देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)
Taro Pharmaceuticals U.S.A., Inc.
diclofenac sodium
diclofenac sodium 30 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium topical gel is contraindicated in the following patients: - With known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions (5.1, 5.3, 5.10) and Description (11) ]. - With the 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 (5.1, 5.2) ]. - Application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds [see Warnings and Precautions (5.3) ]. - In the setting of coronary bypass graft (CABG) surgery [see Warnings and Precautions (5.4) ]. Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, can cause premature closure of the fetal ductus arteri
Diclofenac Sodium Topical Gel, 3% is available in 50 g (NDC 51672-1363-3) and 100 g (NDC 51672-1363-7) tubes. Each gram of topical gel contains 30 mg of diclofenac sodium. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing.
Abbreviated New Drug Application
Taro Pharmaceuticals U.S.A., Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: August 2023 Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides Medication Guide Diclofenac (dye-KLOE-fen-ak) Sodium Topical Gel, 3% What is the most important information I should know about diclofenac sodium topical gel and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take or use NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)". Avoid taking NSAIDs after a recent heart attack unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take or use NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What is diclofenac sodium topical gel? Diclofenac sodium topical gel is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Diclofenac sodium topical gel is not for use in children. Do not use diclofenac sodium topic पूरा दस्तावेज़ पढ़ें
DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL TARO PHARMACEUTICALS U.S.A., INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DICLOFENAC SODIUM TOPICAL GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM TOPICAL GEL INITIAL U.S. APPROVAL: 2000 WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ 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. (5.4) DICLOFENAC SODIUM TOPICAL GEL IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. (4, 5.4) 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 (5.5) INDICATIONS AND USAGE Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK). (1) DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with the individual patient treatment goals. (2) Apply to lesion areas twice daily to adequately cover each lesion. (2) Use 0.5 g of gel (pea size) on each 5 cm × 5 cm lesion site. (2) The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be re-evaluated and management reconsidered. (2) Avoid contact in eyes, n पूरा दस्तावेज़ पढ़ें