DICLOFENAC SODIUM DELAYED RELEASE- diclofenac sodium tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carlsbad Technology, Inc.

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 takin

Product summary:

25 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on the side), supplied in bottles of 60, 100 and 1000. 50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000. 75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000. Bottles of 60 ..................................................................NDC 61442-102-60 Bottles of 100 ................................................................NDC 61442-102-01 Bottles of 1000 ..............................................................NDC 61442-102-10 Bottles of 60 ..................................................................NDC 61442-103-60 Bottles of 100 ................................................................NDC 61442-103-01 Bottles of 500 ................................................................NDC 61442-103-05 Bottles of 1000 ..............................................................NDC 61442-103-10 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 and Distributed by: Carlsbad Tech Carlsbad, CA 92008 USA Revised: 05/2016 CTI-11 Rev. H Printed in USA

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM DELAYED RELEASE - DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
Carlsbad Technology, Inc.
----------
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 taki

Summary of Product characteristics

DICLOFENAC SODIUM DELAYED RELEASE - DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
CARLSBAD TECHNOLOGY, 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
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.
14
10
2
2
The mec