A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Talwin Nx Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentazocine and Naloxone
Talwin Nx Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentazocine and Naloxone
WARNINGS
|
TALWIN® Nx is intended for oral
use only. Severe, potentially lethal, reactions may result
from misuse of TALWIN Nx by injection
either alone or in combination with other substances. (See
ADVERSE REACTIONS: DRUG
ABUSE AND DEPENDENCE subsection.)
|
Drug Dependence
Pentazocine can cause
a physical and psychological
dependence. (See ADVERSE REACTIONS: DRUG
ABUSE AND DEPENDENCE subsection.)
Head Injury and Increased Intracranial Pressure
As in the case of other
potent analgesics, the
potential of pentazocine
for elevating cerebrospinal
fluid pressure
may be attributed to CO2 retention due to the respiratory
depressant effects
of the drug. These effects may be markedly exaggerated in the presence
of head injury,
other intracranial lesions, or a preexisting increase in intracranial
pressure. Furthermore, pentazocine
can produce effects which may obscure
the clinical course of patients with head
injuries. In such
patients, pentazocine
must be used with extreme caution and only if its use is deemed
essential.
Usage with Alcohol
Due to the potential
for increased CNS depressants
effects, alcohol should be used with caution in patients who are
currently receiving pentazocine.
Patients Receiving Narcotics
Pentazocine is a mild narcotic
antagonist. Some patients previously given narcotics, including
methadone for the daily treatment
of narcotic dependence, have experienced withdrawal
symptoms after receiving pentazocine.
Certain Respiratory Conditions
Although respiratory
depression has rarely
been reported after oral administration of pentazocine, the drug
should be administered with caution to patients with respiratory
depression from any
cause, severely limited respiratory reserve, severe bronchial
asthma, and other obstructive
respiratory conditions, or cyanosis.
Acute CNS Manifestations
Patients receiving therapeutic
doses of pentazocine
have experienced hallucinations (usually visual), disorientation,
and confusion which
have cleared spontaneously within a period
of hours. The mechanism
of this reaction is not known. Such patients should be very closely
observed and vital signs
checked. If the drug is
reinstituted, it should be done with caution since these acute
CNS manifestations may recur.
PRECAUTIONS
CNS Effect
Caution should be used when pentazocine
is administered to patients prone to seizures; seizures have occurred
in a few such patients
in association with the use of pentazocine
though no cause
and effect relationship
has been established.
Impaired Renal or Hepatic Function
Decreased metabolism
of pentazocine by
the liver in extensive
liver disease may predispose to accentuation of side
effects. Although laboratory tests have not indicated that pentazocine
causes or increases renal
or hepatic impairment,
the drug should be administered
with caution to patients with such
impairment.
In prescribing pentazocine
for long-term use, the physician
should take precautions to avoid increases in dose
by the patient.
Biliary Surgery
Narcotic drug products
are generally considered to elevate biliary
tract pressure for varying periods following their administration.
Some evidence suggests that pentazocine
may differ from other marketed narcotics in this respect (i.e.,
it causes little or no elevation
in biliary tract
pressures). The clinical
significance of these findings, however, is not yet known.
Information for Patients
Since sedation, dizziness,
and occasional euphoria
have been noted, ambulatory patients should be warned not to operate
machinery, drive cars,
or unnecessarily expose
themselves to hazards. Pentazocine may cause
physical and psychological
dependence when taken
alone and may have additive
CNS depressant properties when taken in combination with alcohol
or other CNS depressants.
Myocardial Infarction
As with all drugs, pentazocine
should be used with caution in patients with myocardial
infarction who have
nausea or vomiting.
Drug Interactions
Usage with Alcohol: See WARNINGS
.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals to test
for carcinogenesis
have been performed with the components of TALWIN Nx.
Pregnancy Category C
Animal reproduction
studies have not been conducted with TALWIN Nx. It is also not known
whether TALWIN Nx can cause
fetal harm when administered
to pregnant women or
can affect reproduction
capacity. TALWIN Nx should be given to pregnant
women only if clearly needed. However, animal
reproduction studies with pentazocine
have not demonstrated teratogenic
or embryotoxic effects.
Labor and Delivery
Patients receiving pentazocine
during labor have experienced
no adverse effects other
than those that occur with commonly used analgesics. TALWIN Nx should
be used with caution in women delivering premature
infants. The effect of TALWIN Nx on the mother
and fetus, the duration
of labor or delivery,
the possibility that forceps
delivery or other intervention
or resuscitation of the new-born may be necessary, or the effect
of TALWIN Nx on the later growth, development, and functional
maturation of the
child are unknown at the
present time.
Nursing Mothers
It is not known whether this drug
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when TALWIN Nx is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness
in children below the age
of 12 years have not been established.
top
