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Mobic (Meloxicam) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Osteoarthritis (OA)

MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ].

Rheumatoid Arthritis(RA)

MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ].

Juvenile RheumatoidArthritis (JRA) Pauciarticular and Polyarticular Course

MOBIC 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 [ see Clinical Studies ].

DOSAGE AND ADMINISTRATION

General Instructions

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

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 Warnings and Precautions , Use in Specific Populations , and Clinical Pharmacology ].

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 RheumatoidArthritis (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:

  0.125 mg/kg
Weight Dose
(1.5 mg/mL)
Delivered dose
12 kg (26 lb) 1.0 mL 1.5 mg
24 kg (54 lb) 2.0 mL 3.0 mg
36 kg (80 lb) 3.0 mL 4.5 mg
48 kg (106 lb) 4.0 mL 6.0 mg
≥60 kg (132 lb) 5.0 mL 7.5 mg

DOSAGE FORMS AND STRENGTHS

Tablets:

  • 7.5 mg: pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg. Impressed with the Boehringer Ingelheim logo on one side and the letter “M” on the other.
  • 15 mg: pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. Impressed with the tablet code “15” on one side and the letter “M” on the other.

Oral Suspension:

  • yellowish green tinged viscous suspension containing 7.5 mg meloxicam in 5 mL.

HOW SUPPLIED/STORAGEAND HANDLING

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: NDC 0597-0029-01; Bottles of 100

MOBIC tablets 15 mg: NDC 0597-0030-01; Bottles of 100

MOBIC oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mL

Storage

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

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

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

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