Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ), ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
STAT RX USA LLC
NAPROXEN
NAPROXEN 375 mg
ORAL
PRESCRIPTION DRUG
VIMOVO is a combination product that contains naproxen and esomeprazole. It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months. VIMOVO is contraindicated in patients with known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any of the excipients. VIMOVO is contraindicated in patients who have experienced asthma, urticaria, or 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 and Precautions (5.8, 5.13) ]. Hypersensitivity reactions, eg, angioedema a
VIMOVO 375 mg/20 mg tablets are oval, yellow film-coated tablets printed with 375/20 in black ink, supplied as: NDC 0186-0510-60 Bottles of 60 tablets VIMOVO 500 mg/20 mg tablets are oval, yellow film-coated tablets printed with 500/20 in black ink, supplied as: NDC 0186-0520-60 Bottles of 60 tablets NDC 0186-0520-39 Unit Dose Blisters, package of 100 tablets Storage: Store at 25°C (77°F); excursions permitted to 15- 30°C (59-86°F) [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.
New Drug Application
VIMOVO - NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE STAT RX USA LLC ---------- MEDICATION GUIDE VIMOVO (vi-moh´-voh) (naproxen and esomeprazole magnesium) Delayed Release Tablets Read this Medication Guide before you start taking VIMOVO and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about VIMOVO? VIMOVO, which contains naproxen [a nonsteroidal anti-inflammatory drug (NSAID)] and esomeprazole magnesium, 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-containing medicines, such as VIMOVO, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG). NSAID-containing medicines, such as VIMOVO, 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 steroid hormones (corticosteroids) and blood thinners (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 Прочитајте комплетан документ
VIMOVO - NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE STAT RX USA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION _THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VIMOVO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING_ _INFORMATION FOR VIMOVO._ VIMOVO _(NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) DELAYED RELEASE TABLETS_ INITIAL U.S. APPROVAL: APRIL 2010 WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ CARDIOVASCULAR RISK • NAPROXEN, A COMPONENT OF VIMOVO, MAY CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY INCREASE WITH DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS FOR CARDIOVASCULAR DISEASE MAY BE AT GREATER RISK. _(5.1)_ • VIMOVO IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE PAIN IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. _(4, 5.1)_ GASTROINTESTINAL RISK • NSAIDS, INCLUDING NAPROXEN, A COMPONENT OF VIMOVO, CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL 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 ARE AT GREATER RISK FOR SERIOUS GASTROINTESTINAL (GI) EVENTS. _(5.4)_ RECENT MAJOR CHANGES WARNINGS AND PRECAUTIONS 05/2011 Hypomagnesemia (5.19) Concomitant use of St John’s Wort or Rifampin with VIMOVO (5.20) 06/2011 INDICATIONS AND USAGE Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers (1) (1) DOSAGE AND ADMINISTRATION One tablet twice daily. Use the lowest effective dose. Should be avoided in moderate/severe renal insufficiency or in severe hepatic insufficiency. Consider dose reduction in mild/moderate hepatic insufficiency (2) (2) DOSAGE FORMS AN Прочитајте комплетан документ