PROPOXYPHENE NAPSYLATE 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:

Apotheca, 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 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 acetaminophen tablets should be prescribed and administered with the same degree of caution appro

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TABLET, FILM COATED
Apotheca, Inc.
----------
MEDICATION GUIDE
Ask your Pharmacist for a Medication Guide for Propoxyphene Napsylate
and Acetaminophen Tablets,
USP
Read the Medication Guide prior to using propoxphene napsylate and
acetaminophen.
This information does not take the place of talking to your Doctor
about your medical condition or your
treatment.
A complete copy of the Medication Guide for Propoxyphene Napsylate and
Acetaminophen Tablets,
USP 100mg/650mg
is available upon request Call 1-800-262-5244
Revised: 3/2010
Document Id: ab220c1d-8551-4a9d-b4d3-9199121420df
Set id: f2bc3c76-fd41-4a79-aa5d-3eb45133c1ee
Version: 1
Effective Time: 20100311
Apotheca, Inc.

Summary of Product characteristics

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN - PROPOXYPHENE NAPSYLATE AND
ACETAMINOPHEN TABLET, FILM COATED
APOTHECA, INC.
----------
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLET USP 100MG/650MG CS-
CIV
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
Propoxyphene napsylate