DICLOFENAC SODIUM solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

DIRECT RX

INN (Algemene Internationale Benaming):

DICLOFENAC SODIUM

Samenstelling:

DICLOFENAC SODIUM 16.05 mg in 1 mL

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium 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 8.1 Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Risk Summary Use of NSAIDs, including diclofenac, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAI

Product samenvatting:

Diclofenac sodium topical solution 1.5% w/w 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 room temperature 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature]. Keep product stored upright at all times.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
DIRECT RX
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Advise the patient to read the FDA-approved patient labeling
(Medication Guide) and Instructions for
Use that accompanies each prescription dispensed. Inform patients,
families, or their caregivers of the
following information before initiating therapy with diclofenac sodium
topical solution and periodically
during the course of ongoing therapy.
Cardiovascular Thrombotic Events
Advise patients to be alert for the symptoms of cardiovascular
thrombotic events, including chest pain,
shortness of breath, weakness, or slurring of speech, and to report
any of these symptoms to their health
care provider immediately [see Warnings and Precautions (5.1)].
Gastrointestinal Bleeding, Ulceration, and Perforation
Advise patients to report symptoms of ulcerations and bleeding,
including epigastric pain, dyspepsia,
melena, and hematemesis to their health care provider. In the setting
of concomitant use of low-dose
aspirin for cardiac prophylaxis, inform patients of the increased risk
for and the signs and symptoms of GI
bleeding [see Warnings and Precautions (5.2)].
Hepatotoxicity
Inform patients of the warning signs and symptoms of hepatotoxicity
(e.g., nausea, fatigue, lethargy,
pruritus, diarrhea, jaundice, right upper quadrant tenderness, and
"flu-like" symptoms). If these occur,
instruct patients to stop diclofenac sodium topical solution and seek
immediate medical therapy [see
Warnings and Precautions (5.3)].
Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart
failure including shortness of breath,
unexplained weight gain, or edema and to contact their healthcare
provider if such symptoms occur [see
Warnings and Precautions (5.5)].
Anaphylactic Reactions
Inform patients of the signs of an anaphylactic reaction (e.g.
difficulty breathing, swelling of the face or
throat). Instruct patients to seek immediate emergency help if these
occur [see Contraindications (4) and
Warnings and Precautions (5.7)].
Serious Skin Reactions

Productkenmerken

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
DIRECT RX
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DICLOFENAC SODIUM TOPICAL SOLUTION 1.5%
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
Cardiovascular Thrombotic Events
•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 [see Warnings and
Precautions (5.1)].
•Diclofenac sodium topical solution is contraindicated in the
setting of coronary artery bypass
graft (CABG) surgery [see Contraindications (4) and Warnings and
Precautions (5.1)].
Gastrointestinal Bleeding, Ulceration, and Perforation
•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 [see Warnings and Precautions (5.2)].
Diclofenac sodium topical solution is indicated for the treatment of
signs and symptoms of
osteoarthritis of the knee(s) (1).
2.1 General Dosing Instructions
Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment
goals [see Warning and Precautions (5.2)]
For the relief of the signs and symptoms of osteoarthritis of the
knee(s), the recommended dose is 40
drops per knee, 4 times a day.
Apply diclofenac sodium topical solution to clean, dry skin.
To avoid spillage, dispense diclofenac sodium topical solution 10
drops at a time either directly onto
the knee or first into the hand and then onto the knee. Spread
diclofenac sodium topical solution evenly
around front, back and sides of the knee. Repeat this procedure until
40 drops have been applied and the
knee is completely covered with solution.
To treat the other knee