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:

Ingenus Pharmaceuticals, LLC

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; Gastrointestinal Bleeding, Ulceration, and Perforation). 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 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 allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have bee

Product summary:

Diclofenac Potassium Tablets, USP are available containing 50 mg of diclofenac potassium, USP. The 50 mg tablets are white, film-coated, round, unscored tablets debossed with I on one side and 279 on the other side. They are available as follows: NDC 50742-279-01 (bottles of 100 tablets) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. PHARMACIST: Dispense with Medication Guide available at: www.ingenus.com/medguide/diclofenac-potassium-tablets.pdf Rx only 554801 Revised: 07/2023 Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811 ingenus Dispense with Medication Guide available at: www.ingenus.com/medguide/diclofenac-potassium-tablets.pdf

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ingenus Pharmaceuticals, LLC
----------
MEDICATION GUIDE
DICLOFENAC POTASSIUM (DYE-KLOE-FEN-
AK POE-TAS-EE-UM) TABLETS, USP
What is the most important information I should know about medicines
called Non- Steroidal 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
• longer use of NSAIDs
• smoking
• drinking alcohol
• older age
• poor health
• advanced liver disease
• 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 NSAIDs, tell your healthcare provider abo

Summary of Product characteristics

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
INGENUS PHARMACEUTICALS, LLC
----------
DICLOFENAC POTASSIUM TABLETS USP, 50 MG
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 POTASSIUM 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 potassium tablets, USP are a benzeneacetic acid derivative.
Diclofenac
potassium tablets are available as tablets of 50 mg (white) for oral
administration.
Diclofenac potassium, USP is a white or slightly yellowish crystalline
powder and is
sparingly soluble in water at 25ºC. The chemical name is
2-[(2,6-dichlorophenyl)amino]
benzeneacetic acid, monopotassium salt. The molecular weight is 334.24
g/mol. Its
molecular formula is C
H
Cl
NKO , and it has the following structural formula:
14
10
2
2
The inactive ingredients in diclofenac potassium tablets include:
anhydrous lactose,
microcrystalline cellulose, croscarmellose sodium, sodium lauryl
sulfate, colloidal silicon
dioxide, magnesium stearate, titanium dioxide, polydextrose,
hypromellose, triacetin,
and polyethylene glycol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Diclofenac has analgesic, anti-inflammat