Download Prograf® (tacrolimus)

Practical Issues for Dietitians
SUPPLEMENTAL SLIDES
Presented by
David B. Goldwater R.Ph
Clinical Consultant Pharmacist
March 31, 2011
CONTENTS
MEGACE-ES ADVERSE EFFECTS
 PROGRAF
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Source: Am J Geriatr Pharmacother 2008; 6:167–172
MEGACE & ADRENAL
INSUFFICIENCY
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MEGACE & ADRENAL INSUFFICIENCY
Source: Am J Geriatr Pharmacother 2008; 6:167–172
FOCUS OF CONCERN
 Malnourished older patients who are given Megestrol
acetate could be at risk for adrenal insufficiency.
 It might be difficult to detect because the signs and
symptoms are subtle.
CASE STUDY
 In Kansas City, Missouri, an 80-yearold woman with
Dyspnea was being treated for major depression with
psychotic features. Her physical functioning had declined.
 Because she was losing weight, Megestrol acetate
was prescribed to stimulate her appetite.
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DURING HOSPITALIZATION
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Her Dyspnea worsened. She was transferred to the
intensive-care unit, where she was intubated. Her
blood pressure dropped.
After infectious, cardiac, and neurological causes of
hypotension were ruled out, a cosyntropin stimulation
test, was performed to exclude adrenal insufficiency.
IT INDICATED A SUBOPTIMAL RESPONSE.
The medication was discontinued, and steroid
replacement was initiated.
Blood pressure returned to normal, and the patient
slowly improved.
She was weaned from the ventilator several weeks
later.
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OUTCOME
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Two months later, her respiratory function improved,
and cosyntropin stimulation test findings were
normal.
Chronically ill, malnourished elderly patients with
adrenal insufficiency may experience depression and
reduced appetite, making the diagnosis difficult.
In this case, adrenal insufficiency was not suspected
at first because the presentation was unusual,
The patient’s clinical history was complicated by
other illnesses, and she had NOT been using
Megestrol for a long time.
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MEGACE-ES
CONCLUSION/ RECOMMENDATION
For patients who need more than 12 weeks of
treatment with Megestrol…...
 Free cortisol levels should be checked at 12
weeks and biweekly thereafter.
THE RESEARCHERS RECOMMEND:
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During periods of illness( in patients receiving
Megestrol)……..
Consider EMPIRICAL THERAPY with stress doses
of corticosteroids
Do not D/C Megace abruptly. Always taper
gradually
GO BACK TO SLIDE # 66
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An Interesting Drug-Alcohol
Interaction
Implications for Drug
Abuse
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An Interesting Drug-Alcohol Interaction
**Implications for Drug Abuse**
Published in Journal Watch General Medicine January 31, 1992
Citations: DiPadova C et al. Comparison with other H2-receptor antagonists. JAMA 1992 Jan 1 267 83-86
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A study measuring the effects of Ranitidine
(Zantac®) and Cimetidine (Tagamet®) on
the bioavailability of ethanol suggests that
drinking with these drugs is NOT a wise
choice because……….
RANITIDINE AND CIMETIDINE INCREASE
BLOOD ALCOHOL LEVELS.
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An Interesting Drug-Alcohol Interaction
**Implications for Drug Abuse**

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Researchers tested the blood alcohol levels of
20 healthy male volunteers (mean age, 35)
During a baseline period and after a oneweek course of EITHER
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Ranitidine (300 mg/d),
Cimetidine (1000 mg/d) or
Famotidine (Pepcid)
Before each test, the subjects received Oral
or intravenous alcohol equivalent to:
 1 beer or 1 glass of wine.
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RESULTS
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In subjects given alcohol intravenously,
none of the three drugs significantly
increased alcohol bioavailability.
Among subjects taking alcohol ORALLY,
bioavailability increased significantly
with Ranitidine and Cimetidine
……..but NOT with Famotidine.
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RESULTS
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The authors speculate that Ranitidine
and Cimetidine affected the absorption
of oral doses because they INHIBIT
gastric alcohol dehydrogenase activity.
However……. Famotidine (Pepcid®) has
NO effect on this enzyme!
Don’t confuse with Prilosec®
(omeprazole which is a PPI and not an
H2 Blocker)
In patients with regular but moderate
alcohol use, Famotidine (Pepcid®) may
be a preferable H2- blocker
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ABUSE POTENTIAL FOR THIS INTERACTION:
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This study indicates the need for
extreme caution when drinking alcohol
with Cimetidine or Ranitidine,
particularly before driving!
As recreational drinking is an
ORAL event ……………….
This interaction may be intentional
in people who want to get
inebriated on fewer drinks!
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Prograf® (tacrolimus):
….Timing is Everything!
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Prograf® (tacrolimus): INDICATION
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Tacrolimus is an immunosuppressive
agent derived from the fungus Streptomyces
tsukubaensis.
Originally found in a soil sample taken from
the base of Mt. Tsukuba in Japan.
Tacrolimus has been studied in patients
receiving heart, kidney, liver, lung, pancreas,
small bowel, or bone marrow transplants.
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Prograf® (tacrolimus)

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Effective in graft rejection prophylaxis
and in the management of acute and
steroid- or cyclosporine-resistant
transplant rejection.
Tacrolimus is an alternative to cyclosporine
immunosuppression and is10—100 times
more potent than cyclosporine
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Prograf® (tacrolimus)
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Administer at approximately the same
time each day.
REASON
If given WITH FOOD or WITHIN 1
HOUR OF A MEAL, especially high-fat
meals, results in significantly decreased
absorption.
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Goals for Scheduling this drug
in relationship to meals
 Consistency is important TO MINIMIZE ANY
Variations in bioavailability.
 Administer consistently with OR without
food.
 Ask resident what time of day they have
been taking this drug at home in
relationship to meals times and what type
of meal.
 If possible attempt to accommodate the
same schedule.
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