For Healthcare Professionals: Gastrointestinal

For Healthcare Professionals
Applies to aspirin: compounding powder, oral capsule

extended release, oral delayed release capsule, oral
delayed release tablet, oral gum, oral powder for
reconstitution, oral tablet, oral tablet chewable, oral
tablet disintegrating, oral tablet dispersible, oral
tablet extended release, rectal suppository
Gastrointestinal
Endoscopically identifiable gastric mucosal lesions
occur in most patients who receive a single dose of
aspirin. Clinically evident gastrointestinal bleeding
has been reported in as many as 3% of treated
elderly patients. Anorectal ulceration and rectal
stenosis have been reported in patients who abuse
aspirin-containing rectal suppositories. One case-
controlled study has suggested that an association
between aspirin (and other NSAID) consumption and
appendicitis may exist.
The risk of developing dyspeptic events (i.e.,

epigastric pain, heartburn, nausea, ulcers) is low in
rheumatic patients with no prior gastrointestinal
symptoms who receive low-dose (less than 650
mg/day) aspirin therapy.[Ref]
Gastrointestinal side effects have included epigastric
distress (in as many as 83% of patients treated with
regular aspirin), abdominal discomfort or pain,
endoscopically identifiable gastric mucosal lesions,
nausea, and vomiting. More serious gastrointestinal
effects include hemorrhage, peptic ulcers,
perforation, small bowel enteropathy, and
esophageal ulcerations.[Ref]
Renal
The mechanism of an aspirin-induced decrease in
renal function may be related to inhibition of renal
prostaglandin synthesis with consequent decreases
in renal blood flow. Vasodilating renal prostaglandins
may be particularly important in patients who exhibit
arterial underfilling (i.e. heart failure, cirrhosis). The
administration of high doses of NSAIDs to such
patients has produced acute renal failure in rare
instances.[Ref]
Renal side effects have included reduction in
glomerular filtration rate (particularly in patients who
are sodium restricted or who exhibit diminished
effective arterial blood volume, such as patients with
advanced heart failure or cirrhosis), interstitial
nephritis, papillary necrosis, elevations in serum
creatinine, elevations in blood urea nitrogen,
proteinuria, hematuria, and renal failure.[Ref]
Hematologic
Hematologic side effects have included increased
blood fibrinolytic activity. In addition,
hypoprothrombinemia, thrombocytopenia,
thrombocyturia, megaloblastic anemia, and
pancytopenia have been reported rarely. Aplastic
anemia and eosinophilia have also been reported.
[Ref]
Hypersensitivity
The mechanism of aspirin-induced hypersensitivity
may be related to an up-regulation of the 5-
lipoxygenase pathway of arachidonic acid
metabolism with a resulting increase in the products
of 5-lipoxygenase (such as leukotrienes).[Ref]
Hypersensitivity side effects have included
bronchospasm, rhinitis, conjunctivitis, urticaria,
angioedema, and anaphylaxis. Approximately 10%
to 30% of asthmatics are aspirin-sensitive (with the
clinical triad of aspirin sensitivity, bronchial
asthma, and nasal polyps).[Ref]
upper right abdominal or stomach
vomiting of blood or material that looks like coffee
grounds
weakness or heaviness of the legs
weight gain
yellow eyes and skin
Aspirin side effects
Get emergency medical help if you have signs of an
allergic reaction to aspirin: hives; difficult
breathing; swelling of your face, lips, tongue, or
throat.
Stop using this medicine and call your doctor at once
if you have:
ringing in your ears, confusion, hallucinations, rapid
breathing, seizure (convulsions);
severe nausea, vomiting, or stomach pain;
bloody or tarry stools, coughing up blood or vomit
that looks like coffee grounds;
fever lasting longer than 3 days; or
swelling, or pain lasting longer than 10 days.
Common aspirin side effects may include:
upset stomach, heartburn;
drowsiness; or
mild headache.
This is not a complete list of side effects and others
may occur. Call your doctor for medical advice about
side effects. You may report side effects to FDA at 1-
800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect
aspirin?
Ask your doctor before using aspirin if you take an
antidepressant such as citalopram, escitalopram,
fluoxetine (Prozac), fluvoxamine, paroxetine,
sertraline (Zoloft), trazodone, or vilazodone. Taking
any of these medicines with an NSAID may cause
you to bruise or bleed easily.
Ask a doctor or pharmacist if it is safe for you to use
aspirin if you are also using any of the following
drugs:
a blood thinner (warfarin, Coumadin, Jantoven), or
other medication used to prevent blood clots; or
other salicylates such as Nuprin Backache Caplet,
Kaopectate, KneeRelief, Pamprin Cramp Formula,
Pepto-Bismol, Tricosal, Trilisate, and others.
This list is not complete. Other drugs may interact
with aspirin, including prescription and over-the-
counter medicines, vitamins, and herbal products.
Not all possible interactions are listed in this
medication guide
If you use the orally disintegrating tablet or the
dispersible tablet, follow all dosing instructions
provided with your medicine.
If you need surgery, tell the surgeon ahead of time
that you are using this medicine. You may need to
stop using it for a short time.
Do not take this medicine if you smell a strong
vinegar odor in the bottle. The medicine may no
longer be effective.
Store at room temperature away from moisture and
heat.
See also: Dosage Information (in more detail)
What happens if I miss a dose?
Since aspirin is used when needed, you may not be
on a dosing schedule. If you are on a schedule, use
the missed dose as soon as you remember. Skip the
missed dose if it is almost time for your next
scheduled dose. Do not use extra medicine to make
up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison
Help line at 1-800-222-1222.
Overdose symptoms may include temporary hearing
loss, seizure (convulsions), or coma.
What should I avoid while
taking aspirin?
Avoid drinking alcohol while you are taking aspirin.
Alcohol may increase your risk of stomach bleeding.
If you are taking this medicine to prevent heart
attack or stroke, avoid also taking ibuprofen (Advil,
Motrin). Ibuprofen may make this medicine less
effective. If you must use both medications, take the
ibuprofen at least 8 hours before or 30 minutes after
you take the aspirin (non-enteric coated form).
Ask a doctor or pharmacist before using any cold,
allergy, or pain medication. Many medicines
available over the counter contain aspirin or an
NSAID. Taking certain products together can cause
you to get too much of this type of medication.
Check the label to see if a medicine contains aspirin,
ibuprofen, ketoprofen, naproxen, or an NSAID.
You should not use aspirin if you are allergic to it, or if

