MELOXICAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)

Available from:

Direct Rx

INN (International Name):

MELOXICAM

Composition:

MELOXICAM 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MELOXICAM- MELOXICAM TABLET
Direct Rx
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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:

Summary of Product characteristics

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