Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/728
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Talwin (Injection, Solution)
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Adults, Excluding Patients
in Labor: The recommended single parenteral dose is 30 mg
by intramuscular, subcutaneous, or intravenous route. This may be
repeated every 3 to 4 hours. Doses in excess of 30 mg intravenously
or 60 mg intramuscularly or subcutaneously are not recommended. Total
daily dosage should not exceed 360 mg. Elderly patients may be more
sensitive to the analgesic effects of TALWIN than younger patients.
Elderly patients generally should be started on low doses of TALWIN
and observed closely. The subcutaneous route
of administration should be used only when necessary because of possible
severe tissue damage at injection sites (see WARNINGS). When frequent injections
are needed, the drug should be administered intramuscularly. In addition,
constant rotation of injection sites (e.g., the upper outer quadrants
of the buttocks, mid-lateral aspects of the thighs, and the deltoid
areas) is essential. Patients in Labor: A single, intramuscular 30 mg dose has
been most commonly administered. An intravenous 20 mg dose has given
adequate pain relief to some patients in labor when contractions become
regular, and this dose may be given two or three times at two- to
three-hour intervals, as needed. Pediatric Patients Excluding Patients Less Than One
Year Old: The recommended single parenteral dose as premedication
for sedation is 0.5 mg/kg by intramuscular route. CAUTION: TALWIN should not be
mixed in the same syringe with soluble barbiturates because precipitation
will occur.
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TALWIN injection, Pentazocine Lactate Injection,
USP, is a member of the benzazocine series (also known as the benzomorphan
series). Chemically, pentazocine lactate is 1, 2, 3, 4, 5, 6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol
lactate, a white, crystalline substance soluble in acidic aqueous
solutions.
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TALWIN is a potent analgesic and 30 mg is usually
as effective an analgesic as morphine 10 mg or meperidine 75 mg to
100 mg; however, a few studies suggest the TALWIN to morphine ratio
may range from 20 mg to 40 mg TALWIN to 10 mg morphine. The duration
of analgesia may sometimes be less than that of morphine. Analgesia
usually occurs within 15 to 20 minutes after intramuscular or subcutaneous
injection and within 2 to 3 minutes after intravenous injection. TALWIN
weakly antagonizes the analgesic effects of morphine,meperidine,
and phenazocine; in addition, it produces incomplete reversal of cardiovascular,
respiratory, and behavioral depression induced by morphine and meperidine.
TALWIN has about 1/50 the antagonistic activity of nalorphine. It
also has sedative activity. Clinical data indicate
that differences in various pharmacokinetic parameters may be observed
with increasing age. In one study, elderly patients exhibited a longer
mean elimination half-life, a lower mean total plasma clearance, and
a larger mean area under the concentration-time curve than younger
patients.
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The pH of TALWIN solutions is adjusted between
4 and 5 with lactic acid or sodium hydroxide. The air in the ampuls
and vials has been displaced by nitrogen gas. Store at 20 to 25��C (68 to 77��F). [See USP Controlled Room
Temperature.] Rev. August, 2006
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Certain Respiratory Conditions: The possibility that TALWIN may cause respiratory depression should
be considered in treatment of patients with bronchial asthma. TALWIN
should be administered only with caution and in low dosage to patients
with respiratory depression (e.g., from other medication, uremia,
or severe infection), severely limited respiratory reserve, obstructive
respiratory conditions, or cyanosis. Impaired Renal or Hepatic Function: Although
laboratory tests have not indicated that TALWIN causes or increases
renal or hepatic impairment, the drug should be administered with
caution to patients with such impairment. Extensive liver disease
appears to predispose to greater side effects (e.g., marked apprehension,
anxiety, dizziness, sleepiness) from the usual clinical dose, and
may be the result of decreased metabolism of the drug by the liver. 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. Patients Receiving Narcotics: TALWIN 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 TALWIN. CNS Effect: Caution should be used when
TALWIN is administered to patients prone to seizures; seizures have
occurred in a few such patients in association with the use of TALWIN
although no cause and effect relationship has been established. Use in Anesthesia: Concomitant use of CNS depressants with parenteral TALWIN may produce
additive CNS depression. Adequate equipment and facilities should
be available to identify and treat systemic emergencies should they
occur.<br/>Usage in Pregnancy:: Safe use of TALWIN during pregnancy (other than labor)
has not been established. Animal reproduction studies have not demonstrated
teratogenic or embryotoxic effects. However, TALWIN should be administered
to pregnant patients (other than labor) only when, in the judgment
of the physician, the potential benefits outweigh the possible hazards.
Patients receiving TALWIN during labor have experienced no adverse
effects other than those that occur with commonly used analgesics.
TALWIN should be used with caution in women delivering premature infants.<br/>Pediatric Use:: The safety and efficacy of TALWIN as preoperative
or preanesthetic medication have been established in pediatric patients
1 to 16 years of age. Use of TALWIN in these age groups is supported
by evidence from adequate and controlled studies in adults with additional
data from published controlled trials in pediatric patients. The safety
and efficacy of TALWIN as a premedication for sedation have not been
established in pediatric patients less than one year old. Information
on the safety profile of TALWIN as a postoperative analgesic in children
less than 16 years is limited.<br/>Geriatric Use:: Elderly patients may be more sensitive to the analgesic
effects of TALWIN than younger patients. (See DOSAGE AND ADMINISTRATION.) Clinical data indicate that differences in various pharmacokinetic
parameters of TALWIN may exist between elderly and younger patients.
