DICLOFENAC SODIUM DELAYED RELEASE- diclofenac sodium tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

זמין מ:

REMEDYREPACK INC.

INN (שם בינלאומי):

DICLOFENAC SODIUM

הרכב:

DICLOFENAC SODIUM 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac is indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac sodium delayed-release tablets are contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product ( see WARNINGS; Anaphylactic Reactions, Serious Skin Reacti

leaflet_short:

Diclofenac sodium delayed-release tablets 50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted CTI;102 on one side), supplied in NDC: 70518-0756-00 PACKAGING: 90 in 1 BOTTLE PLASTIC Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

מצב אישור:

Abbreviated New Drug Application

עלון מידע

DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
REMEDYREPACK INC.
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Medication Guide for Nonsteroidal
Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
Increased risk of heart attack or stroke that can lead to death.This
risk may happen early in treatment and
may increase:
with increasing doses of NSAIDS
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:
anytime during use
without warning symptoms
that may cause death
The risk of getting an ulcer or bleeding increases with:
past history of stomach ulcers, or intestinal bleeding with use of
NSAIDs
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs” or “SNRIs”
increasing doses of NSAIDs
longer use of NSAIDs
smoking
drinking alcohol
NSAIDs should only be used:
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:
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take,
including prescription or over-the-counter
medicines, vitamins, or herbal supplements. NSAIDs and some other
medicines can interact with each other
and cause serious side effects. Do not start taking any new medicine
without talking to your

מאפייני מוצר

DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
REMEDYREPACK INC.
----------
DICLOFENAC SODIUM
Delayed-Release Tablets USP
Rx only
Prescribing information
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
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 (SEE WARNINGS).
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS ARE CONTRAINDICATED IN THE
SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (SEE
CONTRAINDICATIONS, WARNINGS).
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
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 (SEE WARNINGS).
DESCRIPTION
Diclofenac sodium delayed-release tablets is a benzene-acetic acid
derivative. Diclofenac
sodium is a white or slightly yellowish crystalline powder and is
sparingly soluble in water
at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino]
benzeneacetic acid,
monosodium salt. The molecular weight is 318.14. Its molecular formula
is C
H
Cl
NNaO
, and it has the following structural formula
The inactive ingredients in diclofenac sodium delayed-release tablets
include:
hydroxypropyl methylcellulose, lactose monohydrate, magnesium
stearate, methacrylic
14
10
2
2
acid copolymer, microcrystalline cellulose, polyethylene glycol,
povidone, propylene
glycol, sodium starch glycolate, talc, titanium dioxide, triethyl
citrate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Diclofenac has analgesic, anti-inflammatory, and antipyretic
properties.
The mechanism of