DICLOFENAC POTASSIUM tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Teva Pharmaceuticals USA, Inc.

INN (Rahvusvaheline Nimetus):

DICLOFENAC POTASSIUM

Koostis:

DICLOFENAC POTASSIUM 50 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 is 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 been reported i

Toote kokkuvõte:

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. Bottles of 100 (NDC 0093-0948-01) Bottles of 500 (NDC 0093-0948-05) 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). Brands listed are the trademarks of their respective owners. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. P 7/2021

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Diclofenac Potassium (dye kloe’ fen ak poe tas’ ee um)
Tablets
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
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced
liver
disease
•
drinking alcohol
•
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

Toote omadused

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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DICLOFENAC POTASSIUM TABLETS, USP
50 MG
RX ONLY
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 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. 334.24 g/mol
Diclofenac potassium, USP 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
14
10
2
2
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: coll