Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
Direct Rx
MELOXICAM
MELOXICAM 15 mg
ORAL
PRESCRIPTION DRUG
4.1 Allergic Reactions Meloxicam tablets are contraindicated in patients with known hypersensitivity (e.g. anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.13)]. 4.2 Coronary Surgery Meloxicam tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)]. 8.1 Pregnancy Pregnancy Category C; Category D starting 30 weeks gestation There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placental barrier. Prior to 30 weeks gestation, use meloxicam during pregnancy only if the potential benefit justifies the potential risk to the fetus. Starting at 30 weeks gestation, avoid
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 61919-075-20; Bottles of 20 NDC 61919-075-30; Bottles of 30 NDC 61919-075-60; Bottles of 60 NDC 61919-075-90; Bottles of 90 Meloxicam Tablets USP 15 mg are available as follows: NDC 61919-469-30; Bottles of 30 NDC 61919-469-60; Bottles of 60 NDC 61919-469-90; Bottles of 90
Abbreviated New Drug Application
MELOXICAM- MELOXICAM TABLET Direct Rx ---------- INSTRUCTIONS FOR USE Cyclobenzaprine Hydrochloride Extended-Release Capsules Read this Instructions for Use before you prepare your first dose of cyclobenzaprine hydrochloride extended-release capsules mixed with applesauce using the capsule sprinkle method, each time you get a refill, and as needed. There may be new information. Ask your healthcare provider or pharmacist if you have any questions about how to mix or give a dose of cyclobenzaprine hydrochloride extended-release capsules using the capsule sprinkle method. Important Information: Do not chew cyclobenzaprine hydrochloride extended-release capsules or the granules that are in the capsules. The capsule sprinkle method for mixing the contents of cyclobenzaprine hydrochloride extended-release capsules with applesauce may be used for adults who cannot swallow capsules. Do not use any other food in the place of applesauce. Preparing a dose of cyclobenzaprine hydrochloride extended-release capsules using the capsule sprinkle method. Before you prepare a dose of cyclobenzaprine hydrochloride extended-release capsules mixed with applesauce using the capsule sprinkle method, gather the following supplies: paper towels tablespoon applesauce cup of water Step 1: Choose a clean, flat work surface. Place a clean paper towel on the work surface. Then place the other supplies on the paper towel. Step 2: Wash and dry your hands well. Step 3: Check the dose that was prescribed by your healthcare provider. Take out the number of cyclobenzaprine hydrochloride extended-release capsules needed to prepare your dose. Place them on the paper towel. Step 4: Place enough applesauce to fill your tablespoon. Set the tablespoon down on the paper towel. [image] Step 5: Hold the cyclobenzaprine hydrochloride extended-release capsule in an upright position (vertical) directly over the tablespoon. Hold each end of the cyclobenzaprine hydrochloride extended-release capsule between your thumbs and index (pointer) fingers. [image] Step 6: Lire le document complet
MELOXICAM- MELOXICAM TABLET DIRECT RX ---------- MELOXICAM FULL PRESCRIPING INFORMATION 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 tablets are 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 Meloxicam tablets are 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)]. 2. DOSAGE AND ADMINISTRATION 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 Lire le document complet