DICLOFENAC SODIUM- diclofenac sodium solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Sircle Laboratories, LLC

INN (International ime):

DICLOFENAC SODIUM

Sastav:

DICLOFENAC SODIUM 16.05 mg in 1 mL

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 well-controlled studies of diclofenac sodium topical solution in pregnant w

Proizvod sažetak:

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. Storage Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Sircle Laboratories, LLC
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Please refer to the package insert for more information
Revised: 12/2018
Document Id: 7d4f42aa-5036-2484-e053-2991aa0ad9c4
34391-3
Set id: 22b24f35-9ff5-4950-e054-00144ff88e88
Version: 3
Effective Time: 20181218
Sircle Laboratories, LLC

Svojstava lijeka

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
SIRCLE LABORATORIES, LLC
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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
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
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)
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)
Apply diclofenac sodium topical solution to clean, dry skin. ( 2.1)
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 s