NAPROXEN tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)

থেকে পাওয়া:

MARKSANS PHARMA LIMITED

INN (International Name):

NAPROXEN

রচনা:

NAPROXEN 250 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Naproxen Tablets are indicated for: the relief of the signs and symptoms of: ·         rheumatoid arthritis ·         osteoarthritis ·         ankylosing spondylitis ·         Polyarticular Juvenile Idiopathic Arthritis ·         tendonitis ·         bursitis ·         acute gout the management of ·         pain ·         primary dysmenorrhea Naproxen Tablets are contraindicated in the following patients: •  Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see Warnings and Precautions (5.7, 5.9)] •  History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)] •  In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)] Risk Summary   Use of NSAIDs, including naproxen tablets, can cause premature closure of the feta

পণ্য সারাংশ:

N aproxen Tablets, USP 250 mg : white to off-white, round shaped tablet with “138” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 30 and 1000. 30’s (bottle): NDC 25000-138-03 1000’s (bottle): NDC 25000-138-14 Naproxen Tablets, USP 375 mg : white to off-white, oval shaped tablet with “139” debossed on one side and plain on other side. Packaged in light-resistant bottles of 30 and 1000. 30’s (bottle): NDC 25000-139-03 1000’s (bottle): NDC 25000-139-14 Naproxen Tablets, USP 500 mg : white to off-white, capsule-shaped tablets with “140” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 30 and 1000. 30’s (bottle): NDC 25000-140-03 1000’s (bottle): NDC 25000-140-14 Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) in well-closed containers [see USP Controlled Room Temperature]. Dispense in light-resistant containers.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

MARKSANS PHARMA LIMITED
----------
SPL MEDGUIDE SECTION
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
Inflammatory
Drugs
(NSAIDs)?
NSAIDs
can
cause
serious
side
effects,
including:
- Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and
may
increase:
o
with
increasing
doses
of
NSAIDs
o
with
longer
use
of
NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
- Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth
to
the
stomach),
stomach
and
intestines:
o
anytime
during
use
o
without
warning
symptoms
o
that
may
cause
death
The
risk
of
getting
an
ulcer
or
bleeding
increases
with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o
taking
medicines
called
“corticosteroids”,
“anticoagulants”,
“SSRIs”,
or
“SNRIs”
o
increasing
doses
of
NSAIDs
o
older
age
o
longer
use
of
NSAIDs
o
poor
health
o
smoking
o
advanced
liver
disease
o
drinking
alcohol
o
bleeding
problems
NSAIDs
should
only
be
used:
o
exactly
as
prescribed
o
at
the
lowest
dose
possible
for
your
treatment
o for the shortest time needed
What
are
NSAIDs?
NSAIDs 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
NSAIDs?
Do
not
take
NSAIDs:
• if you have had an asthma attack, hives, or other allergic
reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, includ

পণ্য বৈশিষ্ট্য

NAPROXEN - NAPROXEN TABLET
MARKSANS PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN
TABLETS.
NAPROXEN TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1976 EXCERPTS
NAPROXEN TABLETS, USP 250 MG, 375 MG AND 500 MG
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH
CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE
WITH DURATION
OF USE. (5.1)
NAPROXEN TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT
(CABG) SURGERY. (4,5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.10, 5.11) 05/2021
INDICATIONS AND USAGE
Naproxen Tablets, USP is a non-steroidal anti-inflammatory drug
indicated for: (1)
the relief of the signs and symptoms of: (1)
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of: (1)
pain
primary dysmenorrhea
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals.
(2.1)
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
Naproxen Tablets,
USP
250 mg
twice daily
375 mg
twice daily
500 mg
twice daily
The dose may be adjusted up or down depending on the clinical response
of the patient.