দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac is indicated: Diclofenac sodium delayed-release tablets are contraindicated in the following patients:
50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 120. Bottles of 30 ..............................................................NDC 71205-995-30 Bottles of 60 ..............................................................NDC 71205-995-60 Bottles of 90 ..............................................................NDC 71205-995-90 Bottles of 100 ............................................................NDC 71205-995-00 Bottles of 120 ............................................................NDC 71205-995-72 Bottles of 180 ............................................................NDC 71205-995-78 Bottles of 1000 ..........................................................NDC 71205-995-11 75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000. Bottles of 30 ..............................................................NDC 71205-991-30 Bottles of 60 ..............................................................NDC 71205-991-60 Bottles of 90 ..............................................................NDC 71205-991-90 Bottles of 100 ............................................................NDC 71205-991-00 Bottles of 120 ............................................................NDC 71205-991-72 Bottles of 180 ............................................................NDC 71205-991-78 Bottles of 500 ............................................................NDC 71205-991-55 Bottles of 1000 ..........................................................NDC 71205-991-11 Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Manufactured and Distributed by: Carlsbad Tech Carlsbad, CA 92008 USA Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 05/2016 CTI-11 Rev. H Printed in USA
Abbreviated New Drug Application
DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED RELEASE Proficient Rx LP ---------- Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of 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. • 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 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 have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: • have liver or kidney problems • have high blood pressure • have asthma • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. • are breastfeeding or plan to breast feed. Tell your healthcare provider about all of the medicines you t সম্পূর্ণ নথি পড়ুন
DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED RELEASE PROFICIENT RX LP ---------- DICLOFENAC SODIUM Delayed-Release Tablets USP Rx only Prescribing information WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS CARDIOVASCULAR THROMBOTIC EVENTS • • GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION • DESCRIPTION Diclofenac sodium delayed-release tablets is a benzene-acetic acid derivative. Diclofenac sodium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C H Cl NNaO , and it has the following structural formula 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 (SEE WARNINGS). DICLOFENAC SODIUM DELAYED-RELEASE TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (SEE CONTRAINDICATIONS, WARNINGS). NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) 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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS (SEE WARNINGS). 14 10 2 2 The inactive ingredients in diclofenac sodium delayed-release tablets include: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The m সম্পূর্ণ নথি পড়ুন