General Dosing Instructions

Carefully consider the potential benefits and risks of MOBIC and other treatment options before deciding to use MOBIC. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

After observing the response to initial therapy with MOBIC, adjust the dose to suit an individual patient's needs.

In adults, the maximum recommended daily oral dose of MOBIC is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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.

Shake the oral suspension gently before using.

MOBIC may be taken without regard to timing of meals.

Osteoarthritis

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.

Rheumatoid Arthritis

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.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

To improve dosing accuracy in smaller weight children, the use of the MOBIC oral suspension is recommended. MOBIC oral suspension is available in the strength of 7.5 mg/5 mL. 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:

Renal Impairment

The use of MOBIC in subjects with severe renal impairment is not recommended.

In patients on hemodialysis, the maximum dosage of MOBIC is 7.5 mg per day [see Clinical Pharmacology (12.3)].

Non-Interchangeability with Other Formulations of Meloxicam

MOBIC Suspension has not shown equivalent systemic exposure to other approved formulations of oral meloxicam. Therefore, MOBIC Suspension is not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same. Do not substitute similar dose strengths of MOBIC Suspension with other formulations of oral meloxicam product.