מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Amneal Pharmaceuticals of New York LLC
DICLOFENAC SODIUM
DICLOFENAC SODIUM 30 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Diclofenac Sodium Gel, 3% is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. Diclofenac Sodium Gel, 3% is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol and/or polyethylene glycol monomethyl ether 350. Diclofenac Sodium Gel, 3% is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.
Available in tubes of 100 g and 50 g. Each gram of gel contains 30 mg of diclofenac sodium. 100 g tube – NDC 0115-1483-61 50 g tube – NDC 0115-1483-56 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. † Voltaren® is a registered trademark of Novartis. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006125 Rev. 0 04/19
Abbreviated New Drug Application
Amneal Pharmaceuticals of New York LLC ---------- MEDICATION GUIDE DICLOFENAC (DYE KLOE’ FEN AK) SODIUM GEL, 3% What is the most important information I should know about Diclofenac Sodium Gel, 3% and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? Diclofenac Sodium Gel, 3% is an NSAID medicine that is used on the skin only (topical). Do not use Diclofenac Sodium Gel, 3% 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: • 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 Gel, 3%? Diclofenac Sodium Gel, 3% is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Diclofenac Sodium Gel, 3% is not for use in children. Who should not use Diclofenac Sodium Gel, 3%? Do not use Diclofenac Sodium Gel קרא את המסמך השלם
DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL AMNEAL PHARMACEUTICALS OF NEW YORK LLC ---------- DICLOFENAC SODIUM GEL, 3% RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS CARDIOVASCULAR THROMBOTIC EVENTS - 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. - DICLOFENAC SODIUM GEL, 3% IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. DESCRIPTION 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: Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hydroxyethyl cellulose, methoxypolyethylene glycol 350, PEG-60 hydrogenated castor oil, and purified water. 1 g of Diclofenac Sodium Gel, 3% contains 30 mg of the active substance, diclofenac sodium. 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 diclofenac sodium gel, 3% 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 syste קרא את המסמך השלם