FLECTOR- diclofenac epolamine system

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Diclofenac Epolamine (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1)

Sẵn có từ:

Pfizer, Inc.

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

FLECTOR® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. FLECTOR 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) ] - FLECTOR is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. Risk Summary Published literature reports that use of NSAIDs, including FLECTOR, after 30 weeks of gestation increase

Tóm tắt sản phẩm:

Storage Store at 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].

Tình trạng ủy quyền:

New Drug Application

Tờ rơi thông tin

Pfizer, Inc.
----------
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 bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of your
medical conditions, including if
you:

Đặc tính sản phẩm

FLECTOR- DICLOFENAC EPOLAMINE SYSTEM
PFIZER, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLECTOR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLECTOR.
FLECTOR (DICLOFENAC EPOLAMINE) TOPICAL SYSTEM
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)
FLECTOR 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
Indications and Usage
3/2019
INDICATIONS AND USAGE
FLECTOR is a nonsteroidal anti-inflammatory drug (NSAID) and is
indicated for the topical treatment of acute pain due
to minor strains, sprains, and contusions in adults and pediatric
patients 6 years and older. (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consist with the
individual patient treatment goals. (2.1)
The recommended dose of FLECTOR for adults and pediatric patients 6
years and older is one (1) topical system to the
most painful area twice a day. (2)
FLECTOR should not be applied to damaged or non-intact skin. (2)
DOSAGE FORMS AND STRENGTHS
FLECTOR (diclofenac epolamine) topical system 1.3%, for topical use.
Each individual FLECTOR is debossed. (3)
CONTRAINDICATIONS
Known hypersensitivity to diclofenac or any co