Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)
PharmaDerm a division of Fougera Pharmaceuticals Inc.
diclofenac sodium
diclofenac sodium 30 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Solaraze® (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. Solaraze® (diclofenac sodium) Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium. Solaraze® (diclofenac sodium) Gel is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.
Available in tubes of 100 g (NDC 10337-844-01). Each gram of gel contains 30 mg of diclofenac sodium. Storage: Store at controlled room temperature 20°-25°C (68-77°F); excursions permitted between 15°-30°C (59°-86°F). Protect from heat. Avoid freezing. †Voltaren® is a registered trademark of Novartis. 46185066B R04/2021 #330
New Drug Application
SOLARAZE- DICLOFENAC SODIUM GEL PharmaDerm a division of Fougera Pharmaceuticals Inc. ---------- Medication Guide Solaraze (sol-ar-aze) (diclofenac sodium) Gel, 3% What is the most important information I should know about Solaraze Gel and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? Solaraze Gel is an NSAID medicine that is used on the skin only (topical). Do not use Solaraze Gel in or on the eyes. 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: o with increasing doses of NSAIDs o 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: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o 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 Solaraze Gel? Solaraze Gel is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Solaraze Gel is not for use in children. Who should not use Solaraze Gel? Do not use Solaraze Gel: • if you have had an allergic reaction to any of the ingredients in Solara Baca dokumen lengkap
SOLARAZE- DICLOFENAC SODIUM GEL PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- SOLARAZE GEL DICLOFENAC SODIUM-3% RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS CARDIOVASCULAR THROMBOTIC EVENTS • • DESCRIPTION Solaraze (diclofenac sodium) Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether. The chemical name for diclofenac sodium is: Sodium [_o_-(2,6-dichloranilino) phenyl] acetate Diclofenac sodium has a molecular weight of 318.13. The CAS number is CAS-15307-79-6. The structural formula is represented below: Solaraze Gel also contains benzyl alcohol, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water. 1 g of Solaraze (diclofenac sodium) Gel contains 30 mg of the active substance, diclofenac sodium. ® 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. SOLARAZE IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ® ® ® CLINICAL PHARMACOLOGY The mechanism of action of diclofenac sodium in the treatment of actinic keratoses (AK) is unknown. The contribution to efficacy of individual components of the vehicle has not been established. PHARMACOKINETICS _ABSORPTION_ When Solaraze is applied topically, diclofenac is absorbed into the epidermis. In a study in patients with compromised skin (mainly atopic dermatitis and other dermatitic conditions) of the hands, arms or face, approximately 10% of the applied dose (2 grams of 3% gel over 100 cm ) of diclofenac was absorbed systemically in both normal and Baca dokumen lengkap