Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Sola Pharmaceuticals
DICLOFENAC SODIUM
DICLOFENAC SODIUM 16.05 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
Sola Pharmaceuticals ---------- 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 Citiți documentul complet
DICLOFENAC SODIUM 1.5%- DICLOFENAC SODIUM TOPICAL SOLUTION SOLUTION SOLA PHARMACEUTICALS ---------- 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 Citiți documentul complet