देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Sun Pharmaceutical Industries, Inc.
HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE 2.5 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (generally less than 10 days) management of acute pain. Hydrocodone bitartrate and ibuprofen tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis. Hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rar
2.5 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘281’ on one side and plain on the other side. Each tablet contains 2.5 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-281-83 Bottles of 30 CRC NDC 57664-281-88 Bottles of 100 CRC NDC 57664-281-08 Bottles of 100 NDC 57664-281-13 Bottles of 500 NDC 57664-281-18 Bottles of 1000 5 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘203’ on one side and plain on the other side. Each tablet contains 5 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-203-83 Bottles of 30 CRC NDC 57664-203-88 Bottles of 100 CRC NDC 57664-203-08 Bottles of 100 NDC 57664-203-13 Bottles of 500 NDC 57664-203-18 Bottles of 1000 7.5 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘102’ on one side and plain on the other side. Each tablet contains 7.5 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-102-83 Bottles of 30 CRC NDC 57664-102-88 Bottles of 100 CRC NDC 57664-102-08 Bottles of 100 NDC 57664-102-13 Bottles of 500 NDC 57664-102-18 Bottles of 1000 10 mg/200 mg: White to off-white, film-coated, round, biconvex, beveled edged tablets debossed with ‘280’ on one side and plain on the other side. Each tablet contains 10 mg of hydrocodone bitartrate, USP and 200 mg of ibuprofen, USP. They are supplied as follows: NDC 57664-280-83 Bottles of 30 CRC NDC 57664-280-88 Bottles of 100 CRC NDC 57664-280-08 Bottles of 100 NDC 57664-280-13 Bottles of 500 NDC 57664-280-18 Bottles of 1000 Store at 20° - 25°C (68° - 77°F). (See USP for Controlled Room Temperature). Dispense in a tight, light-resistant container with a child-resistant closure. PHARMACIST: Dispense with a Medication Guide. A Scheduled Controlled Drug Substance. DEA ORDER FORM REQUIRED Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 6121T02 Rev. 09/2014
Abbreviated New Drug Application
COATED Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDS) HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS CII Rx Only (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 each other and cause serious side effects. Keep a list of your medicines to show to your hea पूरा दस्तावेज़ पढ़ें
HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS CII RX ONLY DESCRIPTION Hydrocodone bitartrate and ibuprofen is supplied in a fixed combination tablet form for oral administration. Hydrocodone bitartrate and ibuprofen combines the opioid analgesic agent, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen. Hydrocodone bitartrate is a semisynthetic and centrally acting opioid analgesic. Its chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: C H NO •C H O •21/2H O, and the molecular weight is 494.50. Its structural formula is: Ibuprofen is a nonsteroidal anti-inflammatory agent [non-selective COX inhibitor] with analgesic and antipyretic properties. Its chemical name is: (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is: C H O , and the molecular weight is: 206.29. Its structural formula is: Hydrocodone bitartrate and ibuprofen tablets for oral administration are available in the following strengths: HYDROCODONE BITARTRATE, USP IBUPROFEN, USP 18 21 3 4 6 6 2 13 18 2 2.5 mg/200 mg 2.5 mg 200 mg 5 mg/200 mg 5 mg 200 mg 7.5 mg/200 mg 7.5 mg 200 mg 10 mg/200 mg 10 mg 200 mg Inactive ingredients in each hydrocodone bitartrate and ibuprofen tablets include: butylated hydroxyanisole, butylated hydroxytoluene, colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, and titanium dioxide. CLINICAL PHARMACOLOGY HYDROCODONE COMPONENT Hydrocodone is a semisynthetic opioid analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opioids is not known, although it is believed t पूरा दस्तावेज़ पढ़ें