DICLOFENAC SODIUM tablet, delayed release

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

AvKARE

INN:

DICLOFENAC SODIUM

composition:

DICLOFENAC SODIUM 50 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 Reactions ). - 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; Anaphylactic Reaction, Exacerbation of Asthma Related to Aspirin Sensitivity ). - In the setting of coronary artery bypass graft (CABG) surgery ( see Warnings; Cardiovascular Thrombotic Events ).

leaflet_short:

Diclofenac sodium delayed-release tablets 25 mg - white to off-white, biconvex, round-shaped, unscored (imprinted "CT1 101" on the side) 50 mg - white to off-white, biconvex, round-shaped, unscored (imprinted "CTI 102" on one side), supplied in bottles of 180 NDC 42291-230-18 and 1000 NDC 42291-230-10 75 mg - white to off-white, biconvex, round shaped, unscored (imprinted "CTI 103" on one side), supplied in bottles of 60 NDC 42291-231-60, bottles of 180 NDC 42291-231-18 and 1000 NDC 42291-231-10 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). Manufactured for: AvKARE Inc. Pulaski, TN 38478 Mfg. Rev. 08/16 AV Rev. 08/18 (P)

authorization_status:

Abbreviated New Drug Application

PIL

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
AvKARE
----------
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
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
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 prov

SPC

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
AVKARE
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS USP
RX ONLY
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
acid copolymer, microcrystalline cellulose, polyethylene glycol,
povidone, propylene
glycol, sodium starch glycolate, talc, titanium dioxide, triethyl
citrate.
14
10
2
2
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Diclofenac has analgesic, anti-inflammatory, and antipyretic
properties.
The mec