DICLOFENAC SODIUM- diclofenac sodium tablet, delayed release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Preferred Pharmaceuticals, Inc.

INN (Medzinárodný Name):

DICLOFENAC SODIUM

Zloženie:

DICLOFENAC SODIUM 50 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated: Diclofenac sodium delayed-release tablets are contraindicated in the following patients:

Prehľad produktov:

Diclofenac Sodium Delayed-Release Tablets, USP are available containing 50 mg or 75 mg of diclofenac sodium, USP. The 50 mg tablets are a light brown, enteric coated, round, unscored tablet imprinted with G-DS-50 in black ink. They are available as follows: Bottle of 30 - 68788-9185-3 Bottle of 60 - 68788-9185-6 Bottle of 90 - 68788-9185-9 Bottle of 100 - 68788-9185-1 Bottle of 120 - 68788-9185-8 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Preferred Pharmaceuticals, Inc.
----------
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:
•
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:
•
any time 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 stomach or intestinal bleeding with
use of
NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or
“SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
older age
•
poor health
•
smoking
•
drinking alcohol
•
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 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
med

Súhrn charakteristických

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PREFERRED PHARMACEUTICALS, INC.
----------
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•
DESCRIPTION
Diclofenac sodium delayed-release tablets, USP are a benzene-acetic
acid derivative. Diclofenac
sodium delayed-release tablets are available as enteric-coated tablets
of 50 mg (light brown) or 75 mg
(light pink) for oral administration. Diclofenac sodium, USP is a
faintly yellowish white to light beige
crystalline powder and is sparingly soluble in water at 25°C. The
chemical name is Sodium [_o_-(2,6-
dichloroanilino)phenyl]acetate. The molecular weight is 318.13. 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: crospovidone, FD&C
Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate,
magnesium stearate, methacrylic
acid copolymer, microcrystalline cellulose, polyethylene glycol,
povidone, simethicone, sodium
hydroxide, talc and titanium dioxide. The 50 mg tablets also contain
FD&C Blue No. 2 Aluminum Lake
and yellow iron oxide. The 75 mg tablets also contain FD&C Red No. 40
Aluminum Lake.
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 PEP