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:

PD-Rx Pharmaceuticals, Inc.

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, USP are 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

Prehľad produktov:

Diclofenac Sodium Delayed-Release Tablets, USP are available as follows: 50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 14 (NDC 43063-566-14), 15 (NDC 43063-566-15). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PD-Rx 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 ○ older age
•
longer use of NSAIDs ○ poor health
•
smoking ○ advanced liver disease
•
drinking alcohol ○ 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 N

Súhrn charakteristických

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PD-RX PHARMACEUTICALS, INC.
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
40-9184
REVISED – OCTOBER 2017
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, USP are a benzene-acetic
acid derivative. Diclofenac
sodium, USP is a white to almost white 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 318.13. Its molecular formula is C
H
Cl
NNaO
, and it has the following
structural formula
14
10
2
2
Each enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium, USP.
In addition, each tablet contains the following inactive ingredients:
aluminum hydrate, colloidal silicon
dioxide, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate,
propylene glycol, silica, sodium
alginate, sodium starc