meloxicam- Meloxicam tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

şimdi satın al

Indir Ürün özellikleri (SPC)
30-03-2007

Aktif bileşen:

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

Mevcut itibaren:

Watson Laboratories Inc.

INN (International Adı):

Meloxicam

Farmasötik formu:

TABLET

Kompozisyon:

7.5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 (seeWARNINGS ). 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 (seeWARNINGS, Anaphylactoid Reactions , andPRECAUTIONS, Pre-existing Asthma ). Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS ).

Ürün özeti:

Meloxicam tablets, 7.5 mg are round, biconvex, uncoated yellow tablets debossed with “3230” and “WPI” on one side of the tablet. Meloxicam tablets, 15 mg are round, flat beveled, uncoated yellow tablets debossed with “3231” and “WPI” on one side of the tablet. Meloxicam Tablets 7.5 mg are available as follows: NDC 0591-3230-01; Bottles of 100 NDC 0591-3230-05; Bottles of 500 NDC 0591-3230-10; Bottles of 1000 Meloxicam Tablets 15 mg are available as follows: NDC 0591-3231-01; Bottles of 100 NDC 0591-3231-05; Bottles of 500 NDC 0591-3231-10; Bottles of 1000 Store at 20° to 25°C (68° to 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: Watson Laboratories Inc. Corona, CA 92880 USA Manufactured by: Cipla Ltd. Kurkumbh, INDIA Revised: August 2006

Bilgilendirme broşürü

                                Watson Laboratories Inc.
----------
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 caus
                                
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Ürün özellikleri

                                MELOXICAM- MELOXICAM TABLET
WATSON LABORATORIES INC.
----------
MELOXICAM TABLETS
7.5 MG AND 15 MG
REVISED: AUGUST 2006
RX ONLY
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 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)-
2_H_-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 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)
= 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.
14
13
3
4
2
app
The inactive ingredients in Meloxicam tablets include anhydrous
lactose, colloidal silicon dioxide,
magnesium stearate, microcrystalline cellulose, pregelatinized starch,
sodium citrate dehydrat
                                
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