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:

Stat Rx USA

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 immediate-release tablets and other treatment options before deciding to use diclofenac potassium immediate-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).       Diclofenac potassium immediate-release 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 immediate-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac potassium immediate-release 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, Anaphyla

Product summary:

Diclofenac Potassium Tablets 50 mg are available for oral administration as light brown, round shaped, unscored, film coated tablets, imprinted “APO” on one side and “DP” over “50” on the other side. They are supplied as follows: Bottles of 100 NDC 60505-0135-0 Bottles of 1000 NDC 60505-0135-1 Store at 20°-25°C (68°-77° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Apotex Inc. Diclofenac Potassium Tablets 50 mg Manufactured by:         Manufactured for: Apotex Inc.                 Apotex Corp. Toronto, Ontario          Weston, Florida Canada, M9L 1T9        33326 Revised: January 2006 Rev. 03

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC POTASSIUM - DICLOFENAC POTASSIUM TABLET, FILM COATED
Stat Rx USA
----------
Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
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 you are pregnant. NSAID medicines should not be used by pregnant

Summary of Product characteristics

DICLOFENAC POTASSIUM - DICLOFENAC POTASSIUM TABLET, FILM COATED
STAT RX USA
----------
DICLOFENAC POTASSIUM TABLET, FILM COATED
DESCRIPTION
Diclofenac potassium is a benzeneacetic acid derivative. Diclofenac
potassium is available as
immediate-release tablets of 50 mg (light brown) for oral
administration. The chemical name is 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The
molecular weight is 334.25. Its
molecular formula is C14H10Cl2NKO2, and it has the following
structural formula:
Each diclofenac potassium immediate-release tablet, intended for oral
administration, contains 50 mg
diclofenac potassium for oral administration. In addition, each tablet
contains the following inactive
ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, iron
oxides, magnesium stearate,
methanol, polyethylene glycol, povidone, sodium bicarbonate and
titanium dioxide.
CLINICAL PHARMACOLOGY PHARMACODYNAMICS
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,
and antipyretic activities in animal models. The mechanism of action
of diclofenac, like that of other
NSAIDs, is not completely understood but may be related to
prostaglandin synthetase inhibition.
PHARMACOKINETICS Absorption
Diclofenac is 100% absorbed after oral administration compared to IV
administration as measured by
urine recovery. However, due to first-pass metabolism, only about 50%
of the absorbed dose is
systemically available. In some fasting volunteers, measurable plasma
levels are observed within 10
minutes of dosing with diclofenac potassium immediate-release tablets.
Peak plasma levels are achieved
approximately 1 hour in fasting normal volunteers, with a range of .33
to 2 hours. Food has no
significant effect on the extent of diclofenac absorption. However,
there is usually a delay in the onset
of absorption and a reduction in peak plasma levels of approximately
30%.
Distribution
The apparent volume of distribution (V/F) of diclofenac potassium is
1.3 L/kg.
Diclofenac is m