you have:
a recent history of stomach or intestinal bleeding;
a bleeding disorder such as hemophilia; or
if you have ever had an asthma attack or severe
allergic reaction after taking aspirin or an NSAID
(non-steroidal anti-inflammatory drug) such as Advil,
Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren,
Toradol, Mobic, Relafen, Feldene, and others.
To make sure this medicine is safe for you, tell your
doctor if you have:
asthma or seasonal allergies;
stomach ulcers;
liver disease;
kidney disease;
a bleeding or blood clotting disorder;
gout; or
heart disease, high blood pressure, or congestive
heart failure.
Taking aspirin during late pregnancy may
cause bleeding in the mother or the baby
during delivery. Tell your doctor if you are pregnant
or plan to become pregnant.
Aspirin can pass into breast milk and may harm a
nursing baby. You should not breast-feed while using
this medicine.
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How should I take aspirin?
Take aspirin exactly as directed on the label, or as
prescribed by your doctor. Do not use in larger or
smaller amounts or for longer than recommended.
Take with food if aspirin upsets your stomach.
Do not crush, chew, break, or open an enteric-
coated or delayed-release pill. Swallow it whole.
The chewable tablet form must be chewed before
swallowing.
What is aspirin?
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Aspirin is a salicylate (sa-LIS-il-ate). It works by
reducing substances in the body that cause pain,
fever, and inflammation.
Aspirin is used to treat pain, and reduce fever or
inflammation. It is sometimes used to treat or
prevent heart attacks, strokes, and chest pain
(angina).
Aspirin should be used for cardiovascular conditions
only under the supervision of a doctor.
Important information
You should not use aspirin if you have a bleeding
disorder such as hemophilia, a recent history of
stomach or intestinal bleeding, or if you are allergic
to an NSAID (non-steroidal anti-inflammatory drug)
such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine,
Voltaren, Toradol, Mobic, Relafen, Feldene, and
others.
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Do not give this medication to a child or teenager
with a fever, flu symptoms, or chicken pox.
Salicylates can cause Reye's syndrome, a
serious and sometimes fatal condition in
children.
Before taking this medicine
Do not give this medicine to a child or teenager with
a fever, flu symptoms, or chicken pox. Aspirin can
cause Reye's syndrome, a serious and
sometimes fatal condition in children.
You should not use aspirin if you are allergic to it, or if
you have:
What is Ativan?
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Ativan (lorazepam) belongs to a group of drugs called
benzodiazepines. Lorazepam affects chemicals in the
brain that may be unbalanced in people with anxiety.
Ativan is used to treat anxiety disorders.
Ativan may also be used for purposes not listed in
this medication guide.
Important information
You should not use Ativan if you have narrow-angle
glaucoma or myasthenia gravis, or if you are allergic
to Valium or a similar medicine.
Do not use lorazepam if you are pregnant. This
medicine can cause birth defects or life-threatening
withdrawal symptoms in a newborn.
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Lorazepam may be habit-forming and should be used
only by the person it was prescribed for. Misuse of
habit-forming medicine can cause addiction,
overdose, or death. Ativan should never be shared
with another person, especially someone who has a
history of drug abuse or addiction. Keep the
medication in a secure place where others cannot get
to it.
Do not drink alcohol while taking Ativan. Lorazepam
can increase the effects of
Studies have demonstrated that treatment with
atorvastatin is associated with significant reductions
in the risk of cardiovascular endpoints and stroke in
various patient populations for both primary and
secondary prevention.
For primary prevention, atorvastatin treatment was

