DICLOTRAL PAK- diclofenac sodium, capsaicin kit

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

제공처:

Patchwerx Labs, Inc.

INN (International Name):

DICLOFENAC SODIUM

구성:

DICLOFENAC SODIUM 16.05 mg in 1 mL

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). Diclofenac sodium topical solution is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of diclofenac sodium topical solution. Diclofenac sodium topical solution is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.10)]. Diclofenac sodium topical solution is contraindicated 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. Teratogenic Effects: There are no adequate and w

제품 요약:

Diclofenac Sodium Topical Solution is supplied as a clear, colorless to yellow solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white opaque low density polyethylene bottle with a white linear low density polyethylene valve seal dispensing cap. NDC Number & Size 150 mL bottle NDC # 60505-0399-5 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Patchwerx Labs, Inc.
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MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant, NSAID medicines should not be

제품 특성 요약

DICLOTRAL PAK- DICLOFENAC SODIUM, CAPSAICIN
PATCHWERX LABS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DICLOFENAC SODIUM TOPICAL SOLUTION, 1.5% (W/W)
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM TOPICAL SOLUTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICLOFENAC
SODIUM TOPICAL SOLUTION.
DICLOFENAC SODIUM TOPICAL SOLUTION 1.5% W/W IS FOR TOPICAL USE ONLY.
INITIAL U.S. APPROVAL: 1988
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
strong>Cardiovascular Risk
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) MAY CAUSE AN INCREASED
RISK OF SERIOUS CARDIOVASCULAR
THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE
FATAL. THIS RISK MAY INCREASE WITH
DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS
FOR CARDIOVASCULAR DISEASE MAY BE
AT GREATER RISK _[SEE WARNINGS AND PRECAUTIONS (5.1)]._
DICLOFENAC SODIUM TOPICAL SOLUTION IS CONTRAINDICATED IN THE
PERIOPERATIVE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY _[SEE CONTRAINDICATIONS (4)] _.
GASTROINTESTINAL RISK
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL 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 ARE
AT GREATER RISK FOR SERIOUS
GASTROINTESTINAL EVENTS _[SEE WARNINGS AND PRECAUTIONS (5.2)]._
RECENT MAJOR CHANGES
Dosage and Administration ( 2). . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . .
. . . . . . . . 10/2013
INDICATIONS AND USAGE
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory
drug (NSAID) indicated for the treatment of signs
and symptoms of osteoarthritis of the knee(s). ( 1)
DOSAGE AND ADMINISTRATION
FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS OF THE
KNEE(S), THE RECOMMENDED DOSE IS 40 DROPS ON
EACH PAINFUL KNEE, 4 TIMES A D