DICLOFENAC POTASSIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

DICLOFENAC POTASSIUM

Composition:

DICLOFENAC POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 potassium tablets are contraind

Product summary:

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, in 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. I 7/2009 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
----------
Medication Guidefor 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 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 you are pregnant. NSAID m

Summary of Product characteristics

DICLOFENAC POTASSIUM - DICLOFENAC POTASSIUM TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
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 are a benzeneacetic acid derivative.
Diclofenac potassium tablets, 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 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: colloidal silicon
dioxide, corn starch, F