Diclofenac Delayed Release (Diclofenac Sodium) - Indications and Dosage

INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Diclofenac sodium delayed-release tablets, are indicated:

• For relief of signs and symptoms of osteoarthritis
• For relief of signs and symptoms of rheumatoid arthritis
• For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).

For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).

For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.

Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

HOW SUPPLIED

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as:

25 mg: round, yellow, enteric-coated tablets imprinted GG 737 on one side in black ink and plain on the reverse side are supplied as:

NDC 0781-1785-60 bottles of 60 tablets

NDC 0781-1785-01 bottles of 100 tablets

NDC 0781-1785-10 bottles of 1000 tablets

NDC 0781-1785-13 unit dose packages of 100 tablets

50 mg: round, brown, enteric-coated tablets imprinted GG 738 on one side in black ink and plain on the reverse side are supplied as:

NDC 0781-1787-60 bottles of 60 tablets

NDC 0781-1787-01 bottles of 100 tablets

NDC 0781-1787-10 bottles of 1000 tablets

NDC 0781-1787-13 unit dose packages of 100 tablets

75 mg: round, pink, enteric-coated tablets imprinted GG 739 on one side in black ink and plain on the reverse side are supplied as:

NDC 0781-1789-60 bottles of 60 tablets

NDC 0781-1789-01 bottles of 100 tablets

NDC 0781-1789-10 bottles of 1000 tablets

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture.

Dispense in a tight, light-resistant container.