PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPOXYPHENE NAPSYLATE (UNII: 38M219L1OJ) (PROPOXYPHENE - UNII:S2F83W92TK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

RedPharm Drug Inc.

INN (International Name):

PROPOXYPHENE NAPSYLATE

Composition:

PROPOXYPHENE NAPSYLATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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

Summary of Product characteristics

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