DICLOFENAC SODIUM DELAYED RELEASE- diclofenac sodium tablet, delayed release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Preferred Pharmaceuticals Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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: Diclofenac sodium delayed-release tablets are contraindicated in the following patients:

Povzetek izdelek:

50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of; 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 Repackaged By; Preferred Pharmaceuticals Inc.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
Preferred Pharmaceuticals 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:
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.
•
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 provider about all of your
medical conditions, including if you:
•
have liver or kidney problems
•
have high blood pressure
•
have asthma
•
are pregnant or plan to become pregnant. Talk to your healthcare
provider if you are considering taking
NSAIDs during pregnancy.
You should not take NSAIDs after 29 weeks of pregnancy.
•
are breastfeeding or plan to breast feed.
Tell your healthcare provider about all of the medic

Lastnosti izdelka

DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
DICLOFENAC SODIUM
Delayed-Release Tablets USP
Rx only
Prescribing information
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•
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
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).
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).
14
10
2
2
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
pro