DICLOFENAC POTASSIUM tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

DICLOFENAC POTASSIUM (UNII: L4D5UA6CB4) (DICLOFENAC - UNII:144O8QL0L1)

Dostupno od:

Lake Erie Medical DBA Quality Care Products LLC

INN (International ime):

DICLOFENAC POTASSIUM

Sastav:

DICLOFENAC POTASSIUM 50 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac potassium tablets are indicated: - For treatment of primary dysmenorrhea - For relief of mild to moderate pain - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis Diclofenac potassium tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac potassium tablets should not be given to patients who have experienced asthma, urticaria, or 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 , Anaphylactic Reactions and PRECAUTIONS , Preexisting Asthma ). Diclofenac potassium tablets are contraindicate

Proizvod sažetak:

Diclofenac potassium tablets USP, 50 mg are available as orange, round, unscored, biconvex, film-coated tablets debossed with the numbers “93” and “948” on one face of the tablet and plain on the other 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 defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. J 3/2011

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Lake Erie Medical DBA Quality Care Products LLC
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(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 of 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
pharmacist.
•
if y

Svojstava lijeka

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
DICLOFENAC POTASSIUM TABLETS USP, 50 MG
0948
RX ONLY
CARDIOVASCULAR RISK
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 potassium tablets are contraindicated for the treatment of
perioperative pain in the setting of coronary artery bypass graft
(CABG) surgery
(see WARNINGS).
GASTROINTESTINAL RISK
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).
Throughout this package insert, the term NSAID refers to a non-aspirin
non-
steroidal anti-inflammatory drug.
DESCRIPTION
Diclofenac potassium tablets USP are a benzeneacetic acid derivative.
Diclofenac
potassium tablets USP, 50 mg are available as orange, film-coated
tablets for oral
administration. The chemical name is 2-[(2,6-dichlorophenyl)amino]
benzeneacetic acid,
monopotassium salt. The structural formula is:
C
H
Cl
KNO M.W. 334.25
Diclofenac potassium is a faintly yellowish white to light beige,
virtually odorless, slightly
hygroscopic crystalline powder. It is freely soluble in methanol,
soluble in ethanol and
water, and practically insoluble in chloroform and in dilute acid. The
n-octanol/water
1
1
14
10
2
2
partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. It has a
single dissociation
constant (pKa) of 4.0 ± 0.2 at 25°C in water.
Each tablet, for oral administration, contains 50 mg of diclofenac
potassium. In addition,
each tablet contains the following inactive ingredients: c