DICLOFENAC SODIUM tablet, delayed release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)

Inapatikana kutoka:

Proficient Rx LP

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 ). Diclofenac sodium delayed-release tablets, are indicated: Diclofenac sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium delayed-release tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions , and PRECAUTIONS, Preexisting Asthma ). Diclofenac sodium delayed-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see

Bidhaa muhtasari:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 75 mg : round, Light brown, enteric-coated tablets imprinted P 75 on one side in black ink and plain on the reverse side are supplied as: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Proficient Rx LP
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MEDICATION GUIDE for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
MEDICINES CALLED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery bypass
graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during treatment.
Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
WHAT ARE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)?
NSAID medicines 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 A NON-STEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each other
and cause serious side effects. Keep a list of your medicines to show
to your healthcare provider and
ph

Tabia za bidhaa

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PROFICIENT RX LP
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DICLOFENAC SODIUM DELAYED-RELEASE TABLETS USP, 75 MG
Rx only
Prescribing information
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic
events, myocardial infarction, and stroke, which can be fatal. This
risk may
increase with duration of use. Patients with cardiovascular disease or
risk
factors for cardiovascular disease may be at greater risk. (See
WARNINGS.)
Diclofenac sodium delayed-release tablets are contraindicated for the
treatment of perioperative pain in the setting of coronary artery
bypass graft
(CABG) surgery (see WARNINGS).
NSAIDs cause an increased risk of serious gastrointestinal adverse
events
including inflammation, 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 are at greater risk for
serious
gastrointestinal events. (See WARNINGS ).
Diclofenac sodium delayed-release tablets are a benzene-acetic acid
derivative.
Diclofenac sodium delayed-release tablets are available as
delayed-release tablets of
75 mg for oral administration. 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
14
10
2
2
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac sodium delayed-release tablets, are a nonsteroidal
anti-inflammatory drug
(NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic
activities in animal
models. The mechanism of action of diclofenac sodium delayed-release
tablets, like that
of other NSAIDs, is not completely understood but may be related to
prostaglandin
synthetase inhibition.
PHARMACOKINETICS
ABSORPTION
TABLE 1. PHARMACOKINETIC PARAMETERS FOR DICLOFENAC
NORMAL HEALTHY ADULTS (20-48 YRS.)
PK PARAMETER
MEAN
COEFFICIENT OF MEAN
VARIATI