Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
STAT Rx USA LLC
IBUPROFEN
IBUPROFEN 100 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Ibuprofen Oral Suspension and other treatment options before deciding to use Ibuprofen Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). In Pediatric Patients , Ibuprofen Oral Suspension is indicated: ● For reduction of fever in patients aged 6 months up to 2 years of age. ● For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. ● For relief of signs and symptoms of juvenile arthritis. In Adults , Ibuprofen Oral Suspension is indicated: ● For treatment of primary dysmenorrhea. ● For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see PRECAUTIONS - Drug Interactions ). Ibuprofen Oral Suspension is co
Ibuprofen Oral Suspension USP, 100 mg/5 mL is available as follows: Orange-colored, berry-flavored suspension Bottle of 4 FL OZ (120 mL) NDC 16590-422-04 Shake well before using. Store at 20 - 25°C (68 - 77°F) [see USP Controlled Room Temperature]. Do not freeze.
Abbreviated New Drug Application
STAT Rx USA LLC ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSALDS) (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" ●drinking alcohol and "anticoagulants" ●older age ●longer use ●having poor health ●smoking NSAID medicines should only be used: ●exactly as prescribed ●for the shortest time needed ●at the lowest dose possible for your treatment ______________________________________________________________________ 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 each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. Leggi il documento completo
IBUPROFEN- IBUPROFEN SUSPENSION STAT RX USA LLC ---------- IBUPROFEN ORAL SUSPENSION USP, 100 MG/5 ML RX ONLY CARDIOVASCULAR RISK ● NSAIDs 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 (see WARNINGS). ● Ibuprofen Oral Suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). GASTROINTESTINAL RISK ● NSAIDs 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 events (see WARNINGS). DESCRIPTION The active ingredient in Ibuprofen Oral Suspension USP, 100 mg/5 mL is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74° to 77°C. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43+0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (+)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C H 0 and it has the following structural formula: Ibuprofen Oral Suspension is a sweetened, orange colored, berry flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: anhydrous citric acid, artificial berry flavor, butylparaben, D&C red #33, FD&C yellow #6, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene Leggi il documento completo