PROPOXYPHENE HYDROCHLORIDE - propoxyphene hydrochloride capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

PROPOXYPHENE HYDROCHLORIDE (UNII: CB2TL9PS0T) (PROPOXYPHENE - UNII:S2F83W92TK)

थमां उपलब्ध:

Heritage Pharmaceuticals Inc

INN (इंटरनेशनल नाम):

PROPOXYPHENE HYDROCHLORIDE

रचना:

PROPOXYPHENE HYDROCHLORIDE 65 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Propoxyphene hydrochloride capsule is a Schedule IV narcotic under the U.S. Controlled Substances Act. Propoxyphene hydrochloride capsule 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 hydrochloride capsule should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications. Since propoxyphene hydrochloride capsule is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. Addiction to opioids prescribed for pain management has not been estimated. However, requests for opioids from opioid-addicted patients occur. As such, physicians should take appropriate care in prescribing propoxyphene hydrochloride capsule. Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the d

उत्पाद समीक्षा:

Propoxyphene Hydrochloride Capsules, USP 65 mg are bright pink, two piece, hard shell # 3, opaque capsule filled with white powder, imprinted axially “HP” over “12” on each half in edible black ink. They are available as follows: Bottles of 100 NDC 23155-012-01 Bottles of 500 NDC 23155-012-05 Storage: Store at 20º to 25º C (68° to 77º F) [see USP Controlled Room Temperature] Inform patients of the availability of a Medication Guide for propoxyphene hydrochloride capsule  that accompanies each prescription dispensed. Instruct patients to read the propoxyphene hydrochloride capsule Medication Guide prior to using propoxyphene hydrochloride capsule. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 1.866.901.DRUG (3784) Manufactured by: Amneal Pharmaceuticals, L.L.C. Paterson, NJ 07504 Iss. 10/09 MEDICATION GUIDE Propoxyphene Hydrochloride Capsule, USP Read this Medication Guide before you start taking propoxyphene hydrochloride capsule, 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. Propoxyphene hydrochloride capsule, and other medicines that contain propoxyphene can cause serious side effects, including: Overdoses by accident or on purpose (intentional overdose). Overdoses with propoxyphene hydrochloride capsule 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 hydrochloride capsule. Many of the deaths that happen in people who take propoxyphene hydrochloride capsule happen in those who: • Before taking propoxyphene hydrochloride capsule tell your doctor if you: Take propoxyphene hydrochloride capsule exactly as prescribed. Do not change your dose or stop taking propoxyphene hydrochloride capsule without first talking to your doctor. It is not known if propoxyphene hydrochloride capsules are safe and effective in children younger than age 18. Do not take propoxyphene hydrochloride capsule if you: Before you take propoxyphene hydrochloride capsule, tell your doctor: Symptoms of withdrawal in a newborn baby may include: Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins, and herbal supplements. Propoxyphene hydrochloride capsule interacts with many medicines and may lead to serious side effects. The doses of certain medicines may need to be changed. Especially tell your doctor if you take: See “What is the most important information I should know about propoxyphene hydrochloride capsule?” Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine. See “ What is the most important information I should know about propoxyphene hydrochloride capsule? ” Signs and symptoms of an overdose of propoxyphene hydrochloride capsule include: Propoxyphene hydrochloride capsule can cause serious side effects, including: See “What is the most important information I should know about propoxyphene hydrochloride capsule?” Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking propoxyphene hydrochloride capsule. You may need to stop propoxyphene hydrochloride capsule more slowly. Common side effects of propoxyphene hydrochloride capsule include: Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088. You may also report side effects to Heritage Pharmaceuticals Inc. at 1-866-901-DRUG (3784). Keep propoxyphene hydrochloride capsule and all medicines out of the reach of children. General information about propoxyphene hydrochloride capsule Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use propoxyphene hydrochloride capsule for a purpose for which it was not prescribed. Do not give propoxyphene hydrochloride capsule to others even if they have the same symptoms you have. It may harm them and is against the law. This Medication Guide summarizes the most important information about propoxyphene hydrochloride capsule. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about propoxyphene hydrochloride capsule that is written for health professionals. For more information, go to www.heritagepharma.com or call 1-866-901-(DRUG) 3784. Propoxyphene hydrochloride capsule, USP: Active ingredient: propoxyphene hydrochloride Inactive ingredients: starch NF, magnesium stearate NF, gelatin, titanium dioxide, FD & C Red #40, D & C Red #28 and FD & C Blue #1. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 1.866.901.DRUG (3784) Manufactured by: Amneal Pharmaceuticals, L.L.C. Paterson, NJ 07504 Iss. 10/09 This Medication Guide has been approved by the U.S. Food and Drug Administration.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

Heritage Pharmaceuticals Inc
PROPOXYPHENE HYDROCHLORIDE - PROPOXYPHENE HYDROCHLORIDE CAPSULE
HERITAGE PHARMACEUTICALS INC
----------
PROPOXYPHENE HYDROCHLORIDE CAPSULES, USP
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 Hydrochloride, USP is an odorless, white crystalline
powder with a bitter taste. It is
freely soluble in water. Chemically, it is
(2S,3R)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-
butanol propionate (ester) hydrochloride, which can be represented by
the accompanying structural
formula. Its molecular weight is 375.94.
Each capsule contains 65 mg (172.9 µmol) propoxyphene hydrochloride.
It also contains starch NF,
magnesium stearate NF, gelatin, titanium dioxide, FD & C Red #40, D &
C Red #28 and FD & C Blue
#1.
CLINICAL PHARMACOLOGY
PHARMACOLOGY
Propoxyp