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Diclofenac Delayed Release (Diclofenac Sodium) - Indications and Dosage

 
 



INDICATIONS & USAGE

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

Diclofenac is indicated:

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

DOSAGE & ADMINISTRATION

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. 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, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of osteoarthritis, the recommended dosage is 100 to 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 to 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 to 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 delayed-release 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

50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted

on one side), supplied in bottles of 60, 100 and 1000.

75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted

on one side), supplied in bottles of 60, 100, 500 and 1000.

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

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured and Distributed by:
Carlsbad Technology, Inc.
Carlsbad, CA 92008 USA

Revised: February 2010
CTI-11 Rev. C
Printed in USA

 

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