DICLOFENAC POTASSIUM- diclofenac potassium, film coated tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Havix Group Inc d-b-a Aavis Pharmaceuticals

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 to off white, film-coated, round, unscored tablets, debossed with "A" over "46" on one side and plain on the other side. They are available as follows: Bottles of 100 tablets with child-resistant closure: NDC 71337-046-01 Bottles of 500 tablets with child-resistant closure: NDC 71337-046-05 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. The brands listed are trademarks of their respective owners. Manufactured and distributed by: Aavis Pharmaceuticals Inc. Hoschton, GA 30548 U.S.A. Rev.: 06/2023 Code: L7069/00

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM, FILM COATED TABLET
Havix Group Inc d-b-a Aavis Pharmaceuticals
----------
MEDICATION GUIDE FOR
NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
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"
ο increasing doses of NSAIDs
ο longer use of NSAIDs
ο smoking
ο drinking alcohol
ο older age
ο poor health
ο advanced liver disease
ο 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, tel

Summary of Product characteristics

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM, FILM COATED TABLET
HAVIX GROUP INC D-B-A AAVIS PHARMACEUTICALS
----------
DICLOFENAC POTASSIUM TABLETS, USP
BOXED WARNING
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
NON-STEROIDAL 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 for oral administration. Diclofenac
potassium, USP is a
white to off-white or slightly yellowish crystalline powder, Slightly
hygroscopic and is
sparingly soluble in water, Freely soluble in methanol; soluble in
alcohol, slightly soluble in
acetone. The chemical name is Potassium
[o-(2,6-dichloroanilino)phenyl] acetate. The
molecular weight is 334.24. Its molecular formula is C
H
Cl
KNO , and it has the
following structural formula:
14
10
2
2
The inactive ingredients in diclofenac potassium tablets include:
Lactose Anhydrous,
Microcrystalline Cellulose, NF, Colloidal Silicon Dioxide, NF,
Croscarmellose Sodium, NF,
Magnesium Stearate, NF, Titanium Dioxide, USP, Polydextrose, NF,
Hypromellose, USP
2910 (6 mPas), Hypromellose, USP 2910 (3 mPas), Hypromellose, USP 2910