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Mobic

Mobic Recall

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1  Osteoarthritis (OA)

MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].

1.2  Rheumatoid Arthritis (RA)

MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].

1.3  Juvenile Rheumatoid Arthritis (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 (14.2)].

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History

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Other Information

Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow MOBIC tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Each bottle of MOBIC oral suspension contains 7.5 mg meloxicam per 5 mL. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula:

Mobic Structure

Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2.

MOBIC is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, and as an oral suspension containing 7.5 mg meloxicam per 5 mL.

The inactive ingredients in MOBIC tablets include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate dihydrate.

The inactive ingredients in MOBIC oral suspension include colloidal silicon dioxide, hydroxyethylcellulose, sorbitol, glycerol, xylitol, monobasic sodium phosphate (dihydrate), saccharin sodium, sodium benzoate, citric acid (monohydrate), raspberry flavor, and purified water.

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Mobic Manufacturers

  • Boehringer Ingelheim Pharmaceuticals, Inc.
    Mobic | Boehringer Ingelheim Pharmaceuticals, Inc.
    No Recall

    Mobic | Boehringer Ingelheim Pharmaceuticals, Inc.

    Mobic | Boehringer Ingelheim Pharmaceuticals, Inc.
    2.1  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 (5.4)].

    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 (5.6), 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.

    2.2  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.

    2.3  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.

    2.4  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:

      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
  • Pd-rx Pharmaceuticals, Inc.
    Mobic | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Mobic | Pd-rx Pharmaceuticals, Inc.

    Mobic | Pd-rx Pharmaceuticals, Inc.
    2.1  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 (5.4)].

    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 (5.6), 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.

    2.2  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.

    2.3  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.

    2.4  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:

      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
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