DICLOFENAC POTASSIUM powder, for solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Ascend Laboratories, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use - Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine. - The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population. Diclofenac potassium for oral solution 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 [

পণ্য সারাংশ:

Diclofenac potassium for oral solution, USP 50 mg, is a white to off-white, peppermint flavored powder for oral solution, supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. NDC 67877-772- 49 Individual diclofenac potassium for oral solution, USP packets NDC 67877-772- 58 Boxes of nine (9) diclofenac potassium for oral solution, USP packets Storage Store at 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Ascend Laboratories, LLC
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MEDICATION GUIDE
Diclofenac Potassium (dye-KLOE-fen-ak poe-TAS-ee-um) for oral solution
What is the most important information I should know about diclofenac
potassium for oral solution?
Diclofenac potassium for oral solution contains diclofenac (a
non-steroidal anti-inflammatory drug or
NSAID).
NSAIDs, including diclofenac potassium for oral solution, 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, including diclofenac potassium for oral solution
right before or after a heart surgery called a “coronary artery
bypass graft (CABG)."Avoid taking
NSAIDs, including diclofenac potassium for oral solution, 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:
•
anytime 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 o older age
•
longer use of NSAIDs o poor health
•
smoking o advanced liver disease
•
drinking alcohol o bleeding problems
Diclofenac potassium for oral solution should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What is diclofenac potassium for oral solution?
Diclofenac potassium for oral solution is a prescription medicine used
to treat migraine attacks in adults. It
does not prevent or lessen the number of migraines

পণ্য বৈশিষ্ট্য

DICLOFENAC POTASSIUM - DICLOFENAC POTASSIUM POWDER, FOR SOLUTION
ASCEND LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC POTASSIUM
FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DICLOFENAC POTASSIUM FOR ORAL SOLUTION.
DICLOFENAC POTASSIUM FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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 (5.1)
DICLOFENAC POTASSIUM FOR ORAL SOLUTION 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, 5.12) 4/2021
INDICATIONS AND USAGE
Diclofenac potassium for oral solution is a non-steroidal
anti-inflammatory drug (NSAID) indicated for the
acute treatment of migraine attacks with or without aura in adults 18
years of age or older (1)
Limitations of Use (1):
Diclofenac potassium for oral solution is not indicated for the
prophylactic therapy of migraine
Safety and effectiveness of diclofenac potassium for oral solution not
established for cluster headache,
which is present in an older, predominantly male population
DOSAGE AND ADMINISTRATION
Single 50 mg dose; mix single packet contents with 1 to 2 ounces or 2
to 4 tablespoons (30 to 60 mL) of water prior