Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
PROPOXYPHENE NAPSYLATE (UNII: 38M219L1OJ) (PROPOXYPHENE - UNII:S2F83W92TK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Altura Pharmaceuticals, Inc.
PROPOXYPHENE NAPSYLATE
PROPOXYPHENE NAPSYLATE 100 mg
ORAL
PRESCRIPTION DRUG
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 is a Schedule IV narcotic under the U.S. Controlled Substances Act. Propoxyphene napsylate and acetaminophen 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 acetaminophen should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-c
Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mg are available as follows: Orange film coated, unscored, capsule shaped tablets, debossed "5111" over "V" on one side and plain on the reverse side. Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mg are available as follows: Orange film coated, unscored, capsule shaped tablets, debossed "5112" over "V" on one side and plain on the reverse side. White film coated, unscored, capsule shaped tablets, debossed "5113" over "V" on one side and plain on the reverse side Pink film coated, unscored, capsule shaped tablets, debossed "5114" over "V" on one side and plain on the reverse side. They are supplied by Altura Pharmaceuticals, Inc. as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
PROPOXYPHENE AND ACETAMINOPHEN - PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLET, FILM COATED Altura Pharmaceuticals, Inc. ---------- Inform patients of the availability of a Medication Guide for propoxyphene napsylate and acetaminophen tablets that accompanies each prescription dispensed. Instruct patients to read the propoxyphene napsylate and acetaminophen tablets Medication Guide prior to using propoxyphene napsylate and acetaminophen tablets. MEDICATION GUIDE Read this Medication Guide before you start taking propoxyphene napsylate and acetaminophen tablets 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? Propoxyphene napsylate and acetaminophen tablets 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 may happen when it is taken by itself, 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. Many of the deaths that happen in people who take propoxyphene napsylate and acetaminophen tablets 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 without talking to your doctor. • Before taking propoxyphene napsylate and acetaminophen tablets tell your doctor if you: • have a lung problem, such as COPD or cor pulmonale • have liver or kidney problems • have problems with yo read_full_document
PROPOXYPHENE AND ACETAMINOPHEN - PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLET, FILM COATED ALTURA PHARMACEUTICALS, INC. ---------- PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 50 MG/325 MG AND 100 MG/650 MG CIV 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, and WARNINGS, PRECAUTIONS and DOSAGE AND ADMINISTRATION for further information). DESCRIPTION Propoxyphene Napsylate, USP is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (α_S_,1_R_)-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2- napthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet read_full_document