DICLOFENAC POTASSIUM capsule, liquid filled

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Trifluent Pharma LLC

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Diclofenac Potassium Capsules is indicated for relief of mild to moderate acute pain in adult patients. Pediatric use information is approved for Assertio Therapeutics Inc's ZIPSOR (diclofenac potassium) Capsules. However, due to Assertio Therapeutics Inc's marketing exclusivity rights, this drug product is not labeled with that information. Diclofenac Potassium Capsules 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 and Precautions (5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8) ] - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] - Diclofenac Potassium Capsules

Огляд продуктів:

Diclofenac Potassium Capsules 25 mg, are translucent, pale yellow, liquid-filled capsules printed with "25" in black ink supplied as: NDC Number 73352-095-60                             Bottles of 60 Capsules Storage Store at 20o C to 25o C (68o F to 77o F); excursions permitted between 15o C to 30o C (59o F to 86o F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense in tight, light resistant container as defined in USP.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Trifluent Pharma LLC
----------
Medication Guide for Nonsteroidal 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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with :
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of
NSAIDs
o taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
o increasing doses of NSAIDs
o longer use of NSAIDS
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used :
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are NSAIDs?
o 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 have 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, including if you:
• have liver or kidney

Характеристики продукта

DICLOFENAC POTASSIUM - DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED
TRIFLUENT PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC POTASSIUM
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DICLOFENAC
POTASSIUM CAPSULES.
DICLOFENAC POTASSIUM CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 (5.1)
DICLOFENAC POTASSIUM CAPSULES IS CONTRAINDICATED IN THE SETTING OF
CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY (4, 5.1)
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 (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.10, 5.11) 05/2021
INDICATIONS AND USAGE
Diclofenac Potassium Capsules is a non-steroidal anti-inflammatory
drug indicated for relief of mild to
moderate acute pain in adult patients (1) (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
(2.1)
The dosage is 25 mg four times a day
DOSAGE FORMS AND STRENGTHS
Diclofenac Potassium Capsules: 25 mg (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to diclofenac or any components of the drug
product (4)
History of asthma, urticaria, or other allergic-type reactions after
taking aspirin or other NSAIDs (4)
In the setting of CABG surgery (4)
Diclofenac Potassium C