Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)
Preferred Pharmaceuticals, Inc.
TOPICAL
PRESCRIPTION DRUG
Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. Diclofenac Sodium Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium. Diclofenac Sodium Gel is contraindicated in the following patients:
Diclofenac Sodium Gel, 3% is available in 100 g (NDC 68788-7546-01) tubes. Each gram of gel contains 30 mg of diclofenac sodium. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing.
Abbreviated New Drug Application
Preferred Pharmaceuticals, Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 12/2016 Medication Guide Diclofenac (dye-KLOE-fen-ak) Sodium Gel, 3% What is the most important information I should know about Diclofenac Sodium Gel and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? Diclofenac Sodium Gel is an NSAID medicine that is used on the skin only (topical). Do not use Diclofenac Sodium Gel in or on the eyes. NSAIDs can cause serious side effects, including: 1. Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: 1. with increasing doses of NSAIDs 2. 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. 2. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: 3. anytime during use 4. without warning symptoms 5. that may cause death The risk of getting an ulcer or bleeding increases with: 6. past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs 7. taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" • increasing doses of NSAIDs • longer use of NSAIDs • • older age • poor health • smoking • drinking alcohol advanced liver disease • bleeding problems NSAIDs should only be used: 1. exactly as prescribed 2. at the lowest dose possible for your treatment 3. for the shortest time needed What is Diclofenac Sodium Gel? Diclofenac Sodium Gel is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Diclofenac Sodium Gel is not for use in children. Who should not use Diclofenac Sodium Gel? Do Прочетете целия документ
DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL PREFERRED PHARMACEUTICALS, INC. ---------- DICLOFENAC SODIUM GEL, 3% RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS CARDIOVASCULAR THROMBOTIC EVENTS 1. 2. 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, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water. 1 g of Diclofenac Sodium Gel 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. 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 US E. DICLOFENAC SODIUM GEL IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. PHARMACOKINETICS ABS ORPTION When diclofenac sodium gel 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 compromised epider Прочетете целия документ