Carefully consider the potential benefits and risks of Mobic® (meloxicam) tablets/oral suspension and other treatment options before deciding to use MOBIC tablets/oral suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

MOBIC tablets/oral suspension is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.

MOBIC tablets/oral suspension is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older.

Osteoarthritis and Rheumatoid Arthritis

Carefully consider the potential benefits and risks of Mobic® (meloxicam) tablets/oral suspension and other treatment options before deciding to use MOBIC tablets/oral suspension. 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 MOBIC tablets/oral suspension, the dose should be adjusted to suit an individual patient's needs.

For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of MOBIC is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of MOBIC is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

MOBIC oral suspension 7.5 mg/5 mL or 15 mg/10 mL may be substituted for MOBIC tablets 7.5 mg or 15 mg, respectively.

The maximum recommended daily oral dose of MOBIC is 15 mg regardless of formulation.

Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

MOBIC oral suspension is available in the strength of 7.5 mg/5 mL. To improve dosing accuracy in smaller weight children, the use of the MOBIC oral suspension is recommended. For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of MOBIC is 0.125 mg/kg once daily up to a maximum of 7.5 mg. There was no additional benefit demonstrated by increasing the dose above 0.125 mg/kg once daily in these clinical trials.

Juvenile Rheumatoid Arthritis dosing using the oral suspension should be individualized based on the weight of the child:

0.125 mg/kg

Shake the oral suspension gently before using.

Mobic® (meloxicam) tablets/oral suspension may be taken without regard to timing of meals.

MOBIC is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. The 7.5 mg tablet is impressed with the Boehringer Ingelheim logo on one side, and on the other side, the letter “M”. The 15 mg tablet is impressed with the tablet code “15” on one side and the letter “M”on the other. MOBIC is also available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.

MOBIC tablets 7.5 mg is available as follows: NDC 0597-0029-01; Bottles of 100
MOBIC tablets 15 mg is available as follows: NDC 0597-0030-01; Bottles of 100
MOBIC oral suspension 7.5 mg/5 mL is available as follows: NDC 0597-0034-01; Bottles of 100 mL

Store at 25° C (77° F); excursions permitted to 15° C-30° C (59° F-86° F). Keep MOBIC tablets in a dry place.

Please address medical inquiries to http://us.boehringer-ingelheim.com, (800) 542-6257 or (800) 459-9906 TTY.

Dispense tablets in a tight container. Keep oral suspension container tightly closed.

Keep this and all medications out of the reach of children.

Mobic tablets 7.5 mg and 15 mg are manufactured by: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany and Boehringer Ingelheim Promeco, S.A. de C.V., Mexico City, Mexico
Mobic oral suspension 7.5 mg/5 mL is manufactured by: Boehringer Ingelheim Roxane, Inc. Columbus, OH 43216 USA. Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. FDA rev date: 06/27/08

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