APRIL 2002
FORMULARY
ADDITIONS
Fondaparinux Sodium Arixtra® 2.5 mg/0.5 mL syringe Restricted to Orthopedics Fondaparinux, also known as
fondaparin, is an anti-factor Xa anticoagulant that is similar to
low-molecular weight heparin in action.
The fondaparin molecule is a copy of the antithrombin III binding area
of heparin. Once bound to
antithrombin III, a complex is formed that inhibits the activity of factor Xa
and decreases thrombin generation without affecting circulating thrombin. The
lack of impact on circulating thrombin levels occurs because the molecular
size of fondaparinux is smaller than heparin so it selectively binds to
factor Xa but not to the thrombin molecule. A comparison of the FDA approved
indications for fondaparin and other low molecular weight heparins is
provided in Table 1. Table 1. Comparative indications for low molecular weight heparins on formulary
Fondaparinux is contraindicated in
patients allergic to the drug or any component of its formulation. It is also
contraindicated in patients with severe renal impairment (CrCl < 30
mL/min) as these patients are at increased risk of accumulation and increased
risk of bleeding episodes. Fondaparinux is also contraindicated in patients
weighing less than 50 kg. In clinical trials, major bleeding events were
doubled in patients weighing less than 50 kg. The use of this agent is also contraindicated in patients with
active major bleeding, bacterial endocarditis, and in patients wit
thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of
fondaparinux sodium. This
drug is not indicated for intramuscular injection and can not be used
interchangeably (unit for unit) with other low molecular weight heparins. Fondaparinux
has been well-tolerated in clinical trials.
Like other low-molecular weight heparins and heparoids, major and
minor bleeding is a dose-related risk with fondaparinux therapy. Like other
LMW heparins, this drug should be used with extreme caution in conditions of
increased risk of hemorrhage. Thrombocytopenia has occurred a rate of 2.9% in
clinical trials. Fondaparinux pharmacokinetics are not altered by concomitant aspirin or warfarin administration. Concurrent therapy with aspirin may enhance the antithrombotic effects of each agent or increase the risk of bleeding. Fondaparinux has no impact on the effect of warfarin on INR.
DOSAGE
AND ADMINISTRATION:
The recommended dose of fondaparinux after surgery is 2.5 mg administered
once daily subcutaneously. After hemostasis has been established, the initial
dose should be given 6 to 8 hours after surgery. Administration before 6
hours after surgery has been associated with increased risk of bleeding. The
usual duration of administration is 5 to 9 days and up to 11 days has been
tolerated. Nesiritide
Natrecor® 1.5 mg single-use vials, sterile
lyophilized powder Restricted to Cardiology Consult Nesiritide is a human B-type
natriuretic peptide that is indicated for the intravenous treatment of
acutely decompensated congestive heart failure in patients with dyspnea at
rest or with minimal activity.
Hemodynamic effects of nesiritide, including venous and arterial
vasodilation, result in decreased preload and afterload and decreases
pulmonary capillary wedge pressure, mean right atrial pressure, pulmonary
pressures, and systemic vascular resistance.
Although nesiritide does not exhibit direct inotropic effects, cardiac
index is also increased secondary to afterload reduction. These effects are sustained through 48
hours. Nesiritide had a mild diuretic effect and causes increased sodium
excretion. Nesiritide should not be used in patients with systolic blood pressure < 90 mm Hg or in those in cardiogenic shock. Administration to patients with low cardiac filling pressures should be avoided. Nesiritide is not recommended for patients with significant valvular stenosis, restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return. Serum creatinine was increased over baseline when compared to standard therapies when administered at doses greater than 0.01 mcg/kg/min. Dose-dependent hypotension may occur with nesiritide; monitor blood pressure closely. Nesiritide should be discontinued or the dose reduced in patients who develop hypotension.
Adverse reactions occurring with at least 3% frequency include hypotension, ventricular tachycardia and extrasystoles, headache, and nausea. In studies comparing the occurrence of ventricular arrhythmias of dobutamine and nesiritide, ventricular arrhythmias, including sustained and nonsustained ventricular tachycardia, occurred more often with dobutamine than nesiritide. Concomitant oral ACE inhibitor-therapy resulted in an increased frequency of hypotension compared to therapy without oral ACE inhibitors. Nesiritide has not been administered with nitroglycerin, nitroprusside, milrinone, or intravenous ACE inhibitors, effects are unknown. INCOMPATABILITIES: Nesiritide
is physically incompatible with heparin, furosemide, insulin, bumetanide,
ethacrynate sodium, enalaprilat, and hydralazine. DOSAGE
AND ADMINISTRATION: Nesiritide
should only be administered in a setting where blood pressure can be closely
monitored. The recommended dose of
nesiritide is an IV bolus of 2 mcg/kg followed by a continuous infusion at
0.01 mcg/kg/min. In clinical trials,
nesiritide was increased by 0.005 mcg/kg/min at no more than every three hours,
up to a maximum of 0.03 mcg/kg/min.
