DICLOFENAC SODIUM 1.5%- diclofenac sodium topical solution solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Sola Pharmaceuticals

INN (Mezinárodní Name):

DICLOFENAC SODIUM

Složení:

DICLOFENAC SODIUM 16.05 mg in 1 mL

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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)]. 8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Teratogenic Effects: There are no adequate and well-controlled studies of diclofenac sodium topical solution in pregnant women. Diclofenac sodium topical solution should not be used by pregnant women as its safe use has not been adequately de

Přehled produktů:

16. HOW SUPPLIED/STORAGE AND HANDLING Diclofenac Sodium Topical Solution is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low-density dropper cap. NDC Number & Size Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Sola Pharmaceuticals
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Revised: 1/2021
Document Id: b8bd41e9-b7a5-5daa-e053-2a95a90ad691
34391-3
Set id: 5e1f20e0-4743-fc3c-e053-2991aa0aa7ad
Version: 5
Effective Time: 20210112
Sola Pharmaceuticals

Charakteristika produktu

DICLOFENAC SODIUM 1.5%- DICLOFENAC SODIUM TOPICAL SOLUTION SOLUTION
SOLA PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
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. Patients with cardiovascular
disease or risk factors for cardiovascular disease may be at greater
risk. (5.1)
Diclofenac sodium topical solution is contraindicated for the
treatment of perioperative pain in the setting of coronary
artery bypass graft (CABG) surgery. (4)
Gastrointestinal Risk
NSAIDs, including diclofenac sodium topical solution 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. (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) (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 day. (2) (2)
Apply diclofenac sodium topical solution to clean, dry skin. (2.1) (2)
Dispense diclofenac sodium topical solution 10 drops at a tim