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
Indocin Indications, Dosage, Storage, Stability - Indomethacin
Indocin Indications, Dosage, Storage, Stability - Indomethacin
INDICATIONS
Indomethacin capsules have been found effective in active stages
of the following:
1. Moderate to severe rheumatoid
arthritis including
acute flares of chronic
disease.
2. Moderate to severe ankylosing spondylitis.
3. Moderate to severe osteoarthritis.
4. Acute painful shoulder
(bursitis and/or tendinitis).
5. Acute gouty arthritis.
Indomethacin may enable the reduction
of steroid dosage
in patients receiving steroids for the more severe forms of rheumatoid
arthritis. In such instances the steroid
dosage should be reduced
slowly and the patients followed very closely for any adverse effects.
The use of indomethacin
in conjunction with aspirin
or other salicylates is not recommended. Controlled clinical
studies have shown that the combined use of indomethacin
and aspirin does not
produce any greater therapeutic effect than the use of indomethacin
alone. Furthermore, in one of those clinical studies, the incidence
of gastrointestinal
side effects was significantly
increased with combined therapy
(see DRUG INTERACTlONS).
DOSAGE AND ADMINISTRATION
INDOCIN is available as 25 and 50 mg Capsules INDOCIN, Oral Suspension
INDOCIN, containing 25 mg of indomethacin per 5 mL, and 50 mg
Suppositories INDOCIN for rectal use.
Adverse reactions appear to correlate with the size of the dose of
INDOCIN in most patients but not all. Therefore, every effort should be
made to determine the smallest effective dosage for the individual
patient.
Always give Capsules INDOCIN or Oral Suspension INDOCIN with food,
immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use
INDOCIN ordinarily should not be prescribed for pediatric patients 14
years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages
of the Following:
- Moderate to severe rheumatoid arthritis
including acute flares of chronic disease; moderate to severe ankylosing
spondylitis; and moderate to severe osteoarthritis. Suggested Dosage:
Capsules INDOCIN 25 mg b.i.d. or t.i.d. If this is well tolerated,
increase the daily dosage by 25 or by 50 mg, if required by continuing
symptoms, at weekly intervals until a satisfactory response is obtained
or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS
AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG. In
patients who have persistent night pain and/or morning stiffness, the
giving of a large portion, up to a maximum of 100 mg, of the total daily
dose at bedtime, either orally or by rectal suppositories, may be
helpful in affording relief. The total daily dose should not exceed 200
mg. In acute flares of chronic rheumatoid arthritis, it may be necessary
to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased,
reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT
CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After
the acute phase of the disease is under control, an attempt to reduce
the daily dose should be made repeatedly until the patient is receiving
the smallest effective dose or the drug is discontinued. INDOCIN.
(Indomethacin)
Careful instructions to, and observations
of, the individual patient are essential to the prevention of serious,
irreversible, including fatal, adverse reactions.
As advancing
years appear to increase the possibility of adverse reactions, INDOCIN
should be used with greater care in the elderly (see PRECAUTIONS,
Geriatric Use).
- Acute painful shoulder (bursitis and/or
tendinitis).
Initial Dose:
75-150 mg daily in 3 or 4 divided
doses.
The drug should be discontinued after the signs and symptoms
of inflammation have been controlled for several days. The usual course
of therapy is 7-14 days.
- Acute gouty arthritis.
Suggested Dosage:
Capsules INDOCIN 50 mg t.i.d. until pain is tolerable. The dose
should then be rapidly reduced to complete cessation of the drug. Definite
relief of pain has been reported within 2 to 4 hours. Tenderness and heat
usually subside in 24 to 36 hours, and swelling gradually disappears in 3
to 5 days.
PEDIATRIC USE
Indomethacin ordinarily should not be prescribed for children 14
years of age and under (see
WARNINGS).
HOW SUPPLIED
No. 3316 — Capsules INDOCIN, 25 mg are opaque blue and white capsules,
coded INDOCIN and MSD 25. They are supplied as follows:
NDC 0006-0025-68 bottles of 100
NDC 0006-0025-82 bottles of 1000. No. 3317 — Capsules
INDOCIN, 50 mg are opaque blue and white capsules, coded INDOCIN and MSD
50. They are supplied as follows:
NDC 0006-0050-68
bottles of 100.
No. 3376 — Oral Suspension INDOCIN, 25 mg per 5 mL, is
an off-white suspension with a pineapple coconut mint flavor. It is
supplied as follows:
NDC 0006-3376-66 in bottles of
237 mL.
No. 3354 — Suppositories INDOCIN, 50 mg each, are white,
opaque, rectal suppositories and are supplied as follows:
NDC 0006-0150-30, boxes of 30.
Storage
Store Oral Suspension INDOCIN
below 30°C (86°F). Avoid temperatures above 50°C (122°F). Protect from
freezing.
Store Suppositories INDOCIN below 30°C (86°F). Avoid transient
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