Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
NuCare Pharmaceuticals,Inc.
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) . Diclofenac sodium delayed-release tablets, USP are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac sodium delayed-release tablets are contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS; Anaphylactic Reactions, Serious Skin Reaction
75 mg — Each white, round, enteric-coated tablet printed with on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 0228-2551-06) Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184 Revised — October 2017
Abbreviated New Drug Application
DFS 75MG DR/MS 25%/MENTH 6%/CAP 0.025% PAK- DICLOFENAC SODIUM, METHYL SALICYLATE, MENTHOL, CAPSAICIN NuCare Pharmaceuticals,Inc. ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDS) What is the most important information I should know about 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 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 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: • any time 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 ○ older age • longer use of NSAIDs ○ poor health • smoking ○ advanced liver disease • drinking alcohol ○ bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs 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 NSAIDs? Do not take NSAIDs: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or aft read_full_document
DFS 75MG DR/MS 25%/MENTH 6%/CAP 0.025% PAK- DICLOFENAC SODIUM, METHYL SALICYLATE, MENTHOL, CAPSAICIN NUCARE PHARMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DICLOFENAC SOD DR . SEE FULL PRESCRIBING INFORMATION FOR DICLOFENAC SOD DR . INITIAL U.S. APPROVAL 40-9184 REVISED – OCTOBER 2017 RX ONLY PRESCRIBING INFORMATION INDICATIONS AND USAGE Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness. (15) DOSAGE AND ADMINISTRATION Shake before each use. Prior to first use rub small amount to check for sensitivity. Apply product directly to affected area. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Product may be used as necessary, but should not be used more than four times per day. (20) STORE BELOW (90°F/32°C) (20) SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 10/2017 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS DESCRIPTION CLINICAL PHARMACOLOGY MECHANISM OF ACTION PHARMACOKINETICS INDICATIONS AND USAGE CONTRAINDICATIONS WARNINGS CARDIOVASCULAR THROMBOTIC EVENTS GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION HEPATOTOXICITY HYPERTENSION HEART FAILURE AND EDEMA RENAL TOXICITY AND HYPERKALEMIA ANAPHYLACTIC REACTIONS EXACERBATION OF ASTHMA RELATED TO ASPIRIN SENSITIVITY SERIOUS SKIN REACTIONS Premature Closure of Fetal Ductus Arteriosus Hematologic Toxicity PRECAUTIONS GENERAL INFORMATION FOR PATIENTS LABORATORY MONITORING DRUG INTERACTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility PREGNANCY LABOR OR DELIVERY NURSING MOTHERS PEDIATRIC USE GERIATRIC USE ADVERSE REACTIONS OVERDOSAGE DOSAGE AND ADMINISTRATION HOW SUPPLIED * FULL PRESCRIBING INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS CARDIOVASCULAR THROMBOTIC EVENTS NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE read_full_document