Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
Diclofenac Sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)
Stat Rx USA
Diclofenac Sodium
Diclofenac Sodium 50 mg
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 sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac sodium delayed-release tablets, are indicated: - For relief of signs and symptoms of osteoarthritis - For relief of 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 patients with known hypersensitivity to diclofenac. Diclofenac sodium delayed-release tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions
Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 25 mg: round, yellow, enteric-coated tablets imprinted GG 737 on one side in black ink and plain on the reverse side are supplied as: NDC 0781-1785-60 bottles of 60 tablets NDC 0781-1785-01 bottles of 100 tablets NDC 0781-1785-10 bottles of 1000 tablets NDC 0781-1785-13 unit dose packages of 100 tablets 50 mg: round, brown, enteric-coated tablets imprinted GG 738 on one side in black ink and plain on the reverse side are supplied as: NDC 0781-1787-60 bottles of 60 tablets NDC 0781-1787-01 bottles of 100 tablets NDC 0781-1787-10 bottles of 1000 tablets NDC 0781-1787-13 unit dose packages of 100 tablets 75 mg: round, pink, enteric-coated tablets imprinted GG 739 on one side in black ink and plain on the reverse side are supplied as: NDC 0781-1789-60 bottles of 60 tablets NDC 0781-1789-01 bottles of 100 tablets NDC 0781-1789-10 bottles of 1000 tablets Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE Stat Rx USA ---------- DICLOFENAC SODIUM - diclofenac sodium tablet Sandoz Inc. ---------- Diclofenac Sodium Delayed-release Tablets, USPMEDICATION 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 your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with eac Lugege kogu dokumenti
DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE STAT RX USA ---------- DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET DESCRIPTION Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6- dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is: soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: Black iron oxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, red iron oxide, and titanium dioxide. The 25 MG also contains: D and C Yellow #10 Aluminum Lake and pharmaceutical glaze shellac. The 50 MG also contains: Pharmaceutical glaze shellac and yellow iron oxide. The 75 MG also contains: carnauba wax, glycerol monostearate, shellac, and yellow iron oxide. CLINICAL PHARMACOLOGYPharmacodynamics Diclofenac sodium delayed-release tablets are a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of diclofenac sodium delayed-release tablets, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. PharmacokineticsAbsorption 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. Food has no significant effect on the extent of diclofenac absorpt Lugege kogu dokumenti