ZORVOLEX- diclofenac capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Iroko Pharmaceuticals LLC

INN (nemzetközi neve):

DICLOFENAC

Összetétel:

DICLOFENAC 18 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

ZORVOLEX is indicated for: - Management of mild to moderate acute pain - Management of osteoarthritis pain ZORVOLEX 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) ] Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Risk Summary Use of NSAIDs, including ZORVOLEX, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including ZORVOLEX, in pregnant women starting at 30 weeks of gestation

Termék összefoglaló:

ZORVOLEX (diclofenac) capsules are supplied as: Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

Iroko Pharmaceuticals LLC
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Issued or Revised: May 2016
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:
•
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:
•
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
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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 have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart b

Termékjellemzők

ZORVOLEX- DICLOFENAC CAPSULE
IROKO PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZORVOLEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZORVOLEX.
ZORVOLEX (DICLOFENAC) 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)
ZORVOLEX 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
Boxed Warning
5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5)
5/2016
INDICATIONS AND USAGE
ZORVOLEX is a nonsteroidal anti-inflammatory drug indicated for
management of mild to moderate acute pain (1)
management of osteoarthritis pain.(1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals. (2)
The dosage for acute pain is 18 mg or 35 mg orally three times a day.
(2)
The dosage for osteoarthritis pain is 35 mg orally three times a day.
(2)
DOSAGE FORMS AND STRENGTHS
ZORVOLEX (diclofenac) capsules: 18 mg and 35 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to diclofenac or any components of the drug
product (4)
History of asthma, urticaria, o