DICLOFENAC POTASSIUM powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

DICLOFENAC POTASSIUM

Composition:

DICLOFENAC POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 [se

Product summary:

Diclofenac potassium for oral solution USP, 50 mg is supplied as individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water. Diclofenac potassium for oral solution, USP is a white to off-white, flavored powder for oral solution packaged in individual unit dose packets. Individual diclofenac potassium for oral solution Packet - NDC 49884-905-52 Boxes of three (3) diclofenac potassium for oral solution Packets - NDC 49884-905-24 Boxes of nine (9) diclofenac potassium for oral solution Packets - NDC 49884-905-64 Storage Store at 25°C (77°F). Excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Par Pharmaceutical, Inc.
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MEDICATION GUIDE
Medication Guide
Diclofenac Potassium for Oral Solution, USP
(dye-KLOE-fen-ak poe-TAS-ee-um)
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
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
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 o

Summary of Product characteristics

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM POWDER, FOR SOLUTION
PAR PHARMACEUTICAL, INC.
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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 t