Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Direct RX
DICLOFENAC SODIUM
DICLOFENAC SODIUM 100 mg
ORAL
PRESCRIPTION DRUG
- Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium extended-release tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium extended-release tablets are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - Diclofenac sodium extend
Diclofenac Sodium Extended-release Tablets, USP 100 mg- Pink round convex film coated tablet debossed with DX 41 on one side. Bottle of 100 Watson NDC 0591-0676-01. Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in tight container (USP). Manufactured for: Watson Laboratories Inc. Corona, CA 92880 USA Manufactured by: Dexcel ® Ltd. 1 Dexcel Street Or-Akiva 30600, Israel
Abbreviated New Drug Application
Direct RX ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (SEE THE END OF THIS MEDICATION GUIDE FOR A LIST OF PRESCRIPTION NSAID MEDICINES.) • What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants”: • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. NSAID medicines should n Leggi il documento completo
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE DIRECT RX ---------- DICLOFENAC SODIUM BOXED WARNING SPL UNCLASSIFIED SECTION Diclofenac Sodium Extended-release Tablets, USP, Tablets of 100 mg Prescribing Information Rx only DESCRIPTION Diclofenac sodium extended-release tablets, USP are benzeneacetic acid derivative. Diclofenac sodium extended-release tablets of 100 mg (pink) are available for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula: The inactive ingredients in diclofenac sodium extended-release tablets include: carnauba wax, cetostearyl alcohol, colloidal silicon dioxide, compressible sugar, copovidone, gum acacia, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, polyethylene glycol, povidone, sugar, talc, titanium dioxide. Meets USP Dissolution Test 2. CLINICAL PHARMACOLOGY Pharmacodynamics Diclofenac sodium extended-release tablets, USP are a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of diclofenac sodium extended-release tablets, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. Pharmacokinetics Absorption Diclofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1). When diclofenac sodium extended-release tablet is taken with food, there is a delay of 1 to 2 hours in the Tmax and a two-fold increase in Cmax values. The extent of absorption of diclofenac, however, is not significantly affected by food intake. TABLE 1. PHARMACOKINETIC PARAMETERS FOR DICLOFENAC PK Parameter Normal Healthy Adults (18 - 48 yrs.) Mean Coefficient of Variation (% Leggi il documento completo