País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
STAT RX USA LLC
DICLOFENAC SODIUM
DICLOFENAC SODIUM 16.05 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). PENNSAID is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID. PENNSAID 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) ] . PENNSAID 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 PENNSAID in pregnant women. PENNSAID should not be used by pregnant women as its safe use has not been adequately determined and starting at 30 weeks gestation, diclofen
PENNSAID 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 Room Temperature].
New Drug Application
STAT RX USA LLC ---------- 17.10 MEDICATION GUIDE Medication Guide For Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: • different types of arthritis • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. Leer el documento completo
PENNSAID - DICLOFENAC SODIUM LIQUID STAT RX USA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PENNSAID SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PENNSAID. PENNSAID (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) PENNSAID IS CONTRAINDICATED FOR THE TREATMENT OF PERIOPERATIVE PAIN IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. (4) GASTROINTESTINAL RISK NSAIDS, INCLUDING PENNSAID, 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) INDICATIONS AND USAGE PENNSAID 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 PENNSAID to clean, dry skin. (2.1) Dispense PENNSAID 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread PENNSAID 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. (2.1) Wash hands completely after administering the product. Wait until the area is completely dry bef Leer el documento completo