meloxicam- Meloxicam tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
01-01-2007

Aktiv ingrediens:

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

Tilgjengelig fra:

Dr. Reddy's Laboratories Limited

INN (International Name):

Meloxicam

Legemiddelform:

TABLET

Sammensetning:

7.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Meloxicam tablets 7.5 mg are available as a pale yellow to yellow colored oval, biconvex tablets, debossed with ‘RDY’ on one side and ‘233’ on the other side. They are supplied in bottles of 30's, 100's, 500's. Bottles of 30                                                  NDC 55111-233-30 Bottles of 100                                                NDC 55111-233-01 Bottles of 500                                                NDC 55111-233-05 Meloxicam tablets 15 mg are available as a pale yellow to yellow colored round, biconvex tablets, debossed with ‘RDY’ on one side and ‘234’ on the other side. They are supplied in bottles of 30's, 100's, 500's Bottles of 30                                                  NDC 55111-234-30 Bottles of 100                                                NDC 55111-234-01 Bottles of 500                                                NDC 55111-234-05 Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°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.

Informasjon til brukeren

                                Dr. Reddy's Laboratories Limited
----------
ATTENTION DISPENSER: Accompanying Medication Guide must be dispensed
with this product.
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(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 a list of your medicines to
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Preparatomtale

                                MELOXICAM- MELOXICAM TABLET
DR. REDDY'S LABORATORIES LIMITED
----------
MELOXICAM TABLETS 7.5 MG AND 15 MG
ATTENTION DISPENSER: ACCOMPANYING MEDICATION GUIDE MUST BE DISPENSED
WITH THIS
PRODUCT.
PRESCRIBING INFORMATION
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 pale yellow to yellow 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)-_2H_-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The
molecular weight is 351.4. Its
empirical formula is C
H N O S and it has the following structural formula.
Meloxicam is a pale yellow to yellow powder, practically insoluble in
water, slightly soluble in
dimethyl formamide and dimethyl sulphoxide. 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
monohydrate, magnesium stear
                                
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