meloxicam- Meloxicam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Meloxicam (UNII: VG2QF83CGL) (meloxicam - UNII:VG2QF83CGL)

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

Meloxicam

Pharmaceutical form:

TABLET

Composition:

7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis. Meloxicam is contraindicated in patients with known hypersensitivity to meloxicam. Meloxicam 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 , Anaphylactoid Reactions , and PRECAUTIONS , Pre-existing Asthma ). Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Product summary:

Meloxicam tablets 7.5 mg and 15 mg are available as a pastel yellow colored, slightly mottled round biconvex uncoated tablets Meloxicam tablets 7. 5 mg are available as follows and debossed with ‘RA61’ on one side and plain on other side: NDC 63304-619-30 Bottles of 30 NDC 63304-619-10 Bottles of 1000 Meloxicam tablets 15 mg are available as follows and debossed with ‘RA62’ on one side and plain on other side: NDC 63304-620-30 Bottles of 30 NDC 63304-620-10 Bottles of 1000 Store at 20 – 25° C (68 – 77° F). (See USP Controlled Room Temperature).Keep meloxicam tablets in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA February 2007

Patient Information leaflet

Ranbaxy Pharmaceuticals Inc.
----------
MEDICATION Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
ATTENTION DISPENSER: Accompanying Medication Guide mustbe dispensed
with this product.
MELOXICAM TABLETS
Rx only
(See the end of this Medication Guide for a list of prescription NSAID
medicines).
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
• with longer use of NSAID medicines
• in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
• can happen without warning symptoms
• may cause death
The chance of a person getting an ulcer or bleeding increases with:
• taking medicines called “corticosteroids” and
“anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health
NSAID medicines should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
• different types of arthritis
• menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
• if you had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery
Tell your healthcare provider:
• about all of your medical conditions
• about all of the medicines you take. NSAIDs and some other
medicines can interact with each other and
cause serious side effects. Keep

Summary of Product characteristics

MELOXICAM- MELOXICAM TABLET
RANBAXY PHARMACEUTICALS INC.
----------
MELOXICAM TABLETS 7.5 MG AND 15 MG
RX ONLY
ATTENTION DISPENSER: ACCOMPANYING MEDICATION GUIDE MUST BE DISPENSED
WITH THIS
PRODUCT.
WARNING
CARDIOVASCULAR RISK
•NSAIDS MAY CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR
THROMBOTIC EVENTS,
MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY
INCREASE WITH DURATION
OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS FOR
CARDIOVASCULAR DISEASE MAY
BE AT GREATER RISK (SEE WARNINGS AND CLINICAL TRIALS).
•MELOXICAM IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE
PAIN IN THE SETTING OF
CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (SEE WARNINGS).
GASTROINTESTINAL RISK
•NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL ADVERSE
EVENTS INCLUDING
BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR INTESTINES,
WHICH CAN BE FATAL. THESE
EVENTS CAN OCCUR AT ANY TIME DURING USE AND WITHOUT WARNING SYMPTOMS.
ELDERLY PATIENTS
ARE AT GREATER RISK FOR SERIOUS GASTROINTESTINAL EVENTS (SEE
WARNINGS).
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-3-carboxamide-1,1-dioxide. The molecular weight is
351.4. Its molecular formula is
C
H N O S and it has the following structural formula.
Meloxicam is a pastel yellow powder, practically insoluble in water,
slightly soluble in acetone,
soluble in dimethyl formamide, very slightly soluble in ethanol (96%)
and in methanol. Meloxicam has
an apparent partition coefficient (log P)
= 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 include colloidal silicon
dioxide, crospovidone, lactose
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