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INDICATIONS AND USES
ARTHROTEC is indicated for treatment of the signs and
symptoms of osteoarthritis or rheumatoid arthritis in
patients at high risk of developing NSAID-induced gastric
and duodenal ulcers and their complications. See WARNINGS
Gastrointestinal effects for a list of factors that may
increase the risk of NSAID-induced gastric and duodenal
ulcers and their complications.
DOSAGE AND ADMINISTRATION
ARTHROTEC is administered as ARTHROTEC 50 (50 mg diclofenac
sodium/200 mcg misoprostol) or as ARTHROTEC 75 (75 mg
diclofenac sodium/200 mcg misoprostol).
Note: See SPECIAL DOSING CONSIDERATIONS
section, below.
Osteoarthritis: The recommended dosage for maximal GI
mucosal protection is ARTHROTEC 50 tid. For patients who
experience intolerance, ARTHROTEC 75 bid or ARTHROTEC
50 bid can be used, but are less effective in preventing
ulcers. This fixed combination product, ARTHROTEC, is
not appropriate for patients who would not receive the
appropriate dose of both ingredients. Doses of the components
delivered with these regimens are as follows:
| |
OA
regimen |
Diclofenac
sodium
(mg/day) |
Misoprostol
(mcg/day) |
| ARTHROTEC
50 |
tid | 150 |
600 |
| bid | 100 |
400 |
| ARTHROTEC 75 |
bid | 150 |
400 |
Rheumatoid Arthritis: The recommended
dosage is ARTHROTEC 50 tid or qid. For patients who experience
intolerance, ARTHROTEC 75 bid or ARTHROTEC 50 bid can be
used, but are less effective in preventing ulcers. This
fixed combination product, ARTHROTEC, is not appropriate
for patients who would not receive the appropriate dose
of both ingredients. Doses of the components delivered with
these regimens are as follows:
| |
RA
regimen |
Diclofenac
sodium
(mg/day) |
Misoprostol
(mcg/day) |
|
ARTHROTEC 50
|
qid |
200 |
800 |
| tid |
150 |
600 |
| bid |
100 |
400 |
|
ARTHROTEC 75
|
bid |
150 |
400 |
SPECIAL DOSING CONSIDERATIONS:
ARTHROTEC contains misoprostol, which provides protection
against gastric and duodenal ulcers (see CLINICAL STUDIES
). For gastric ulcer prevention, the 200 mcg qid and tid
regimens are therapeutically equivalent, but more protective
than the bid regimen. For duodenal ulcer prevention, the
qid regimen is more protective than the tid or bid regimens.
However, the qid regimen is less well tolerated than the
tid regimen because of usually self-limited diarrhea related
to the misoprostol dose (see ADVERSE REACTIONS Gastrointestinal
), and the bid regimen may be better tolerated than tid
in some patients.
Dosages may be individualized using the separate products
(misoprostol and diclofenac), after which the patient
may be changed to the appropriate ARTHROTEC dose. If clinically
indicated, misoprostol co-therapy with ARTHROTEC, or use
of the individual components to optimize the misoprostol
dose and/or frequency of administration, may be appropriate.
The total dose of misoprostol should not exceed 800 mcg/day,
and no more than 200 mcg of misoprostol should be administered
at any one time. Doses of diclofenac higher than 150 mcg/day
in osteoarthritis or higher than 225 mg/day in rheumatoid
arthritis are not recommended.
For additional information, it may be helpful to refer
to the package inserts for Cytotec® tablets and Voltaren®
tablets.
HOW SUPPLIED
ARTHROTEC (diclofenac sodium/misoprostol) is supplied
as a film-coated tablet in dosage strengths of either
50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac
sodium/200 mcg misoprostol. The 50 mg/200 mcg dosage strength
is a round, biconvex, white to off-white tablet imprinted
with four "A's" encircling a "50"
in the middle on one side and "SEARLE" and "1411"
on the other. The 75 mg/200 mcg dosage strength is a round,
biconvex, white to off-white tablet imprinted with four
"A's" encircling a "75" in the middle
on one side and "SEARLE" and "1421"
on the other.
The dosage strengths are supplied in:
|
Strength
|
NDC Number
|
Size
|
|
50/200
|
0025-1411-60
|
bottle of 60
|
|
0025-1411-90
|
bottle of 90
|
|
0025-1411-34
|
|
|
75/200
|
0025-1421-60
|
bottle of 60
|
|
0025-1421-34
|
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Store at or below 25°C (77°F), in a dry area.
Keep out of reach of children.
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