Mobic

DESCRIPTION

MOBIC (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow MOBIC tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5methyl2thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide.

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.

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

DOSAGE AND ADMINISTRATION

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].

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 and CLINICAL PHARMACOLOGY].

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.

For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of MOBIC is 7.5 mg once daily in children who weigh ≥ 60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials.

MOBIC tablets should not be used in children who weigh < 60 kg.

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.

Non-Interchangeability With Other Formulations of Meloxicam

MOBIC Tablets have not shown equivalent systemic exposure to other approved formulations of oral meloxicam. Therefore, MOBIC Tablets are 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 Tablets with other formulations of oral meloxicam product.

HOW SUPPLIED

MOBIC (meloxicam) 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.

Storage And 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.

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