A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Bayer ASA Indications, Dosage, Storage, Stability - Aspirin
Bayer ASA Indications, Dosage, Storage, Stability - Aspirin
INDICATIONS
Analgesic, antipyretic,
anti-inflammatory. For the temporary relief of headache; painful discomfort
and fever of colds; muscular
aches and pains; temporary relief
of minor pains of arthritis;
toothache, and pain following dental
procedures; menstrual pain.
Antiarthritic Effect
Conditions requiring chronic
or long-term aspirin therapy
for pain and/or inflammation,
e.g., rheumatoid arthritis,
juvenile rheumatoid
arthritis, systemic lupus erythematosus,
osteoarthritis (degenerative
joint disease), ankylosing spondylitis,
psoriatic arthritis, Reiter's
syndrome, and fibrositis.
Antiplatelet Effect
In MI Prophylaxis: Aspirin
is indicated to reduce the
risk of death
and/or nonfatal myocardial infarction in patients with a previous infarction
or unstable angina pectoris.
In Transient Ischemic Attacks: Aspirin is indicated for
reducing the risk of recurrent
transient ischemic attacks
(TIAs) or stroke in men who
have transient ischemia
of the brain due to fibrin
emboli. There is no evidence
that aspirin is effective
in reducing T.A. in women, or
is of benefit in the treatment
of completed strokes in men or women.
See More Indications below
DOSAGE AND ADMINISTRATION
Directions: The following dosages are those provided in
the packaging, as appropriate
for self-medication. Larger or more frequent dosage
may be necessary as appropriate
to the condition or needs
of the patient. The hydroxypropyl methylcellulose
coating makes Genuine Bayer Aspirin particularly appropriate for those
who have difficulty in swallowing
uncoated tablets and caplets.
Usual Adult Dose: Adults and Children 12 years and over: One or two tablets/caplets
with water. May be repeated every four hours as necessary up to 12 tablets/caplets
a day or as directed by a doctor. Do not give to children under 12 unless
directed by a doctor.
The following information is based upon the FDA's Final Rule for professional
labeling of aspirin** issued October 1998.
Ischemic Stroke and TIA: 50-325 mg once a day. Continue therapy
indefinitely.
Suspected Acute MI: The initial dose of 160-162.5 mg is administered
as soon as an MI is suspected. The maintenance dose of 160-162.5 mg a
day is continued for 30 days post-infarction. After 30 days, consider
further therapy based on dosage and administration for prevention of recurrent
MI.
Prevention of Recurrent MI: 75-325 mg once a day. Continue therapy
indefinitely.
Unstable Angina Pectoris: 75-325 mg once a day. Continue therapy
indefinitely.
Chronic Stable Angina Pectoris: 75-325 mg once a day. Continue
therapy indefinitely.
CABG: 325 mg daily starting 6 hours post-procedure. Continue therapy
for 1 year post-procedure.
PTCA: The initial dose of 325 mg should be given 2 hours pre-
surgery. Maintenance dose is 160-325 mg daily. Continue therapy indefinitely.
Carotid Endarterectomy: Doses of 80 mg once daily to 650 mg twice
daily, started presurgery, are recommended. Continue therapy indefinitely.
Rheumatoid Arthritis: The initial dose is 3 g a day in divided
doses. Increase as needed for anti-inflammatory efficacy with target plasma
salicylate levels of 150-300 g/mL. At high doses (i.e., plasma
levels of greater than 200 mg/mL), the incidence of toxicity increases.
Juvenile Rheumatoid Arthritis: Initial dose is 90-130 mg/kg/day
in divided doses. Increase as needed for anti-inflammatory efficacy with
target plasma salicylate levels of 150-300 g/mL. At high doses
(i.e., plasma levels of greater than 200 mg/mL), the incidence of toxicity
increases.
Spondyloarthropathies: Up to 4 g per day in divided doses.
Osteoarthritis: Up to 3 g per day in divided doses.
Arthritis and Pleurisy of SLE: The initial dose is 3 g a day in
divided doses. Increase as needed for anti-inflammatory efficacy with
target plasma salicylate levels of 150-300 g/mL. At high doses
(i.e., plasma levels of greater than 200 mg/mL), the incidence of toxicity
increases.
HOW SUPPLIED
No information provided.
REFERENCES
1. Elwood PC, et al: A randomized controlled trial of
acetylsalicylic acid in the secondary
prevention of mortality
from myocardial infarction.
Br Med J 1974;1:436-440.
2. The Coronary Drug Project Research Group: Aspirin
in coronary heart disease.
J Chronic Dis 1976;29:625-642.
3. Breddin K, et al: Secondary prevention
of myocardial infarction:
A comparison of acetylsalicylic acid,
phenprocoumon or placebo. Homeostasis 1979;470:263-268.
4. Aspirin Myocardial Infarction Study Research Group:
A randomized, controlled trial of aspirin
in persons recovered from myocardial
infarction. JAMA 1980;245:661-669.
5. Elwood PC, Sweetnam PM: Aspirin and secondary
mortality after myocardial
infarction. Lancet, December 22-29, 1979, pp 1313-1315.
6. The Persantine-Aspirin Reinfarction Study Research
Group: Persantine and aspirin
in coronary heart
disease. Circulation 1980;62:449-460.
7. Lewis, HD, et al: Protective effects of aspirin
against acute myocardial infarction
and death in men with unstable
angina: Results of a Veterans Administration Cooperative Study. N Engl
J Med 1983;309:396-403.
8. The Canadian Cooperative Study Group: A randomized
trial of aspirin and sulfinpyrazone
in threatened stroke. N Engl J Med 1978;299:53-59.
9. Fields WS, et al: Controlled trial of aspirin
in cerebral ischemia. Stroke 1977;8:301-316.
10. **Food and Drug Administration. Internal analgesic,
antipyretic, and antirheumatic drug products for over the counter human
use; final rule for professional labeling of aspirin, buffered aspirin,
and aspirin in combination with antacid drug products. Federal Register.
October 23, 1998; 63:56802-56819.
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