
pharmacist. If you have any questions about vancomycin , please talk with
your doctor, nurse, pharmacist, or other health care provider.
 If you think there has been an overdose, call your poison control center or
get medical care right away. Be ready to tell or show what was taken, how
much, and when it happened.
 2) INSTRUCTIONS FOR TOPICAL USE (IF ANY)………………………………

……………………………………………………………………………………………………………

3) For I/V ROUTE

IV Bolus, Rate Of Administration
Vancomycin shall only be administered
as slow intravenous infusion of at least one
hour duration or at a
maximum rate of 10 mg/min
(whichever is longer) which is
sufficiently diluted

Solvent For Reconstitution Reconstituted solutions containing

(for dry powder for injection) 1g vancomycin must be diluted with at least
200ml diluent. 0.9% sodium chloride
intravenous infusion or 5% dextrose
intravenous infusion are suitable diluents.

Volume To Be Added/ Concentration reconstitute the vial with Sterile Water

for Injection by adding 10 mL of the
diluting solution to the 500-mg vial

Temperature And Storage Time After After reconstitution, the vials may
Reconstitution be stored in a refrigerator for 96 hours
 9. DRUG—DRUG INTERACTIONS
Interacting Severity Mechanism Outcome Management
Drug
Cholera severe Both produce No effect of Avoid
vaccine and pharmacodynamics vaccine administration of
vancomycin antagonism vaccine with
systemic
vancomycin

Cidofovir and Severe Both can increase Kidney Go for modified

vancomycin risk of damage therapy
nephrotoxicity

bacitracin Severe Both can increase Hearing Use alternative

and nephrotoxicity and lose ,kidney medicine
vancomycin otoxocity damage

Gentamycin Minor Both can cause Kidney Avoid

and nephrotoxicity damage Coadministration
vancomycin of both drugs
10. DRUG FOOD INTERACTION
Food Nature Of Interaction
No as such food interaction is
found

11. DRUG—LAB INTERACTIONS

Lab Test Nature Of Interaction

Direct bilirubin concentration is falsely

increased in the presence of
vancomycin , and potassium is affected
at high concentrations.
12. TOXICOLOGY
Toxic Dose Sign & Symptoms Of Management/Treatment
Toxicity (including antidote)
More than 4g per day -nephrotoxicity Most mild cases of
-Ototoxicity vancomycin nephrotoxicity
-Neutropenia resolve upon
discontinuation of the
medication.
Aggressive drug elimination
is indicated in patients with
severely elevated plasma
vancomycin concentrations
compounded by impaired
clearance due to oliguria, as
this further increases the risk
of permanent renal damage.
Standard membrane dialysis
is ineffective in clearing large
mass molecules such as
vancomycin, but high-flux
hemodialysis allows for
improved elimination of large
Tayyabawith
molecules, mumtaz
a reported
vancomycin removal rate of
up toRoll
79%no: 17