DECEMBER 2003
FDA Safety Alert:
Concentrated Morphine Sulfate Solutions Elan Pharmaceuticals and the FDA issued a "Dear Healthcare Professional" reporting serious adverse events and deaths resulting from accidental overdose of high concentration morphine sulfate oral solutions. In most of these cases, morphine oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product, resulting in 20-fold overdoses. To assure that your patient receives
the proper dose of morphine sulfate oral solution, please write a
prescription for morphine sulfate oral solution clearly by including the
following:
1.
The
concentration of morphine sulfate oral solution to be dispensed.
2.
The intended dose of morphine in milligrams (mg) with the
corresponding volume in milliliters (mL or cc)
written out in the directions. The KU
Hospital Pharmacy stocks two oral liquid morphine products:
·
Morphine solution 20 mg/10 mL - This is the PREFERRED
product for general use on the nursing units.
·
Morphine concentrate 20 mg/1 mL (Roxanol) - This is a
product used for special pain control situations, and should NOT be
ordered for general use. Note: Roxanol is the brand name for the morphine
concentrate ONLY. Roxanol should NOT
be used as a general term for morphine liquid, as this can lead to increased
risk of morphine overdoses. |
|
Example order for morphine solution |
|
Example order for morphine
concentrate |
|
(general use) |
|
(use in special pain control
situations) |
|
Morphine solution 20 mg/ 10 mL Sig: 15 mg (7.5 mL)
q4 hours prn |
Roxanol concentrate 20 mg/mL Sig: 15 mg (0.75 mL)
q4 hours prn |
|
Formulary Product Change:
Renal Vitamin Capsules to Tablets Current Product Nephrocaps capsules by Fleming New Product Nephplex Rx tablets by Nephro-Tech On Comparison of Vitamin Components B5 [dexpanthenol]: Tablet contains twice as much as capsule. C [ascorbic acid]:
Tablet contains 60% of capsule amount. Biotin: Tablet
contains twice as much as capsule. |
|
Ingredient |
Nephrocaps |
Nephplex Rx |
|
B1 |
1.5 |
1.5 |
|
B2 |
1.7 |
1.7 |
|
B3 |
20 |
20 |
|
B5 |
5 |
10 |
|
B6 |
10 |
10 |
|
B12 |
6 |
6 |
|
C |
100 |
60 |
|
Folic acid |
1 |
1 |
|
Biotin |
150 |
300 |
|
Formulary Addition Bivalirudin (AngiomaxÒ) Single-use
injection (1 vial = 250 mg) Bivalirudin is a specific and reversible direct thrombin
inhibitor. Bivalirudin
directly inhibits thrombin by specifically binding both the catalytic site
and the anion-binding exosite of circulating and
clot-bound thrombin. Thrombin is a
serine protease that cleaves fibrinogen into fibrin monomers and activates
Factor XII to Factor XIIIa, allowing fibrin to
develop a covalently cross-linked framework that stabilizes the
thrombus. Bivalirudin
is indicated for use as an anticoagulant in patients with unstable angina
undergoing percutaneous transluminal
coronary angioplasty (PTCA). Bivalirudin is intended for use with aspirin and has been
studied only in patients receiving concomitant aspirin. Bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI). Bivalirudin is contraindicated in patients with active major bleeding and or hypersensitivity to bivalirudin or its components. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of bivalirudin administration. DRUG AND FOOD INTERACTIONS The manufacturer’s prescribing
information lists no food/drug interactions. DOSAGE AND ADMINISTRATION The recommended
dosage of bivalirudin is an intravenous (IV) bolus
dose of 1.0 mg/kg followed by a 4-hour IV infusion at a rate of 2.5
mg/kg/h. After completion of the
initial 4-hour infusion, an additional IV infusion of bivalirudin
may be initiated at a rate of 0.2 mg/kg/h for up to 20 hours, if needed. Bivalirudin is
intended for use with aspirin (300-325 mg daily). Treatment with bivalirudin
should be initiated just prior to PTCA.
Bivalirudin is intended for IV injection and infusion. To each 250 mg vial, add 5 mL of Sterile Water for Injection. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL. The dose to be administered is adjusted according to the patient’s weight (see table). Table: Bivalirudin
Dosing
|
|
Weight (kg) |
Using 5 mg/mL
concentration |
Using 0.5 mg/mL concentration |
|
|
Bolus (1 mg/kg) (mL) |
Initial
4-hour infusion (2.5 mg/kg/hr) (mL/hr) |
Subsequent
low-rate infusion (0.2 mg/kg/hr) (mL/hr) |
|
|
43
to 47 48
to 52 53
to 57 58
to 62 63
to 67 68
to 72 73
to 77 78
to 82 83
to 87 88
to 92 93
to 97 98
to 102 103
to 107 108
to 112 113
to 117 118
to 122 123
to 127 128
to 132 133
to 137 138
to 142 143
to 147 148
to 152 |
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 |
22.5 25 27.5 30 32.5 35 37.5 40 42.5 45 47.5 50 52.5 55 57.5 60 62.5 65 67.5 70 72.5 75 |
18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 |
|
If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. Reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5 mg/mL. Do
not mix other medications with bivalirudin before
or during administration. No
incompatibilities have been observed with glass bottles or polyvinyl chloride
bags. The following drugs should NOT
be administered in the same intravenous line with bivalirudin
as they will result in haze formation, microparticulate
formation, or gross precipitation: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl,
diazepam, prochlorperazine edisylate,
reteplase, streptokinase, and vancomycin
HCl. |
