Drug Catalog - Product Detail
MELOXICAM TB 15MG 1000
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 29300-0125-10 | UNICHEM PHARMACEUTICALS | 1000 | 15MG | TABLET |
PACKAGE FILES
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Description
11. DESCRIPTION Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N -(5-methyl-2-thiazolyl)-2 H -1,2-benzothiazine-3carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14 H 13 N 3 O 4 S 2 and it has the following structural formula. 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. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate. Structure
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Meloxicam Tablets USP are available as light yellow, round, flat, uncoated tablets containing meloxicam 7.5 mg or as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. The 7.5 mg tablet is impressed with letter U and L on one side and tablet code 7.5 on the other side. The 15 mg tablet is impressed with letter U and L on one side and tablet code 15 on the other side. Meloxicam Tablets USP 7.5 mg are available as follows: NDC 29300-124-13; Bottles of 30 NDC 29300-124-01; Bottles of 100 NDC 29300-124-10; Bottles of 1000 NDC 29300-124-50; Bottles of 5000 Meloxicam Tablets USP 15 mg are available as follows: NDC 29300-125-13; Bottles of 30 NDC 29300-125-01; Bottles of 100 NDC 29300-125-10; Bottles of 1000 NDC 29300-125-50; Bottles of 5000 Storage Store at Controlled Room Temperature 20 0 -25 0 C (68 0 -77 0 F) [See USP]. Keep Meloxicam Tablets USP in a dry place Dispense tablets in a tight container. Keep this and all medications out of the reach of children.
Indications & Usage
1. INDICATIONS AND USAGE Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) 1.1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies (14.1) ]. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablet are indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies (14.1) ].
Dosage and Administration
2. DOSAGE AND ADMINISTRATION Use the lowest effective dose for the shortest duration consistent with individual treatment goals for the individual patient. • OA ( 2.2 ) and RA ( 2.3 ): Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily 2.1 General Instructions Carefully consider the potential benefits and risks of meloxicam tablets USP and other treatment options before deciding to use meloxicam tablets USP. 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 meloxicam tablets USP, adjust the dose to suit an individual patient's needs. In adults, the maximum recommended daily oral dose of meloxicam tablets USP 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) ]. Meloxicam tablets USP 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 meloxicam tablets USP 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 meloxicam tablets USP is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.