Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
PROPOXYPHENE NAPSYLATE (UNII: 38M219L1OJ) (PROPOXYPHENE - UNII:S2F83W92TK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
RedPharm Drug Inc.
PROPOXYPHENE NAPSYLATE
PROPOXYPHENE NAPSYLATE 100 mg
ORAL
PRESCRIPTION DRUG
Propoxyphene napsylate and acetaminophen tablets are indicated for the relief of mild to moderate pain. Propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen. Propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. Propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. Propoxyphene napsylate and acetaminophen tablets are a Schedule IV narcotic under the U.S. Controlled Substances Act. Propoxyphene napsylate and acetaminophen tablets can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. Propoxyphene napsylate and aceta
Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) are available as film-coated, oblong, pink tablets debossed either "93"-"890" or "TEVA"-"890", in bottles of 100 and 500 tablets. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) are available as film-coated, oblong, white tablets debossed either "93"-"490" or "TEVA"-"490", in bottles of 100 and 500 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Inform patients of the availability of a Medication Guide for propoxyphene napsylate and acetaminophen tablets USP that accompanies each prescription dispensed. Instruct patients to read the propoxyphene napsylate and acetaminophen Medication Guide prior to using propoxyphene napsylate and acetaminophen tablets USP. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. W 10/2009
Abbreviated New Drug Application
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN - PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLET, FILM COATED RedPharm Drug Inc. ---------- MEDICATION GUIDE PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS USP CIV Rx only Read this Medication Guide before you start taking propoxyphene napsylate and acetaminophen tablets USP and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP? Propoxyphene napsylate and acetaminophen tablets USP and other medicines that contain propoxyphene can cause serious side effects, including: Overdoses by accident or on purpose (intentional overdose). Overdoses with propoxyphene napsylate and acetaminophen tablets USP may happen when they are taken by themselves, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy. • Death can happen within 1 hour of taking an overdose of propoxyphene napsylate and acetaminophen tablets USP. Many of the deaths that happen in people who take propoxyphene napsylate and acetaminophen tablets USP happen in those who: • have emotional problems • have thoughts of suicide or attempted suicide, or • also take antidepressants, sedatives, tranquilizers, muscle relaxants, or other medicines that affect your breathing and make you very sleepy. You should not use any of these medicines with propoxyphene napsylate and acetaminophen tablets USP without talking to your doctor. • Before taking propoxyphene napsylate and acetaminophen tablets USP tell your doctor if you: • have a lung problem, such as COPD or cor pulmonale • have liver or kidney problems • have problems with your pancreas or gallbladder • have a history of head injury • are over age 65 • have a history of drug or alcohol abuse or addiction Take propoxyphene napsylate and acetaminophen tablets USP exactly as prescri Lestu allt skjalið
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN - PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLET, FILM COATED REDPHARM DRUG INC. ---------- PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG CIV 0490 0890 RX ONLY WARNINGS THERE HAVE BEEN NUMEROUS CASES OF ACCIDENTAL AND INTENTIONAL OVERDOSE WITH PROPOXYPHENE PRODUCTS EITHER ALONE OR IN COMBINATION WITH OTHER CNS DEPRESSANTS, INCLUDING ALCOHOL. FATALITIES WITHIN THE FIRST HOUR OF OVERDOSAGE ARE NOT UNCOMMON. MANY OF THE PROPOXYPHENE-RELATED DEATHS HAVE OCCURRED IN PATIENTS WITH PREVIOUS HISTORIES OF EMOTIONAL DISTURBANCES OR SUICIDAL IDEATION/ATTEMPTS AND/OR CONCOMITANT ADMINISTRATION OF SEDATIVES, TRANQUILIZERS, MUSCLE RELAXANTS, ANTIDEPRESSANTS, OR OTHER CNS-DEPRESSANT DRUGS. DO NOT PRESCRIBE PROPOXYPHENE FOR PATIENTS WHO ARE SUICIDAL OR HAVE A HISTORY OF SUICIDAL IDEATION. The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (see CLINICAL PHARMACOLOGY, DRUG INTERACTIONS; WARNINGS; PRECAUTIONS; and DOSAGE AND ADMINISTRATION for further information). DESCRIPTION Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (α_S_,1_R_)- α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2- naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula: C H NO •C H O S•H O M.W. 565.74 P Lestu allt skjalið