(See CLINICAL PHARMACOLOGY.) Sedating drugs may cause confusion and oversedation
in the elderly; elderly patients generally should be started on low
doses of TALWIN and observed closely. This drug
is known to be substantially excreted by the kidney, and the risk
of toxic reactions to this drug may be greater in patients with impaired
renal function. Because elderly patients are more likely to have decreased
renal function, care should be taken in dose selection, and it may
be useful to monitor renal function.
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Manifestations: Clinical experience with TALWIN overdosage has been insufficient
to define the signs of this condition. Treatment: Oxygen, intravenous fluids,
vasopressors, and other supportive measures should be employed as
indicated. Assisted or controlled ventilation should also be considered.
For respiratory depression due to overdosage or unusual sensitivity
to TALWIN, parenteral naloxone is a specific and effective antagonist.
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Pentazocine Lactate
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Talwin (Injection, Solution)
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The most commonly occurring reactions are: nausea,
dizziness or lightheadedness, vomiting, euphoria. Dermatologic Reactions: Soft
tissue induration, nodules, and cutaneous depression can occur at
injection sites. Ulceration (sloughing) and severe sclerosis of the
skin and subcutaneous tissues (and, rarely, underlying muscle) have
been reported after multiple doses. Other reported dermatologic reactions
include diaphoresis, sting on injection, flushed skin including plethora,
dermatitis including pruritus. Infrequently
occurring reactions are���respiratory: respiratory depression, dyspnea, transient apnea in a small number
of newborn infants whose mothers received TALWIN during labor; cardiovascular: circulatory depression,
shock, hypertension; CNS effects: dizziness, lightheadedness, hallucinations, sedation, euphoria,
headache, confusion, disorientation; infrequently weakness, disturbed
dreams, insomnia, syncope, visual blurring and focusing difficulty,
depression; and rarely tremor, irritability, excitement, tinnitus; gastrointestinal: constipation, dry
mouth; other: urinary retention,
headache, paresthesia, alterations in rate or strength of uterine
contractions during labor. Rarely reported reactions
include���neuromuscular and psychiatric: muscle tremor,
insomnia, disorientation, hallucinations; gastrointestinal: taste alteration, diarrhea and cramps; ophthalmic: blurred vision, nystagmus,
diplopia, miosis; hematologic: depression of white blood cells (especially granulocytes), which
is usually reversible, moderate transient eosinophilia; other: tachycardia, weakness or faintness,
chills; allergic reactions including edema of the face, toxic epidermal
necrolysis. (See Acute CNS Manifestations and Drug Dependence under WARNINGS.)
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Drug Dependence:Special care should be exercised in
prescribing pentazocine for emotionally unstable patients and for
those with a history of drug misuse. Such patients should be closely
supervised when greater than 4 or 5 days of therapy is contemplated.
There have been instances of psychological and physical dependence
on TALWIN in patients with such a history and, rarely, in patients
without such a history. Extended use of parenteral TALWIN may lead
to physical or psychological dependence in some patients. When TALWIN
is abruptly discontinued, withdrawal symptoms such as abdominal cramps,
elevated temperature, rhinorrhea, restlessness, anxiety, and lacrimation
may occur. However, even when these have occurred, discontinuance
hasbeen accomplished with minimal difficulty. In the rare patient
in whom more than minor difficulty has been encountered, reinstitution
of parenteral TALWIN with gradual withdrawal has ameliorated the patient's
symptoms. Substituting methadone or other narcotics for TALWIN in
the treatment of the pentazocine abstinence syndrome should be avoided.
There have been rare reports of possible abstinence syndromes in newborns
after prolonged use of TALWIN during pregnancy. In prescribing parenteral
TALWIN for chronic use, particularly if the drug is to be self-administered,
the physician should take precautions to avoid increases in dose and
frequency of injection by the patient. Just as with all medication, the oral
form of TALWIN is preferable for chronic administration. Tissue Damage at
Injection Sites: Severe sclerosis of the skin, subcutaneous
tissues, and underlying muscle have occurred at the injection sites
of patients who have received multiple doses of pentazocine lactate.
Constant rotation of injection sites is, therefore, essential. In
addition, animal studies have demonstrated that TALWIN is tolerated
less well subcutaneously than intramuscularly. (See DOSAGE AND ADMINISTRATION.) Head
Injury and Increased Intracranial Pressure: As in the case
of other potent analgesics, the potential of TALWIN injection for
elevating cerebrospinal fluid pressure may be attributed to COretention 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, TALWIN can produce effects
which may obscure the clinical course of patients with head injuries.
In such patients, TALWIN must be used with extreme caution and only
if its use is deemed essential. 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 closely observed and vital signs checked.
If the drug is reinstituted, it should be done with caution since
these acute CNS manifestations may recur. Due
to the potential for increased CNS depressant effects, alcohol should
be used with caution in patients who are currently receiving pentazocine. Ambulatory 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. Myocardial Infarction: Caution
should be exercised in the intravenous use of pentazocine for patients
with acute myocardial infarction accompanied by hypertension or left
ventricular failure. Data suggest that intravenous administration
of pentazocine increases systemic and pulmonary arterial pressure
and systemic vascular resistance in patients with acute myocardial
infarction. NOTE: Acetone sodium bisulfite, a sulfite that may cause allergic-type
reactions including anaphylactic symptoms and life-threatening or
less severe asthmatic episodes in certain susceptible people, is contained
in multiple-dose vials. The overall prevalence of sulfite sensitivity
in the general population is unknown and probably low. Sulfite sensitivity
is seen more frequently in asthmatic than in nonasthmatic people. The ampuls in the Uni-Amp Pak do not
contain acetone sodium bisulfite.
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For the relief of moderate to severe pain. TALWIN
may also be used for preoperative or preanesthetic medication and
as a supplement to surgical anesthesia.
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Talwin
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