effective in hypertensive patients with normal or
mildly elevated cholesterol levels as well as in
patients with type II diabetes. Patients had relatively
low cholesterol levels at baseline in both trials;
however, treatment with this medicine still resulted
in significant reductions in cardiovascular outcomes
and stroke.
For secondary prevention, intensive lipid lowering

therapy with atorvastatin 80 mg/day was associated
with significant incremental clinical benefit beyond
therapy with 10 mg/day in patients with stable
coronary heart disease. It was also shown to
significantly reduce the risk of clinical outcomes in
coronary heart disease patients versus usual medical
care.
Usual Adult Dose for Hyperlipidemia:
Initial dose: 10, 20 or 40 mg orally once a day. The
40 mg starting dose is recommended for patients
who require a reduction in LDL-cholesterol of more
than 45%.
Dose adjustments should be made at intervals of 2 to

4 weeks.
Maintenance dose: 10 to 80 mg orally once a day.

Usual Pediatric Dose for Heterozygous Familial
Hypercholesterolemia:
10 to 17 years:
10 mg per day (max dose is 20 mg per day).
Adjustments should be made at intervals of 4 weeks
or more.
What other drugs will affect
atorvastatin?
Certain other drugs can increase your risk of serious
muscle problems, and it is very important that your
doctor knows if you are using any of them. Tell your
doctor about all your current medicines and any you
start or stop using, especially:
antibiotic or antifungal medicine;

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For Healthcare Professionals: Gastrointestinal

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For Healthcare Professionals

Applies to aspirin: compounding powder, oral capsule

The risk of developing dyspeptic events (i.e.,

You should not use aspirin if you are allergic to it, or if

For primary prevention, atorvastatin treatment was

For secondary prevention, intensive lipid lowering

Dose adjustments should be made at intervals of 2 to

Maintenance dose: 10 to 80 mg orally once a day.

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