PROPOXYPHENE AND ACETAMINOPHEN- 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:

Keltman Pharmaceuticals 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 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

Product summary:

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 Keltman Pharmaceuticals Inc. as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PROPOXYPHENE AND ACETAMINOPHEN - PROPOXYPHENE NAPSYLATE AND
ACETAMINOPHEN TABLET, FILM COATED
Keltman 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

Summary of Product characteristics

PROPOXYPHENE AND ACETAMINOPHEN - PROPOXYPHENE NAPSYLATE AND
ACETAMINOPHEN TABLET, FILM COATED
KELTMAN 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