DICLOFENAC POTASSIUM tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Golden State Medical Supply, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 fat

Ringkasan produk:

Diclofenac Potassium Tablets, USP 50 mg are available for oral administration as light brown, round shaped, unscored, film coated tablets, imprinted “AMI” on one side and “DP” over “50” on the other side. They are supplied as follows: Bottles of 100 NDC 51407-443-01 Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure. Keep container tightly closed. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. PHARMACIST: Dispense a Medication Guide with each prescription. AMICI PHARMACEUTICALS LLC. DICLOFENAC POTASSIUM TABLETS, USP 50 mg Distributed by: Amici Pharmaceuticals LLC. Melville, NY 11747 Revision date: March 2021 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Golden State Medical Supply, Inc.
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MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS )
What is the most important information I should know about medicines
called Nonsteroidal 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 NSAIDsowith 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 healthoadvanced liver disease
•bleeding problems
NSAIDs should only be used:
•exactly as prescribed
•at the lowest dose possible for your treatment of or 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 about all of your
medical conditions, includi

Ciri produk

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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DICLOFENAC POTASSIUM TABLETS, USP 50MG
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 are available as 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 C
H
C
NKO
, and it has the following structural formula:
Each diclofenac potassium tablet, USP 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 oxide
red, magnesium stearate, methanol, polyethylene glycol, povidone,
sodium bicarbonate,
14
10
l2
2
titanium dioxide and yellow iron oxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Diclofenac has analgesic, anti-inflammatory, and antipyretic
properties.
The mechan