There is limited experience with nesiritide administration beyond 48
hours and is therefore not recommended. Papain-Urea-Chlorophyllin
Copper Complex Sodium Debriding Ointment
Panafil®
30 g tube, 1 pound jar Panafil is a debriding ointment indicated for several different types of wounds (see Table 2). Panafil is similar to another debriding agent currently on the formulary, Accuzyme, except Panafil contains one additional ingredient, chlorophyllin copper complex. The addition of the chlorophyllin copper complex adds healing action to the cleansing and debriding action of the papain-urea combination. Chlorophyllin also inhibits the hemagglutinating and inflammatory properties of protein degradation products in the wound. Table 2: Indications for
Papain/Urea Combination Products
A transient burning sensation may be
experienced by a small percentage of patients upon applying the
ointment. Occasionally, the profuse
exudate from enzymatic digestion may irritate the skin. In such cases, more frequent dressing
changes will alleviate discomfort until exudate decreases. This product is contraindicated in
patients who have shown sensitivity to papain or any other components of this
preparation. Avoid cleansing the wound with hydrogen peroxide solution as it may inactivate the papain. Papain may also be inactivated by the salts of heavy metals such as lead, mercury, and silver. Contact with medications containing these metals should be avoided. Terramycin, aureomycin, and chloromycetin may inhibit protein degradation.
DOSAGE AND
ADMINISTRATION:
Cleanse wounds with saline, AllClenz Wound Cleanser or Curasol Wound
Cleanser. Apply Panafil directly to
the wound, cover with appropriate dressing and secure into place. Daily or twice daily applications are
preferred. Irrigate the wound at each
dressing change to remove any accumulation of liquefied necrotic material. Ertapenem Sodium Invanz® 1
Gram IM/IV
Restricted
to Complicated Intra-abdominal Infections and Diabetic Foot Ulcers
INVANZ (ertapenem for injection) is a
carbapenem antibiotic that is structurally related to beta-lactam
antibiotics. INVANZ is indicated for various types of infections but will be
restricted at KU Med for the treatment of severe, complicated intra-abdominal
infections and diabetic foot ulcers. INVANZ is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to penicillin or other beta-lactams. Before initiating therapy with INVANZ, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams, and other allergens. Due to the use of lidocaine HCl as a
diluent, intramuscular administration of INVANZ is contraindicated in
patients hypersensitive to local anesthetics of the amide type. Caution
should be taken when administering INVANZ intramuscularly to avoid
inadvertent injection into a blood vessel. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ertapenem, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. During clinical investigations,
seizures occurred in 0.5% of patients. Seizures occurred most commonly in
patients with CNS disorders (e.g., brain lesions or history of seizures)
and/or compromised renal function. Close adherence to the recommended dosage
regimen is urged, especially in patients with predisposing factors. Dose adjustment is recommended in patients
with reduced renal function. The most common drug-related adverse experiences in patients treated with INVANZ, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%). Consult the full INVANZ prescribing information for a complete list of adverse reactions observed in clinical studies. In clinical studies, ertapenem
was discontinued due to laboratory changes in 0.3% of patients. Drug-related
laboratory changes reported in > 1.0% of patients were increases in ALT
(6.0%), AST (5.2%), alkaline phosphatase (3.4%), platelet counts (2.8%), and
eosinophils (1.1%). Additional
laboratory changes that occurred in > 0.1% but < 1.0% of patients
included increases in BUN, direct and indirect serum bilirubin, serum sodium,
monocytes, PTT, urine epithelial cells and decreases in serum bicarbonate.
DRUG INTERACTIONS: No
specific clinical drug interaction studies have been conducted other than
with probenecid. When used
concomitantly with probenecid, the renal clearance of ertapenem is
reduced. Ertapenem has not been found
to inhibit P-glycoprotein-mediated transport of digoxin or vinblastine or to
be a substrate for P-glycoprotein-mediated transport. Ertapenem also does not
inhibit metabolism mediated by any of the cytochrome P450 (CYP) isoforms.
DOSAGE AND
ADMINISTRATION The
usual adult dose of INVANZ is 1 gram once daily given by IV infusion for up
to 14 days or by IM injection for up to 7 days. When administered IV, INVANZ
should be infused over a period of 30 minutes. Do not mix or co-infuse INVANZ with any other medications. Do not use diluents containing dextrose.
*
Defined as creatinine clearance >90 mL/min/1.73 m2 †
Due to the designated pathogens Renal Insufficiency: In patients whose creatinine
clearance is > 30 mL/min, no dose adjustment is necessary. When the
creatinine clearance is < 30 mL/min or in end-stage renal disease
(creatinine clearance < 10 mL/min) the dose should be reduced to 500 mg
daily. When patients on hemodialysis
are given the recommended daily dose of 500 mg of INVANZ within 6 hours prior
to hemodialysis, a supplementary dose of 150 mg is recommended following the
hemodialysis session. If INVANZ is given at least 6 hours prior to
hemodialysis, no supplementary dose is needed. There is no data in patients
undergoing peritoneal dialysis or hemofiltration. Patients with Hepatic
Insufficiency: No dose adjustment recommendations can be made in patients with
impaired hepatic function. PREPARATION OF SOLUTION: For Intravenous administration: Do not mix or co-infuse INVANZ
with other medications. Do not use
diluents containing dextrose. INVANZ
must be reconstituted and diluted prior to administration. 1.
Reconstitute
the 1-gm vial with 10 mL of Water for Injection, 0.9% Sodium Chloride
Injection, or Bacteriostatic Water for Injection. 2. Shake well to dissolve and immediately transfer contents of the
reconstituted vial to 50 ml of 0.9% Sodium Chloride Injection. 3. Complete the infusion within 6 hours of
reconstitution. For intramuscular
administration: INVANZ must be reconstituted
prior to administration. 1. Reconstitute the 1-gm vial with 3.2 mL of 1.0% lidocaine HCl
injection. Shake vial thoroughly to form solution. 2. Immediately withdraw the contents of the vial and administer by
deep IM injection into a large muscle mass (such as the gluteal muscles or
lateral part of the thigh). 3. The reconstituted IM solution should be used within 1 hour after
preparation. The reconstituted
intramuscular solution should never be administered intravenously.
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